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Organogenesis Applauds CMS’s Significant Step In Payment Reform

Key Takeaway: Organogenesis Holdings Inc. has praised the Centers for Medicare & Medicaid Services (CMS) for its recent payment reform for skin substitutes under the CY 2026 Physician Fee Schedule. The new policy aims to enhance access to PMA products and address issues in the existing system. CEO Gary S. Gillheeney expressed confidence that this reform will incentivize innovation and investment in regenerative medicine.
Price reaction · baseline $4.095 (2025-11-03T18:08:00.000Z) · hit during market hours · 2 other ORGO headline(s) in the window, move may be shared
day 0 close · peak
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From our catalyst data and publicly available data · not financial advice
Cash runway
~4 mo
High dilution risk
Lead asset
Amniotic Allograft
Phase 3 · Knee Osteoarthritis

Full Press Release Details

CANTON, Mass., Nov. 03, 2025 (GLOBE NEWSWIRE) -- Organogenesis Holdings Inc. (Nasdaq: ORGO), a leading regenerative medicine company focused on the development, manufacture, and commercialization of product solutions for the Advanced Wound Care and Surgical and Sports Medicine markets, applauds the Centers for Medicare & Medicaid Services’ (CMS) significant step in payment reform for skin substitutes/cellular and tissue-based products (CTPs) under the CY 2026 Physician Fee Schedule.
“We congratulate CMS on taking this significant step in payment reform and are pleased CMS finalized FDA classifications and a per centimeter square payment methodology in both the physician office and hospital outpatient settings,” said Gary S. Gillheeney, Sr., President, CEO, and Chair of the Board for Organogenesis. “We believe this new policy will increase access to PMA products while addressing abuse under the current system.”
Mr. Gillheeney continued, “We are also pleased that CMS has recognized the clinical differentiation of PMA products and taken steps toward higher payment and expanded access for PMA products. We remain committed to working with CMS and other stakeholders to further expand access to these life-saving technologies as well as incentivize investment and innovation in the space and achieve long-term market stability.”
“With more than forty years of leadership in regenerative medicine, and a diverse evidenced-based portfolio with technologies in each FDA category, we believe we are best positioned in the skin substitutes market for 2026 and beyond,” concluded Mr. Gillheeney.

Forward-Looking Statements

This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements relate to expectations or forecasts of future events. Forward-looking statements may be identified by the use of words such as “will,” “forecast,” “intend,” “seek,” “target,” “anticipate,” “believe,” “expect,” “estimate,” “plan,” “outlook,” and “project” and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. Such forward-looking statements include statements relating to CMS’s new payment structure and the likelihood that it will increase access to PMA products and address abuse under the current system. Forward-looking statements with respect to the operations of the Company, future growth, strategies, prospects, and other aspects of the business of the Company, including the Company’s positioning in the skin substitutes market for 2026 and beyond, are based on current expectations that are subject to known and unknown risks and uncertainties, which could cause actual results or outcomes to differ materially from expectations expressed or implied by such forward-looking statements. These factors include, but are not limited to the risks and uncertainties described in the Company’s filings with the Securities and Exchange Commission, including Item 1A (Risk Factors) of the Company’s Form 10-K for the year ended December 31, 2024 and subsequently filed periodic reports. You are cautioned not to place undue reliance upon any forward-looking statements, which speak only as of the date made. Although it may voluntarily do so from time to time, the Company undertakes no commitment to update or revise the forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable securities laws.

Frequently Asked Questions

What recent change did CMS implement?

CMS introduced a new payment reform for skin substitutes under the CY 2026 Physician Fee Schedule.

How will the CMS reform affect PMA products?

The reform is expected to increase access to PMA products and address current system abuses.

Who is the CEO of Organogenesis?

The CEO of Organogenesis is Gary S. Gillheeney.

What is Organogenesis's focus area?

Organogenesis focuses on regenerative medicine, particularly in advanced wound care.

Last updated: Nov 3, 2025