$PROF·8-K

Profound Medical Corp. · Mar 13, 10:35 AM ET

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Profound Medical Corp. 8-K

Research Summary

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Updated

Profound Medical Corp. Announces CAPTAIN Trial Met Primary Safety Endpoint

What Happened
Profound Medical Corp. announced on March 13, 2026, that its CAPTAIN clinical trial comparing the company’s MRI-guided TULSA Procedure™ to robotic radical prostatectomy met the trial’s primary safety endpoint. The company furnished a press release describing the result and filed the information on Form 8-K under Item 7.01 (Regulation FD Disclosure).

Key Details

  • Announcement and Form 8-K filing date: March 13, 2026.
  • Trial name: CAPTAIN; intervention: MRI-guided TULSA Procedure™; comparator: robotic radical prostatectomy.
  • Result reported: CAPTAIN met its primary safety endpoint (as disclosed in the press release).
  • Press release related to the disclosure is furnished as Exhibit 99.1 to the Current Report on Form 8-K.

Why It Matters
Meeting a primary safety endpoint is a material clinical milestone that the company has publicly reported via Form 8-K and an accompanying press release. For investors, this is a factual update on the CAPTAIN trial’s progress and may be relevant when evaluating Profound’s clinical program and ongoing disclosures.

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