Organogenesis supports CMS's payment reform for skin substitutes, enhancing access and market stability for advanced wound care technologies.
Quiver AI Summary
Organogenesis Holdings Inc. has praised the Centers for Medicare & Medicaid Services (CMS) for its recent payment reform for skin substitutes and cellular tissue-based products under the 2026 Physician Fee Schedule. CEO Gary S. Gillheeney expressed satisfaction with CMS's finalization of FDA classifications and a new payment methodology based on size for these products in both physician offices and hospital outpatient settings. He believes the policy will enhance access to PMA products and reduce existing abuses in the system. Gillheeney also highlighted the clinical differentiation of PMA products and the company's intention to collaborate with CMS to further improve access, foster innovation, and ensure market stability in the regenerative medicine sector. The company feels well-positioned in the skin substitutes market as it approaches 2026.
Potential Positives
- Organogenesis Holdings Inc. commends the Centers for Medicare & Medicaid Services for implementing important payment reforms for skin substitutes and tissue-based products, which could enhance reimbursement for their offerings.
- The new per centimeter square payment methodology for PMA products is expected to increase access to these life-saving technologies, potentially expanding the company's market reach and patient impact.
- CMS's recognition of the clinical differentiation of PMA products may lead to higher payments and improved accessibility, suggesting potential profitability and growth opportunities for Organogenesis.
- Organogenesis emphasizes its strong position in the regenerative medicine field, backed by over forty years of leadership and a diverse, evidence-based product portfolio, positioning the company favorably for 2026 and beyond.
Potential Negatives
- Company relies heavily on forward-looking statements that include significant risks and uncertainties, which may make stakeholders cautious about its future performance.
- Potential dependence on CMS's new payment structure for increased access and market stability may place the company's future growth at risk if the expected benefits do not materialize.
FAQ
What is Organogenesis Holdings Inc. known for?
Organogenesis Holdings Inc. specializes in regenerative medicine, focusing on advanced wound care and surgical products.
What recent development did CMS announce regarding skin substitutes?
The Centers for Medicare & Medicaid Services finalized a payment reform for skin substitutes under the CY 2026 Physician Fee Schedule.
How will the new CMS payment method affect access to products?
The new payment methodology aims to increase access to PMA products and address abuse in the current system.
Who commented on the CMS payment reform?
Gary S. Gillheeney, the CEO and Chair of Organogenesis, expressed support for the payment reform and its implications.
What is the company's outlook for the skin substitutes market?
Organogenesis believes it is well-positioned for the skin substitutes market in 2026 and beyond, with a diverse portfolio.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
$ORGO Insider Trading Activity
$ORGO insiders have traded $ORGO stock on the open market 3 times in the past 6 months. Of those trades, 3 have been purchases and 0 have been sales.
Here’s a breakdown of recent trading of $ORGO stock by insiders over the last 6 months:
- LORI FREEDMAN (Chief Admin. and Legal Officer) has made 3 purchases buying 252,264 shares for an estimated $725,290 and 0 sales.
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$ORGO Hedge Fund Activity
We have seen 58 institutional investors add shares of $ORGO stock to their portfolio, and 82 decrease their positions in their most recent quarter.
Here are some of the largest recent moves:
- FIRST LIGHT ASSET MANAGEMENT, LLC added 6,777,163 shares (+inf%) to their portfolio in Q2 2025, for an estimated $24,804,416
- DEERFIELD MANAGEMENT COMPANY, L.P. removed 4,447,740 shares (-100.0%) from their portfolio in Q2 2025, for an estimated $16,278,728
- ASSENAGON ASSET MANAGEMENT S.A. added 1,997,038 shares (+69.9%) to their portfolio in Q3 2025, for an estimated $8,427,500
- DRIEHAUS CAPITAL MANAGEMENT LLC removed 1,795,347 shares (-100.0%) from their portfolio in Q2 2025, for an estimated $6,570,970
- INVESCO LTD. removed 920,555 shares (-86.1%) from their portfolio in Q2 2025, for an estimated $3,369,231
- DEUTSCHE BANK AG\ added 836,047 shares (+34.2%) to their portfolio in Q2 2025, for an estimated $3,059,932
- VANGUARD GROUP INC added 765,378 shares (+17.3%) to their portfolio in Q2 2025, for an estimated $2,801,283
To track hedge funds' stock portfolios, check out Quiver Quantitative's institutional holdings dashboard.
$ORGO Analyst Ratings
Wall Street analysts have issued reports on $ORGO in the last several months. We have seen 2 firms issue buy ratings on the stock, and 0 firms issue sell ratings.
Here are some recent analyst ratings:
- BTIG issued a "Buy" rating on 09/26/2025
- Cantor Fitzgerald issued a "Overweight" rating on 08/08/2025
To track analyst ratings and price targets for $ORGO, check out Quiver Quantitative's $ORGO forecast page.
$ORGO Price Targets
Multiple analysts have issued price targets for $ORGO recently. We have seen 2 analysts offer price targets for $ORGO in the last 6 months, with a median target of $8.0.
Here are some recent targets:
- Ryan Zimmerman from BTIG set a target price of $7.0 on 09/26/2025
- Ross Osborn from Cantor Fitzgerald set a target price of $9.0 on 08/08/2025
Full Release
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.