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Organogenesis Supports CMS' Local Coverage Determination Implementation Delay to Review Coverage Policies to Maintain Patient Access with High Quality Evidence of Effectiveness

1. Organogenesis supports CMS's delay on local coverage determinations for skin substitutes. 2. CMS will review coverage policies to enhance access to effective products. 3. CEO advocates for an integrated policy to manage Medicare costs. 4. Organogenesis leads in regenerative medicine and advanced wound care therapies. 5. Company aims for patient access while reducing costs in Medicare.

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Why Bullish?

The CMS delay could enhance ORGO's market positioning by improving product access. Historically, favorable regulatory changes have boosted stock prices in the healthcare sector.

How important is it?

The article addresses key regulatory changes impacting ORGO's products, likely influencing investor sentiment and stock performance.

Why Short Term?

Immediate effects from CMS's decision could influence ORGO's stock in the near term. Similar past delays fostered short-term price rallies for other medical companies.

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CANTON, Mass., April 11, 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 supports the U.S. Centers for Medicare & Medicaid Services’ (CMS) decision to delay the local coverage determinations (LCDs) for skin substitute grafts/cellular and tissue-based products (CTP) for the treatment of diabetic foot ulcers (DFU) and venous leg ulcers (VLU) to review its coverage policies. “Organogenesis supports an evidence-based approach to coverage and is pleased that CMS has delayed LCD implementation to review its coverage policies to ensure that patients have access to products with “high quality evidence of effectiveness”, which we believe includes real-world evidence,” said Gary S. Gillheeney, Sr., President, Chief Executive Officer, and Chair of the Board of Organogenesis. “Real-world evidence not only demonstrates a product’s safety and efficacy, but also outcomes in actual clinical use.” Gillheeney continued, “Although we believe this is an important first step for the industry, we believe coverage policies alone are not sufficient to address rapidly escalating Medicare costs while ensuring cost-effective patient care and innovation. To that end, we recommend CMS implement an integrated coverage and payment policy. As a leader in the space, we will continue to bring stakeholders together to develop and advocate for such an integrated policy that will ensure patient access to the most appropriate products while achieving significant savings to Medicare.” Organogenesis has been a leader in regenerative medicine for four decades, innovating and manufacturing a diverse portfolio of highly effective advanced wound care therapies. The Company is a pioneer in bioengineered living cell products, creating the skin substitutes and CTP category in the chronic wound space. Organogenesis has multiple technology platforms supporting clinically proven safe and effective solutions that substantially improve outcomes while lowering the overall cost of care. About Organogenesis Holdings Inc. Organogenesis Holdings Inc. is a leading regenerative medicine company focused on the development, manufacture, and commercialization of solutions for the advanced wound care and surgical and sports medicine markets. Organogenesis offers a comprehensive portfolio of innovative regenerative products to address patient needs across the continuum of care. For more information, visit www.organogenesis.com.

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