Orthofix Medical Inc. 8-K

What Happened Orthofix Medical Inc. announced on May 21, 2026 (filing date) that the FDA issued a final order on April 16, 2026 reclassifying non‑invasive bone growth stimulators from Class III to Class II. Following that reclassification, CMS updated billing requirements and Medicare fee schedule treatment for devices billed under HCPCS codes E0747, E0748 and E0760 for dates of service on or after May 18, 2026. Based on the updated billing and payment information, Orthofix now expects average Medicare reimbursement for these codes to decline by approximately 10% and has reduced its full‑year 2026 financial outlook.

Key Details

• FDA reclassification announced April 16, 2026; CMS billing changes effective for services on/after May 18, 2026.
• Expected Medicare reimbursement decline of ~10% for HCPCS codes E0747, E0748 and E0760.
• Updated 2026 guidance: net sales now expected $838M–$848M; non‑GAAP adjusted EBITDA $90M–$93M.
• Company currently does not expect positive free cash flow for full‑year 2026 and says its prior three‑year financial targets are no longer applicable.

Why It Matters Lower Medicare reimbursement directly reduces revenue and profitability for Orthofix’s non‑invasive bone growth stimulator business, prompting the company to cut its 2026 sales and EBITDA guidance and to suspend prior multi‑year targets. Investors should note the company warns that further CMS changes could require additional adjustments. The filing also includes the usual forward‑looking statement disclosures that actual results may differ due to risks and uncertainties described in its public filings.