On April 16, 2026, the U.S. Food and Drug Administration ("FDA") issued a final order reclassifying non-invasive bone growth stimulators, including the Company's Exogen® Ultrasound Bone Healing System, from Class III to Class II devices. In connection with this reclassification, the Centers for Medicare & Medicaid Services ("CMS") has updated certain billing requirements and the Medicare fee schedule 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.

Based on currently available information, the Company does not presently expect the changes to the reimbursement rates applicable to its Exogen device to have a material impact on its financial results for fiscal year 2026. Accordingly, the Company is reiterating its previously issued financial guidance for 2026.

The Company will continue to evaluate the potential long-term impact of current and any future CMS actions. Potential further changes by CMS to the applicable Medicare reimbursement rates for the Exogen device could require the Company to revise its financial outlook.

 

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