As filed with the U.S. Securities and Exchange Commission on July 17, 2025.

Registration No. 333-

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM S-1

REGISTRATION STATEMENT

UNDER

THE SECURITIES ACT OF 1933

Heartflow, Inc.

(Exact name of registrant as specified in its charter)


Delaware	3841	26-0506743
(State or other jurisdiction of incorporation or organization)	(Primary Standard Industrial Classification Code Number)	(I.R.S. Employer Identification Number)

331 E. Evelyn Avenue

Mountain View, California 94041

(650) 241-1221

(Address, including zip code, and telephone number, including area code, of registrant’s principal executive offices)

John C.M. Farquhar

President and Chief Executive Officer

Heartflow, Inc.

331 E. Evelyn Avenue

Mountain View, California 94041

(650) 241-1221

(Name, address, including zip code, and telephone number, including area code, of agent for service)

Copies to:


Shelly Heyduk	Angela Ahmad	Dave Peinsipp
Ryan Coombs	Heartflow, Inc.	Kristin VanderPas
O’Melveny & Myers LLP	331 E. Evelyn Avenue	Denny Won
610 Newport Center Drive, 17th Floor	Mountain View, California 94041	Charles S. Kim
Newport Beach, California 92660	(650) 241-1221	Cooley LLP
(949) 823-6900		3 Embarcadero Center, 20th Floor
		San Francisco, California 94111
		(415) 693-2000

Approximate date of commencement of proposed sale to the public: As soon as practicable after the effective date of this Registration Statement.

If any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, check the following

box. ☐

If this Form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, please check the following box and list the Securities Act

registration statement number of the earlier effective registration statement for the same offering. ☐

If this Form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number

of the earlier effective registration statement for the same offering. ☐

If this Form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement number

of the earlier effective registration statement for the same offering. ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company.

See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.


Large accelerated filer	☐	Accelerated filer	☐
Non-accelerated filer	☒	Smaller reporting company	☐
		Emerging growth company	☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial

accounting standards provided pursuant to Section 7(a)(2)(B) of the Securities Act. ☐

The registrant hereby amends this registration statement on such date or dates as may be necessary to delay its effective date until the registrant shall file a further

amendment which specifically states that this registration statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933, as

amended, or until the registration statement shall become effective on such date as the U.S. Securities and Exchange Commission, acting pursuant to said Section

8(a), may determine.

Subject to Completion, dated July 17, 2025

The information in this preliminary prospectus is not complete and may be changed. We may not sell these securities until the registration statement filed

with the U.S. Securities and Exchange Commission is effective. This preliminary prospectus is not an offer to sell these securities and it is not soliciting an

offer to buy these securities in any jurisdiction where the offer or sale is not permitted.

Preliminary prospectus

Common stock

This is an initial public offering of shares of common stock of Heartflow, Inc. We are offering shares of

our common stock to be sold in this offering. The initial public offering price is expected to be between $

and $ per share.

Prior to this offering, there has been no public market for our common stock. We have applied to list our common

stock on the Nasdaq Global Select Market under the trading symbol “HTFL,” and this offering is contingent upon

obtaining such approval.

Upon completion of this offering, our executive officers, directors, owners of 5% or more of our capital stock and

their respective affiliates will own, in the aggregate, approximately % of our common stock (assuming no

exercise of the underwriters’ option to purchase additional shares and no purchases of shares in this offering by

anyone in this group). These stockholders will be able to exercise significant control over matters requiring

stockholder approval, including the election of directors, amendment of our organizational documents, and

approval of any merger, sale of assets, and other major corporate transactions.

We are an “emerging growth company” as defined under the U.S. federal securities laws and, as such, have

elected to comply with certain reduced public company reporting requirements in this prospectus and may elect to

do so in future filings. See the section titled “Prospectus summary—Implications of being an emerging growth

company.”


	Per share	Total
Initial public offering price ...................................................................................................	$	$
Underwriting discounts and commissions(1) ....................................................................	$	$
Proceeds to Heartflow, Inc., before expenses .................................................................	$	$

(1)See the section titled “Underwriting” for a description of the compensation payable to the underwriters.

We have granted the underwriters an option for a period of 30 days to purchase up to additional

shares of common stock.

Investing in our common stock involves a high degree of risk. Please see “Risk factors” beginning on

page 22.

Neither the Securities and Exchange Commission (“SEC”) nor any state securities commission has

approved or disapproved of these securities or determined if this prospectus is truthful or complete. Any

representation to the contrary is a criminal offense.

The underwriters expect to deliver the shares of common stock to the purchasers on or about , 2025.


J.P. Morgan		Morgan Stanley		Piper Sandler


Stifel		Canaccord Genuity

, 2025

Table of contents


	Page

Prospectus summary .....................................................................................................................................	1

Risk factors ......................................................................................................................................................	22

Special note regarding forward-looking statements .................................................................................	72

Market and industry data...............................................................................................................................	74

Use of proceeds .............................................................................................................................................	75

Dividend policy ................................................................................................................................................	77

Capitalization ..................................................................................................................................................	78

Dilution .............................................................................................................................................................	81

Management’s discussion and analysis of financial condition and results of operations ...................	85

Business ..........................................................................................................................................................	105

Management ...................................................................................................................................................	155

Executive and director compensation .........................................................................................................	165

Certain relationships and related-party transactions ................................................................................	181

Principal stockholders ....................................................................................................................................	187

Description of capital stock ...........................................................................................................................	191

Shares eligible for future sale .......................................................................................................................	198

Material U.S. federal income tax consequences to non-U.S. holders ...................................................	201

Underwriting ....................................................................................................................................................	205

Legal matters ..................................................................................................................................................	218

Experts .............................................................................................................................................................	218

Where you can find additional information .................................................................................................	218

Index to consolidated financial statements ................................................................................................	F-1

Through and including , 2025 (the 25th day after the date of this prospectus), all dealers effecting

transactions in our common stock, whether or not participating in this offering, may be required to deliver

a prospectus. This delivery requirement is in addition to a dealer’s obligation to deliver a prospectus when

acting as an underwriter and with respect to an unsold allotment or subscription.

We have not, and the underwriters have not, authorized anyone to provide you any information or to

make any representations other than those contained in this prospectus or in any free writing prospectus

prepared by or on behalf of us or to which we have referred you. Neither we nor the underwriters take

responsibility for, or provide any assurance as to the reliability of, any other information others may give

you. We and the underwriters are offering to sell only the shares offered hereby, and only under

circumstances and in jurisdictions where it is lawful to do so. We are not, and the underwriters are not,

making an offer to sell these securities in any jurisdiction where the offer or sale is not permitted. The

information contained in this prospectus is accurate only as of the date of this prospectus, regardless of

the time of delivery of this prospectus or any sale of the shares of our common stock. Our business,

financial condition, and results of operations may have changed since that date.

For investors outside the United States: We have not, and the underwriters have not, done anything that

would permit this offering or the possession or distribution of this prospectus or any free writing

prospectus in connection with this offering in any jurisdiction where action for that purpose is required,

other than in the United States. Persons outside the United States who come into possession of this

prospectus must inform themselves about, and observe any restrictions relating to, the offering of the

shares of common stock and the distribution of this prospectus outside the United States. “Heartflow,” the

Heartflow logos, and other trade names, trademarks, or service marks of Heartflow appearing in this

prospectus are the property of Heartflow. Other trade names, trademarks, or service marks appearing in

this prospectus are the property of their respective holders. We do not intend our use or display of other

companies’ trade names, trademarks, or service marks to imply a relationship with, or endorsement or

sponsorship of us, by these other companies. Solely for convenience, trade names, trademarks, and

service marks referred to in this prospectus appear without the ®, ™, and SM symbols, but those

references are not intended to indicate, in any way, that we will not assert, to the fullest extent under

applicable law, our rights or that the applicable owner will not assert its rights, to these trade names,

trademarks, and service marks.

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Prospectus summary

This summary highlights select information contained in greater detail elsewhere in this prospectus. This

summary is not complete and does not contain all of the information you should consider in making your

investment decision. Before investing in our common stock, you should carefully read this entire

prospectus. You should carefully consider, among other things, the sections titled “Risk factors,” “Special

note regarding forward-looking statements,” “Business,” and “Management’s discussion and analysis of

financial condition and results of operations” and our consolidated financial statements and the related

notes included elsewhere in this prospectus before making an investment decision. Unless the context

otherwise requires, the terms “Heartflow,” “the Company,” “we,” “us,” and “our” in this prospectus refer to

Heartflow, Inc. and its wholly owned subsidiaries, or either or both of them as the context may require.

Overview

We have pioneered the use of software and AI to deliver a more accurate and clinically effective non-

invasive solution for diagnosing and managing coronary artery disease (“CAD”), a leading cause of death

worldwide. As of March 31, 2025, our Heartflow Platform has been used to assess CAD in more than

400,000 patients, including 132,000 in 2024 alone. We believe that we are the most widely adopted AI-

powered test for CAD. Our novel platform leverages AI and advanced computational fluid dynamics to

create a personalized 3D model of a patient’s heart from a single coronary computed tomography

angiography (“CCTA”), a specialized type of scan that provides detailed images of the heart’s arteries.

Our Heartflow Platform delivers actionable insights on blood flow, stenosis, plaque volume and plaque

composition thereby overcoming the limitations of traditional non-invasive imaging tests which rely on

indirect measures of coronary disease and lead to higher false negative and false positive rates, as

demonstrated by our PRECISE trial. We believe the differentiated accuracy and clinical utility of our

Heartflow Platform, along with its ability to enhance workflows, will continue to support our growth and

advance the “CCTA + Heartflow” pathway as the definitive standard for the non-invasive diagnosis and

management of CAD.

Cardiovascular disease is the leading cause of death worldwide, with CAD being the most lethal form.

CAD occurs when plaque—a buildup of cholesterol, fat, calcium and other substances—accumulates on

the walls of the coronary arteries, restricting blood flow and increasing the risk of heart attack or stroke.

This condition is responsible for half of all cardiovascular-related deaths globally. In the United States

alone, the Centers for Disease Control (“CDC”) estimates that approximately 805,000 people suffer a

heart attack each year. Despite significant advancements in therapeutic and interventional treatments,

CAD remains a leading cause of death globally because healthcare systems generally lack scalable

methods to efficiently detect, diagnose and quantify CAD at a personalized level.

Based on our analyses using Clarivate’s ProcedureFinder data repository, we estimate that there were

approximately 9.5 million non-invasive tests (“NITs”) in the United States in 2023 for patients experiencing

stable or acute chest pain, which we refer to as symptomatic CAD patients. These NITs primarily include

stress tests, such as single-photon emission computed tomography (“SPECT”), echocardiography and

positron emission tomography (“PET”), which infer the presence of heart disease based on how well

blood is supplied to the heart, and do not measure the actual disease itself. Accordingly, these tests have

been shown to be unreliable and inconsistent.

CCTA has emerged as a leading non-invasive imaging method for evaluating CAD, offering direct and

detailed visualization of the coronary arteries. Unlike traditional stress-based NITs, CCTA enables

physicians to identify the presence and extent of coronary blockage. As a result, CCTA has become the

preferred first-line test for patients with suspected CAD, as evidenced by the AHA and ACC guidelines

elevating CCTA to Class 1, Level A. However, while CCTA provides superior anatomical imaging, it does

not independently quantify the severity of CAD, assess blood flow limitations, or characterize plaque

composition—critical factors for determining the most appropriate, personalized course of treatment for a

patient.

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Our Heartflow Platform builds upon the well established strengths of CCTA by going beyond its limitations

and providing new quantified insights and compelling visualizations of data. By applying our advanced AI-

powered technology to a single CCTA scan, we generate a precise, patient-specific analysis that

quantifies blood flow, measures plaque burden, and characterizes plaque composition—at every point in

the major coronary arteries.

To date, we have developed three software products (with a fourth product expected to launch in 2026)

under the Heartflow Platform that provide physicians with the critical insights needed to effectively

diagnose and manage CAD:

•Heartflow RoadMap Analysis offers a highly intuitive anatomic visualization of the coronary arteries,

helping physicians quickly identify clinically relevant areas to focus their review. We provide Heartflow

RoadMap Analysis to accounts as an integrated feature to enhance the efficiency of their CCTA

program and it is not a stand-alone product.

•Heartflow FFRCT Analysis calculates blood flow and pinpoints clinically significant CAD, which is CAD

with a fractional flow reserve (“FFR”) value of 0.80 or below, at every point in the major coronary

arteries. FFR measures the severity of blood flow restriction in the coronary arteries on a scale of 1.0

(no restriction) to 0.0 (complete blockage) by assessing pressure differences across a stenosis during

induced stress, guiding decisions on whether a patient requires invasive revascularization.

•Heartflow Plaque Analysis provides a comprehensive assessment of coronary plaque, enabling

optimized medical treatment strategies.

•Heartflow PCI Planner, which we expect to launch in 2026, will provide advanced visualization and

clinical insights to optimize revascularization strategies, guide device selection, enhance procedural

efficiency, and improve patient care. We plan to provide Heartflow PCI Planner to accounts as an

integrated feature to enhance procedural efficiency, not as a stand-alone product.

We believe we are the first and most widely-adopted AI-powered test for CAD. With over a decade of

commercial presence, we have established a competitively differentiated data set of approximately 110

million annotated images, which is primarily sourced from our commercial relationships with customers,

driving training and refinement of our algorithms for over 10 years and the ability to train new AI models

for future products.

We believe our Heartflow Platform delivers the following key benefits:

•More accurate non-invasive test for CAD, clinically validated to provide superior assessment of

blood flow, plaque volume and plaque characterization compared to traditional non-invasive methods.

•More informed assessments, personalized care, and better risk stratification, positively

impacting physician decisions on which patients should receive an intervention, supporting more

efficient intervention planning and driving more personalized medical management.

•Superior economic efficiency and enhanced interventional treatment planning, accurately

identifying more patients who need interventional treatment while reducing unnecessary invasive

procedures—significantly improving the efficiency of the catheterization lab and therefore hospital

economics.

•Proprietary, secure bi-directional data communication with customers that feeds a growing

database of approximately 110 million annotated CCTA images that we leverage to improve the

Heartflow Platform’s accuracy, automation and clinical utility and seamlessly deliver new features and

workflow efficiencies to our customers.

•Improved workflow through our Heartflow RoadMap Analysis that, as demonstrated in our SMART-

CT study, reduces CCTA interpretation times by approximately 25% and reduces variability between

reviewing physicians by approximately 40%, leading to more consistent diagnoses and standardized

patient care.

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•Better patient and provider experience, by leveraging a single CCTA for all of our products,

patients complete their test in approximately 20 minutes with significantly lower radiation exposure

compared to nuclear imaging tests such as SPECT and PET that take multiple hours and require

radioactive tracers to be injected into the bloodstream. By providing a definitive diagnosis upfront, the

Heartflow Platform eliminates the need for layered testing, streamlining the patient journey and

reducing anxiety associated with uncertain or inconclusive results.

We estimate our current market opportunity in the United States for our Heartflow FFRCT Analysis and

Heartflow Plaque Analysis is approximately $5 billion. Based on our analyses using Clarivate’s

ProcedureFinder data repository, we estimate that approximately 9.5 million unique stable chest pain

patients receive NITs in the United States annually. In addition, based on our FORECAST randomized

trial, we further estimate that 33% of patients have stenosis levels between 40% and 90%, which results

in approximately 2.8 million patients eligible for our Heartflow FFRCT Analysis in the stable setting. Based

on the Martin paper, where there were approximately 577,000 hospital discharges in the United States in

2020 due to a principal diagnosis of acute chest pain, and the Bhatt paper, where No ST Elevation

(“NSTE”) related acute chest pain accounted for approximately 70% of acute chest pain, we further

estimate that the annual incidence of patients who have acute chest pain with NSTE is approximately 0.4

million patients. Of these approximately 0.4 million patients, we estimate based on the Kofoed paper that

approximately 70% have obstructive disease and are eligible for our Heartflow FFRCT Analysis, which

results in approximately 0.3 million acute chest pain patients eligible for our Heartflow FFRCT Analysis.

Therefore, we believe there is a market opportunity of approximately 3.1 million patients eligible for our

Heartflow FFRCT Analysis, which, at a U.S. average sales price of $1,067, translates to an estimated

market opportunity of approximately $3.3 billion in the United States.

In addition, we believe our Heartflow Plaque Analysis is applicable to approximately 60% of those 9.5

million NIT patients annually and the majority of patients experiencing acute chest pain. Based on our

PROMISE trial and the Hoffmann paper, we estimate that approximately 60% of CCTA patients have

plaque and are eligible for plaque analysis, which translates to approximately 5.1 million patients eligible

for our Heartflow Plaque Analysis in a stable setting. Based on our internal analysis and the findings in the

Wang paper, where less than 5% of patients were expected to be contraindicated for CCTA, we also

estimate that all of the approximately 0.4 million patients with acute chest pain with NSTE referred to

above will be eligible for our Heartflow Plaque Analysis. Therefore, we believe there is a market

opportunity of approximately 5.5 million patients eligible for our Heartflow Plaque Analysis, which, at an

estimated U.S. sales price of $300, translates to an estimated market opportunity of approximately an

incremental $1.7 billion in the United States.

Beyond the commercialization of Heartflow FFRCT Analysis and Heartflow Plaque Analysis in symptomatic

CAD, we see a significant market opportunity for our technologies in at-risk individuals who show no

symptoms, a segment comprised of approximately 200 million people globally, based on data from the

U.S. Census Bureau, CDC, Eurostat, United Kingdom Office of National Statistics, the Yang paper and

the MacDonald paper. To unlock this potential, we are continuing to evaluate new product opportunities

and appropriate clinical evidence supporting eventual regulatory approval, payor coverage and

commercialization.

We believe the Heartflow Platform is the most extensively studied AI-enabled test for CAD. Our belief is

grounded in our analysis, including that the Heartflow Platform and its accuracy, clinical utility and

economic benefits have been evaluated in over 100 clinical studies and more than 130,000 patients,

including our PRECISE and FORECAST trials, each a large randomized controlled trial, with results

published in over 600 peer-reviewed clinical publications. Our studies, including the PRECISE, NXT and

PACIFIC trials, have consistently demonstrated that the Heartflow Platform is more accurate than

traditional non-invasive tests and highly concordant to invasive testing, reduces unnecessary invasive

testing, and enables physicians to optimize treatment and ultimately provide more efficient care.

We have developed a highly scalable, capital efficient commercial model that combines Territory Sales

Managers (“TSMs”) who drive new account adoption with Territory Account Managers (“TAMs”) who focus

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on increasing utilization by educating referring physicians. Our commercial team does not cover cases or

otherwise spend time in an operating room or lab setting, which enables them to focus solely on driving

commercial adoption and educational activities.

Our technology is simple and intuitive and does not require the purchase of any capital equipment. Our

onboarding process seamlessly integrates the Heartflow Platform into the customer’s daily workflow.

These unique attributes of our business model afford our commercial organization a differentiated level of

efficiency and scalability.

Current clinical guidelines strongly support the adoption of the Heartflow Platform. The CCTA + Heartflow

FFRCT Analysis pathway is supported by the American Heart Association (“AHA”) and American College of

Cardiology (“ACC”) guidelines, with CCTA identified as a Class 1, Level A test and Heartflow FFRCT

Analysis identified as a Class 2a, Level B test for the diagnosis of CAD in certain patients with stable or

acute chest pain and no known CAD. The AHA and ACC guidelines utilize Classes and Levels to indicate

the strength of a recommendation and the quality of supporting evidence, respectively. Class 1 represents

the strongest recommendation, followed by Class 2a, which represents a moderate recommendation.

Similarly, Level A signifies the highest quality of evidence, while Level B indicates moderate quality.

We believe current reimbursement policies support the adoption of the Heartflow Platform. Our Heartflow

FFRCT Analysis is reimbursed under a dedicated Category I Current Procedural Terminology (“CPT”)

code, effective as of January 1, 2024, and has established coverage policies representing approximately

99% of covered lives in the United States. A Category I CPT code was recently established for Heartflow

Plaque Analysis. It will go into effect on January 1, 2026, and is covered by all seven Medicare

administrative contractor (“MACs”). A Category I CPT code designates a procedure or service that uses

device(s) with Food and Drug Administration (“FDA”) clearance or approval (when required), is performed

by many physicians across the United States for its intended clinical use, aligns with current medical

practice, and has documented efficacy in literature. The Category I CPT status for our Heartflow FFRCT

Analysis and Heartflow Plaque Analysis validates their widespread use and distinguish them from

emerging technologies that are assigned Category III CPT codes.

We primarily generate revenue on a “pay-per-click” basis each time a physician chooses to review either

our Heartflow FFRCT Analysis, Heartflow Plaque Analysis, or both. Heartflow FFRCT Analysis has served

as our commercial foundation, representing 99% of our total revenue as of March 31, 2025. In the second

half of 2023, we initiated limited market education efforts for Heartflow Plaque Analysis, our second

commercial product. Our Heartflow RoadMap Analysis is generally provided as a workflow efficiency tool

to drive customer retention and loyalty and is not a stand-alone product. We expect to launch our next

product, Heartflow PCI Planner, in 2026 as an integrated feature to enhance procedural efficiency, not as

a stand-alone product.

We have experienced significant revenue growth since we began commercializing the Heartflow Platform

in 2015. We recognized revenue of $125.8 million for the year ended December 31, 2024, compared to

revenue of $87.2 million for the year ended December 31, 2023, representing 44% year-over-year growth.

We recognized revenue of $37.2 million for the three months ended March 31, 2025, compared to

revenue of $26.8 million for the three months ended March 31, 2024, representing 39% growth over the

prior year period. The software-based nature of our Heartflow Platform produces an attractive gross

margin profile, which continues to expand as we leverage AI to automate an increasing portion of our

“human-in-the loop” quality control process, where learnings are fed back into our algorithms to make

them smarter and more efficient. For the twelve months ended December 31, 2024, we generated gross

margins of 75%, an increase of 8 percentage points year-over-year from December 31, 2023. Our net

losses were $95.7 million and $96.4 million for the years ended December 31, 2023 and 2024,

respectively. Our accumulated deficit was $874.5 million and $971.0 million as of December 31, 2023 and

2024, respectively. Our net losses were $20.9 million and $32.3 million for the three months ended March

31, 2024 and 2025, respectively. Our accumulated deficit was $1.0 billion as of March 31, 2025. For the

three months ended March 31, 2025, we generated gross margins of 75%, an increase of 3 percentage

points over the three months ended March 31, 2024.

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Market overview and opportunity

Overview of CAD

Cardiovascular disease is the leading cause of death worldwide, with CAD being the most lethal form.

CAD occurs when plaque—a buildup of cholesterol, fat, calcium and other substances—accumulates on

the walls of the coronary arteries, restricting blood flow and increasing the risk of heart attack or stroke.

This condition is responsible for half of all cardiovascular-related deaths globally.

Key risk factors, including high cholesterol, hypertension, smoking, diabetes, obesity, physical inactivity,

and genetic predisposition, accelerate plaque formation and destabilization. In the United States alone,

the CDC estimates that approximately 805,000 people suffer a heart attack each year. CAD can be

effectively treated with well-established therapeutics designed to reduce plaque progression and change

its composition, or interventional procedures used to open the arteries and restore blood flow. However,

achieving an accurate diagnosis for the condition has historically been the primary roadblock for the

effective care and management of CAD.

NITs are the first line approach for detecting CAD in symptomatic patients. Based on our analyses using

Clarivate’s ProcedureFinder data repository, with 9.5 million tests performed for the diagnosis of CAD in

the United States in 2023, NITs are by far the most widely used method to diagnose CAD. However,

traditional NITs are not able to measure lesion-specific blood flow and are not an efficient or effective way

to calculate plaque volume and composition. As a result, they lack the key metrics physicians need to

guide treatment decisions and have been clinically shown to be unreliable and inconsistent for diagnosing

CAD.

Limitations of traditional non-invasive tests for CAD

There are two primary types of NITs: (i) stress tests, which infer the presence of CAD based on blood

perfusion, and (ii) CCTA, which directly images the patient’s coronary arteries.

Stress-based NITs include SPECT, PET and stress echocardiography. Stress-based NITs rely on

surrogate markers of CAD to deduce the disease in the coronary artery without actually assessing the

coronary arteries or the disease itself. As a result, approximately 20–50% of patients who undergo stress-

based NITs go home with false negatives, or undetected CAD that should have required an intervention,

based on the Nakanishi paper and the Yokota paper. In addition, based on the 2014 Patel paper, up to

55% of patients receive false positives and are sent to the cardiac catheterization lab for an invasive

diagnostic angiography when an intervention was never needed exposing patients to unnecessary risks

including vascular injury and bleeding complications. This results in significant additional costs to the

healthcare system and poor patient experience.

CCTA is a high-resolution 3D imaging method that uses X-rays to produce detailed pictures of the heart's

arteries and other structures. The analyses performed by our Heartflow Platform rely on CCTA images

from third-party CT manufacturers. Because CCTA images are used across multiple medical practices, by

different medical professionals and others, CT scanners have historically and currently output CCTA

images in standard file formats rather than proprietary formats. Unlike stress tests that rely on indirect

measures to infer heart disease, CCTA provides direct visualization of the patient’s anatomy and can

allow for a comprehensive visual assessment of coronary stenosis and plaque burden. CCTA has been

clinically demonstrated in the SCOT-HEART trial to have the highest diagnostic performance of all

traditional non-invasive imaging tests for CAD. In recognition of its superior diagnostic accuracy, in

October 2021 the AHA and ACC elevated CCTA to a first line Class 1, Level A test in the guidelines for

certain patients with stable or acute chest pain and no known CAD, above stress testing which is Class 1,

Level B. While CCTA accurately identifies stenosis in the coronary arteries, it does not calculate the blood

flow through the arteries to identify whether the stenosis is clinically significant and does not provide

plaque quantification or composition without significant and time-consuming and variable manual

calculations.

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Our Heartflow Platform, which requires a CCTA image from a CT scanner to perform its analysis,

significantly improves the clinical utility of CCTA and addresses the limitations of traditional non-invasive

CAD testing by combining existing CCTA images with our AI algorithms to provide actionable data on

blood flow, stenosis, plaque volume and plaque composition. This delivers superior clinical utility relative

to other NITs and compelling economic benefits, which are supported by extensive clinical evidence. As a

result, we believe the CCTA + Heartflow pathway will become the standard of care for the non-invasive

diagnosis of CAD over time.


Traditional NITs vs. Heartflow
Stress Echocardiogram	SPECT and PET	CCTA	Heartflow FFRCT Analysis

Figure 1: A comparison of the visual output of traditional non-invasive tests. Left: Stress echocardiogram.

Center: SPECT and PET. Right: CCTA image. Far Right: Heartflow FFRCT Analysis image which color

codes coronary blood flow to identify clinically significant blockages.

Our symptomatic CAD market opportunity

We estimate our current market opportunity in the United States for our Heartflow FFRCT Analysis and

Heartflow Plaque Analysis is approximately $5 billion. Based on our analyses using Clarivate’s

ProcedureFinder data repository, we estimate that there were approximately 9.5 million NITs in the United

States for the diagnosis of CAD in 2023. In addition, based on our FORECAST randomized trial and the

Wang paper, we believe there were approximately 8.6 million patients that were addressable with CCTA

after accounting for layered testing and contraindications to CCTA. CCTA testing volumes have grown

rapidly, and we believe they will continue to outpace the broader market growth driven by the recently

established Class 1, Level A guidelines, superior clinical utility to stress tests and improved

reimbursement.

Our Heartflow FFRCT Analysis is reimbursed for use on any CCTA showing 40% to 90% stenosis, which,

based on our FORECAST randomized trial, we estimate to be approximately 33% of all CCTAs annually.

We believe that CCTA + Heartflow FFRCT Analysis therefore is applicable to 33% of the NIT market and a

majority of patients experiencing acute chest pain, which represents 3.1 million patients and an estimated

market opportunity of approximately $3.3 billion in the United States. Our Heartflow Plaque Analysis is

reimbursed for plaque identified on CCTA with 1% to 69% stenosis, which, based on our PROMISE trial

and the Hoffmann paper, we estimate to cover approximately 60% of all CCTAs annually and a majority of

patients experiencing acute chest pain. We believe that CCTA + Heartflow Plaque Analysis is therefore

applicable to 60% of the NIT market, which represents 5.5 million patients and an estimated market

opportunity of an incremental approximately $1.7 billion in the United States.

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While our current focus is on the United States and the Heartflow Platform has been cleared by the FDA

(K213857), our Heartflow FFRCT Analysis has commercial presence and regulatory approval in the United

Kingdom, European Union, Australia, Canada and Japan. The Heartflow Platform has also been cleared

by the equivalent regulatory authorities in Israel, Saudi Arabia, United Arab Emirates, and licensed in

Bahrain. In the future we may expand our international presence beyond these markets and extend our

platform to additional indications.

Our technology

Heartflow enhances CCTA, the most advanced non-invasive imaging modality for assessing CAD, with

AI-powered analysis to deliver more accurate and clinically actionable insights for diagnosing and

managing CAD. The Heartflow Platform applies deep learning, an advanced form of AI, and

computational fluid dynamics to CCTA images to create a personalized 3D model of a patient’s heart

based on a single CCTA image. This model provides actionable insights into blood flow, stenosis, plaque

volume and plaque composition allowing precise diagnosis, risk stratification, and treatment planning –

without the need for an invasive procedure.

The CCTA + Heartflow pathway addresses the limitations of traditional non-invasive tests that only assess

indirect measures for coronary disease and therefore result in higher rates of false negative and false

positive CAD diagnoses, as demonstrated by our PRECISE trial. We believe the differentiated accuracy

and clinical utility of the CCTA + Heartflow pathway will continue to support our growth and advance the

standard for the non-invasive diagnosis and management of CAD.

We designed our AI-powered software platform to be highly scalable, seamlessly integrate into existing

physician workflows for diagnosing CAD, and improve as we ingest more data over time. By leveraging AI

to process massive volumes of cases and a “human-in-the loop” quality control process, where learnings

are fed back into our algorithms to improve their performance and efficiency, we have rapidly scaled our

platform to deliver accurate, timely results to benefit physicians and patients alike.

Figure 2: The CCTA + Heartflow pathway

Our product portfolio

To date, we have created three software products (with a fourth product expected to launch in 2026) in a

unified platform and user experience that provide the critical data physicians need to effectively manage

patients with suspected CAD.

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Heartflow RoadMap Analysis: The Heartflow RoadMap Analysis provides

a highly intuitive anatomic visualization of the patient’s coronary anatomy

based on CCTA images. It rapidly orients the imaging physician to clinically

relevant areas of the patient anatomy and provides a preview of what they

will review in the native CCTA images to aid the physician in accurately,

efficiently and consistently identifying stenosis in the coronary arteries.

Heartflow RoadMap Analysis supports more efficient radiology workflow,

improving CCTA read times by 25% and increasing consistency between

reviewing physicians by approximately 40%, as demonstrated in our

SMART-CT study. Physicians use Heartflow Roadmap Analysis as a first-

line assessment tool along with CCTA interpretation to determine whether

to order our more detailed Heartflow FFRCT Analysis or Heartflow Plaque

Analysis reports. We generally provide Heartflow RoadMap Analysis to

accounts as an integrated feature to enhance the efficiency and

consistency of their CCTA programs and it is not a stand-alone product.

We believe the efficiency that Heartflow RoadMap Analysis provides our

customers has resulted in enhanced customer loyalty and retention.

Heartflow FFRCT Analysis: Our flagship product, Heartflow FFRCT

Analysis, consists of a patient-specific, interactive, 3D anatomical

reconstruction of the coronary anatomy that identifies clinically significant

CAD at every point in the major coronary arteries to determine the need

for intervention. Our Heartflow FFRCT Analysis has the highest diagnostic

accuracy for a non-invasive CAD test and has demonstrated a high level

of concordance to invasive FFR, as seen in our PRECISE, NXT and

PACIFIC trials. Current AHA and ACC guidelines designated CCTA as a

Class 1, Level A test for CAD in certain patients with stable or acute chest

pain and no known CAD, and Heartflow FFRCT Analysis as a Class 2a,

Level B test to help physicians guide patient treatment decisions. As of

March 31, 2025, Heartflow FFRCT Analysis represented 99% of our total

revenue.

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Heartflow Plaque Analysis: Heartflow Plaque Analysis transforms

coronary plaque assessment from a time-consuming and variable manual

process, which is seldom clinically used, into a rapid, automated, and

highly precise AI-driven solution. The Heartflow Plaque Analysis

automatically provides a comprehensive 3D assessment of a patient’s

coronary plaque, including a characterization of plaque types and

quantification of plaque volumes at every point in the major coronary

arteries. The Heartflow Plaque Analysis has been validated against the

reference standard of invasive intravascular ultrasound (“IVUS”) and

shown to have a 95% agreement with IVUS in quantifying total coronary

plaque volume in our REVEALPLAQUE study. Moreover, our current

findings from the DECIDE registry show the Heartflow Plaque Analysis

led to medical management change in over half of patients beyond CCTA

alone. Because coronary plaque volume is a strong predictor of a

patient’s risk of having a heart attack, this data offers incremental

predictive power over risk factors and stenosis alone and can aid the physician in optimizing medical

management. Our Heartflow Plaque Analysis was cleared by the FDA in October 2022. We began our

limited market education efforts in the second half of 2023, and we expect to broaden our market

education efforts as payor coverage for Heartflow Plaque Analysis increases. We also anticipate our

Heartflow Plaque Analysis to be included in updated cardiac imaging guidelines by radiology benefit

manager EviCore by Evernorth, which provides coverage guidelines to leading commercial health

insurers, effective October 1, 2025.

Heartflow PCI Planner: Heartflow PCI Planner, which we expect to launch in 2026, will enable pre-

percutaneous coronary intervention (“PCI”) assessment of coronary anatomy, lesion-specific physiology

and plaque localization through an interactive 3D model, combined in a single interface. The tool will

provide interventional cardiologists with advanced visualization and clinical insights to help answer critical

questions for revascularization strategies, such as which lesions to treat, how to treat them, the

complexity of PCI, the need for calcium modification, what ancillary tool to use and how to optimize stent

quantity, size and placement. We expect Heartflow PCI Planner to offer procedural efficiency through

advanced preparation, improved patient care by ensuring optimal treatment at the right time and

increased clinician confidence with detailed pre-procedure knowledge. We plan to provide Heartflow PCI

Planner to accounts as an integrated feature to enhance procedural efficiency, not as a stand-alone

product.

Key benefits of our Heartflow Platform

We believe the unique features of our technology allow us to offer superior clinical utility and economic

value to our customers and the broader healthcare system. The key benefits offered by our Heartflow

Platform include:

•More accurate non-invasive test for CAD: Our Heartflow products provide a more accurate non-

invasive assessment of blood flow, plaque characterization and plaque volume compared to

traditional non-invasive tests. Our clinical trials have demonstrated that Heartflow FFRCT Analysis and

Heartflow Plaque Analysis have a high level of concordance to the invasive reference standards of

FFR and IVUS, respectively, and that Heartflow FFRCT Analysis has superior diagnostic accuracy to

CCTA alone as well as both SPECT and PET.

•More informed assessments and personalized care: Our Heartflow FFRCT Analysis and Heartflow

Plaque Analysis have been clinically demonstrated to improve physician decisions on intervention

and treatment planning. Multiple studies and registries have demonstrated that physicians changed

their treatment approach after reviewing our AI-powered reports.

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•Superior economic efficiency: Our PRECISE prospective randomized controlled trial demonstrated

that our Heartflow FFRCT Analysis was 78% more likely to identify patients in need of

revascularization and showed a 69% reduction in unnecessary invasive tests as compared to a “usual

care” pathway. The net effect of this pathway was 2x the yield of invasive coronary angiography

leading to a revascularization procedure. As a result, our internal analysis based on the PRECISE

data demonstrated a 20% increase in net revenue for the cardiac catheterization lab, on average.

•Improved workflow: Our Heartflow RoadMap Analysis offers significant workflow benefits, including

improving workflow efficiency by reducing CCTA interpretation times by approximately 25%, as

demonstrated in our SMART-CT study.

•Enhanced interventional treatment planning: The additional detail on individual patient anatomy

and disease state provided by our Heartflow Platform allows for pre-operative selection of appropriate

tools. We believe this saves valuable cardiac catheterization lab time and facilitates a more efficient

procedure.

•Better patient and provider experience: By leveraging a single CCTA for all of our products,

patients complete their test in approximately 20 minutes with significantly lower radiation exposure

compared to nuclear imaging tests such as SPECT and PET that take multiple hours and require

radioactive tracers to be injected into the bloodstream. By providing a definitive diagnosis upfront, the

Heartflow Platform eliminates the need for layered testing, streamlining the patient journey and

reducing anxiety associated with uncertain or inconclusive results.

We believe the benefits of our Heartflow Platform add significant value across all the subspecialties that

impact cardiovascular care including referring cardiologists, imaging physicians and interventionalists. We

have structured our sales force to efficiently call on these key physician stakeholders, with a primary

focus on the imaging physicians who are instrumental in new account adoption and the referring

physicians who are critical to driving volume growth at our existing accounts.

Our success factors

We believe the continued growth of our company will primarily be driven by the following success factors:

•Differentiated approach to the non-invasive diagnosis and management of CAD

•Market leader in AI-powered quantitative CAD analysis with strong customer relationships

•Attractive revenue model with significant operating leverage potential

•Large addressable market opportunity with a significant unmet need

•Robust and compelling portfolio of clinical evidence

•Established reimbursement coverage and favorable society support

•Unique and scalable AI, data and R&D capabilities

•Experienced leadership team

Our growth strategies

We believe the following key strategies will play a critical role in our continued growth:

•Expand adoption of our Heartflow Platform by new accounts

•Broaden awareness of the CCTA + Heartflow pathway to drive volume at existing accounts

•Launch and drive adoption of our Heartflow Plaque Analysis product

•Invest in additional clinical evidence to support adoption and expand our indications

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•Extend our technology leadership through continued investment in our platform

•Leverage our platform to pursue adjacent and international markets

Recent developments

Preliminary estimated consolidated financial results as of and for the three months ended June

30, 2025

Our consolidated financial results as of and for the three months ended June 30, 2025 are not yet

complete and will not be available until after the completion of this offering. Accordingly, we are presenting

below certain preliminary estimated and unaudited consolidated data as of and for the three months

ended June 30, 2025. Actual results remain subject to the completion of our financial close processes and

management’s final reviews of our consolidated financial data. Such estimated and unaudited

consolidated data constitute forward-looking statements based solely on information available to us as of

the date of this prospectus and may differ from actual results. This data should not be considered a

substitute for the consolidated financial information to be filed with the SEC in our Quarterly Report on

Form 10-Q for the quarter ended June 30, 2025, when it is due after the completion of our initial public

offering. For additional information, see “Special note regarding forward-looking statements” and “Risk

factors.”

The preliminary consolidated financial data included in this registration statement as of and for the three

months ended June 30, 2025, has been prepared by, and is the responsibility of, Heartflow, Inc.'s

management. PricewaterhouseCoopers LLP has not audited, reviewed, examined, compiled, nor applied

agreed-upon procedures with respect to the preliminary consolidated financial data. Accordingly,

PricewaterhouseCoopers LLP does not express an opinion or any other form of assurance with respect

thereto.

After our quarter-end financial closing process is completed, we may report consolidated financial results

and other data that could differ, although we do not expect the actual results to differ materially from those

reflected in the preliminary estimates. While we believe that such information and estimates are based on

reasonable assumptions, our actual results may vary. Factors that could cause the preliminary estimated

and unaudited consolidated data to differ include, but are not limited to: additional adjustments arising

from discovery of new information that affects accounting estimates, management judgment, or impacts

valuation methodologies underlying these estimated results.

The following preliminary estimated and unaudited consolidated data as of and for the three months

ended June 30, 2025 is presented below:


	Three months ended June 30,
	2025	2025	2024
(in thousands)	(estimated low)	(estimated high)	(actual)
Consolidated statements of operations data:
Revenue ........................................................................................	$	$	$31,054
Gross margin ................................................................................	%	%	77%

As of June 30, 2025, our cash and cash equivalents balance is expected to be $ million as compared to

$109.8 million as of March 31, 2025.

Information regarding comparisons to prior quarters is provided below for additional context.

We expect preliminary unaudited revenue for the three months ended June 30, 2025 to be approximately

$ million to $ million, as compared to $31.1 million for the same period in 2024, an increase of %

to %, and our gross margin to be between % and % for the three months ended June 30, 2025, as

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compared to 77% for the same period in 2024. The estimated increase in revenue is primarily attributable

to a % increase in revenue case volume. We expect the number of revenue cases to be

approximately in the three months ended June 30, 2025 as compared to 33,039 for the same period in

2024, an increase of %. The estimated decrease in our gross margin for the three months ended June

30, 2025 was primarily attributable to our investment in the hiring and training of additional personnel in

our production team to support our increasing revenue case volume. Although we expect to continue to

invest in the hiring and training of additional personnel in our production team, we expect our gross

margin will increase over the longer term.

Risk factors summary

Our business is subject to a number of risks and uncertainties, as more fully described in the section titled

“Risk factors” immediately following this prospectus summary. You should read these risks before you

invest in our common stock. These risks include, among others, the following:

•We have incurred significant net losses since our inception, we expect to incur additional substantial

losses in the foreseeable future and we may not be able to achieve or sustain profitability.

•Our revenue is currently generated almost entirely from the sales of only one product, Heartflow

FFRCT Analysis, and we are therefore highly dependent on the success of this product, which makes

it difficult to evaluate our current business, predict our future prospects and forecast our financial

performance and any growth.

•If healthcare providers are unwilling to change their standard practice regarding the evaluation of

CAD, our business, financial condition, results of operations and prospects will be adversely affected.

•If third-party payors, including government payors, do not cover and provide adequate, or any,

reimbursement for the Heartflow Platform, or if existing payment amounts are reduced or coding

changes, adoption of the Heartflow Platform by healthcare providers will be negatively impacted, and

our business, financial condition, results of operations and prospects will be adversely affected.

•We face risks associated with a concentrated customer base.

•We face significant competition in an environment of rapid technological change, and there is a

possibility that our competitors may develop products that are more effective, accurate, reliable, cost-

effective or more advanced than ours, which may harm our financial condition. If we are unable to

compete successfully or our potential market share is reduced, we may be unable to increase or

sustain our revenue or achieve profitability.

•The commercialization of the Heartflow Plaque Analysis product is nascent, and we may not be able

to achieve or maintain sufficient market acceptance or the levels of utilization we expect from the

Heartflow Plaque Analysis product or any other future product.

•We face risks associated with our use and development of artificial intelligence models, which may

result in operational challenges, legal liability, reputational concerns and competitive risks.

•If we fail to properly manage our future growth, our business could suffer.

•Our business could be disrupted by catastrophic events.

•We depend on our information technology systems, and any failure of these systems could harm our

business and adversely affect our business and operating results.

•Our networks and those of our third-party service providers may become the target of bad actors or

security breaches that we cannot anticipate or successfully defend, which could have an adverse

impact on our business.

•We face extensive, regulatory requirements to bring our products to market, and our failure to receive

and maintain regulatory clearances or approvals of our current and future products in the United

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States or abroad or to comply with medical device regulatory requirements could adversely affect our

business.

•If we are unable to obtain and maintain sufficient intellectual property rights, or the scope of our rights

is not sufficiently broad, third parties could develop and commercialize technology and products

similar or identical to ours, and our ability to successfully commercialize our technology and products

may be adversely affected.

•Our credit agreement contains certain restrictions that may limit our ability to operate our business. If

we raise additional capital through debt financing, the terms of any new debt could further restrict our

ability to operate our business.

The summary risk factors described above should be read together with the text of the full risk factors in

the section titled “Risk factors” and the other information set forth in this prospectus, including our

consolidated financial statements and the related notes. The risks summarized above or described in full

elsewhere in this prospectus are not the only risks that we face. Additional risks and uncertainties not

presently known to us, or that we currently deem to be immaterial, may also materially adversely affect

our business, financial condition, results of operations, and prospects.

Corporate information

We were incorporated under the laws of the State of Delaware in 2007. On March 1, 2021, we completed

an internal reorganization in which a newly formed parent holding company was put in place. The

previous holders of our common stock and preferred securities became holders of common stock and

preferred securities of HeartFlow Holding, Inc. The equity incentive plan, outstanding equity awards,

outstanding warrants and certain other equity-related agreements of HeartFlow, Inc. were assumed by

HeartFlow Holding, Inc. Our operations and business activities remained at HeartFlow, Inc., and the

wholly-owned non-U.S. subsidiaries of HeartFlow, Inc. remained in place. On July 17, 2025, we

consolidated HeartFlow Holding, Inc. into HeartFlow, Inc. and the previous holders of HeartFlow Holding,

Inc. common stock and preferred securities became holders of our common stock and preferred

securities, and the equity incentive plan, outstanding equity awards, outstanding warrants and certain

other equity-related agreements of HeartFlow Holding, Inc. were assumed by us. In connection with this

consolidation, we changed our name to Heartflow, Inc., whose name appears on the cover of this

prospectus. Our principal executive offices are located at 331 E. Evelyn Avenue, Mountain View,

California 94041, and our telephone number is (650) 241-1221. Our corporate website address is

www.heartflow.com. Information contained on, or accessible through, our website shall not be deemed

incorporated into and is not a part of this prospectus or the registration statement of which it forms a part.

We have included our website in this prospectus solely as an inactive textual reference.

Implications of being an emerging growth company

We qualify as an “emerging growth company” as defined in the Jumpstart Our Business Startups Act of

2012 (the “JOBS Act”). We will remain an emerging growth company until the earliest of: (i) the last day of

the fiscal year following the fifth anniversary of the completion of this offering; (ii) the last day of the fiscal

year in which we have total annual gross revenue of at least $1.235 billion; (iii) the last day of the fiscal

year in which we are deemed to be a “large accelerated filer” as defined in Rule 12b-2 under the

Securities Exchange Act of 1934, as amended (the “Exchange Act”), which would occur if the market

value of our common stock held by non-affiliates exceeded $700.0 million as of the last business day of

the second fiscal quarter of such year; or (iv) the date on which we have issued more than $1.0 billion in

non-convertible debt securities during the prior three-year period. An emerging growth company may take

advantage of specified reduced reporting requirements and is relieved of certain other significant

requirements that are otherwise generally applicable to public companies. As a result, the information that

we provide to our stockholders may be different than you might receive from other public reporting

companies in which you hold equity interests.

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As an emerging growth company, we have elected to take advantage of certain reduced disclosure

obligations in the registration statement that this prospectus is a part of, and may elect to take advantage

of other reduced reporting requirements in future filings. In particular:

•we will present in this prospectus only two years of audited financial statements, plus any required

unaudited financial statements, and related management’s discussion and analysis of financial

condition and results of operations;

•we will avail ourselves of the exemption from the requirement to obtain an attestation and report from

our independent registered public accounting firm on the assessment of our internal control over

financial reporting pursuant to the Sarbanes-Oxley Act of 2002;

•we will avail ourselves of relief from compliance with the requirements of the Public Company

Accounting Oversight Board regarding the communication of critical audit matters in the auditor’s

report on the financial statements;

•we will provide less extensive disclosure about our executive compensation arrangements; and

•we will not be required to hold stockholder non-binding advisory votes on executive compensation or

golden parachute arrangements.

In addition, the JOBS Act provides that an emerging growth company can take advantage of an extended

transition period for complying with new or revised accounting standards. This provision allows an

emerging growth company to delay the adoption of some accounting standards until those standards

would otherwise apply to private companies. We have elected to use the extended transition period for

any other new or revised accounting standards during the period in which we remain an emerging growth

company; however, we may adopt certain new or revised accounting standards early. As a result of these

elections, the information that we provide in this prospectus, including our financial statements, may be

different than the information you may receive from other public companies in which you hold equity

interests. In addition, it is possible that some investors will find our common stock less attractive as a

result of these elections, which may result in a less active trading market for our common stock and

higher volatility in our share price.

Basis of presentation

Certain monetary amounts, percentages, and other figures included elsewhere in this prospectus have

been subject to rounding adjustments. Accordingly, figures shown as totals in certain tables or charts may

not be the arithmetic aggregation of the figures that precede them, and figures expressed as percentages

in the text may not total 100% or, as applicable, when aggregated may not be the arithmetic aggregation

of the percentages that precede them.

The consolidated financial statements include the accounts of HeartFlow Holding, Inc. and its

subsidiaries. On July 17, 2025, we consolidated HeartFlow Holding, Inc. into HeartFlow, Inc., and the

previous holders of HeartFlow Holding, Inc. common stock and preferred securities became holders of

our common stock and preferred securities and the equity incentive plan, outstanding equity awards, the

outstanding warrants and other equity agreements of HeartFlow Holding, Inc. have been assumed by us.

The consolidation did not have a material effect on our consolidated financial statements included

elsewhere in this prospectus. The consolidated financial statements of HeartFlow Holding, Inc. are that of

Heartflow, Inc., the registrant whose name appears on the cover of this prospectus.

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The offering


Common stock offered by us .......		shares.

Option to purchase additional shares .................................................		We have granted the underwriters an option for a period of 30 days to purchase up to additional shares of common stock from us at the public offering price, less underwriting discounts and commissions on the same terms as set forth in this prospectus.

Common stock to be outstanding after this offering .............................		shares (or shares if the underwriters exercise in full their option to purchase additional shares).

Use of proceeds ...............................		We estimate that the net proceeds from this offering will be approximately $ million (or approximately $ million if the underwriters exercise in full their option to purchase up to additional shares of common stock), based on the assumed initial public offering price of $ per share, which is the midpoint of the estimated price range set forth on the cover page of this prospectus, after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us. In connection with the completion of this offering, we are obligated to use certain of the net proceeds from this offering to repay $50.0 million (or $55.0 million if the underwriters exercise any portion of their option to purchase additional shares of common stock) of the indebtedness outstanding under the amended credit agreement and guaranty (as amended, the “2024 Credit Agreement”) with Hayfin Services, LLP (“Hayfin”) and to pay approximately $ million of fees in connection therewith. In connection with the issuance of the 2025 Convertible Notes (as defined below) in January 2025, we entered into Amendment No. 1 to the 2024 Credit Agreement, pursuant to which entities affiliated with Hayfin converted $23.0 million of outstanding indebtedness under the 2024 Credit Agreement in connection with the 2024 Term Loan Conversion (as defined in the section titled “Certain relationships and related-party transactions”) and became holders of 5% or more of our capital stock as of March 31, 2025. We expect to use the remainder of the net proceeds from this offering, together with our existing cash and cash equivalents, to fund our sales and marketing efforts, fund research and product development activities and for other general corporate purposes, including working capital, operating expenses, and capital expenditures.

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		We may also use a portion of the net proceeds from this offering to acquire complementary businesses, products, services, or technologies. We periodically evaluate strategic opportunities; however, we have no current understandings or commitments to enter into any such acquisitions or make any such investments. We will have broad discretion in the way that we use the net proceeds of this offering. See the section titled “Use of proceeds” for additional information.

Risk factors .......................................		You should read the section titled “Risk factors” for a discussion of factors to consider carefully, together with all the other information included in this prospectus, before deciding to invest in our common stock.

Proposed Nasdaq trading symbol		“HTFL”

Lock-up agreements .......................		In connection with this offering, we, our directors, our executive officers, and the holders of substantially all of our common stock, stock options, and other securities convertible into or exercisable or exchangeable for our common stock, have agreed that, without the prior written consent of J.P. Morgan Securities LLC, Morgan Stanley & Co. LLC and Piper Sandler & Co. on behalf of the underwriters, subject to certain exceptions more fully described under the section titled “Underwriting”, we and they will not, among other things, sell or otherwise transfer or dispose of any of our securities during the period from the date of this prospectus continuing through the date 180 days after the date of this prospectus. See the section titled “Underwriting” for additional information.

The number of shares of our common stock to be outstanding after this offering is based on

shares of our common stock outstanding as of March 31, 2025 and excludes:

•25,066,625 shares of our common stock issuable upon the exercise of outstanding stock options as

of March 31, 2025 under our HeartFlow Holding, Inc. Amended and Restated 2009 Equity Incentive

Plan (the “2009 Equity Incentive Plan”), with a weighted-average exercise price of $1.71 per share;

•621,827 shares of our common stock issuable upon the exercise of outstanding stock options granted

subsequent to March 31, 2025 under our 2009 Equity Incentive Plan, with a weighted-average

exercise price of $4.67 per share;

•4,811,190 shares of our common stock issuable upon the exercise of warrants outstanding as of

March 31, 2025 held by Hayfin, with an exercise price of $0.01 per share;

•939,911 shares of our common stock reserved for future issuance under our 2009 Equity Incentive

Plan;

• shares of our common stock to be reserved for future issuance under our 2025 Performance

Incentive Plan (the “2025 Plan”), which will become effective upon the commencement of trading of

our common stock on the Nasdaq Global Select Market, from which we will grant restricted stock

units (“RSUs”) covering approximately shares of common stock concurrently with this

offering (based on the assumed initial public offering price of $ per share, which is the midpoint

of the price range set forth on the cover page of this prospectus), as well as any future increases in

the number of shares of common stock reserved for issuance under the 2025 Plan; and

• shares of our common stock reserved for future issuance under our 2025 Employee Stock

Purchase Plan (the “ESPP”), which will become effective upon the commencement of trading of our

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common stock on the Nasdaq Global Select Market, as well as any future increases in the number of

shares of common stock reserved for issuance under the ESPP.

Unless otherwise indicated, all information contained in this prospectus assumes or gives effect to:

•the adoption, filing, and effectiveness of our amended and restated certificate of incorporation, to be

in effect upon the completion of this offering, and the adoption of our amended and restated bylaws,

to be in effect upon the effectiveness of the amended and restated certificate of incorporation;

•the automatic conversion of 122,231,454 outstanding shares of our Series A, Series B-1, Series B-2,

Series C, Series D, Series E, Series F and Series F-1 redeemable convertible preferred stock

(collectively, our “redeemable convertible preferred stock”) as of March 31, 2025 into an aggregate

of 149,581,128 shares of our common stock, the conversion of which will occur immediately prior to

the completion of this offering (the “Preferred Stock Conversion”);

•the automatic conversion of $98.3 million of convertible promissory notes with original maturity dates

of 48 months from the dates of issuance into an aggregate of shares of our common stock,

which amount includes the $23.0 million aggregate principal amount of notes issued in the 2024 Term

Loan Conversion (collectively, the “2025 Convertible Notes”), assuming the assumed initial public

offering price of $ per share, which is the midpoint of the estimated price range set forth on the

cover page of this prospectus, issued by us in January and March 2025, which will be automatically

converted upon the completion of this offering into an aggregate of shares of our common

stock without interest (the “Convertible Notes Conversion”);

•a -for- reverse stock split of our common stock, which we effected on , 2025 and a

corresponding adjustment to the Preferred Stock Conversion and adjustment to our outstanding

warrants;

•no exercise, settlement or termination of the outstanding options or warrants described above; and

•no exercise by the underwriters of their option to purchase up to additional shares of our

common stock in this offering.

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Summary consolidated financial data

The following tables summarize our consolidated financial data for the periods and as of the dates

indicated. The following summary consolidated statements of operations data for the years ended

December 31, 2023 and 2024 have been derived from our audited consolidated financial statements and

related notes included elsewhere in this prospectus. The following summary interim consolidated

statements of operations data for the three months ended March 31, 2024 and 2025, and the summary

interim consolidated balance sheet data as of March 31, 2025, have been derived from our unaudited

interim consolidated financial statements included elsewhere in this prospectus. Our audited consolidated

financial statements and unaudited interim consolidated financial statements included elsewhere in this

prospectus have been prepared in accordance with U.S. generally accepted accounting principles

(“GAAP”). Our unaudited interim consolidated financial statements were prepared on a basis consistent

with our audited consolidated financial statements and include, in our opinion, all adjustments of a normal

and recurring nature that are necessary for the fair statement of the financial information set forth in those

statements included elsewhere in this prospectus. Our historical results are not necessarily indicative of

the results that may be expected for any period in the future and results for the three months ended

March 31, 2025 are not necessarily indicative of results to be expected for the year ended December 31,

2025. You should read the following summary consolidated financial data together with our audited

consolidated financial statements and unaudited interim consolidated financial statements and the related

notes included elsewhere in this prospectus and the section titled “Management’s discussion and analysis

of financial condition and results of operations.” The summary consolidated financial data included in this

section are not intended to replace the consolidated financial statements and the related notes included

elsewhere in this prospectus and are qualified in their entirety by the consolidated financial statements

and the related notes thereto included elsewhere in this prospectus.

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	Year ended December 31,		Three months ended March 31,
(in thousands, except share and per share amounts)	2023	2024	2024	2025
Consolidated statements of operations data:
Revenue .........................................................	$87,174	$125,808	$26,843	$37,205
Cost of revenue .............................................	29,123	31,359	7,420	9,264
Gross profit ....................................................	58,051	94,449	19,423	27,941
Operating expenses: ....................................
Research and development ...................	35,854	43,517	9,443	13,924
Selling, general and administrative .......	95,111	112,154	26,038	31,519
Total operating expenses ..................	130,965	155,671	35,481	45,443
Loss from operations ...................................	(72,914)	(61,222)	(16,058)	(17,502)
Interest expense, net ...............................	(19,237)	(18,702)	(4,731)	(4,550)
Other expense, net ..................................	(2,957)	(16,449)	(215)	(10,293)
Loss before provision from income taxes .	(95,108)	(96,373)	(21,004)	(32,345)
(Provision for) benefit from income taxes ...........................................................	(547)	(53)	72	—
Net loss ...........................................................	$(95,655)	$(96,426)	$(20,932)	$(32,345)
Cumulative dividends on Series C redeemable convertible preferred stock ...........................................................	(1,239)	—	—	—
Deemed dividend upon down round of redeemable convertible preferred stock ...........................................................	(26,794)	—	—	—
Net loss attributable to common stockholders ...................................................	$(123,688)	$(96,426)	$(20,932)	$(32,345)
Net loss per share attributable to common stockholders, basic and diluted(1) ..........................................................	$(8.67)	$(6.16)	$(1.45)	$(1.80)
Weighted-average shares used to compute net loss per share attributable to common stockholders, basic and diluted(1) ..........................................................	14,265,293	15,661,682	14,435,241	18,001,364
Pro forma net loss per share attributable to common stockholders, basic and diluted(2) ..........................................................		$		$
Pro forma weighted-average shares used to compute net loss per share attributable to common stockholders, basic and diluted(2) ........................................

(1)See Notes 2 and 16 to our consolidated financial statements included elsewhere in this prospectus for an explanation of the calculation

of our basic and diluted net loss per share attributable to common stockholders and the weighted-average number of shares used in the

computation of the per share amounts.

(2)Unaudited pro forma net loss per share attributable to common stockholders, basic and diluted, for the year ended December 31, 2024

and for the three months ended March 31, 2025 is calculated by giving effect to (i) removal of the effect of interest expense related to

the 2024 Term Loan Conversion of $23.0 million and the $50.0 million partial repayment of the indebtedness outstanding, (ii) the

Preferred Stock Conversion, as if the shares resulting from the Preferred Stock Conversion were outstanding as of January 1, 2024, (iii)

the Convertible Notes Conversion at the assumed initial public offering price of $ per share, which is the midpoint of the

estimated price range set forth on the cover page of this prospectus, as if the shares resulting from the Convertible Notes Conversion

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were outstanding as of January 1, 2024, (iv) the removal of other expense, net related to the change in fair value of the derivative

liability, and (v) stock-based compensation expense related to the grant of RSUs concurrent with this offering at the assumed

initial public offering price of $ per share, which is the midpoint of the estimated price range set forth on the cover page of this

prospectus, as if the RSUs had been granted on January 1, 2024. The total stock-based compensation expense related to the

concurrent RSU award is estimated to be $ million. The RSUs will be settled in shares of common stock and vest over four years in

annual equal increments, subject to continued service, on the anniversary of the grant date. The following table summarizes our

unaudited pro forma net loss per share for the year ended December 31, 2024 and the three months ended March 31, 2025:


(in thousands, except share and per share amounts)	Year ended December 31, 2024	Three months ended March 31, 2025
Numerator:
Net loss attributable to common stockholders, basic and diluted ..................	$(96,426)	$(32,345)
Pro forma adjustment to remove interest expense related to debt conversion and repayment ...................................................................................
Pro forma adjustment to remove other expense, net related to the change in fair value of derivative liability ..........................................................................
Pro forma adjustment to add stock-based compensation expense related to the RSUs ............................................................................................................
Pro forma net loss attributable to common stockholders ................................	$	$
Denominator:
Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted ..................................	15,661,682	18,001,364
Pro forma adjustment to reflect the Preferred Stock Conversion ..................
Pro forma adjustment to reflect the Convertible Notes Conversion ..............
Pro forma weighted-average shares used in computing pro forma net loss per share attributable to common stockholders, basic and diluted ................
Pro forma net loss per share attributable to common stockholders, basic and diluted ..............................................................................................................	$	$


	As of March 31, 2025
(in thousands)	Actual	Pro forma(1)	Pro forma as adjusted(2)(3)
Consolidated balance sheet data:
Cash and cash equivalents .......................................................	$109,786	$	$
Working capital(4) ........................................................................	101,231
Total assets ..................................................................................	184,441
2024 Term Loan ..........................................................................	113,831
2025 Convertible Notes .............................................................	65,824
Derivative liability ........................................................................	40,945
Redeemable convertible preferred stock ................................	768,566
Accumulated deficit ....................................................................	(1,003,304)
Total stockholders’ equity (deficit) ............................................	(888,995)

(1)The pro forma column above reflects (a) the Preferred Stock Conversion, which will occur immediately prior to the completion of this

offering, as if it had occurred on March 31, 2025, (b) the Convertible Notes Conversion at the assumed initial public offering price of

$ per share, which is the midpoint of the estimated price range set forth on the cover page of this prospectus and the resultant

reclassification of our derivative liability to additional paid-in capital, a component of stockholders’ equity (deficit), which will occur upon

the completion of this offering, as if each had occurred as of March 31, 2025, and (c) the adoption, filing, and effectiveness of our

amended and restated certificate of incorporation, to be in effect upon or following the completion of this offering.

(2)The pro forma as adjusted column gives effect to (a) the pro forma adjustments set forth in (1) above, (b) the issuance and sale

of shares of our common stock in this offering at the assumed initial public offering price of $ per share, which is the

midpoint of the estimated price range set forth on the cover page of this prospectus, after deducting estimated underwriting discounts

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and commissions and estimated offering expenses payable by us, and (c) the assumed repayment of $50.0 million of the indebtedness

outstanding under the 2024 Credit Agreement and payment of approximately $ million of fees in connection therewith.

(3)The pro forma as adjusted information above is illustrative only and will depend on the actual initial public offering price and other terms

of this offering determined at pricing. Each $1.00 increase or decrease in the assumed initial public offering price of $ per share

of our common stock, which is the midpoint of the estimated price range set forth on the cover page of this prospectus, would increase

or decrease, as applicable, each of our pro forma as adjusted cash and cash equivalents, total stockholders’ equity (deficit), and total

capitalization by approximately $ million, assuming the number of shares offered by us, as set forth on the cover page of this

prospectus, remains the same, and after deducting estimated underwriting discounts and commissions and estimated offering

expenses payable by us. Similarly, each increase or decrease of 1.0 million shares in the number of shares of common stock offered by

us would increase or decrease, as applicable, each of our pro forma as adjusted cash and cash equivalents, total stockholders’ equity

(deficit), and total capitalization by approximately $ million, assuming the assumed initial public offering price of $ per

share of our common stock, which is the midpoint of the estimated price range set forth on the cover page of this prospectus, remains

the same, and after deducting estimated underwriting discounts and commissions and estimated offering expenses payable by us.

(4)Working capital is defined as current assets less current liabilities. See our unaudited interim consolidated financial statements and

related notes included elsewhere in this prospectus for further details regarding our current assets and current liabilities.

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Risk factors

Investing in our common stock involves a high degree of risk. You should carefully consider the risks

described below, as well as the other information in this prospectus, including our financial statements

and the related notes and “Management’s discussion and analysis of financial condition and results of

operations,” before deciding whether to invest in our common stock. The occurrence of any of the events

or developments described below could have a material adverse effect on our business, financial

condition, results of operations and prospects. In such an event, the market price of our common stock

could decline, and you may lose all or part of your investment. Additional risks and uncertainties not

presently known to us or that we currently believe are not material may also impair our business, financial

condition, results of operations and prospects. Please also see the sections titled “Special note regarding

forward-looking statements” and “Market and industry data.”

Risks related to our business and industry

We have incurred significant net losses since our inception, we expect to incur additional

substantial losses in the foreseeable future and we may not be able to achieve or sustain

profitability.

We have incurred significant net losses since our inception in 2007, and we expect to incur additional

substantial losses in the foreseeable future. For the fiscal years ended December 31, 2023 and 2024, and

the three months ended March 31, 2025, we incurred net losses of $95.7 million, $96.4 million and $32.3

million, respectively. As of December 31, 2023 and 2024, we had an accumulated deficit of $874.5 million

and $971.0 million, respectively. As of March 31, 2025, we had an accumulated deficit of $1.0 billion.

Since inception, we have spent significant amounts of cash to develop the Heartflow Platform, to fund

research and development, including our preclinical research and development activities and clinical trials

related to our products, to scale our commercial operations and to recruit and retain key talent.

The net losses we incur may fluctuate significantly from quarter to quarter and year to year, such that a

period-to-period comparison of our results of operations may not be a good indication of our future

performance. We expect to continue to incur significant research and development, sales and marketing,

regulatory and other expenses as we expand our marketing efforts to increase adoption of our products,

expand existing relationships with our customers, obtain regulatory clearances or approvals for our

planned or future products, conduct clinical trials to extend applicability of our platform into new

indications or to develop new products or add new features to our existing products. The investments in

our business may be more costly than we expect, and if we do not achieve the benefits anticipated from

these investments, or if the realization of these benefits is delayed, they may not result in increased

revenue or growth in our business. In addition to the anticipated costs of growing our business, we expect

our general and administrative expenses to increase following this offering due to the additional costs of

being a public company. If our revenue growth does not increase to more than offset the anticipated

increases in our operating expenses, we may not be able to achieve or sustain profitability and our

business, financial condition, results of operations and prospects will be harmed.

In addition, our revenue may decline or our revenue growth, if any, may be constrained. Our ability to

increase sales is uncertain, and we may never be able to achieve or sustain profitability for many

reasons, including that: our Heartflow FFRCT Analysis may not achieve widespread adoption among

healthcare providers and we may be unable to increase revenue generated from sales of our Heartflow

FFRCT Analysis; our Heartflow Plaque Analysis may not achieve widespread adoption among healthcare

providers and we may be unable to generate sufficient revenue from sales of our Heartflow Plaque

Analysis; payors, such as insurance companies and government insurance programs, may decide not to

reimburse for our products, may set the amount of such reimbursement too low or reduce the amount of

such reimbursement; healthcare industry trends, including growth in CCTA usage, may move in directions

that do not allow for adoption of our products or that do not provide adequate incentives for the adoption

of our products; competitors may develop or acquire a product that successfully competes with ours;

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manufacturers of CT scanners may partner with our competitors or develop or acquire a competing

product and integrate one or more products that successfully competes with ours; we may not be able to

obtain regulatory approval for future versions of our products (including improved versions of our AI

algorithms), new indications for use of our products or other future products; and there may be changes in

existing or anticipated clinical guidelines, including the current ACC and AHA Class 1, Level A guidelines

for CCTA and Class 2a, Level B guidelines for Heartflow FFRCT Analysis for certain patients with stable or

acute chest pain and no known CAD, or the timing of adoption of positive clinical guidelines that support

the use of the Heartflow FFRCT Analysis.

Because of these and the other risks and uncertainties described in this prospectus, we are unable to

predict the extent to which we will be able to increase sales, if at all, or the timing for when or the extent to

which we will become profitable, if ever. We will need to generate significant additional revenue to achieve

and sustain profitability, and even if we do achieve profitability, we may not be able to sustain or increase

profitability. Our failure to become and remain profitable would depress the value of our company and our

stock price and could impair our ability to raise capital, fund our research and development efforts,

expand our business, diversify our product offerings or continue our operations. A decline in the value of

our company could cause you to lose all or part of your investment.

Our revenue is currently generated almost entirely from the sales of only one product, Heartflow

FFRCT Analysis, and we are therefore highly dependent on the success of this product, which

makes it difficult to evaluate our current business, predict our future prospects and forecast our

financial performance and any growth.

As of March 31, 2025, our Heartflow FFRCT Analysis represented 99% of our total revenue. In the second

half of 2023, we began limited market education efforts of our second product, Heartflow Plaque Analysis.

Over the next several years, we expect to continue to devote a substantial amount of resources to

increase sales of our Heartflow FFRCT Analysis and also expand our commercialization efforts and drive

increased adoption of our Heartflow Plaque Analysis. However, we may not succeed in increasing sales

of our Heartflow FFRCT Analysis or in increasing adoption of our Heartflow Plaque Analysis. We expect to

continue to derive almost all of our revenue from sales of Heartflow FFRCT Analysis for the foreseeable

future, so we are highly dependent on its success.

In addition, because we plan to devote substantial resources to increase sales of Heartflow FFRCT

Analysis and rely on it as our main source of revenue, any factors that negatively impact these efforts, our

Heartflow Plaque Analysis commercialization efforts or our ability to diversify our products would have a

material adverse effect on our business, financial condition, results of operations and prospects.

Therefore, it is difficult to predict our future prospects and forecast our financial performance and any

growth, and any such forecasts are inherently limited and subject to a number of uncertainties. If our

assumptions regarding the risks and uncertainties we face, which we use to plan our business, are

incorrect or change due to circumstances in our business or our markets, or if we do not address these

risks successfully, our operating and financial results could differ materially from our expectations and our

business, financial condition, results of operations and prospects could suffer.

If healthcare providers are unwilling to change their standard practice regarding the evaluation of

CAD, our business, financial condition, results of operations and prospects will be adversely

affected.

Our success depends on physicians, hospitals and other healthcare providers adopting and using the

Heartflow Platform to aid in the evaluation of CAD. While we have had some recent success in achieving

broader adoption of the Heartflow Platform, we have in the past faced, and may in the future face,

challenges in achieving higher rates of adoption. Many healthcare providers have extensive experience

with existing non-invasive tests for CAD and have established relationships with the companies that

provide these tests or in some instances own or manage the equipment for these tests in their offices.

Existing tests are performed in a high enough volume that healthcare providers generate sufficient

revenue from their use and are well versed in their use, reimbursement and outcomes. The outcomes and

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workflow efficiencies that we believe our Heartflow Platform provides may not be valued by healthcare

providers as highly as we expect or at all. In addition, healthcare providers have been, and may continue

to be, slower to adopt or recommend our products because we have a more limited commercial track

record and healthcare providers may feel they can generate more revenue from existing tests. Healthcare

providers also may not find our clinical data compelling and may not recommend or use our products until

they receive additional recommendations from other healthcare providers that our products have a clinical

benefit, or at all.

In addition, the Heartflow Platform relies on healthcare providers following the ACC and AHA guidelines

by referring certain patients with stable or acute chest pain and no known CAD to undergo a CCTA, with

the CCTA images to be analyzed by our Heartflow FFRCT Analysis. Although the ACC and AHA guidelines

support CCTA plus our Heartflow FFRCT Analysis as the preferred pathway for diagnosing and managing

CAD in certain patients with stable or acute chest pain and no known CAD, these guidelines may not be

widely adopted by healthcare providers. Moreover, healthcare providers may choose not to adopt the

Heartflow Platform if they are not able to obtain an adequate CCTA. Further, if future studies and trials or

other events, including reimbursement rates of CCTA, adversely impact the rate of use of CCTAs in

practice, then healthcare providers may be less willing to adopt a technology that uses CCTAs.

Also, the Heartflow Platform may be more difficult than we expect to integrate into standard practice

because a provider may be resistant to introduce our embedded information technology and workflow

infrastructure. Due to different laws, policies and preferences of healthcare providers regarding patient

privacy both in the United States and abroad, they may be averse to sending data externally (outside of

their facility) or abroad. Furthermore, if healthcare providers using the Heartflow Platform experience what

they perceive to be false negative result or imprecise readings, including due to user error, they may

determine not to continue using our platform going forward.

We expect that addressing these and similar issues will require a significant amount of our time and

resources, and if we are unsuccessful, we would be unable to achieve broader adoption of the Heartflow

Platform by healthcare providers. If our products do not gain broader acceptance by healthcare providers,

our business, financial condition, results of operations and prospects will be adversely affected.

If third-party payors, including government payors, do not cover and provide adequate

reimbursement for the Heartflow Platform, or if existing payment amounts are reduced or coding

policies change, adoption of the Heartflow Platform by healthcare providers may be negatively

impacted, and our business, financial condition, results of operations and prospects will be

adversely affected.

Our ability to grow sales and revenue from our Heartflow FFRCT Analysis and to successfully

commercialize our Heartflow Plaque Analysis depend, in large part, on whether third-party payors,

including private health insurers, managed care plans and government healthcare programs, such as

Medicare and Medicaid, cover and adequately reimburse for the use of the Heartflow Platform and the

underlying CCTA. Patients generally rely on payors to reimburse all or a significant part of the costs

associated with their treatment. As a result, appropriate coding, coverage determinations, and

reimbursement levels are critical to the commercial success of the Heartflow Platform. Reimbursement is

obtained from a variety of sources, including government sponsored and private health insurance plans,

and varies by country and by region within some countries. These payors determine whether to provide

coverage and payment for specific products and procedures.

In addition, payors continually review new technologies and can, without notice, change coverage

parameters, deny coverage, bundle services, or reduce payment amounts. As a result, the coverage

determination process is often time consuming and costly, with no assurance that coverage and adequate

reimbursement will be obtained or maintained if obtained. If payors change their reimbursement policies,

or if the current Category I CPT codes related to our Heartflow FFRCT Analysis or future Category I CPT

codes related to our Heartflow Plaque Analysis are not favorably categorized or priced, reimbursement for

the Heartflow Platform could be reduced to an amount that would make adoption of our Heartflow

Platform challenging.

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Moreover, physicians, hospitals and other healthcare providers may decline to adopt or reduce usage of

the Heartflow Platform due to the economic impact a negative change in reimbursement may have on

their business and, as a result, we may experience a significant loss of revenue, which would have a

material adverse effect on our business, financial condition, results of operations and prospects.

Reimbursement for our Heartflow Platform, which includes the separately billable services, Heartflow

FFRCT Analysis and Heartflow Plaque Analysis, is subject to periodic changes to reimbursement levels by

government payors and private health insurers. For example, the Centers for Medicare and Medicaid

Services (“CMS”) adopts changes to reimbursement policies during the annual Medicare rulemaking

process, which includes updates to Medicare payment levels to hospitals under the Medicare Hospital

Outpatient Prospective Payment System (“OPPS”) rule, and updates to Medicare payment rates to

physician offices, independent diagnostic testing facilities, and freestanding imaging centers under the

Medicare Physician Fee Schedule (“MPFS”) rule. In addition to risks associated with government

reimbursement, our Heartflow FFRCT Analysis and Heartflow Plaque Analysis technologies face

reimbursement uncertainty from commercial payors, such as UnitedHealthcare, Aetna, Cigna, Anthem,

and regional Blue Cross Blue Shield plans. Such commercial payors routinely reassess their medical

policies, coverage criteria and payment policies and rates, and may choose to deny coverage or payment,

impose restrictive utilization management protocols (such as prior authorization), or reduce or bundle

payment amounts based on internal cost-effectiveness assessments or evolving clinical guidelines. Even

if Medicare maintains favorable reimbursement, commercial payors may independently determine

whether Heartflow FFRCT Analysis or Heartflow Plaque Analysis meets their plans’ medical necessity

standards, which may vary among commercial payors.

As part of their participation in the Medicare program and in support of the annual rulemaking process,

hospitals submit Medicare cost reports and report their charges for specific services provided in the

hospital setting. These cost and charge data reported from hospitals can impact reimbursement rates

because CMS uses that data to determine future Medicare reimbursement levels on an annual basis. In

the aggregate, when costs associated with a specific service reported by the hospitals decrease, there is

a risk that CMS will reduce the reimbursement rate proportionately. These lower reported costs can be a

result of coding errors or erroneous denials of claims, the inclusion of lower-cost services within the APC,

reductions in costs for services within the APC, or other similar issues. For example, in July 2025, CMS

issued the proposed 2026 OPPS rule, which, if finalized as proposed, could result in a reduction of up to

15% in the Medicare reimbursement rate for the clinical APC that includes our Heartflow FFRCT Analysis,

along with other hospital services. CMS publishes final OPPS and MPFS rules in the fourth quarter each

year. We cannot be sure at this time whether the proposed hospital reimbursement rate for Heartflow

FFRCT Analysis for 2026 will be finalized, modified, or if CMS will increase the rate back to 2025 levels.

There is a risk that similar or other coding or claims issues may occur and lead CMS to lower the

reimbursement rate for the Heartflow Platform for 2027 or in future years. In addition, we may not become

aware of any such issues early enough to prevent any adverse impacts to the reimbursement for our

products, and our ability to remedy any such issues may be limited by applicable laws, regulations or

policies.

Given the evolving nature of the healthcare industry and ongoing healthcare cost reforms, we are and will

continue to be subject to effects of changes in the level of reimbursement for our products. We cannot be

sure that third-party payors will maintain the current level of coverage and payment to our customers for

use of our existing products. A reduction in coverage or payment or change in policy by the Medicare

program could cause some commercial third-party payors to implement similar reductions in their

coverage or payment amounts for the Heartflow Platform. Unfavorable coverage or payment

determinations at the national or local level could adversely affect our business, financial condition,

results of operations and prospects.

We face risks associated with a concentrated customer base.

Our Heartflow Platform had an installed base of more than 1,100 accounts in the United States as of

December 31, 2024. We define an “account” as any individual facility that orders a Heartflow FFRCT

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Analysis, Heartflow Plaque Analysis, or both. We define an account as “new” if a unique facility begins

generating revenue cases for our FFRCT Analysis, Plaque Analysis, or both. Accounts may have more

than one reading physician or CT machine. Conversely, a “customer” can be either an individual account

or a health or hospital system with multiple accounts. While a single customer may include multiple

accounts, no single customer accounted for 10% or more of our revenue during the years ended

December 31, 2023 and 2024 or for the three months ended March 31, 2024 and 2025. However, the

decision-making function for some of these accounts is concentrated in a relatively small number of

customers, such that the loss of one customer could result in a disproportionate loss across our accounts.

For example, for the year ended December 31, 2024, our top two largest customers, both large health

systems with multiple accounts, collectively represented approximately 8% of our revenue.

We cannot guarantee that that we will continue to generate revenue from these customers, whether due

to increase in competition, new technologies, our customers’ ability to terminate their contracts with us or

reduce order volumes, or other factors outside of our control. If we do not increase the number of our

customers and drive increased use of the Heartflow Platform as the preferred non-invasive testing

method for assessing CAD, we will continue to face risks associated with a more concentrated customer

base.

Revenue from these customers may fluctuate from time to time due to demand for the Heartflow Platform,

the timing of which may be affected by seasonality or other factors outside of our control such as CT

scanner capacity, contrast availability and staffing availability. These customers could also potentially

pressure us to reduce the prices we charge for the Heartflow Platform, which could have a material

adverse effect on our margins and business. For example, during the year ended December 31, 2024,

our average sales price was impacted by customer pricing contracts that included utilization and volume

rebates and by changes in the mix of customer accounts, which trend we expect to continue in the near

term, and it is possible that similar trends in customer pricing contracts may continue to have a negative

impact on our average sales price in the future. In addition, if any of our largest customers terminates its

relationship with us or otherwise reduces its FFRCT Analysis volumes for any reason, we may be unable

to replace them with a customer who refers a similar number of patients for the Heartflow Platform, and

such termination or reduction in volume could have a material adverse effect on our business, financial

condition, results of operations and prospects.

We face significant competition in an environment of rapid technological change, and there is a

possibility that our competitors may develop products that are more effective, accurate, reliable,

cost-effective or more advanced than ours, which may harm our financial condition. If we are

unable to compete successfully or our potential market share is reduced, we may be unable to

increase or sustain our revenue or achieve profitability.

The medical technology industry is highly competitive, subject to rapid change and significantly affected

by the introduction of new products and technologies and other activities of industry participants. Because

of the size of the market opportunity for the treatment of CAD, we believe current and potential future

competitors will dedicate significant resources to aggressively promote their products or develop new

products or treatments. Our principal competition comes from companies that provide traditional non-

invasive tests that aid physicians in the evaluation of CAD, such as SPECT, stress echocardiography and

PET. Established, traditional non-invasive tests for CAD have been used for many years and are therefore

difficult to change or supplement. Many of the companies that sell these traditional non-invasive tests or

the equipment they require have established relationships with healthcare providers. One of the major

hurdles to adoption of our products is overcoming established testing patterns, which requires education

of physicians and supportive clinical data.

The companies that sell the traditional non-invasive tests for CAD include companies that offer: (i) cardiac

specific tests to primary care and cardiology offices, such as manufacturers of capital equipment for

stress echocardiography and SPECT, including GE Healthcare, Siemens Healthineers AG and Koninklijke

Philips N.V.; and (ii) products used for the invasive FFR testing market.

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With the greater resources of some of these competitors and their more diversified product offerings, it is

possible that they or other entrants into the market may develop competing products or technologies that

could be more effective, accurate, reliable, cost-effective, more advanced or otherwise improved relative

to the Heartflow Platform, which could render our products obsolete or less competitive. In addition, one

or more competitors could develop and market an on-premise solution, which may be more appealing

than our cloud-based offering. Moreover, new treatments, such as GLP-1s, may indirectly reduce stenosis

or plaque build-up, which could reduce the market opportunity for non-invasive CAD tests and, as a

result, our Heartflow Platform. In addition, we currently target our Heartflow Platform for use only on

symptomatic patients and expanding the Heartflow Platform for asymptomatic patients may take years,

with potential delays due to the high-risk nature of the effort. Our competitors who offer traditional non-

invasive tests offer those tests to both symptomatic and asymptomatic patients, and this increased market

penetration could create additional price pressure for our products.

In addition, the field of cardiovascular genomics is subject to rapidly changing technology, and others may

invent and commercialize technology platforms such as next generation sequencing approaches that

could compete with our products or could make our products or any product we may sell in the future

obsolete. We also face competition and price pressure from companies that have developed or are

developing AI-based platforms that leverage CCTA to diagnose CAD, including earlier-stage companies

such as Cleerly, Inc., Elucid Bioimaging Inc. and Keya Medical Technology Co., Ltd. We may also face

competition from companies developing AI-based platforms, even if they are not currently in the CAD

market and recent and future advances in AI may allow other companies to quickly create competing

products, and they may be able to create such products less expensively and benefit from FDA and

reimbursement approvals we and others have obtained. For us to remain competitive, we must

continuously work on our products’ design and features, improve our algorithms, and invest in and

develop new technologies, including in the rapidly evolving area of AI. If we are unable to introduce

products, features and improvements aimed at increasing the value proposition of the Heartflow Platform

for our customers, or if the products, features and improvements we introduce are viewed less favorably

than our competitors’ products, we may be unable to compete successfully. If we are unable to compete

successfully against our current or future competitors, we may be unable to increase market acceptance

for our products, which could prevent us from increasing or sustaining our revenue or achieving

profitability and could cause the market price of our common stock to decline.

In addition, the Heartflow Platform relies on a CCTA first being performed, as the Heartflow Platform

requires a CT image from a CT scanner to perform its analysis. A number of companies manufacture CT

scanners, including, among others, GE Healthcare, Hitachi, Ltd., Koninklijke Philips N.V., Samsung

Electronics Co., Ltd., Siemens Healthineers AG and Canon Medical Systems Corporation. These

companies are more diversified than we are and have substantial financial, manufacturing, sales and

marketing distribution and other resources. Any of these companies or others could determine to develop,

partner with or acquire and offer a product that competes with ours or manufacture CT scanners that are

no longer compatible with our Heartflow Platform. Further, these larger companies have market

penetration in the CT scanner market and understand the market for CAD and, if they are able to develop,

partner with or acquire a competing product, they may offer it as a bundle with the purchase of a CT

scanner, which could prevent us from increasing or sustaining our revenue or achieving profitability. In the

past, three of these companies, Siemens Healthineers AG, Koninklijke Philips N.V. and Canon Medical

Systems Corporation, considered development of a local workstation-based technology prototype aimed

at deriving CT-based blood flow data without an invasive procedure. If these companies decide to further

pursue this technology and obtain regulatory approval or clinical validation, it may become competitive

with our products. In addition, we are reliant on these third-party CCTAs and CT scanners continuing to

support standard output file formats that our Heartflow Platform supports. If a CT manufacturer were to

change to a proprietary format or develop a novel method of performing CT scans, we would need to

further develop our existing technology to accommodate the images its scanners output, which could

materially affect the ability of physicians to use the Heartflow Platform, increase our R&D expenses, and

could adversely affect our business, financial condition, results of operations and prospects.

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The size and expected growth of our addressable market may be smaller than we estimate.

Our estimate of the addressable market for our current products and any future products is subject to

significant uncertainty and is based on assumptions and estimates, including our internal analysis and

industry experience. While we believe our assumptions and the data underlying our estimates are

reasonable, these assumptions and estimates may not be correct. As a result, our estimates of the

addressable market for our current or future products may prove to be incorrect. Moreover, our ability to

serve a significant portion of this estimated market is subject to many factors, including our success in

promoting the use of CCTA as a non-invasive diagnostic test that can be combined with the Heartflow

Platform, which is subject to many risks and uncertainties, and relies on the availability and proximity of

healthcare facilities with active CCTA programs to the patients in our estimated market. Accordingly, if we

are unable to increase the use of CCTA at the rates we estimate, if the actual number of patients who

would benefit from our products is less than we estimate, or if the price at which we can sell future

products or the reimbursement rate received by healthcare providers is less than we estimate, the size

and expected growth of our addressable market would be smaller than our estimates, which could have a

material adverse effect on our business, financial condition, results of operations and prospects.

We may not be successful in updating or otherwise enhancing the Heartflow Platform.

A part of our strategy is bringing new enhancements to our customers through updates to the Heartflow

Platform, which may include offering new products, additional features, applications and improvements to

our technology. We expect to make significant investments to advance these efforts, and enhancing the

Heartflow Platform is a complex and time-consuming endeavor. New products, additional features,

applications and improvements to our technology that initially show promise may fail to achieve the

desired results or may not achieve acceptable levels of analytical accuracy, utility or user friendliness.

Product development and improvement is expensive, may take months or years to complete and can

have uncertain outcomes. Failure can occur at any stage of the development or improvement process

and may occur only after substantial work has been completed, or after completion.

Even if, after development, an updated product appears successful, we may, depending on the nature of

the update, need to obtain regulatory clearances, authorizations or approvals before we can market the

updated product. Such regulatory clearances, authorizations or approvals are likely to require significant

time and expenditures and the applicable regulatory authority may not clear, authorize or approve any

product, update or new product we develop. Obtaining such clearances, authorizations or approvals may

require data from clinical trials, which can be costly and time-consuming to obtain. In certain jurisdictions

or in certain cases, clinical data may also be required in order to obtain reimbursement coverage, and this

clinical data may be in addition to data required to obtain regulatory clearances, authorizations or

approvals. Some clinical studies may fail to meet their endpoints, introducing risk or delay in the ability to

commercialize a new feature or product. In light of these requirements, we may choose to limit the scope

of any new products, additional features, applications and improvements we seek to develop.

Even if we develop a product update or new product that receives regulatory clearance, authorization or

approval, and for which we obtain sufficient commercial third party and government reimbursement

coverage, we would need to commit substantial resources to commercialize and market the updated

product, new product or new application of our existing product, which may never achieve market

acceptance among various stakeholders or be commercially successful. Further, the applicable

regulations or the application of those regulations could change in ways that would impact the Heartflow

Platform and our ability to successfully manufacture or market our products. The expenses or losses

associated with unsuccessful updates to or expansion of the Heartflow Platform could adversely affect our

business, financial condition, results of operations and prospects.

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The commercialization of Heartflow Plaque Analysis is nascent, and we may not be able to

achieve or maintain sufficient market acceptance or the levels of utilization we expect from

Heartflow Plaque Analysis or any other future product.

We began limited market education efforts for our Heartflow Plaque Analysis in the second half of 2023,

and we have generated very minimal revenue from this product. Heartflow Plaque Analysis has taken

time and significant resources to develop, and we may not be able to achieve customer acceptance or

broad commercial reimbursement coverage, which could limit its adoption.

The market for alternative plaque analysis products is competitive in terms of development, availability,

pricing, product quality and time-to-market. We face competition from companies that provide or are

developing similar plaque analysis products, which may distinguish themselves from us through, among

other things, perceived product quality, style and visuals, sleek design, enhanced user-friendliness and

innovative features. In addition, some of these competitors are agile, early-stage companies that may be

able to respond more quickly and effectively than we can to new or changing opportunities, technologies,

standards or customer requirements in the plaque analysis category. Some of these competitors

commercially launched competing plaque analysis products prior to our launch of Heartflow Plaque

Analysis and may have a first-mover advantage as a result. For more information on risks related to our

competition, see the risk factor titled “We face significant competition in an environment of rapid

technological change, and there is a possibility that our competitors may develop products that are more

effective, accurate, reliable, cost-effective or more advanced than ours, which may harm our financial

condition. If we are unable to compete successfully or our potential market share is reduced, we may be

unable to increase or sustain our revenue or achieve profitability.”

Our competitors may also be able to offer plaque analysis products similar or superior to ours at a more

attractive price than we can or may be better positioned to serve certain segments of our market, which

could create additional price pressure. For example, our competitors have in the past, and may in the

future, offer plaque analysis and other products at a more attractive price than we can such that current or

potential customers may select our competitors’ products in lieu of purchasing and using our Heartflow

Plaque Analysis. Moreover, our competitors have in the past, and may in the future, suggest that their

plaque analysis and other products could replace both our Heartflow Plaque Analysis and our Heartflow

FFRCT Analysis, which would adversely affect our ability to achieve sufficient market acceptance for our

Heartflow Plaque Analysis, could affect sales of our Heartflow FFRCT Analysis and could cause our

Heartflow FFRCT Analysis to lose market share. While we believe Heartflow Plaque Analysis represents a

significant long-term opportunity for us, there can be no assurances that we will successfully compete in

such market and our business, financial condition, results of operations and prospects could be materially

and adversely affected.

We face risks associated with our use and development of AI models, which may result in

operational challenges, legal liability, reputational concerns and competitive risks.

We use and develop AI and automated analysis and decision-making technologies, including proprietary

AI algorithms and models and computational fluid dynamics (collectively, “AI Technologies”) to power the

Heartflow Platform. In addition, we use AI Technologies to drive improvements in the performance of the

Heartflow Platform. We expect that significant increased investment will be required in the future to

improve our use and development of AI Technologies.

As with many technological innovations, there are significant risks involved in developing, maintaining and

deploying these technologies. In particular, if the AI Technologies underlying our Heartflow Platform are

incorrectly designed or implemented; trained or reliant on incomplete, inadequate, inaccurate or otherwise

poor quality data; used without sufficient oversight and quality control; misused or used outside of scope

of applicable regulatory authorizations; and/or adversely impacted by unforeseen bugs, defects, technical

challenges, cybersecurity threats or material performance issues, the performance of our Heartflow

Platform and business, as well as our reputation and the reputations of our customers, could suffer or we

could incur liability resulting from the violation of laws or contracts to which we are a party, regulatory

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enforcement actions or civil claims. This could result in fines, penalties and damage awards and

disgorgement of any output, development or technology developed as a result of such violations.

In addition, we leverage a human-in-the-loop AI system that combines advanced algorithms with an

analyst-based quality inspection and monitoring process to create patient-specific reports based on CCTA

images. While we constantly work to improve our Heartflow Platform and algorithms, the AI Technologies

we work with are novel and complex, and we cannot assure you that our AI Technologies will be able to

perform as intended under all circumstances, or that our analyst-based review process will identify and

correct any errors in the outputs of our AI Technologies.

The regulatory framework for AI Technologies is rapidly evolving as many federal, state and foreign

government bodies and agencies have introduced or are currently considering additional laws, regulations

and guidance. For example, the FDA has issued guidance documents relating to the incorporation of AI

Technologies into medical devices and marketing submissions for AI-enabled devices. Specifically, draft

guidance issued on January 7, 2025, titled Artificial Intelligence-Enabled Device Software Functions:

Lifecycle Management and Marketing Submission Recommendations, proposes recommendations for the

design, development and implementation of AI-enabled devices that FDA encourages manufacturers

consider using throughout the total product lifecycle. In addition, the California Privacy Protection Agency

has approved for rulemaking regulations under the CCPA regarding the use of automated decision-

making that may require risks and providing notice and rights to opt-out and access to information

underlying the logic and outputs. Colorado passed the Colorado AI Act, which will go into effect in

February 2026. This law creates duties for developers and deployers to use reasonable care to protect

consumers from any known or reasonably foreseeable risks of “algorithmic discrimination” arising from

the intended and contracted uses of “high-risk AI systems,” including those that impact healthcare

services. Such additional laws, regulations and guidance may impact our ability to develop, use and

commercialize AI Technologies in the future.

It is possible that further new laws and regulations will be adopted in the United States and in other non-

U.S. jurisdictions, or that existing laws and regulations, including competition and antitrust laws, may be

interpreted in ways that would limit our ability to use AI Technologies for our business, or require us to

change the way we use AI Technologies in a manner that negatively affects the performance of our

Heartflow Platform and the way in which we use AI Technologies. We may need to expend resources to

adjust our Heartflow Platform in certain jurisdictions if the laws, regulations or decisions are not consistent

across jurisdictions. Further, the cost to comply with such laws, regulations or decisions and/or guidance

interpreting existing laws, could be significant and would increase our operating expenses (such as by

imposing additional reporting obligations regarding our use of AI Technologies). Such an increase in

operating expenses, as well as any actual or perceived failure to comply with such laws and regulations,

could materially and adversely affect our business, financial condition, results of operations and

prospects.

Our Heartflow Platform and the data and models it generates could have bugs, defects or errors,

including human quality control errors, or otherwise fail to meet the expectations of patients,

physicians and third-party payors, which could adversely affect our reputation, business and

operating results.

We cannot provide assurance that the proprietary technology and algorithms used in our Heartflow

Platform do not contain undetected bugs, defects or errors or that our analyst-based review process will

identify and correct any errors in the outputs of our AI Technologies. We cannot provide assurance that

limitations of the inbound CCTA images and image quality will always allow a true representation of the

patient anatomy, and any such limitations in CCTA images could affect the results of our analyses. We

have in the past, and may in the future, experience defects or errors in our Heartflow Platform or the data

and models it generates that remain undetected by our analyst-based review process, our reputation,

business and operating results could be adversely affected.

Furthermore, the success of the Heartflow Platform depends in part on patients’, physicians’ and third-

party payors’ confidence that our platform can provide reliable, high-quality actionable data and analysis

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that will improve clinical decision making. We believe that patients, physicians and third-party payors are

likely to be sensitive to product defects and errors in the use of our products, including if the defects and

errors affect a physician’s ability to use the CCTA imaging results or result in a misdiagnosis. In the past,

we have experienced software code defects and software release process defects that have resulted in

intermittent interruptions to the physician’s ability to use our Heartflow Platform, and we may experience

such defects in the future. A subset of these defects were reported as part of the FDA’s Manufacturer and

User Facility Device Experience (“MAUDE”) disclosure. For more information, see the risk factor titled

“The Heartflow Platform may be subject to recalls, which could be costly and could harm our reputation

and business.” As a result, the failure of our Heartflow Platform to perform as expected, including to

reduce unnecessary invasive testing or fail to enable physicians to optimize treatment planning or provide

more efficient care, could significantly impact a physician’s willingness to use and rely on the Heartflow

Platform, which would impair our operating results and our reputation. In addition, we may be subject to

legal claims arising from any such failures.

Bugs, defects or errors in the Heartflow Platform or the failure of third-party service providers we rely on,

such as AWS or other cloud storage and telecommunications services providers, to block a virus or

prevent a security breach could harm our reputation and adversely impact our results of operations.

Defects may cause our products to be vulnerable to security attacks, cause them to fail to produce

accurate results or temporarily interrupt our commercial operations. Because the techniques used by

computer hackers to access or sabotage networks change frequently and generally are not recognized

until launched against a target, we or our third-party services providers may be unable to anticipate these

techniques and provide a corrective measure in time to protect the Heartflow Platform and our networks.

Potential defects may further cause the platform to be unavailable for a period of time, affect ability of a

customer to access information, result in a slow or suboptimal user experience, impact turnaround time of

an analysis, or provide other forms of degradation to the overall service.

We depend on our talent to grow and operate our business, and if we are unable to hire, integrate,

develop, motivate and retain our personnel, including highly qualified, technical personnel, we

may not be able to grow effectively and this could adversely affect our business.

To execute our growth plan, we must attract and retain highly qualified, technical personnel. Competition

for these personnel is intense, especially for engineers with high levels of expertise in AI, cloud

architecture, 3D visualization, research scientists and senior sales executives with experience in the

cardiology industry. We may experience difficulty in hiring and retaining employees with appropriate

qualifications. Many of the companies with which we compete for experienced personnel have greater

resources than we have. We also compete with companies that are believed to have high potential growth

opportunities or that have experienced rapid recent growth.

Our future success depends in part on our ability to continue to retain our executive officers and other key

employees and to recruit and hire new employees, including engineers, research scientists, case analysts

and production team members. We do not maintain “key person” insurance for any of our executives or

other employees. The loss of the services of any of these persons could impede the achievement of our

development, research and commercialization objectives. Any of our executive officers and other

employees may terminate employment with us at any time with no advance notice. The replacement of

any of our key personnel likely would involve significant time and costs, may significantly delay or prevent

the achievement of our business objectives and may harm our business.

In addition, job candidates and existing employees often consider the value of the stock awards they

receive in connection with their employment. If the perceived value of our stock awards declines or is

perceived to be less valuable than stock awards of other competing employers, it may adversely affect

our ability to recruit and retain highly skilled employees. In addition, many of our employees have become

or will soon become vested in a substantial amount of stock or number of stock options. Our employees

may be more likely to leave us if the shares they own or the shares underlying their vested options have

significantly appreciated in value relative to the original purchase prices of the shares or the exercise

prices of the options, or if the exercise prices of the options that they hold are significantly below the

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market price of our common stock. If we fail to attract new personnel, or fail to retain and motivate our

current personnel, our business and prospects could be adversely affected.

If we fail to properly manage our future growth, our business could suffer.

We intend to continue to grow and may experience periods of rapid growth and expansion, which could

place a significant additional strain on our limited personnel, information technology systems and other

resources. Our future growth will impose significant added responsibilities on management, including the

need to identify, recruit, train and integrate additional employees. In order to manage our operations and

growth we will need to continue to improve our operational and management controls, administrative and

operational infrastructure, reporting and information technology systems and financial internal control

procedures. Due to our limited financial resources and the limited experience of our management team in

managing a company with such future growth expectations, we may not be able to effectively manage the

expected expansion of our operations or recruit and train additional qualified personnel. Moreover, the

expected expansion of our operations may lead to significant costs and may divert our management and

business development resources. Any inability to manage growth could delay the execution of our

business plans or disrupt our operations.

In addition, as demand for the Heartflow Platform increases, we will need to scale our capacity, expand

customer service and enhance our internal quality assurance program. We may fail to implement any

increases in scale, related improvements and quality assurance, and we may fail to find appropriate

personnel to facilitate the growth of our business. Due to our limited resources, we may not be able to

effectively manage this simultaneous execution and expansion of our operations. This may result in

weaknesses in our infrastructure, give rise to operational mistakes, legal or regulatory compliance

failures, loss of business opportunities, loss of employees and reduced productivity among remaining

employees. The expansion of our operations may lead to significant costs and may divert financial

resources from other projects, such as the development of any new products. If our management is

unable to effectively manage our expected development and expansion, our expenses may increase

more than expected, our ability to generate or increase our revenue could be reduced and we may not be

able to implement our business strategy. Our future financial performance and our ability to compete

effectively and commercialize our Heartflow Plaque Analysis or any of our future products will depend in

part on our ability to effectively manage the future growth and expansion of our company. If we are unable

to manage our growth effectively, it may be difficult for us to execute our business strategy and our

business, financial condition, results of operations and prospects may be adversely affected.

Our business could be disrupted by catastrophic events.

The occurrence of any catastrophic event, including earthquake, fire, flood, tsunami or other weather

event, power loss, telecommunications failure, software or hardware malfunctions, pandemics, political

unrest, geopolitical instability, severe or prolonged economic downturn, cyberattack (including a

ransomware attack), war or terrorist attack, could result in lengthy interruptions in our ability to serve our

customers. In addition, acts of terrorism could cause disruptions to the internet or the economy as a

whole and could disproportionately affect us given our reliance on the internet and cloud-based services.

Specifically, our corporate headquarters are located in Mountain View, California and our production

related computers are currently located in our Mountain View office and in Austin, Texas. California is

considered to be an active earthquake zone, is prone to catastrophic fires, severe weather events and the

follow-on effects thereof, including tsunamis, mudslides, flooding, power outages and other events that

could disrupt our business. Texas is also subject to severe weather events, power outages and other

events that could disrupt our business. Any event that prevents our access to such facilities, physically or

virtually, would prevent us from operating our business and have an adverse effect on our business,

financial condition, results of operations and prospects.

In addition, we rely on our network and third-party infrastructure, including our cloud-based infrastructure

which we outsource to Amazon Web Services (“AWS”), and enterprise applications, internal technology

systems and our website, for our development, marketing, operational support hosted services and sales

activities. In the event of a catastrophic event, we may be unable to continue our operations and may

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endure system interruptions, delays in our ability to generate reports and output them to physicians,

reputational harm, delays in our product development, breaches of data security and loss of critical data,

all of which could have an adverse effect on our future operating results. If we are unable to develop

adequate plans to ensure that our business functions continue to operate during and after a disaster and

to execute successfully on those plans in the event of a disaster or emergency, our business would be

harmed. Even with our disaster recovery arrangements and insurance coverage, the ability of our

customers to access and utilize our Heartflow Platform could be interrupted, or we could close critical

data, which would have a negative impact on our business.

In addition, the occurrence of a catastrophic event could impact providers of CCTAs, contrast agents for

CCTAs or suppliers of iodinated contrast media or similar supplies that are necessary to perform CCTAs.

For example, in 2022, the shutdown of an iodinated contrast media manufacturing facility led to a

significant shortage of iodinated contrast media, which resulted in the cancellation or rescheduling of non-

urgent contrast-requiring cardiac procedures and imaging. Any of these events could affect demand for

the Heartflow Platform, which could have a material adverse effect on our business, financial condition,

results of operations and prospects.

Consolidation among healthcare providers could have an adverse effect on our business,

financial condition, results of operations and prospects.

In the United States, there has been a trend of consolidation among healthcare providers and purchasers

of medical technology devices, often to gain greater market power. As healthcare providers consolidate,

they may try to use their market power to negotiate price concessions or reductions for the products and

services they purchase and use, including our Heartflow Platform. As result, it is unknown whether such

purchasers will decide to stop purchasing our Heartflow Platform or demand discounts on our prices. If we

reduce our prices in response to these industry trends, our revenue would decrease, which could have a

material adverse effect on our business, financial condition, results of operations and prospects.

We may acquire other companies, solutions or technologies, which could divert our

management’s attention, result in additional dilution to our stockholders and otherwise disrupt

our operations and adversely affect our operating results.

We may in the future seek to acquire or invest in companies, solutions or technologies that we believe

could complement or expand our products, enhance our technical capabilities or otherwise offer growth

opportunities. The pursuit of potential acquisitions or other investment opportunities may divert the

attention of management and cause us to incur various expenses in identifying, investigating and

pursuing suitable transactions, whether or not they are consummated.

If we acquire any businesses, we may not be able to integrate the acquired personnel, operations and

technologies successfully, or effectively manage the combined business following the acquisition. We also

may not achieve the anticipated benefits from the acquired business due to a number of factors,

including: inability to integrate or benefit from acquired technologies or services in a profitable manner;

unanticipated costs or liabilities associated with the acquisition; incurrence of acquisition related costs;

difficulty integrating the accounting systems, operations and personnel of the acquired business;

difficulties and additional expenses associated with supporting legacy products and hosting infrastructure

of the acquired business; diversion of management’s attention from other business concerns; use of

resources that are needed in other parts of our business; adverse effects to our existing business

relationships with business partners and customers as a result of the acquisition; the potential loss of key

employees; and use of substantial portions of our available cash to consummate the acquisition.

In addition, a significant portion of the purchase price of any companies, solutions or technologies that we

may acquire may be allocated to acquired goodwill and other intangible assets, which must be assessed

for impairment at least annually. If our acquisitions do not yield expected returns, we may be required to

take charges to our operating results based on this impairment assessment process, which could

adversely affect our results of operations.

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Acquisitions could also result in dilutive issuances of equity securities or the incurrence of debt, which

could adversely affect our operating results and cause the market price of our common stock to decline. If

an acquired company, solution or technology fails to meet our expectations and does not complement or

expand our products, enhance our technical capabilities or otherwise offer growth opportunities, our

business, financial condition, results of operations and prospects may suffer. In addition, the 2024 Credit

Agreement restricts our ability to pursue certain mergers, acquisitions, amalgamations or consolidations

that we may believe to be in our best interest.

Sales to customers outside the United States or with international operations expose us to risks

inherent in international sales.

In our fiscal years ended December 31, 2023 and 2024 and three months ended March 31, 2024 and

2025, sales to customers outside the United States accounted for approximately 11%, 9%, 9% and 8% of

our revenue, respectively. One element of our growth strategy is to further expand our international

operations and worldwide customer base. Operating in international markets requires significant

resources and management attention and subjects us to regulatory, economic and political risks that are

different from those in the United States.

We have limited operating experience in international markets, and we cannot assure you that our

existing presence in the United Kingdom, Europe and Japan or any expansion efforts into other

international markets will be successful. Our experience in the United States and international markets

may not be relevant to our ability to expand in other markets. Our international expansion efforts may not

be successful in creating further demand for our products outside of the United States or in effectively

selling our products in the international markets we enter. In addition, expansion into other international

markets will be costly and will impose additional burdens on our executive and administrative personnel,

finance and legal teams, sales and marketing teams and general managerial resources. If our efforts to

introduce our products into other international markets are not successful, we may have expended

significant resources without realizing the expected benefit. Ultimately, the investment required for

international expansion could exceed the results of operations generated from this expansion.

In addition, we operate in an industry which is subject to significant enforcement scrutiny by both U.S. and

non-U.S. government authorities. Our international business requires us to comply with U.S. and foreign

laws and regulations, such as various anti-bribery and anti-corruption laws, including the U.S. Foreign

Corrupt Practices Act (“FCPA”), the U.S. Fraud Act and in certain cases the U.K. Bribery Act of 2010.

Compliance with these is costly and exposes us to significant civil and criminal penalties for non-

compliance. Any failure to comply with applicable legal and regulatory obligations could impact us in a

variety of ways that include, but are not limited to, significant criminal, civil and administrative fines,

penalties and disgorgement of profits, including imprisonment of individuals, denial of export privileges,

seizure of shipments, restrictions on certain business activities and exclusion or debarment from

government contracting. Our international operations expose us to risks inherent in operating in foreign

jurisdictions that could adversely affect our business.

If we do not obtain and maintain international regulatory registrations, clearances or approvals for

our Heartflow Platform, we will be unable to market and sell our products outside of the United

States.

Any future sales of our products outside of the United States are subject to foreign regulatory

requirements that vary widely from country to country. While the regulations of some countries may not

impose barriers to marketing and selling our products or only require notification, others require that we

obtain the clearance or approval of a specified regulatory authority or a Certificate of Conformity of a

notified body. Complying with foreign regulatory requirements, including obtaining registrations,

clearances or approvals, can be expensive and time consuming and we may not receive regulatory

clearances or approvals in each country in which we plan to market our products or we may be unable to

do so on a timely basis. The time required to obtain registrations, clearances or approvals, if required by

other countries, may be longer than that required for FDA clearance or approval, and requirements for

such registrations, clearances or approvals may significantly differ from FDA requirements. If we modify

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our products, we may need to apply for regulatory clearances or approvals before we are permitted to sell

the modified product.

In addition, AI governing regulations around medical devices evolve rapidly and we may not continue to

meet the quality and safety standards required to maintain the authorizations that we have received. If we

are unable to maintain our authorizations in a particular country, we will no longer be able to sell the

applicable product in that country.

Regulatory registration, clearance, marketing authorization, or approval by the FDA does not ensure

registration, clearance, marketing authorization, or approval by foreign regulatory authorities or authorized

representatives in other countries. Registration, clearance, marketing authorization, or approval by one or

more foreign regulatory authorities or authorized representatives do not ensure registration, clearance,

marketing authorization, or approval by regulatory authorities in other foreign countries or by the FDA.

However, a failure or delay in obtaining registration or regulatory clearance or approval in one country

may have a negative effect on the regulatory process in others.

Risks related to data privacy and information technology

Failure to comply with laws and regulations affecting the transmission, security and privacy of

personal information (including health information) could result in significant penalties.

Federal, state and foreign government bodies and authorities have adopted, are considering adopting, or

may adopt laws and regulations regarding the collection, use, processing, storage and disclosure of

personal information obtained from consumers and individuals. In the United States, federal, state, and

local governments have enacted numerous data privacy and security laws, including data breach

notification laws, personal data privacy laws, consumer protection laws (e.g., Section 5 of the Federal

Trade Commission Act), and other similar laws (e.g., wiretapping laws). Under these laws we may be

required to obtain certain consents to process personal data. For example, some of our data processing

practices have been, and may in the future continue to be, subject to challenges or lawsuits under

privacy, security, and communications laws, including, for example, challenges based on wiretapping laws

for sharing consumer information with third parties through various methods, such as via third-party

marketing pixels or software development kits. Our inability or failure to obtain consent for these practices

could result in adverse consequences, including class action litigation and mass arbitration demands. In

addition, numerous federal and state laws and regulations, including the Health Insurance Portability and

Accountability Act of 1996 (“HIPAA”), as amended by the Health Information Technology for Economic

and Clinical Health Act of 2009 (“HITECH”), govern the collection, dissemination, security, use and

confidentiality of patient identifiable health information. HIPAA and the HITECH Act require us to comply

with standards for the use and disclosure of health information within our company and with third parties.

The Standards for Privacy of Individually Identifiable Health Information (“Privacy Standards”), and the

Security Standards for the Protection of Electronic Protected Health Information (“Security Standards”),

under HIPAA establish a set of basic national privacy and security standards for the protection of

individually identifiable health information by health plans, healthcare clearinghouses and certain

healthcare providers, referred to as covered entities, and the business associates with whom such

covered entities contract for services. As a result, both covered entities and business associates can be

subject to significant civil and criminal penalties for failure to comply with the Privacy Standards or the

Security Standards.

HIPAA, the HITECH Act and the Affordable Care Act (“ACA”) also include standards for common

healthcare electronic transactions and code sets, such as claims information, plan eligibility, payment

information and the use of electronic signatures, unique identifiers, operating rules. Companies that bill

payors for healthcare-related services and device use are required to conform to the transaction

standards. CMS, on behalf of HHS, has the authority to investigate complaints and audit for compliance

with the HIPAA standards for transactions, code sets, unique identifiers and operating rules, including the

Administrative Simplification provisions of HIPAA and the ACA. Failure to comply with these standards,

and any investigation or audit and penalties imposed may have an adverse impact on our business.

HIPAA requires covered entities and business associates to develop and maintain policies and

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procedures with respect to protected health information that is used or disclosed, including the adoption of

administrative, physical and technical safeguards to protect such information. The HITECH Act expands

the notification requirement for breaches of patient identifiable health information, restricts certain

disclosures and sales of patient identifiable health information and provides a tiered system for civil

monetary penalties for HIPAA violations. The Final HIPAA Omnibus Rule modifies the breach reporting

standard in a manner that will likely make more data security incidents qualify as reportable breaches.

The HITECH Act also increased the civil and criminal penalties that may be imposed against covered

entities, business associates and possibly other persons and gave state attorneys general new authority

to file civil actions for damages or injunctions in federal courts to enforce the federal HIPAA laws and seek

attorney fees and costs associated with pursuing federal civil actions. Additionally, states have adopted

comparable privacy and security laws and regulations that differ somewhat from federal and other states’

laws, and that govern where more stringent than federal law.

As a business associate under HIPAA, if we do not comply with the requirements of HIPAA, the HITECH

Act or applicable state privacy and security laws, we could be subject to criminal or civil sanctions that

could adversely affect our financial condition. The costs of complying with privacy and security related

legal and regulatory requirements are substantial and could have an adverse effect on our business. In

addition, we are unable to predict what changes to the HIPAA Privacy Standards and Security Standards

might be made in the future or how those changes could affect our business. Any new legislation or

regulation in the area of privacy and security of personal information, including personal health

information, could also adversely affect our business operations. In addition, a security breach could

require reporting to federal and state government entities, notification to affected individuals, expensive

investigation and remediation and mitigation. Government agencies could, in their discretion, impose fines

and penalties relating to the breach, that would have an adverse effect on our business.

Foreign data privacy regulations, such as the General Data Protection Regulation (E.U.) 2016/679

(“GDPR”), the European Union’s Data Protection Directive (Directive 95/46/EC), and the country specific

regulations that implement Directive 95/46/EC, also govern the processing of personally identifiable data,

and a number of these regulations are stricter than U.S. laws.

In addition, many states have laws, regulations and other authorities that govern data privacy, security

and breach notification. While some of these laws exempt protected health information subject to HIPAA,

they may apply to other personal information we collect, including personal information collected from

employees or from visitors to our website. Failure to comply with these authorities may have an adverse

impact on our business.

We expect to expend significant resources to comply with these laws and regulations. The functional and

operational requirements and costs of compliance with such laws and regulations may adversely impact

our business, and failure to enable our solutions to comply with such laws and regulations could lead to

significant fines and penalties imposed by regulators, as well as claims, lawsuits and contractual

indemnification obligations by or for our customers or third parties and significant reputational harm.

We depend on our information technology systems, and any failure of these systems could harm

our business and adversely affect our business and operating results.

Information technology and telecommunications systems are vulnerable to damage from a variety of

sources, including telecommunications or network failures, failures during the processes of upgrading or

replacing software, power outages, hardware failures, user or human errors and natural disasters.

Moreover, despite network security and back up measures, some of our servers are potentially vulnerable

to cybersecurity incidents, including phishing attacks by computer hackers or other malicious human acts,

computer viruses, ransomware, malware and similar disruptive problems or other methods of

compromising employee or customer administrator credentials to access protected health information and

our internal data. Failures or significant downtime of our information technology or telecommunications

systems could prevent us from operating our business. Any disruption or loss of information technology or

telecommunications systems on which critical aspects of our operations depend could have an adverse

effect on our business and our operating results may suffer.

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In addition, our brand, reputation and ability to attract, retain and serve our customers are dependent

upon the reliable performance of our Heartflow Platform, including our underlying information technology

systems and infrastructure. Our technical infrastructure may not be adequately designed with sufficient

reliability and redundancy to avoid performance delays or outages that could be harmful to our business.

If our Heartflow Platform is unavailable when physicians attempt to access it, or if it does not load as

quickly as they expect, physicians may not use our Heartflow Platform as often in the future, or at all. As

our customer base continues to grow, we will need an increasing amount of technical infrastructure,

including network capacity and computing power, to continue to satisfy the needs of our users.

We rely upon AWS to operate our cloud offering; any disruption of or interference with our use of

AWS would adversely affect our business, results of operations and financial condition.

We outsource all of our cloud-based infrastructure to AWS. Our customers need to be able to access our

cloud-based infrastructure at any time, without interruption or degradation of performance. AWS runs its

own platform that we access, and we are, therefore, vulnerable to service interruptions at AWS. We may

experience interruptions, delays and outages in service and availability from time to time as a result of

problems with our AWS provided infrastructure. For example, in September 2015, AWS suffered a

significant outage that had a widespread impact on cloud-based software and services companies.

Although our customers were not affected by that outage, a similar outage could render our cloud offering

inaccessible to customers. Additionally, AWS has suffered outages at specific customer locations in the

past, rendering the customer unable to access our offering for periods of time. Lack of availability of our

AWS infrastructure could be due to a number of potential causes including technical failures, natural

disasters, fraud or security attacks that we cannot predict or prevent.

In addition, if the security of the AWS infrastructure is compromised or believed to have been

compromised, our business, results of operations and financial condition could be adversely affected. It is

possible that our customers and potential customers would hold us accountable for any breach of security

affecting the AWS infrastructure and we may incur significant liability from those customers and from third

parties with respect to any breach affecting AWS systems. For more information, see the risk factor titled

“Failure to comply with laws and regulations affecting the transmission, security and privacy of personal

information (including health information) could result in significant penalties.” Because our agreement

with AWS limits AWS’ liability for damages, we may not be able to recover a material portion of our

liabilities to our customers and third parties from AWS. Customers and potential customers may refuse to

do business with us because of the perceived or actual failure of our cloud offering as hosted by AWS and

our operating results could be harmed.

Our agreement with AWS allows AWS to terminate the agreement by providing 30 days’ advance notice,

and allows AWS to terminate in case of a material breach of contract if such breach is uncured for 30

days following receipt of notice of such breach, or to terminate immediately upon notice to us (i) if AWS

has the right to suspend our account; (ii) if AWS’ relationship with a third-party software or technology

provider terminates, expires or requires AWS to change the way it provides its services; or (iii) in order to

comply with the law or requests of governmental entities. Although we expect that we could receive

similar services from other third parties, if any of our arrangements with AWS are terminated, we could

experience interruptions on our platform and in our ability to make our platform available to customers, as

well as delays and additional expenses in arranging alternative cloud infrastructure services.

If we fail to offer high quality customer support, our business and reputation could suffer.

Our customers rely on our customer support teams to resolve technical and operational issues if and

when they arise. We may be unable to respond quickly enough to accommodate short-term increases in

customer demand for customer support. We also may be unable to modify the nature, scope and delivery

of our customer support to compete with changes in customer support services provided by our

competitors or to adapt to product and industry developments. Increased customer demand for customer

support, without corresponding revenue, could increase costs and harm our results of operations. In

addition, as we continue to grow our operations and reach a large global customer base, we need to be

able to provide efficient customer support that meets our customers’ needs globally at scale. The number

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of our customers has grown significantly, and that growth has and will continue to put additional pressure

on our support organization. As our business scales, we may need to engage third-party customer

support service providers, which could negatively impact the quality of our customer support if such third

parties are unable to provide customer support that is as effective as that we provide ourselves. Our sales

are highly dependent on our business reputation and on positive recommendations from our existing

customers. Accordingly, high quality customer support is important for the renewal and expansion of our

agreements with existing customers and any failure to maintain such standards of customer support, or a

market perception that we do not maintain high quality customer support, could harm our reputation, our

ability to sell product to existing and prospective customers and our business, financial condition, results

of operations and prospects.

We invest significantly in research and development, and to the extent our research and

development investments do not translate into new products, features or improvements to our

current products, or if we do not use those investments efficiently, our business, financial

condition, results of operations and prospects would be harmed.

A key element of our strategy is to invest significantly in our research and development efforts to

introduce new products, features and improvements aimed at increasing the value proposition of the

Heartflow Platform for our customers. For the years ended December 31, 2023 and 2024 and three

months ended March 31, 2024 and 2025, our research and development expenses were 41%, 35%, 35%

and 37% of our revenue, respectively. If we do not spend our research and development budget efficiently

or effectively on compelling innovation and technologies, our business may be harmed and we may not

realize the expected benefits of our strategy. Moreover, research and development projects can be

technically challenging and expensive. The nature of these research and development cycles may cause

us to experience delays between the time we incur expenses associated with research and development

and the time we are able to offer compelling solutions and generate revenue, if any, from such

investment. For example, investments made to expand the Heartflow Platform to asymptomatic patients

may be expensive, technically challenging, experience delays and may not be successful. Additionally,

anticipated customer demand for a product or feature we are developing could decrease after the

development cycle has commenced, and we would nonetheless be unable to avoid substantial costs

associated with the development of any such product or features. If we expend a significant amount of

resources on research and development and our efforts do not lead to the successful introduction or

improvement of products or features that are competitive in our current or future markets, it would harm

our business, financial condition, results of operations and prospects.

Our networks and those of our third-party service providers may become the target of bad actors

or security breaches that we cannot anticipate or successfully defend, which could have an

adverse impact on our business.

The Heartflow Platform involves the storage and transmission of our customers’ personal information or

identifying information of their patients. Increasingly, we and other companies are subject to a wide variety

of attacks on their networks on an ongoing basis. In addition to attacks from traditional computer

“hackers,” malicious code (such as viruses and worms), employee theft or misuse, ransomware attacks

and denial of service attacks, sophisticated nation state and nation state supported actors now engage in

intrusions and attacks (including advanced persistent threat intrusions), and add to the risks to our

internal networks and the information they store and process. Additionally, such bad actors frequently

attempt to fraudulently induce employees or customers into disclosing sensitive information such as user

names, passwords or other information in order to gain access to our customers’ data, their patient’s data

or our data, including our intellectual property and other confidential business information, or our

information technology systems. Because techniques used to obtain unauthorized access or to sabotage

systems change frequently and generally are not recognized until successfully launched against a target,

we may be unable to anticipate these techniques or to implement adequate preventative measures.

Despite significant efforts to create process and security barriers to such threats, it is virtually impossible

for us to entirely mitigate these risks. Any such breach could compromise our networks, creating system

disruptions or slowdowns and exploiting security vulnerabilities of our products, and the information stored

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on our networks could be accessed, publicly disclosed, lost or stolen, which could subject us to liability

and cause us significant financial harm. Such breaches often result in reputational damage, negative

publicity, loss of industry data security certifications, customers and sales, increased costs to remedy any

problem, costly litigation and contractual indemnification obligations by or for impacted customers or third

parties any of which could adversely affect our business. In addition, although we have, and intend to

maintain, insurance with respect to any such indemnification obligations, the coverage limits of our

insurance policies may not be adequate and one or more successful claims brought against us may have

an adverse effect on our business, financial condition, results of operations and prospects.

We also rely on third-party service providers, such as cloud storage and telecommunications services

providers. Such service providers are also potentially vulnerable to cybersecurity incidents that could

result in the interruption of their services to us or unauthorized access, use or disclosure of our

confidential information and confidential information of our customers and protected health information of

their patients.

Our products are also targets for malicious cybersecurity acts. While some of our products contain

encryption or security algorithms to protect third-party content or patient information or other data stored

in our products, these products could still be hacked or targeted by malicious software programs or other

attacks or the encryption schemes could be compromised, breached or circumvented by motivated or

sophisticated hackers, which could harm our business and our reputation. In addition, see the risk factor

titled “Our Heartflow Platform and the data and models it generates could have bugs, defects or errors,

including human quality control errors, or otherwise fail to meet the expectations of patients, physicians

and third-party payors, which could adversely affect our reputation, business and operating results” for

more information on bugs, defects or errors in the Heartflow Platform.

Risks related to legal and regulatory matters

We face extensive, regulatory requirements to bring our products to market, and our failure to

receive and maintain regulatory clearances or approvals of our current and future products in the

United States or abroad or to comply with medical device regulatory requirements could

adversely affect our business.

In order to market any product, we must establish and comply with numerous and varying regulatory

requirements that vary by country and by region within certain countries. Approval, clearance or marketing

authorization in the United States by the FDA or by a regulatory authority or other body in another country

does not ensure approval by the regulatory authorities in other countries or jurisdictions or ensure

approval, clearance or other marketing authorization for the same conditions of use. Approval processes

vary among countries and can involve additional product testing and validation and additional

administrative review periods. In general, unless an exemption applies, in the U.S. current and future

versions of our products must receive pre-market notification (“510(k)”), de novo classification (“de novo”)

or pre-market approval (“PMA”) from the FDA before they can be marketed in the United States. We

cannot provide assurance that any of our future products, to the extent required, will be cleared, approved

or otherwise authorized by the FDA through any of its pre-market review processes, or that the FDA will

provide export certificates that are necessary to export certain products to certain countries. In addition,

the national health or social security organizations of certain foreign countries, including those outside

Europe, require our products to be qualified before they can be marketed in those countries. Failure to

receive, or delays in the receipt of, relevant foreign qualifications in the European Economic Area or other

foreign countries could have an adverse effect on our business.

Pre-market notification, de novo classification request or PMA applications may require support by data

from clinical trials. We are subject to requirements to publicly register and report the results of our clinical

trials. We must also abide by good clinical practice (“GCP”) requirements in the conduct and

documentation of our clinical trials and report to the FDA significant financial interests of investigators in

any clinical trials we submit to support marketing applications for our products. We, the FDA or an

institutional review board (“IRB”), may suspend or terminate clinical trials at any time on various grounds,

including a finding that patients are being exposed to an unacceptable health risk or that the treatment

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does not have any effect. If the FDA considers data from our clinical trials to be actually or potentially

biased due to investigators’ financial interests, or unreliable due to GCP noncompliance, it can require us

to implement extensive data analyses or other corrective actions, or exclude data from consideration in

support of our marketing applications. These outcomes could result in delay or denial of FDA clearance or

approval and could result in the need to conduct additional, costly and time-consuming clinical trials.

Additionally, we are required to obtain pre-market clearance or approval to market significantly modified

versions of our currently cleared Heartflow Platform, as well as to market the existing product for new

indications. The FDA requires us to make and document a determination as to whether or not a

modification requires a new 510(k) clearance, de novo classification or PMA approval; however, the FDA

can review and disagree with our decision. Although we have received 510(k) clearance from the FDA for

the current version of the Heartflow Platform, we may not be successful in receiving clearances, de novo

classifications or approvals in the future or the FDA may not agree with our decisions not to seek

clearances, de novo classifications or approvals for any new products or particular product modifications

or updates. The FDA may require us to obtain a new 510(k) clearance, de novo classifications or approval

for any past or future modification or a new indication for our existing products. Such submissions may

require the development and submission of additional data, may be time consuming and costly, and

ultimately may not be cleared or approved by the FDA.

If the FDA requires us to obtain pre-market clearances, de novo classifications or approvals for any

marketed modification to a previously cleared version of the Heartflow Platform, we may be required to

cease manufacturing and marketing of the modified product or to recall the modified product until we

obtain such FDA marketing authorization. The FDA may not clear, grant or approve such submissions in a

timely manner, if at all. The FDA also may change its policies, adopt additional regulations, or revise

existing regulations, each of which could prevent or delay pre-market clearance, de novo classification or

approval of our devices, or could impact our ability to market a device that was previously cleared. Any of

the foregoing could adversely impact our business and financial condition.

In addition, the FDA and other comparable foreign regulatory authorities may delay, limit or deny

clearance, de novo classification or approval of future versions of or future indications for our products or

any other potential product for many reasons, including, among others:

•the results of our clinical trials may not meet the level of statistically significant and clinically

meaningful efficacy with an acceptable safety profile as required by FDA, or other comparable

regulatory authorities in other countries, for marketing approval;

•the FDA or other comparable regulatory authorities in other countries may disagree with the number,

design, size, conduct or implementation of our clinical trials;

•the FDA or other comparable regulatory authorities in other countries may disagree with our

interpretation of data from our clinical trials;

•the FDA or other comparable regulatory authorities in other countries may not accept data generated

at one or more of our clinical trial sites;

•if our 510(k) notifications, de novo classification requests, PMA applications, or similar notifications or

applications, if and when submitted, are reviewed by the FDA or other comparable regulatory

authorities, as applicable, the regulatory authorities may have difficulties scheduling the necessary

review meetings in a timely manner, or may recommend against clearance or approval of our

application; or

•the FDA may determine that our 510(k) notifications for new indications, if and when submitted, must

follow a different regulatory pathway than we have attempted, and there may be potentially extended

standards, timelines, reviews (such as by an FDA Advisory Committee) and costs in order to pursue

approval.

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Any of these factors, many of which are beyond our control, could jeopardize our ability to obtain

regulatory clearance, de novo classification or approval for current or future versions of the Heartflow

Platform and could result in difficulties and costs for us. If we fail to comply with regulatory requirements in

international markets or to obtain and maintain required marketing authorizations, or if marketing

authorizations in international markets are delayed, our ability to realize the full market potential of our

new potential products will be limited.

Healthcare policy changes, including recently enacted legislation reforming the U.S. healthcare

system could have an adverse effect on our business, financial condition, results of operations

and prospects.

In the United States, there have been and continue to be a number of legislative and regulatory initiatives

to contain healthcare costs. Federal and state lawmakers regularly propose and, at times, enact

legislation that would result in significant changes to the U.S. healthcare system, some of which are

intended to contain or reduce the costs of medical products and services, including our own products. For

example, on July 4, 2025, the annual reconciliation bill, the “One Big Beautiful Bill Act,” or OBBBA, was

signed into law which is expected to reduce Medicaid spending and enrollment by implementing work

requirements for some beneficiaries, capping state-directed payments, reducing federal funding, and

limiting provider taxes used to fund the program. OBBBA also narrows access to ACA marketplace

exchange enrollment and declines to extend the ACA enhanced advanced premium tax credits, set to

expire in 2025, which, among other provisions in the law, are anticipated to reduce the number of

Americans with health insurance. Current and future legislative proposals to further reform healthcare or

reduce healthcare costs may limit coverage of or lower reimbursement for the diagnostic tests associated

with the use of our products. The cost containment measures that payors and providers are instituting and

the effect of any healthcare reform initiative implemented in the future could impact our revenue from the

sale of our products.

We expect additional state and federal healthcare policies and reform measures to be adopted in the

future, particularly in light of the recent changes in the White House and Congress, any of which could

limit reimbursement for healthcare products and services or otherwise result in reduced demand for our

products or additional pricing pressure and have a material adverse effect on our industry generally and

on our customers. We cannot predict what other healthcare programs and regulations will ultimately be

implemented at the federal or state level or whether any future legislation or regulation in the United

States may negatively affect our business, financial condition, results of operations and prospects. The

continuing efforts of the government, insurance companies, managed care organizations and other

payors of healthcare services to contain or reduce costs of healthcare may adversely affect our ability to

set a price that we believe is fair for our products, our ability to generate revenue and achieve or maintain

profitability and the availability of capital.

Any changes of, or uncertainty with respect to, future coverage or reimbursement rates could affect

demand for our products, which may prevent us from being able to generate additional revenue or attain

profitability.

We are subject to many laws and governmental regulations affecting our marketed products, both

domestically and internationally, and any adverse regulatory action may adversely affect our

business, financial condition, results of operations and prospects.

The Heartflow Platform is subject to regulation by numerous government authorities, including the FDA

and comparable foreign authorities, after clearance or approval of current and future versions of the

product. To varying degrees, each of these authorities requires us to comply with laws and regulations

governing the development, design, testing, manufacture, labeling, advertising, promotion, distribution,

import and export of our products. The Heartflow Platform (also referred to as Heartflow Analysis, which

consists of four main functions, the Heartflow FFRCT Analysis, the Heartflow Plaque Analysis, the

Heartflow RoadMap Analysis and the Heartflow PCI Planner (which we expect to launch in 2026)) has

been cleared by the FDA (K213857), and only the Heartflow FFRCT Analysis function of the Heartflow

Platform is CE Marked in the European Economic Area, the United Kingdom and Australia, received

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medical device licensing in Canada and has been approved for marketing authorization in Japan by the

Pharmaceuticals and Medical Devices Agency (“PMDA”), all for specific indications for use. The Heartflow

Platform has also been cleared by the equivalent regulatory authorities in Israel, Saudi Arabia, United

Arab Emirates, and licensed in Bahrain.

We currently have ongoing responsibilities under U.S., U.K., European Economic Area, Switzerland,

Canada, Australia, Japan, Saudi Arabia, United Arab Emirates, Bahrain and Israel (registered or licensed

regions) regulations, including requirements related to product and facility registration, device listing,

adverse event reporting, reporting of recalls and field corrective actions, manufacturing, advertising,

promotion, distribution, import, and export. In certain jurisdictions outside of the United States, we

contract with third parties (i.e., notified bodies, authorized representatives, manufacturing authorization

holders) who either oversee regulatory compliance or assume regulatory responsibilities for our products

distributed by those third parties. We are subject to periodic inspections and audits by the FDA, notified

bodies, authorized representatives and comparable foreign authorities to determine compliance with

regulatory requirements, including good manufacturing practices such as the Quality System Regulation

of the FDA, Medical Device Single Auditing Program, ISO 13485:2016, and EN ISO 13485:2021

concerning the EU, establishment registration and device listing, medical device reporting, vigilance

reporting of adverse events, notification of corrections, recalls, field safety corrective actions and product

labeling and marketing. These inspections and audits can result in inspectional observations or reports,

warning letters or other forms of enforcement action. If the FDA or comparable foreign authorities

conclude, as a result of these inspections or audits or from any other source of information, that we are

not in compliance with applicable laws or regulations, or that our products are ineffective or pose an

unreasonable health risk, such authorities could ban these products, suspend or cancel our marketing

authorizations, impose “stop sale” and “stop import” orders, refuse to issue export certificates, detain or

seize adulterated or misbranded products, order a recall, repair, replacement, correction or refund of such

products, require us to conduct post-market surveillance studies or change the labeling for our products,

or require us to notify health professionals and others that the products present unreasonable risks of

substantial harm to the public health. Failure to comply with regulatory requirements may also subject us

to additional administrative and judicially imposed sanctions, warning letters, civil and criminal penalties,

injunctions, interruption of manufacturing or clinical trials, total or partial suspension of production and

resulting adverse publicity.

Discovery of previously unknown problems with our products’ design or manufacture may result in

restrictions on the use of the Heartflow Platform, restrictions placed on us or our suppliers or withdrawal

of the existing regulatory clearance of the Heartflow Platform. The FDA or comparable foreign authorities

may also impose operating restrictions, enjoin and restrain violations of applicable law pertaining to

medical devices, assess civil or criminal penalties against our officers, employees or us or recommend

criminal prosecution of our company. Adverse regulatory action of a certain magnitude may restrict us

from effectively marketing and selling our products. In addition, negative publicity or product liability

claims resulting from any adverse regulatory action could have an adverse effect on our business,

financial condition, results of operations and prospects.

In many of the foreign countries in which we market our products, we are subject to extensive medical

device regulations that are similar to those of the FDA, including those in Europe. The regulation of our

products in Europe falls within the European Economic Area, which consists of the 27 member states of

the European Union, as well as Iceland, Liechtenstein and Norway. Only medical devices that comply with

certain conformity requirements of the Medical Devices Regulation (E.U.) 2017/745 (“MDR”) concerning

Medical Devices, or the E.U. Medical Devices Directive, Directive 2006/114/EC are allowed to be

marketed within the European Economic Area.

Foreign governmental regulations have become increasingly stringent and more extensive, and we may

become subject to even more rigorous regulation by foreign governmental authorities in the future.

Penalties for a company’s noncompliance with foreign governmental regulation could be severe, including

revocation or suspension of a company’s business license and civil or criminal sanctions. In some

jurisdictions, such as Germany, any violation of a law related to medical devices is also considered to be

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a violation of unfair competition law. In such cases, governmental authorities, our competitors and

business or consumer associations may then file lawsuits to prohibit us from commercializing the

Heartflow Platform in such jurisdictions. Our competitors may also sue us for damages. Any domestic or

foreign governmental law or regulation imposed in the future may have an adverse effect on our business,

financial condition, results of operations and prospects.

Delays in the commencement or completion of future or ongoing clinical testing could result in

increased costs to us and delay our ability to market the Heartflow Platform for additional

indications.

We are currently enrolling patients for our DECIDE clinical trial to evaluate our Heartflow Plaque Analysis

in a real-world setting. We do not know whether our DECIDE clinical trial will be completed on schedule,

or at all. The commencement or completion of clinical trials can be disrupted for a variety of reasons,

including difficulties in:

•recruiting and enrolling patients to participate in, and investigators to conduct, a clinical trial;

•reaching agreements on acceptable terms with prospective clinical research organizations and trial

sites;

•obtaining approval of an investigational device exemption (“IDE”), application from the FDA or

equivalent authorization from foreign regulatory authorities, if required; or

•obtaining IRB approval to conduct a clinical trial at a prospective site.

A clinical trial may also be suspended or terminated by us, an IRB, the FDA or other regulatory authorities

due to a number of factors, including:

•failure to conduct the clinical trial in accordance with regulatory requirements or in accordance with

our clinical protocols;

•inspection of the clinical trial operations or trial site by the FDA or other regulatory authorities resulting

in the imposition of a clinical hold;

•safety or effectiveness issues; or

•lack of adequate funding to continue the clinical trial.

In addition, changes in regulatory requirements and guidance may occur, and we may need to amend

clinical trial protocols to respond to such changes, which could impact the cost, timing or successful

completion of a clinical trial. If we experience delays in the commencement or completion of our clinical

trials, the commercial prospects for additional indications for our products will be harmed.

Interim, “top-line” and preliminary data from our clinical trials that we announce or publish from

time to time may change as more patient data become available and are subject to audit and

verification procedures that could result in material changes in the final data.

From time to time, we may publicly disclose interim, top-line or preliminary data from our clinical trials,

including our DECIDE clinical trial, which is based on a preliminary analysis of then-available data, and

the results and related findings and conclusions are subject to change following a more comprehensive

review of the data related to the particular trial or additional data collected at a later time. We also make

assumptions, estimations, calculations and conclusions as part of our analyses of data, and we may not

have received or had the opportunity to fully and carefully evaluate all data. As a result, the interim, top-

line or preliminary results that we report may differ from future results of the same trial, or different

conclusions or considerations may qualify such results, once additional data have been received and fully

evaluated. Interim, top-line or preliminary data also remain subject to audit and verification procedures

that may result in the final data being materially different from the interim, top-line or preliminary data we

previously announced. As a result, interim, top-line and preliminary data should be viewed with caution

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until the final data are available. Adverse differences between interim data and final data could

significantly harm our business prospects. Further, disclosure of interim data by us or by our competitors

could result in volatility in our share price.

Further, others, including the FDA and other regulatory authorities or other bodies, may not accept or

agree with our assumptions, estimates, calculations, conclusions or analyses or may interpret or weigh

the importance of data differently, which could impact the value of the particular trial, or the approvability

or potential for commercialization of the particular medical device. In addition, the information we choose

to publicly disclose regarding a particular study or clinical trial is based on what is typically extensive

information, and others may not agree with what we determine is material or otherwise appropriate

information to include in our disclosure. The interim, top-line or preliminary data that we report may differ

from final results, and regulatory authorities and other bodies may disagree with the conclusions reached,

which may harm our ability to obtain marketing authorization for, and commercialize, our future products,

which could harm our business, financial condition, results of operations and prospects.

We may face product liability claims that could result in costly litigation and significant liabilities.

We may not be able to maintain adequate product liability insurance.

Development, marketing and clinical testing of our products may expose us to product liability and other

tort claims. Although we have, and intend to maintain, liability insurance, the coverage limits of our

insurance policies may not be adequate and one or more successful claims brought against us may have

an adverse effect on our business, financial condition, results of operations and prospects. For example,

the U.S. Supreme Court declined to hear an appeal where the U.S. Court of Appeals for the Ninth Circuit

ruled that the 1976 Medical Device Amendments to the Federal Food, Drug and Cosmetic Act did not

preempt state laws in a product liability case involving a medical device company. If other courts in the

United States adopt similar rulings, we may be subject to increased litigation risk in connection with our

products. Product liability claims could negatively affect our reputation, product sales, and our ability to

obtain and maintain regulatory approval for our products.

In addition, although we have product liability and clinical study liability insurance, this insurance is

subject to deductibles and coverage limitations. Our current product liability insurance may not continue to

be available to us on acceptable terms, if at all, and, if available, coverage may not be adequate to protect

us against any future product liability claims. If we are unable to obtain insurance at an acceptable cost,

on acceptable terms with adequate coverage, or at all, or otherwise protect against potential product

liability claims, we will be exposed to significant liabilities, which may harm our business. A product liability

claim, recall or other claim with respect to uninsured liabilities or for amounts in excess of insured

liabilities could have an adverse effect on our reputation, business, financial condition, results of

operations and prospects.

The Heartflow Platform may be subject to recalls, which could be costly and could harm our

reputation and business.

We are subject to ongoing medical device reporting regulations that require us to report to the FDA or

similar governmental authorities in other countries if our products cause, or contribute to, death or serious

injury, or if they malfunction and would be likely to cause, or contribute to, death or serious injury if the

malfunction were to recur. We could voluntarily elect to, or the FDA and similar governmental authorities

in other countries could require us to, perform a correction, field safety corrective action, removal or other

recall of our products in the event of material deficiencies or defects in design, manufacturing or labeling

that could cause harm. Our products have been in the past, and may in the future, be the subject of

medical device reports of adverse events with the MAUDE database, including reports of false negative

results and incorrect or imprecise results or readings. Between 2017 and 2025, 116 Heartflow Platform

MAUDE reports were made, with 104 of those reports due to false negative results, 11 reports due to

incorrect, inadequate or imprecise results or readings, and one report due to an adverse event without an

identified device or use problem. While none of these MAUDE reports resulted in a mandated or voluntary

correction, field safety action, removal or a recall, a government mandated or voluntary correction, field

safety corrective action, removal or other recall could occur as a result of manufacturing errors or design

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defects, including defects in labeling. Any correction, field safety corrective action, removal or other recall

would divert managerial and financial resources and could lead to a substantial loss of physician and

patient confidence in our products and, consequently, have an adverse effect on our growth prospects or

operating results. A correction, field safety corrective action, removal or other recall could also result in

substantial litigation, including product liability claims, with liabilities well in excess of our insurance

coverage limits. Any of these events could have an adverse effect on our reputation, business, financial

condition, results of operations and prospects.

Off-label or other unlawful promotion of our products could result in costly investigations and

sanctions from the FDA and other regulatory bodies.

The Heartflow Platform (also referred to as Heartflow Analysis, which consists of four main functions, the

Heartflow FFRCT Analysis, the Heartflow Plaque Analysis, the Heartflow RoadMap Analysis and the

Heartflow PCI Planner (which we expect to launch in 2026)) has been cleared by the FDA (K213857), and

only the Heartflow FFRCT Analysis function of the Heartflow Platform is CE Marked in the European

Economic Area, the United Kingdom and Australia, received medical device licensing in Canada and has

been approved for marketing authorization in Japan by the PMDA, all for specific indications for use. The

Heartflow Platform has also been cleared by the equivalent regulatory authorities in Israel, Saudi Arabia,

United Arab Emirates, and licensed in Bahrain. We may only promote or market our products for their

specifically cleared or approved indications. We train our marketing and sales force against promoting our

products for uses outside of the cleared or approved indications for use (“off-label use”).

If the FDA determines that our promotional materials or training constitute promotion of an off-label use,

or of claims that are not adequately substantiated or that are otherwise false or misleading, it could

request that we modify our training or promotional materials or subject us to regulatory or enforcement

actions, including the issuance of an untitled letter, a warning letter, injunction, seizure, civil fine or

criminal penalties. It is also possible that other federal, state or foreign enforcement authorities, including

the Federal Trade Commission or Department of Justice, might take action if they consider our business

activities to constitute promotion of an off-label use or other unlawful promotion, which could result in

significant penalties, including criminal, civil and administrative penalties, damages, fines, disgorgement,

exclusion from participation in government healthcare programs and the curtailment of our operations.

Any of these events could significantly harm our business, results of operations, financial condition and

prospects.

Further, the advertising and promotion of our products are subject to European Economic Area Member

States laws implementing the Medical Devices Directive concerning misleading and comparative

advertising, and Directive 2005/29/EC on unfair commercial practices, as well as other European

Economic Area Member State legislation governing the advertising and promotion of medical devices.

European Economic Area Member State legislation may also restrict or impose limitations on our ability to

advertise our products directly to the general public. In addition, voluntary E.U. and national codes of

conduct provide guidelines on the advertising and promotion of our products to the general public and

may impose limitations on our promotional activities with healthcare professionals harming our business,

financial condition, results of operations and prospects.

We are subject to numerous federal, state and foreign healthcare fraud and abuse, compliance,

transparency and privacy laws and regulations, and a failure to comply with such laws and

regulations could have an adverse effect on our business; similarly, an investigation, inquiry or

audit by a government agency that alleges violations of law or regulations may have an adverse

effect on our business.

Our operations are, and will continue to be, directly and indirectly affected by various federal, state and/or

foreign healthcare laws, including those described below. In particular, because the use of our products

are directly or indirectly reimbursed by U.S. federal health care programs, for example Medicare, we are

subject to the federal Anti-Kickback Statute, a criminal law that prohibits, among other things, any person

or entity from knowingly and willfully offering, paying, soliciting or receiving any remuneration in cash or

in-kind (including any kickback or bribe, but also common forms of remuneration, such as service or

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consulting fees, service fees, meals, travel expenses, discounts or rebates), directly or indirectly, overtly

or covertly, in cash or in kind, in return for or to induce the referring, ordering, leasing, purchasing or

arranging for or recommending the referring, ordering, purchasing or leasing of any good, facility, item or

service, for which payment may be made, in whole or in part, under federal healthcare programs, such as

the Medicare and Medicaid programs. The term “remuneration” has been broadly interpreted to include

anything of value. Although there are a number of statutory exceptions and regulatory safe harbors

protecting certain common activities, the exceptions and safe harbors are drawn narrowly. Failure to meet

all of the requirements of a statutory exception or regulatory safe harbor does not make the conduct per

se illegal under the Anti-Kickback Statute. Instead, the arrangement will be evaluated on a case-by-case

basis based on a cumulative review of all of its facts and circumstances. Several courts have interpreted

the statute’s intent requirement to mean that if any one purpose of an arrangement involving

remuneration is to induce referrals of (or purchases, uses or recommendations of prescriptions, uses or

purchases related to) federal healthcare program covered business, the Anti-Kickback Statute has been

implicated and potentially violated. Our practices may not in all cases meet all of the criteria for safe

harbor protection from Anti-Kickback Statute liability. Further, the ACA, amends the intent requirement of

the federal Anti-Kickback Statute and certain criminal healthcare fraud statutes. A person or entity no

longer needs to have actual knowledge of the statute or specific intent to violate it. In addition, the

government may assert that a claim for payment by a government health care program including items or

services resulting from a violation of the Anti-Kickback Statute constitutes a false or fraudulent claim for

purposes of the false claims laws.

The U.S. civil False Claims Act prohibits, among other things, any person or entity from knowingly

presenting, or causing to be presented, a false or fraudulent claim for payment or approval to the federal

government or knowingly making, using, or causing to be made or used a false record or statement

material to a false or fraudulent claim to the federal government. A claim includes “any request or

demand” for money or property presented to the U.S. government. The civil False Claims Act also applies

to false submissions that cause the government to not receive a benefit to which it is entitled, such as a

discounted sales price for products covered by federal healthcare programs. Intent to deceive is not

required to establish liability under the civil False Claims Act. In addition, the civil False Claims Act

includes a whistleblower provision that allows private citizens to bring claims on behalf of the U.S.

government alleging violations of the law. Whistleblowers may be entitled to up to as much as thirty

percent (30%) of the government’s financial recovery resulting from such claims. This incentivizes

potential whistleblowers to file complaints in federal court, which complaints are relied upon heavily by the

government to investigate and prosecute allegations of violations of both the civil False Claims Act and

the Anti-Kickback Statute. U.S. enforcement authorities or private whistleblowers acting on behalf of the

U.S. government may file complaints under the civil False Claims Act alleging that we have caused one or

more of our customers to submit false submissions for reimbursement from federal health care programs,

including Medicare, Medicaid, or the Veterans Affairs program due to alleged kickbacks, the sale of

adulterated or misbranded products, or the provision of false or misleading information to our customers

or other third parties.

Additionally, under the federal Civil Money Penalty Statute, the Department of Health and Human

Services (“HHS”) may impose civil money penalties against entities that make offers to transfer or transfer

remuneration, including gifts, payments or routine waivers of co-payments or deductibles, to any

Medicare beneficiary in order to influence such individual to order or receive any item or service for which

payment may be made, in whole or in part, under Medicare and/or a State health care program.

Violations of these laws and regulations may result in significant criminal and/or civil fines and penalties,

as well as potential exclusion from participation in federal health care programs, that could significantly

impact our business and operations.

We are also subject to other federal and state fraud and abuse laws, including HIPAA’s fraud provisions,

which among other things, are criminal laws that prohibit, among other actions, knowingly and willfully

executing, or attempting to execute, a scheme or artifice to defraud any healthcare benefit program,

including private payors, knowingly and willfully embezzling or stealing from a healthcare benefit program,

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willfully preventing, obstructing, misleading, delaying or attempting to delay a criminal investigation of a

healthcare offense and knowingly and willfully falsifying, concealing or covering up a material fact or

making any materially false, fictitious or fraudulent statement or representation in connection with the

delivery of or payment for healthcare benefits, items or services. Many of these state laws closely mirror

the federal Anti-Kickback Statute or civil False Claims Act, but apply more broadly to products and

services that are paid for in any way, whereas the federal law pertains only to those reimbursed by federal

health care programs. In addition, many states have also adopted laws prohibiting fee-splitting (the

sharing of professional fees with non-state licensed persons or entities), restricting marketing activities

with physicians and/or prohibiting the practice of medicine (or the direction of the practice of medicine) by

corporations or others that are not specifically licensed to practice medicine within the state. While under

our model, licensed practitioners independently are providing any and all medical treatment and

diagnostic services for which a state license is required, these state laws still may apply to us.

We also are subject to foreign fraud and abuse laws and regulations, which vary by country, and can

prohibit many of the same activities addressed by U.S. laws.

We are also subject to the federal and state transparency reporting laws and regulations, gift bans and

compliance reporting provisions. The Physician Payments Sunshine Act (also known as Open Payments)

requires manufacturers of drugs, devices, biologics and medical supplies for which payment is available

under Medicare, Medicaid or the State Children’s Health Insurance Program to report annually to the

Centers for Medicare and Medicaid Services information related to payments and other transfers of value

provided directly or indirectly to physicians (defined to include doctors, dentists, optometrists, podiatrists

and chiropractors), other healthcare providers (such as physician assistants and nurse practitioners) and

teaching hospitals. Such manufacturers are also required to annually report certain ownership and

investment interests held by such U.S. physicians and their immediate family members. Certain states,

like Massachusetts and Vermont have similar reporting requirements. Some states, like Vermont, prohibit

gifts and certain benefits from being provided to physicians licensed within that state. Other states, such

as California and Nevada mandate implementation of compliance programs to ensure compliance with

fraud and abuse laws and regulations, as well as with industry codes of conduct, such as the AdvaMed

Code of Ethics on Interactions with Health Care Professionals. Our business is subject to these many

requirements, which can be nuanced and lacking in clear guidance. Our failure to comply with these laws

or regulations could result in substantial fines or penalties. Further, our reports made pursuant to these

laws may be used by enforcement authorities or whistleblowers to raise or substantiate allegations

against us.

We are also subject to the federal physician self-referral prohibitions, commonly known as the Stark Law,

which prohibits, among other things, physicians who have a financial relationship, including an

investment, ownership or compensation relationship with an entity that submits claims for payment to the

Medicare or Medicaid programs, from referring Medicare or Medicaid patients for certain “designated

health services,” which include diagnostic imaging services related to our products, unless an exception

applies. Similarly, entities may not bill Medicare or any other party for services furnished pursuant to a

prohibited referral. Many states have their own self-referral laws as well, which in some cases apply to all

payors, not just Medicare and Medicaid.

If our operations are found to be in violation of any of the laws described above or any other

governmental regulations that apply to us now or in the future, we may be subject to significant penalties,

including civil and criminal penalties, damages, fines, disgorgement, exclusion from governmental

healthcare programs and the curtailment or restructuring of our operations, any of which could adversely

affect our ability to operate our business and our financial results.

We also note that there is risk of our being found in violation of these laws by the fact that many of them

have not been fully, clearly or consistently interpreted by the regulatory authorities or the courts, and their

provisions are open to a variety of interpretations. Any action against us for violation of these laws, even if

we successfully defend against it, could cause us to incur significant legal expenses and divert our

management’s attention from the operation of our business. Moreover, to achieve compliance with

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applicable federal and state privacy, security and electronic transaction laws, we may be required to

modify our operations with respect to the handling of patient information. Similarly, to achieve compliance

with other applicable federal and state anti-fraud, open payments or other healthcare regulations, we may

be required to modify our operations. Implementing any of these modifications may prove costly. At this

time, we are not able to determine the full consequences to us, including the total cost of compliance, of

these various federal and state laws.

We are subject to U.S. and foreign anti-corruption and anti-money laundering laws with respect to

our operations and non-compliance with such laws can subject us to criminal and/or civil liability

and harm our business.

We are subject to the FCPA, the U.S. domestic bribery statute contained in 18 U.S.C. § 201, the

U.S. Travel Act, the USA PATRIOT Act, the U.K. Bribery Act of 2010 and Proceeds of Crime Act 2002 and

possibly other state and national anti-bribery and anti-money laundering laws in countries in which we

conduct activities. Anti-corruption laws are interpreted broadly and prohibit companies and their

employees and third-party intermediaries from authorizing, promising, offering or providing, directly or

indirectly, improper payments or benefits to recipients in the public or private sector. We use third-party

representatives to support sales of our products abroad. In addition, as we increase our international

sales and business, we may engage with additional business partners and third-party intermediaries to

sell our products abroad and to obtain necessary permits, licenses and other regulatory approvals. We or

our third-party intermediaries may have direct or indirect interactions with officials and employees of

government agencies or state owned or affiliated entities. We can be held liable for the corrupt or other

illegal activities of these third-party intermediaries, our employees, representatives, contractors, partners

and agents, even if we do not explicitly authorize or have actual knowledge of such activities.

Noncompliance with anti-corruption and anti-money laundering laws could subject us to whistleblower

complaints, investigations, sanctions, settlements, prosecution, other enforcement actions, disgorgement

of profits, significant fines, damages, other civil and criminal penalties or injunctions, suspension or

debarment from contracting with certain persons, the loss of export privileges, reputational harm, adverse

media coverage and other collateral consequences. If any subpoenas or investigations are launched, or

governmental or other sanctions are imposed, or if we do not prevail in any possible civil or criminal

litigation, our business, results of operations and financial condition could be materially harmed. In

addition, responding to any action will likely result in a materially significant diversion of management’s

attention and resources and significant defense and compliance costs and other professional fees. In

certain cases, enforcement authorities may even cause us to appoint an independent compliance monitor,

which can result in added costs and administrative burdens. As a general matter, enforcement actions

and sanctions could harm our business, financial condition, results of operations and prospects.

We are subject to governmental export and import controls that could impair our ability to

compete in international markets due to licensing requirements and subject us to liability if we are

not in compliance with applicable laws.

Our products are subject to export control and import laws and regulations, including the U.S. Export

Administration Regulations, U.S. Customs regulations and various economic and trade sanctions

regulations administered by the U.S. Treasury Department’s Office of Foreign Assets Control. Exports of

our products must be made in compliance with these laws and regulations. If we fail to comply with these

laws and regulations, we and certain of our employees could be subject to substantial civil or criminal

penalties, including: the possible loss of export or import privileges; fines, which may be imposed on us

and responsible employees or managers; and, in extreme cases, the incarceration of responsible

employees or managers. Obtaining the necessary authorizations, including any required license, for a

particular sale may be time consuming, is not guaranteed and may result in the delay or loss of sales

opportunities. In addition, changes in our products or changes in applicable export or import regulations

may create delays in the introduction and sale of our products in international markets, prevent our

customers with international operations from deploying our products or, in some cases, prevent the export

or import of our products to certain countries, governments or persons altogether. Any change in export or

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import regulations, shift in the enforcement or scope of existing regulations or change in the countries,

governments, persons or technologies targeted by such regulations, could also result in decreased use of

our products, or in our decreased ability to export or sell our products to existing or potential customers

with international operations. Any decreased use of our products or limitation on our ability to export or

sell our products would likely adversely affect our business.

Furthermore, we incorporate encryption technology into certain of our products. Various countries

regulate the import of certain encryption technology, including through import permitting and licensing

requirements, and have enacted laws that could limit our ability to distribute our products or could limit our

customers’ ability to implement our products in those countries. Encrypted products and the underlying

technology may also be subject to export control restrictions. Governmental regulation of encryption

technology and regulation of imports or exports of encryption products, or our failure to obtain required

import or export approval for our products, when applicable, could harm our international sales and

adversely affect our revenue. Compliance with applicable regulatory requirements regarding the export of

our products, including with respect to new releases of our products, may create delays in the introduction

of our products in international markets, prevent our customers with international operations from

deploying our products throughout their globally distributed systems or, in some cases, prevent the export

of our products to some countries altogether.

Moreover, U.S. export control laws and economic sanctions programs prohibit the shipment of certain

products and services to countries, governments and persons that are subject to U.S. economic

embargoes and trade sanctions. Any violations of such economic embargoes and trade sanction

regulations could have negative consequences, including government investigations, penalties and

reputational harm.

Any future litigation against us could be costly and time-consuming to defend.

We have been in the past, and we may become in the future, subject to legal proceedings and claims that

arise in the ordinary course of business, such as claims brought by our third-party vendors, our customers

or their patients in connection with contractual disputes or the use of our Heartflow Platform, claims

brought by us or by competitors related to intellectual property or employment claims made by our current

or former employees. Litigation might result in substantial costs and may divert management’s attention

and resources, which might seriously harm our business, financial condition, results of operations and

prospects. Insurance might not cover such claims, might not provide sufficient payments to cover all the

costs to resolve one or more such claims, and might not continue to be available at all or on terms

acceptable to us (including premium increases or the imposition of large deductible or co-insurance

requirements). A claim brought against us that is uninsured or underinsured could result in unanticipated

costs, potentially harming our business, financial condition, results of operations and prospects. In

addition, we cannot be sure that our existing insurance coverage will continue to be available on

acceptable terms or at all or that our insurers will not deny coverage as to any future claim.

Risks related to our intellectual property

If we are unable to obtain and maintain sufficient intellectual property rights, or the scope of our

rights is not sufficiently broad, third parties could develop and commercialize technology and

products similar or identical to ours, and our ability to successfully commercialize our technology

and products may be adversely affected.

Our commercial success will depend, in part, on our ability to continue obtaining and maintaining

intellectual property protection for our technology and products, in both the United States and certain

other countries, successfully defending this intellectual property against third-party challenges and

successfully enforcing this intellectual property to prevent third-party infringement. We rely upon a

combination of patents, trade secrets, know-how, copyrights, trademarks, license agreements and

contractual provisions to establish our intellectual property rights and protect our products.

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Our ability to protect our technologies and products from unauthorized or infringing use by third parties

depends in substantial part on our ability to obtain and maintain valid and enforceable patents in both the

United States and certain other countries. The patent positions of medical technology and software

companies can be highly uncertain and involve complex legal, scientific and factual questions for which

important legal principles remain unresolved. In addition, the patent prosecution process is expensive,

time-consuming and complex, and we may not be able to file, prosecute, maintain, enforce, defend or

license all necessary or desirable patents or patent applications at a reasonable cost or in a timely

manner, or in all jurisdictions.

We cannot guarantee that any patents will issue from any pending or future patent applications owned by

or licensed to us, or if issued, the breadth of such patent coverage. In particular, during prosecution of any

patent application, the issuance of any patents based on the application may depend upon our ability to

generate additional preclinical or clinical data that support the patentability of our proposed claims. We

may not be able to generate sufficient additional data on a timely basis, or at all. It is also possible that we

may fail to identify patentable aspects of inventions made in the course of our development and

commercial activities before it is too late to obtain patent protection on such inventions. If we fail to timely

file for patent protection in any jurisdiction, we may be precluded from doing so at a later date.

The issuance of a patent is not conclusive as to its inventorship, ownership, scope, validity or

enforceability, and our owned or licensed patents may be challenged in the courts or the patent offices of

the United States or abroad. Such challenges may result in a loss of exclusivity or in the patent’s claims

being narrowed, invalidated or held unenforceable, in whole or in part, which could limit our ability to stop

third parties from using or commercializing similar or identical products, or limit the duration of patent

protection for our technology and products. In addition, changes in either the patent laws, implementing

regulations or interpretations of patent laws in the United States or foreign countries may diminish the

value of our patent rights.

Even if unchallenged, our owned or licensed patents may not provide us with exclusivity or commercial

value for our products or any significant protection against competitive products or prevent others from

designing around our claims. Our competitors might conduct research and development activities in

countries where we do not have patent rights (or in those countries where we do, under safe harbor

provisions) and then use the information learned from such activities to develop competitive products for

sale in our major commercial markets. Further, if we encounter delays in regulatory approvals, the period

of time during which we could market our products under patent protection could be reduced. Any of

these outcomes could impair our ability to prevent competition from third parties, which may have an

adverse impact on our business.

Patent applications are generally maintained in confidence until publication. In the United States, for

example, patent applications are maintained in secrecy for up to 18 months after their filing. Similarly,

publication of discoveries in scientific or patent literature often lag behind actual discoveries.

Consequently, we cannot be certain that we or our licensors were the first to invent, or the first to file

patent applications on our products. There is also no assurance that all of the potentially relevant prior art

relating to our patents and patent applications has been found, which could be used by a third party to

challenge validity of our patents or prevent a patent from issuing from a pending patent application.

In addition to patents, proprietary trade secrets and unpatented know-how are important to our business.

For information about risks related to these intellectual property rights, see the risk factor titled “If we are

unable to protect the disclosure and use of our confidential information and trade secrets, the value of our

products and technologies and our business and competitive position could be harmed” below. We also

rely on the trademarks we own to distinguish our products from the products of our competitors. We

cannot guarantee that any trademark applications filed by us will be approved. Third parties may also

oppose or attempt to cancel our trademark applications or trademarks, or otherwise challenge our use of

the trademarks. In the event that the trademarks we use are successfully challenged, we could be forced

to rebrand our products, which could result in loss of brand recognition, and could require us to devote

resources to advertising and marketing new brands. Competitors or other parties may adopt trade names

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or trademarks similar to ours, thereby impeding our ability to build brand identity and possibly leading to

market confusion.

Further, we cannot provide assurance that competitors will not infringe the trademarks we use, or that we

will have adequate resources to enforce these trademarks. If we attempt to enforce our trademarks and

assert trademark infringement claims, a court may determine that the marks we have asserted are invalid

or unenforceable, or that the party against whom we have asserted trademark infringement has superior

rights to the marks in question. In this case, we could ultimately be forced to cease use of such

trademarks. We may license our trademarks and trade names to third parties, such as distributors.

Though these license agreements may provide guidelines for how our trademarks and trade names may

be used, a breach of these agreements or misuse of our trademarks and trade names by our licensees

may jeopardize our rights in or diminish the goodwill associated with our trademarks and trade names.

Over the long term, if we are unable to establish name recognition based on our trademarks and trade

names, then we may not be able to compete effectively and our business may be adversely affected.

For information about risks related to our inability to protect our intellectual property rights outside the

United States, see the risk factor titled “We may not be able to adequately protect our intellectual property

rights throughout the world” below.

If we are unable to protect the disclosure and use of our confidential information and trade

secrets, the value of our products and technologies and our business and competitive position

could be harmed.

In addition to patent protection, we also rely on other intellectual property rights, including trade secrets,

know-how, and/or other proprietary information that is not patentable or that we elect not to patent.

However, trade secrets can be difficult to protect, and some courts are less willing or unwilling to protect

trade secrets. Although we have taken steps to protect our trade secrets and unpatented know-how,

including by entering into confidentiality agreements with third parties, and proprietary information and

invention agreements with our employees, consultants and advisors, third parties may still obtain this

information or we may be unable to protect our rights. There can be no assurance that binding

agreements will not be breached, that we would have adequate remedies for any breach, or that our trade

secrets and unpatented know-how will not otherwise become known or be independently discovered by

our competitors. We also seek to preserve the integrity and confidentiality of our data and trade secrets

by maintaining physical security of our premises and physical and electronic security of our information

technology systems. While we have confidence in these individuals, organizations and systems, our

security measures may be breached, and we may not have adequate remedies for any such breach.

If any of our trade secrets were to be lawfully obtained or independently developed by a competitor, we

would have no right to prevent them, or those to whom they communicate it, from using that information to

compete with us. Any exposure of our trade secrets and other proprietary information would impair our

competitive advantages and could have a material adverse effect on our business, financial condition,

results of operations and prospects. In particular, a failure to protect our proprietary rights may allow

competitors to copy our products or technologies, which could adversely affect our pricing and market

share. Unauthorized parties may also attempt to copy or reverse engineer certain aspects of our products

or technologies that we consider proprietary.

Costly and time-consuming litigation could be necessary to enforce and determine the scope of our trade

secret rights and related confidentiality, non-disclosure and non-use provisions, and outcomes of such

litigation are unpredictable. Enforcing a claim that a party illegally disclosed, used or misappropriated a

trade secret can be difficult, expensive and time-consuming, and the outcome is unpredictable. While we

use commonly accepted security measures, trade secret claims are often based on a combination of

federal and state law in the United States, and the criteria for protection of trade secrets can vary among

different jurisdictions. If the steps we have taken to maintain our trade secrets are deemed inadequate,

we may have insufficient recourse against third parties for misappropriating the trade secret. In addition,

agreement terms that address non-competition are difficult to enforce in many jurisdictions and might not

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be enforceable in certain cases. Even if we were to be successful in the enforcement of our claims, we

may not be able to obtain adequate remedies.

Reliance on third parties requires us to share our trade secrets, which increases the possibility

that a competitor will discover them or that our trade secrets will be misappropriated or disclosed

to others.

Any collaboration or other engagement with third parties for the development of our products may require

us, at times, to share trade secrets with them. We may also conduct joint research and development

programs that may require us to share trade secrets under the terms of our research and development

partnerships or similar agreements. We seek to protect our trade secrets and other proprietary technology

in part by entering into confidentiality agreements with third parties prior to beginning research or

disclosing proprietary information. These agreements typically limit the rights of the third parties to use or

disclose our confidential information, including our trade secrets. Despite the contractual provisions

employed when working with third parties, the need to share trade secrets and other confidential

information increases the risk that such trade secrets become known by our competitors, are

inadvertently incorporated into the technology of others, or are disclosed or used in violation of these

agreements. Given that our proprietary Heartflow Platform is based, in part, on our know-how and trade

secrets, a competitor’s discovery of our trade secrets or other unauthorized use or disclosure could have

an adverse effect on our business, financial condition, results of operations and prospects.

In addition, these agreements typically restrict the ability of our advisors, employees, third-party

contractors and consultants to publish data potentially relating to our trade secrets. Despite our efforts to

protect our trade secrets, we may not be able to prevent the unauthorized disclosure or use of our

technical know-how or other trade secrets by the parties to these agreements. Moreover, we cannot

guarantee that we have entered into such agreements with each party that may have or have had access

to our confidential information or proprietary technology and processes. Monitoring unauthorized uses

and disclosures is difficult, and we do not know whether the steps we have taken to protect our

proprietary technologies will be effective. If any of the collaborators, scientific advisors, employees,

contractors and consultants who are parties to these agreements breaches or violates the terms of any of

these agreements, we may not have adequate remedies for any such breach or violation, and we could

lose our trade secrets as a result. Moreover, if confidential information that is licensed or disclosed to us

by our partners, collaborators, or others is inadvertently disclosed or subject to a breach or violation, we

may be exposed to liability to the owner of that confidential information. Enforcing a claim that a third

party illegally obtained and is using our trade secrets, like patent litigation, is expensive and time

consuming, and the outcome is unpredictable. In addition, courts outside the United States are

sometimes less willing to protect trade secrets, and we may need to share our trade secrets and

proprietary know-how with current or future partners, collaborators, contractors and others located in

countries at heightened risk of theft of trade secrets, including through direct intrusion by private parties or

foreign actors, and those affiliated with or controlled by state actors.

Obtaining and maintaining our patent protection depends on compliance with various procedural,

document submission, fee payment and other requirements imposed by governmental patent

agencies, and our patent protection could be reduced or eliminated for noncompliance with these

requirements.

The U.S. Patent and Trademark Office (“USPTO”) and various foreign governmental patent agencies

require compliance with a number of procedural, documentary, fee payment and other similar provisions

during the patent application process. In addition, periodic maintenance fees, renewal fees, annuity fees,

and various other government fees on patents and/or applications will be due to be paid to the USPTO

and various governmental patent agencies outside of the United States over the lifetime of our patents

and/or applications and any patent rights we may obtain in the future. We have systems in place to

remind us to pay these fees, and we employ outside firms to remind us to pay annuity fees due to patent

agencies on our patents and pending patent applications. In many cases, an inadvertent lapse can be

cured by payment of a late fee or by other means in accordance with the applicable rules. However, there

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are situations in which noncompliance can result in abandonment or lapse of the patent or patent

application, resulting in partial or complete loss of patent rights in the relevant jurisdiction. In such an

event, our competitors might be able to enter the relevant market, which would have an adverse effect on

our business. Noncompliance events that could result in abandonment or lapse of a patent or patent

application include failure to respond to official actions within prescribed time limits, non-payment of fees

and failure to properly legalize and submit formal documents.

Changes in patent law, precedents and policies in the United States and other jurisdictions could

diminish the value of patents in general, thereby impairing our ability to protect our products.

Our ability to obtain patents is highly uncertain because, to date, some legal principles remain unresolved,

and there has not been a consistent policy regarding the breadth or interpretation of claims allowed in

patents in the United States. Furthermore, the specific content of patents and patent applications that are

necessary to support and interpret patent claims is highly uncertain due to the complex nature of the

relevant legal, scientific, and factual issues. The United States Supreme Court has ruled on several

patent cases in recent years, either narrowing the scope of patent protection available in certain

circumstances or weakening the rights of patent owners in certain situations. Changes in either the patent

laws or interpretations of patent laws in the United States or other jurisdictions may diminish the value of

our intellectual property. In the United States, in certain circumstances, court rulings may narrow the

scope of patent protection and weaken the rights of patent owners. We cannot predict how decisions by

the courts, the U.S. Congress, the USPTO or changes in the patent laws of other jurisdictions may impact

the value of our patents. Changes in the laws, regulations, precedents and procedures governing patents

could have a material adverse effect on our existing patent portfolio and our ability to protect and enforce

our intellectual property in the future, which could have a material adverse effect on our business,

financial condition, results of operations and prospects.

Further, patent coverage in medical devices and technologies is a subject of evolution and differences

between countries. This is especially true of the definition of patentable subject matter which affects both

computer related inventions and biological inventions. This evolution may cause current granted patents

to be considered non-patent eligible or prevent us from protecting future inventions. U.S. Supreme Court

and Federal Circuit decisions interpreting and/or limiting the scope of patentable subject matter under 35

U.S.C. § 101, in addition to examination guidelines from the USPTO, have made it more difficult for

patentees to obtain and/or maintain patent claims in the United States that are directed to medical

technologies involving computer-implemented applications. Several precedential decisions regarding

patentable subject matter are of particular relevance to patents in the computer-implemented applications

space. Our efforts to seek patent protection for our technologies and products may be impacted by the

evolving case law and guidance or procedures issued by the USPTO or authorities in other jurisdictions

based on such evolving case law.

Similarly, changes in patent laws and regulations in other countries or jurisdictions, changes in the

governmental bodies that enforce them or changes in how the relevant governmental authority enforces

patent laws or regulations may weaken our ability to obtain new patents or to enforce patents that we may

obtain in the future. For example, the complexity and uncertainty of European patent laws have also

increased in recent years. In Europe, a new unitary patent system took effect June 1, 2023, which will

significantly impact European patents, including those granted before the introduction of the new unitary

patent system. Under the unitary patent system, European applications have the option, upon grant of a

patent, of becoming a Unitary Patent which will be subject to the jurisdiction of the Unitary Patent Court

(“UPC”). As the UPC is a new court system, there is no precedent for the court, increasing the uncertainty

of any litigation. Patents granted before the implementation of the UPC have the ability to opt out of the

jurisdiction of the UPC and remain as national patents in the UPC countries. The UPC will provide our

competitors with a new forum to centrally revoke European patents, and allow for the possibility of a

competitor to obtain pan-European injunctions, since patents that remain under the jurisdiction of the UPC

will be potentially vulnerable to a single UPC-based revocation challenge that, if successful, could

invalidate the patent in all countries who are signatories to the UPC. We cannot predict with certainty the

long-term effects of any potential changes.

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Further, the laws of some foreign countries do not protect proprietary rights to the same extent or in the

same manner as the laws of the United States and Europe. As a result, we may encounter significant

problems in protecting and defending our intellectual property both in the United States and abroad. For

example, if the issuance in a given country of a patent covering an invention is not followed by the

issuance in other countries of patents covering the same invention, or if any judicial interpretation of the

validity, enforceability or scope of the claims or the written description or enablement, in a patent issued in

one country is not similar to the interpretation given to the corresponding patent issued in another country,

our ability to protect our intellectual property in those countries may be limited. Changes in either patent

laws or in interpretations of patent laws in the United States and other countries may materially diminish

the value of our intellectual property or narrow the scope of our patent protection.

In addition, on September 16, 2011, the Leahy-Smith America Invents Act (the “Leahy-Smith Act”) was

signed into law. The Leahy-Smith Act includes a number of significant changes to U.S. patent law.

Assuming that other requirements for patentability are met, prior to March 16, 2013, in the United States,

the first to invent the claimed invention was entitled to the patent, while outside the United States, the first

to file a patent application was entitled to the patent. On or after March 16, 2013, under the Leahy-Smith

Act, the United States transitioned to a first inventor to file system in which, assuming that other

requirements for patentability are met, the first inventor to file a patent application will be entitled to the

patent on an invention regardless of whether a third party was the first to invent the claimed invention.

Under this system, a third party that files a patent application in the USPTO before us could be awarded a

patent covering an invention of ours even if we had made the invention before it was made by such third

party. Since patent applications in the United States and most other countries are confidential for a period

of time after filing or until issuance, we cannot be certain that we or our licensors were the first to either (i)

file any patent application related to our products or (ii) invent any of the inventions claimed in our or our

licensors’ patents or patent applications.

The Leahy-Smith Act also changed the way patent applications are prosecuted, including by allowing

third-party submission of prior art to the USPTO during patent prosecution and additional procedures to

challenge the validity of a patent by USPTO administered post-grant proceedings to attack the validity of

a patent. Because of a lower evidentiary standard in USPTO proceedings compared to the evidentiary

standard in U.S. federal courts necessary to invalidate a patent claim, a third party could potentially

provide evidence in a USPTO proceeding sufficient for the USPTO to hold a claim invalid even though the

same evidence might not be sufficient to invalidate the claim if presented in a district court action.

Accordingly, third parties may use USPTO proceedings to invalidate our patent claims that would not have

been invalidated if first challenged in a district court action. Therefore, the Leahy-Smith Act and its

implementation could increase the uncertainties and costs surrounding the prosecution of our patent

applications and the enforcement or defense of our issued patents, which could have a material adverse

effect on our business, financial condition, results of operations and prospects.

We may not be able to adequately protect our intellectual property rights throughout the world.

Our patent portfolio includes patents and patent applications in countries outside of the United States,

including Japan, Korea, China, Canada, Australia, Israel, India and countries in Europe. The requirements

for patentability differ from country to country, the breadth of allowed patent claims can be inconsistent,

the scope of coverage provided by these patents varies and the laws of some foreign countries may not

protect our intellectual property rights to the same extent as laws in the United States. In addition, filing,

prosecuting and defending patents on our products in all countries throughout the world would be

prohibitively expensive. For those countries where we do not have granted patents, we may not have any

ability to prevent the unauthorized sale of our products.

In addition, we may decide to abandon national and regional patent applications before they are granted.

The examination of each national or regional patent application is an independent proceeding. As a result,

patent applications in the same family may issue as patents in some jurisdictions, such as in the United

States, but may issue as patents with claims of different scope or may even be refused in other

jurisdictions. It is also quite common that depending on the country, the scope of patent protection may

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vary for the same product or technology. For example, certain jurisdictions do not allow for patent

protection with respect to methods of treatment.

Consequently, we may not be able to prevent third parties from practicing our inventions in all countries

outside the United States. Competitors may use our technologies in jurisdictions where we have not

obtained patent protection to develop their own products and, further, may export otherwise infringing

products to territories in which we have patent protection that may not be sufficient to terminate infringing

activities. Accordingly, our efforts to enforce our intellectual property and proprietary rights around the

world may be inadequate to obtain a significant commercial advantage from the intellectual property that

we develop or license.

Many countries have compulsory licensing laws under which a patent owner may be compelled to grant

licenses to third parties, government agencies or government contractors. In these countries, the patent

owner may have limited remedies, which could materially diminish the value of such patent. If we or any

of our licensors is forced to grant a license to third parties with respect to any patents relevant to our

business, our competitive position may be impaired, and our business, financial condition, results of

operations and prospects may be adversely affected.

We do not seek or have patent rights in certain foreign countries in which a market may exist. Accordingly,

our efforts to protect our intellectual property rights in such countries may be inadequate, which may have

an adverse effect on our ability to successfully commercialize our products in all of our expected

significant foreign markets. Moreover, in foreign jurisdictions where we do have patent rights, proceedings

to enforce such rights could result in substantial costs and divert our efforts and attention from other

aspects of our business, could put our patents at risk of being invalidated or interpreted narrowly, and our

patent applications at risk of not issuing. Additionally, such proceedings could provoke third parties to

assert claims against us. We may not prevail in any lawsuits that we initiate and the damages or other

remedies awarded, if any, may not be commercially meaningful. Thus, we may not be able to stop a

competitor from marketing and selling in foreign countries products that are the same as or similar to our

products, and our competitive position in the international market would be harmed.

We may be involved in lawsuits to protect or enforce our patents or other intellectual property, or

the patents of our licensors, which could be expensive, time consuming and unsuccessful.

Competitors or other third parties may infringe, misappropriate or otherwise violate our owned or licensed

patents, trade secrets or other intellectual property. To counter infringement or unauthorized use, we may

be compelled to file infringement or misappropriation claims, which can be expensive and time

consuming. We do not carry intellectual property insurance that would cover such claims. In certain

circumstances it may not be practicable or cost effective for us to enforce our intellectual property rights

fully, particularly in certain developing countries or where the initiation of a claim might harm our business

relationships. If we initiate legal proceedings against a third party to enforce a patent covering our

products, the defendant could counterclaim that our patent(s) are invalid and/or unenforceable. In patent

litigation in the United States, counterclaims alleging invalidity and/or unenforceability are common, and

there are numerous grounds upon which a third party can assert invalidity or unenforceability of a patent.

In an infringement proceeding, a court may decide that a patent we own or license is not valid, is

unenforceable or is not infringed, or may refuse to stop the other party from using the technology at issue

on the grounds that our patents do not cover the technology in question. The outcome following legal

assertions of invalidity and unenforceability is unpredictable. With respect to the validity question, for

example, we cannot be certain that there is no invalidating prior art. If a defendant were to prevail on a

legal assertion of invalidity and/or unenforceability, we may lose some, and perhaps all, of the patent

protection covering our products. An adverse result in any litigation or defense proceeding could put one

or more of our patents at risk of being invalidated or interpreted narrowly, could put our patent

applications at risk of not issuing and could have a material adverse impact on our business.

Our defense of litigation may fail and, even if successful, may result in substantial costs and distract our

management and other employees. Even if we establish infringement, the court may decide not to grant

an injunction against further infringing activity and instead award only monetary damages, which may or

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may not be an adequate remedy. For example, the amount of any monetary damages may be inadequate

to compensate us for damage as a result of the infringement and the proceedings. We may not be able to

prevent, alone or with our suppliers, misappropriation of intellectual property rights important to our

business, particularly in countries where the laws may not protect those rights as fully as in the United

States.

Furthermore, because of the substantial amount of discovery required in connection with intellectual

property litigation, there is a risk that some of our confidential information could be compromised by

disclosure during this type of litigation. There could also be public announcements of the results of

hearings, motions or other interim proceedings or developments. If securities analysts or investors

perceive these results to be negative, it could have an adverse effect on the price of our common stock.

Third-party defendants may challenge any patent we own or in-license through adversarial proceedings in

the issuing offices, which could result in the invalidation or unenforceability of some or all of the relevant

patent claims. If a third party asserts a substantial new question of patentability against any claim of a

U.S. patent we own or license, the USPTO may grant a request for reexamination, which may result in a

loss of scope of some claims or a loss of the entire patent. The adoption of the Leahy-Smith Act has

established additional opportunities for third parties to invalidate U.S. patent claims, including inter partes

review and post grant review, on the basis of lower legal standards than reexamination and additional

grounds. Outside of the United States, patents we own or license may become subject to patent

opposition or similar proceedings, which may result in loss of scope of some claims or loss of the entire

patent. Participation in adversarial proceedings is very complex, expensive and may divert our

management’s attention from our core business and may result in unfavorable outcomes that could

adversely affect our ability to prevent third parties from competing with us.

We may be subject to claims challenging the inventorship or ownership of our patents and other

intellectual property rights or alleging that we have violated the intellectual property rights or

other proprietary rights of third parties.

Our commercial success depends, in part, upon our ability to develop, manufacture, market and sell our

products and use our proprietary technologies without infringing the proprietary rights and intellectual

property of third parties. The medical device industry is characterized by extensive and complex litigation

regarding patents and other intellectual property rights. We may be exposed to, or threatened with, future

litigation by third parties having patent or other intellectual property rights alleging that our products or

proprietary technologies infringe on their intellectual property rights. There is a risk that third parties may

choose to engage in litigation with us to enforce or to otherwise assert their patent rights against us. Even

if we believe such claims are without merit, a court of competent jurisdiction could hold that these third-

party patents are valid, enforceable and infringed, which could have a negative impact on our ability to

commercialize our products. This includes litigation, or threatened litigation, with non-practicing entities

that have no relevant product revenue and against whom our own patent portfolio may have no deterrent

effect. The legal threshold for initiating litigation or contested proceedings is low, so that even lawsuits or

proceedings with a low probability of success might be initiated and require significant resources to

defend.

We may also be subject to claims that former employees, collaborators or other third parties have an

ownership interest in our patent rights or other intellectual property, for example, based on conflicting

obligations of consultants or others who are involved in developing our products. Although it is our policy

to require our employees and contractors who may be involved in the conception or development of

intellectual property to execute agreements assigning such intellectual property to us, we may be

unsuccessful in executing such an agreement with each party who, in fact, conceives or develops

intellectual property that we regard as our own, and we cannot be certain that our agreements with such

parties will be upheld in the face of a potential challenge, or that they will not be breached, for which we

may not have an adequate remedy. The assignment of intellectual property rights may not be self-

executing or the assignment agreements may be breached, and litigation may be necessary to defend

against these and other claims challenging inventorship or ownership. If we fail in defending any such

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claims, in addition to paying monetary damages, we may lose valuable intellectual property rights, such

as exclusive ownership of, or right to use, valuable intellectual property. Such an outcome could have a

material adverse effect on our business. Even if we are successful in defending against such claims,

litigation could result in substantial costs and be a distraction to management and other employees.

We employ individuals who were previously employed at other medical technology companies. In

addition, we use publications that are subject to copyright, as well as proprietary information and

materials from third parties in our research. Some of the information and materials we use from third

parties may be subject to agreements that include restrictions on use or disclosure. Although we strive to

ensure proper safeguards, we cannot guarantee strict compliance with such agreements, nor can we be

sure that our employees, consultants and advisors do not use proprietary information, materials or know-

how of others in their work for us. In addition, we may be subject to claims that we or our employees,

consultants or independent contractors have inadvertently or otherwise used or disclosed alleged trade

secrets or other proprietary information of former employers or other third parties. Although we have

procedures in place that seek to prevent our employees and consultants from using the intellectual

property, proprietary information, know how or trade secrets of others in their work for us, we may in the

future be subject to claims that we caused an employee to breach the terms of his or her non-competition

or non-solicitation agreement, or that we or these individuals have, inadvertently or otherwise, used or

disclosed the alleged trade secrets or other proprietary information of a former employer or competitor.

We may also be subject to claims that former employers or other third parties have an ownership interest

in our future patents. In addition, we may be subject to claims that we are infringing other intellectual

property rights, such as trademarks or copyrights, and to the extent that our employees, consultants or

contractors use intellectual property or proprietary information owned by others in their work for us,

disputes may arise as to the rights in related or resulting know-how and inventions. Litigation may be

necessary to defend against these claims. There is no guarantee of success in defending these claims,

and even if we are successful, litigation could result in substantial cost and be a distraction to our

management and other employees.

An unfavorable outcome for any such claim could require us to cease using the related technology or to

attempt to license rights to it from the prevailing party. Our business could be harmed if the prevailing

party does not offer us a license on commercially reasonable terms.

If a third party claims that we infringe its intellectual property rights, we may face a number of issues,

including:

•infringement and other intellectual property claims which, regardless of merit, may be expensive and

time consuming to litigate and may divert our management’s attention from our core business;

•substantial damages for infringement, which we may have to pay if a court decides that the product at

issue infringes or violates the third party’s rights, and if the court finds that the infringement was

willful, we could be ordered to pay treble damages and the patent owner’s attorneys’ fees;

•a court prohibiting us from selling or licensing the product unless the third-party licenses its product

rights to us, which it is not required to do;

•if a license is available from a third party, we may have to pay substantial royalties, upfront fees or

grant cross licenses to intellectual property rights for our products; and

•redesigning our products or processes so they do not infringe, which may not be possible or may

require substantial monetary expenditures and time.

In order to successfully challenge the validity of a U.S. patent in federal court, we would need to

overcome a presumption of validity. As this burden is a high one requiring us to present clear and

convincing evidence as to the invalidity of any such U.S. patent claim, there is no assurance that a court

of competent jurisdiction would invalidate the claims of any such U.S. patent. Foreign courts will have

similar burdens to overcome in order to successfully challenge a third-party claim of patent infringement.

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Some of our competitors may be able to sustain the costs of complex patent litigation more effectively

than we can because they have substantially greater resources. In addition, any uncertainties resulting

from the initiation and continuation of any litigation could have an adverse effect on our ability to raise

additional funds or on our business, financial condition, results of operations and prospects.

The terms of our patents may not be sufficiently long to effectively protect our products and

business.

Patents have a limited lifespan. In the United States, the natural expiration of a patent is generally 20

years after its first effective non-provisional filing date, but can be shorter due to terminal disclaimers or

similar term reductions in other jurisdictions. Although various extensions may be available, the term of a

patent, and the protection it affords, is limited. Even if patents covering our technologies or products are

obtained, once the patent term has expired, we may be open to competition. In addition, although upon

issuance in the United States, a patent’s term can be increased based on certain delays caused by the

USPTO, this increase can be reduced or eliminated based on certain delays caused by the patent

applicant during patent prosecution. Given the amount of time required for the development, testing and

regulatory review of products, patents protecting such potential products might expire before or shortly

after such products are commercialized. If we do not have sufficient patent life to protect our technologies

and products, our business, financial condition, results of operations and prospects will be adversely

affected.

If we do not obtain additional protection under the Hatch-Waxman Amendments or similar foreign

legislation, our business may be materially affected.

Depending upon the timing, duration and specifics of FDA marketing approval for our future products, one

or more of our U.S. patents may be eligible for limited patent term restoration under the Drug Price

Competition and Patent Term Restoration Act of 1984 (the “Hatch-Waxman Amendments”). The Hatch-

Waxman Amendments permit a patent term extension of up to five years beyond the normal expiration of

the patent as compensation for patent term lost during product development and the FDA regulatory

review process, which is limited to the approved indication (or any additional indications approved during

the period of extension). This extension is limited to one patent that covers the approved product, the

approved use of the product, or a method of manufacturing the product. A patent term extension cannot

extend the remaining term of a patent beyond a total of 14 years from the date of product approval, and

only those claims covering such approved product, a method for using it or a method for manufacturing it

may be extended. However, the applicable authorities, including the FDA and the USPTO in the United

States, and any equivalent regulatory authority in other countries or areas, may not agree with our

assessment of whether such extensions are available, and may refuse to grant extensions to our patents,

or may grant more limited extensions than we request. We may not be granted an extension because of,

for example, failing to apply within applicable deadlines, failing to apply prior to expiration of relevant

patents or otherwise failing to satisfy applicable requirements. Moreover, the applicable time period or

scope of patent protection afforded could be less than we request. If we are unable to obtain patent term

extension or restoration of the term of any such extension is less than we request, our competitors may

obtain approval for competing products following our patent expiration, and our ability to generate

revenues may be adversely affected.

Open-source software licenses often impose unanticipated or unclear restrictions on us or could

expose us to litigation, and using open-source software has inherent risks, any of which could

impair our ability to successfully commercialize the Heartflow Platform.

Our technology platform implements software modules licensed to us by third parties under “open source”

licenses. The terms of many open source licenses have not been interpreted by U.S. courts, and there is

a risk that these licenses could be construed in ways that could impose unanticipated conditions or

restrictions on our ability to commercialize our products. Moreover, we cannot be certain that our

processes for controlling our use of open-source software in connection with our products will be

effective. From time to time, we may face claims from third parties asserting ownership of, or demanding

release of, the open-source software or derivative works that we developed using such software (which

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could include our proprietary source code), or otherwise seeking to enforce the terms of the applicable

open source license. These claims could result in litigation. If we are held to have breached the terms of

an open source software license, we could be required to seek licenses from third parties to continue

offering our products on terms that are not economically feasible, to re-engineer our proprietary code, to

discontinue the sale of our products if re-engineering could not be accomplished on a timely or cost

effective basis, or to make generally available, in source code form, our proprietary code, any of which

could adversely affect our business, financial condition, results of operations and prospects.

The use of open-source software may entail greater risks than the use of third-party commercial software,

as open source licensors generally do not provide warranties or other contractual protections regarding

infringement or the quality or ownership of the code. Many of these risks cannot be eliminated, and could,

if not properly addressed, negatively affect our business. We cannot be sure that all open source software

is submitted for approval prior to use in connection with our products.

In addition, some open-source licenses contain requirements that we make available source code for

modifications or derivative works we create based upon the type of open-source software we use. If we

combine our proprietary software with open-source software in a certain manner, we could, under certain

open-source licenses, be required to release portions of the source code of our proprietary software to the

public. This would allow our competitors to create similar products with less development effort and time

and ultimately could result in a loss of sales for us.

Intellectual property rights do not necessarily address all potential threats to our competitive

advantage.

The degree of future protection afforded by our intellectual property rights is uncertain because

intellectual property rights have limitations and may not adequately protect our business or permit us to

maintain our competitive advantage. The following examples are illustrative:

•others may be able to make products that are similar to or otherwise competitive with our potential

products but that are not covered by the claims of our current or future patents;

•an in-license necessary for the manufacture, use, sale, offer for sale or importation of one or more of

our potential products may be terminated by the licensor;

•we or future collaborators might not have been the first to make the inventions covered by our issued

or future issued patents or our pending patent applications;

•we or future collaborators might not have been the first to file patent applications covering certain of

our inventions;

•others may independently develop similar or alternative technologies or duplicate any of our

technologies without infringing our intellectual property rights;

•it is possible that our pending patent applications will not lead to issued patents;

•issued patents that we own or in-license may be held invalid or unenforceable as a result of legal

challenges by our competitors;

•issued patents that we own or in-license may not provide coverage for all aspects of our new potential

products in all countries;

•our competitors might conduct research and development activities in countries where we do not

have patent rights and then use the information learned from such activities to develop competitive

products for sale in our major commercial markets;

•we may not develop additional proprietary technologies that are patentable; and

•the patents of others may have an adverse effect on our business.

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Should any of these events occur, they could significantly harm our business, results of operations and

prospects.

Risks related to financing and tax matters

We may require additional capital to support business growth, and this capital might not be

available on terms favorable to us, or at all, and may dilute ownership of our common stock for

our stockholders, including purchasers of common stock in this offering.

We intend to continue to make investments to support our business growth and may require additional

funds to respond to business challenges and opportunities, including the need to develop new products,

enhance our existing products, enhance our operating infrastructure, potentially expand internationally

and potentially acquire complementary businesses and technologies. In order to achieve these objectives,

we may make future commitments of capital resources. Accordingly, we may need to engage in equity or

debt financings to secure additional funds. If we raise additional funds through further issuances of equity

or convertible debt securities, our stockholders, including any purchasers of common stock in this

offering, could suffer significant dilution, and any new equity securities we issue could have rights,

preferences and privileges superior to those of holders of our common stock. In addition, our ability to

incur indebtedness is subject to limitations under the 2024 Credit Agreement and, if incurred, would

increase our fixed obligations and could include covenants or other restrictions that would impede our

ability to manage our operations. Further, if additional financing is needed, we may not be able to obtain

additional financing on terms favorable to us or at all. Our inability to obtain adequate financing or

financing on terms satisfactory to us, when we require it, could significantly limit our ability to continue

supporting our business growth and responding to business challenges and opportunities.

Our operating results may fluctuate significantly, which makes our future operating results

difficult to predict and could cause our operating results to fall below expectations or any

guidance we may provide.

Our quarterly revenue and results of operations may fluctuate from quarter to quarter due to, among

others, the following reasons:

•the level of physicians’ acceptance and adoption of our products, and changes in the rates at which

physicians order our Heartflow FFRCT Analysis or the percentage of CCTA scans for which our

Heartflow FFRCT Analysis is ordered;

•determinations, including the timing of determinations, by payors concerning coverage and

reimbursement of our products;

•changes in coverage amounts or government and payors’ reimbursement policies;

•the timing, expense and results of research and development activities, clinical trials and any

additional regulatory approvals;

•changes in AHA or ACC guidelines, or guidelines in other countries, that lower support for our

products or elevate alternative products as the preferred pathway for diagnosis and management of

CAD;

•fluctuations in our expenses associated with expanding our commercial operations and operating as

a public company;

•patients meeting their annual health insurance deductible later in the calendar year;

•the introduction of new products and technologies by our competitors;

•changes in our pricing policies or in the pricing policies of our competitors;

•the productivity of our sales and marketing teams, and their ability to identify physicians who

Heartflow, Inc. S-1