Regulation FD Disclosure (Form 8-K)

Item 7.01 Regulation FD Disclosure.

On April 16, 2026, the U.S. Food and Drug Administration ("FDA") issued a final order reclassifying non-invasive bone growth stimulators from Class III to Class II devices. Following that order, the Centers for Medicare & Medicaid Services ("CMS") modified certain billing requirements and Medicare fee schedule treatment applicable to non-invasive bone growth stimulators billed under HCPCS codes E0747, E0748 and E0760 (the "Devices") for dates of service on or after May 18, 2026.

On July 1, 2026, CMS issued revised guidance that withdrew those changes and directed that Devices furnished on or after May 18, 2026 be processed and paid consistent with the treatment in effect prior to the FDA reclassification.

Based on these developments, Orthofix Medical Inc. (the "Company") currently expects average Medicare reimbursement for these codes will return to the rates in effect prior to May 18, 2026.