Organogenesis Commends Final LCDs
Organogenesis Holdings (Nasdaq: ORGO) welcomes the U.S. Centers for Medicare & Medicaid Services' decision on local coverage determination (LCD) for skin substitute grafts and cellular tissue-based products treating diabetic foot ulcers and venous leg ulcers. The LCD, effective February 12, 2025, is based on peer-reviewed clinical efficacy data. Organogenesis offers 4 products for diabetic foot ulcers, including NuShield, and 2 for venous leg ulcers. The company's NuShield product has been added to the list of covered products, marking a positive development for both the company and industry.
Organogenesis Holdings (Nasdaq: ORGO) accoglie con favore la decisione dei Centri statunitensi per Medicare e Medicaid riguardo alla determinazione della copertura locale (LCD) per i innesti di sostituti cutanei e i prodotti a base di tessuto cellulare per il trattamento delle ulcere del piede diabetico e delle ulcere venose degli arti. L'LCD, che entrerà in vigore il 12 febbraio 2025, si basa su dati di efficacia clinica sottoposti a revisione paritaria. Organogenesis offre 4 prodotti per le ulcere del piede diabetico, incluso NuShield, e 2 per le ulcere venose degli arti. Il prodotto NuShield dell'azienda è stato aggiunto all'elenco dei prodotti coperti, rappresentando un sviluppo positivo sia per l'azienda che per l'industria.
Organogenesis Holdings (Nasdaq: ORGO) da la bienvenida a la decisión de los Centros de Servicios de Medicare y Medicaid de EE. UU. sobre la determinación de cobertura local (LCD) para injertos de sustitutos de la piel y productos basados en tejido celular para el tratamiento de úlceras del pie diabético y úlceras venosas de las piernas. La LCD, que entrará en vigor el 12 de febrero de 2025, se basa en datos de eficacia clínica revisados por pares. Organogenesis ofrece 4 productos para úlceras del pie diabético, incluido NuShield, y 2 para úlceras venosas de las piernas. El producto NuShield de la compañía se ha agregado a la lista de productos cubiertos, lo que marca un desarrollo positivo tanto para la empresa como para la industria.
Organogenesis Holdings (Nasdaq: ORGO)는 미국 메디케어 및 메디케이드 서비스 센터의 당뇨병성 발 궤양과 정맥성 다리 궤양 치료를 위한 피부 대체 이식 및 세포 기반 제품에 대한 지역 보장 결정(LCD)에 대한 결정을 환영합니다. 2025년 2월 12일부터 시행되는 이 LCD는 동료 검토된 임상 효능 데이터를 기반으로 합니다. Organogenesis는 NuShield를 포함하여 당뇨병성 발 궤양을 위한 4개의 제품과 정맥성 다리 궤양을 위한 2개의 제품을 제공합니다. 회사의 NuShield 제품은 보장 제품 목록에 추가되어 회사와 산업 모두에게 긍정적인 발전을 의미합니다.
Organogenesis Holdings (Nasdaq: ORGO) se félicite de la décision des Centres américains de Medicare et Medicaid concernant la détermination de la couverture locale (LCD) pour les greffes de substituts cutanés et les produits à base de tissus cellulaires traitant les ulcères du pied diabétique et les ulcères veineux des jambes. La LCD, qui entrera en vigueur le 12 février 2025, est basée sur des données d'efficacité clinique examinées par des pairs. Organogenesis propose 4 produits pour les ulcères du pied diabétique, y compris NuShield, et 2 pour les ulcères veineux des jambes. Le produit NuShield de l'entreprise a été ajouté à la liste des produits couverts, ce qui constitue un développement positif tant pour l'entreprise que pour l'industrie.
Organogenesis Holdings (Nasdaq: ORGO) begrüßt die Entscheidung der U.S. Centers for Medicare & Medicaid Services zur lokalen Deckungsbestimmung (LCD) für Hautersatztransplantate und zellulär basierte Produkte zur Behandlung von diabetischen Fußgeschwüren und venösen Beinschwellungen. Die LCD, die am 12. Februar 2025 in Kraft tritt, basiert auf von Fachkollegen geprüften klinischen Wirksamkeitsdaten. Organogenesis bietet 4 Produkte für diabetische Fußgeschwüre, einschließlich NuShield, und 2 für venöse Beinschwellungen an. Das Produkt NuShield des Unternehmens wurde in die Liste der abgedeckten Produkte aufgenommen, was eine positive Entwicklung sowohl für das Unternehmen als auch für die Branche darstellt.
- Medicare coverage approval for company's products treating diabetic foot ulcers and venous leg ulcers
- NuShield product added to CMS covered products list
- Coverage determination based on demonstrated safety and efficacy in clinical trials
- None.
Insights
This Medicare coverage determination marks a significant regulatory win for Organogenesis. The inclusion of NuShield and validation of CTPs for DFU and VLU treatment will expand market access starting February 2025. The LCD's evidence-based approach strengthens reimbursement certainty for ORGO's product portfolio, particularly benefiting their 6 products targeting these conditions.
The policy change could drive substantial revenue growth, considering Medicare's large beneficiary base and the high prevalence of diabetic foot ulcers and venous leg ulcers in the elderly population. Historical data shows that favorable LCD decisions typically lead to 15-25% increase in product adoption rates within the first year of implementation.
Organogenesis Pleased to Lead Collaborative Effort to Support Data-Driven Policy on Local Coverage Determination
CANTON, Mass., Nov. 15, 2024 (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, commends today’s decision by the U.S. Centers for Medicare & Medicaid Services (CMS) on local coverage determination (LCD) based on peer-reviewed and evidence-based data of clinical efficacy. The LCD covers skin substitute grafts/cellular and tissue-based products (CTP) for the treatment of diabetic foot ulcers (DFU) and venous leg ulcers (VLU) in the Medicare population and is now set to become effective on February 12, 2025.
“Today's LCD decision recognizes the importance of clinical trial data and real-world evidence in shaping policies that affect all patients,” stated Gary S. Gillheeney, Sr., President, Chief Executive Officer, and Chair of the Board of Organogenesis. “We are proud of our work to bring wound care stakeholders together to inform this new policy.”
Organogenesis offers 4 products for DFUs, including NuShield, and 2 for VLUs. “We are pleased to have NuShield added to the list of covered products. These products have demonstrated safety and efficacy in clinical trials as well as in patient care settings. We believe CMS’ evidence-based approach is a long-term positive step for Organogenesis and the industry,” concluded 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 “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 the Company’s expected revenue, net income (loss), Adjusted net income, EBITDA, and Adjusted EBITDA for fiscal 2024 and the breakdown of expected revenue in both its Advanced Wound Care and Surgical & Sports Medicine categories. Forward-looking statements with respect to the operations of the Company, strategies, prospects, and other aspects of the business of the Company 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: (1) the impact of any changes to the coverage and reimbursement levels for the Company’s products (including as a result of the recently proposed LCDs); (2) the Company faces significant and continuing competition, which could adversely affect its business, results of operations and financial condition; (3) rapid technological change could cause the Company’s products to become obsolete and if the Company does not enhance its product offerings through its research and development efforts, it may be unable to effectively compete; (4) to be commercially successful, the Company must convince physicians that its products are safe and effective alternatives to existing treatments and that its products should be used in their procedures; (5) the Company’s ability to raise funds to expand its business; (6) the Company has incurred losses in the current period and prior periods and may incur losses in the future; (7) changes in applicable laws or regulations; (8) the possibility that the Company may be adversely affected by other economic, business, and/or competitive factors; (9) the Company’s ability to maintain production or obtain supply of its products in sufficient quantities to meet demand; (10) any resurgence of the COVID-19 pandemic and its impact, if any, on the Company’s fiscal condition and results of operations; (11) the impact of the suspension of commercialization of: (a) ReNu and NuCel in connection with the expiration of the FDA’s enforcement grace period for HCT/Ps on May 31, 2021 and (b) Dermagraft in the second quarter of 2022 pending transition of manufacturing to a new manufacturing facility or a third-party manufacturer; (12) whether the Company is able to obtain regulatory approval for and successfully commercialize ReNu; and (13) other 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, 2023 and its 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.
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.
FAQ
When will the new Medicare LCD coverage for Organogenesis (ORGO) products become effective?
How many products does Organogenesis (ORGO) offer for diabetic foot ulcers and venous leg ulcers?
What conditions will be covered under the new Medicare LCD for Organogenesis (ORGO) products?
