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Get filing alertsOrthofix cuts 2026 guidance, withdraws three-year targets on Medicare reimbursement cuts
Filed May 21, 2026 · Period ending May 21, 2026 · ~1 min read
Key Changes
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Medicare reimbursement for bone growth stimulators drops ~10% effective May 18, 2026, following FDA device reclassification from Class III to Class II.
Item 7.01 verify on EDGAR → -
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Full-year 2026 revenue guidance lowered to $838-$848 million, adjusted EBITDA to $90-$93 million; company now expects negative free cash flow for the year.
Item 7.01 verify on EDGAR → -
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Three-year financial targets withdrawn due to uncertainty around long-term impact of current and potential future CMS reimbursement changes.
Item 7.01 verify on EDGAR →
Summary
Orthofix disclosed that Medicare reimbursement for its bone growth stimulators will decline approximately 10% starting May 18, 2026, following an FDA reclassification of the devices from Class III to Class II. The Centers for Medicare & Medicaid Services updated billing requirements and fee schedules for the affected product codes (E0747, E0748, E0760) in response to the FDA action.
The reimbursement cut hits a core product line and forced immediate guidance revisions. The company lowered its full-year 2026 revenue outlook to $838-$848 million and adjusted EBITDA to $90-$93 million, and now expects negative free cash flow for the year. Management also withdrew its three-year financial targets, citing uncertainty about the long-term impact of current and potential future CMS actions.
The withdrawal removes medium-term visibility and suggests the company is reassessing its strategic plan in light of the new reimbursement environment. Investors should watch for management's updated long-term outlook and any operational adjustments to offset the revenue headwind.
Section-by-Section Diff
Event · Item 7.01 — Regulation FD Disclosure
Medicare reimbursement cuts for bone growth stimulators prompt guidance reduction and withdrawal of three-year targets.
Added in current filing · verify on EDGAR →
On April 16, 2026, the U.S. Food and Drug Administration issued a final order reclassifying non-invasive bone growth stimulators from Class III to Class II devices. In connection with that reclassification, the Centers for Medicare & Medicaid Services (“CMS”) recently updated certain billing requirements and Medicare fee schedule treatment applicable to non-invasive bone growth stimulators billed under HCPCS codes E0747, E0748 and E0760 for dates of service on or after May 18, 2026.
The FDA reclassified bone growth stimulators to a lower device class, triggering CMS to revise Medicare billing and payment rules effective May 18, 2026. The company expects average Medicare reimbursement for the affected product codes to decline by approximately 10%, directly impacting revenue from a core product line.
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Figures/quotes linked to EDGAR · Narrative written by AI · Jul 8, 2026 · How we verify