{"url_path":"/sec/bvs/8-k/2026-05-21/item-7-01","section_key":"item-7-01","section_title":"Item 7.01 Regulation FD Disclosure.","topic":"sec","document":{"doc_type":"8-K","doc_date":"2026-05-21","source_url":"https://www.sec.gov/Archives/edgar/data/1665988/0001665988-26-000029-index.html","accession_number":"0001665988-26-000029","cik":"0001665988","ticker":"BVS","issuer_name":"Bioventus Inc.","edgar_url":"https://www.sec.gov/Archives/edgar/data/1665988/0001665988-26-000029-index.html","primary_entity_key":"0001665988","primary_entity_name":"Bioventus Inc."},"word_count":469,"has_tables":true,"body_markdown":"Item 7.01. Regulation FD Disclosure.\n\nOn 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.\n\nBased 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.\n\nThe 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.\n\nLegal Notice Regarding Forward-Looking Statements\n\nThis Current Report on Form 8-K contains forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E of the Exchange Act. All statements contained in this Current Report on Form 8-K that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements including the implementation of the revised reimbursement rates and rules and other risks and uncertainties affecting the Company’s business, or the timing of any of the foregoing. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. Factors that could cause our actual results to differ materially from those contemplated in this Current Report on Form 8-K include, but are not limited to the potential long-term impact of the FDA’s down classification of bone growth stimulators and any current or future CMS actions, as well as the risks identified in our Annual Report on Form 10-K for the year ended December 31, 2025, as such factors may be updated from time to time in Bioventus’ other filings with the Securities and Exchange Commission (the “SEC”) which are accessible on the SEC’s website at www.sec.gov and the Investor Relations page of Bioventus’ website at https://ir.bioventus.com. Except to the extent required by law, the Company undertakes no obligation to update or review any estimate, projection, or forward-looking statement. Actual results may differ materially from those set forth in the forward-looking statements.\n\nSIGNATURES\n\nPursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.\n\n \n\nBIOVENTUS INC.\n\nDate: May 21, 2026\n\nBy:\n\n/s/ Anthony D’Adamio\n\nAnthony D’Adamio\n\nSenior Vice President and General Counsel"}