Welcome to our dedicated page for Organogenesis Hldgs news (Ticker: ORGO), a resource for investors and traders seeking the latest updates and insights on Organogenesis Hldgs stock.
Organogenesis Holdings Inc. (Nasdaq: ORGO) is a regenerative medicine company focused on product solutions for the Advanced Wound Care and Surgical & Sports Medicine markets. The Organogenesis news feed highlights company announcements, clinical updates, financial results, and regulatory developments that help investors and healthcare professionals understand how the business is evolving.
News about Organogenesis frequently covers its regenerative medicine portfolio and its position in the skin substitutes and cellular and tissue-based products (CTP) market. The company issues press releases on quarterly and year-to-date financial performance, including net product revenue from Advanced Wound Care and Surgical & Sports Medicine products, net income or loss, and adjusted metrics such as adjusted net income and adjusted EBITDA. These updates often include management commentary on market conditions, reimbursement dynamics, and expectations for future periods.
A major theme in Organogenesis news is the development of ReNu, a cryopreserved amniotic suspension allograft for symptomatic knee osteoarthritis. The company publishes detailed updates on Phase 3 randomized controlled trials, including pain and function outcomes, safety observations, and plans for regulatory submissions. Announcements have described FDA Regenerative Medicine Advanced Therapy (RMAT) designation for ReNu, plans for a Biologics License Application (BLA), and the initiation of a rolling BLA submission.
Additional news items include commentary on Centers for Medicare & Medicaid Services (CMS) payment reforms for skin substitutes/CTPs, participation in investor conferences, and corporate governance developments such as inducement equity grants and stockholder meeting results. By following this page, readers can review a chronological record of how Organogenesis communicates its financial performance, clinical progress, reimbursement environment, and corporate actions.
Organogenesis (Nasdaq: ORGO) announced inducement equity awards tied to its newly hired Chief Technology Officer, Michael Catarina, effective October 29, 2025.
The Board granted 82,542 non‑statutory stock options (NSOs) with an exercise price of $4.17 per share and 47,962 restricted stock units (RSUs). Both awards vest in substantially equal annual installments over four years beginning October 20, 2025, subject to continued employment. Although granted outside the 2018 Equity Incentive Plan, the awards are governed by that plan's terms and the related award agreements.
The awards were made as an inducement material to Mr. Catarina’s acceptance of employment pursuant to Nasdaq Listing Rule 5635(c)(4).
Organogenesis Holdings (Nasdaq: ORGO), a regenerative medicine company specializing in Advanced Wound Care and Surgical and Sports Medicine markets, has scheduled its Q3 2025 earnings release for November 6, 2025, after market close.
Management will host a conference call at 5:00 p.m. Eastern Time on the same day, featuring a corporate update and Q&A session. Investors can join via webcast or teleconference using the dial-in numbers 800-715-9871 (US) or 646-307-1963 (international) with access code 9073428. The webcast will be available on the company's investor relations website for approximately one year.
Organogenesis (NASDAQ: ORGO) announced that its second Phase 3 trial for ReNu®, a treatment for knee osteoarthritis (OA), did not meet its primary endpoint despite showing improved pain reduction. The trial demonstrated a numerical improvement of -0.51 favoring ReNu (p=0.0393) compared to saline, falling short of the p=0.023 target threshold.
Key highlights include baseline pain reduction of -6.9 at six months in the second Phase 3 study, improving from -6.0 in the first Phase 3 study. The company maintains confidence in ReNu's potential and plans to request a pre-BLA meeting with the FDA by end of October to discuss submission pathway, leveraging combined efficacy analysis from both Phase 3 studies.
ReNu has been studied in three large RCTs with over 1,300 patients and has received FDA's Regenerative Medicine Advanced Therapy (RMAT) designation.
Organogenesis Holdings (Nasdaq: ORGO), a regenerative medicine company specializing in Advanced Wound Care and Surgical & Sports Medicine markets, has announced its participation in two major healthcare investor conferences in September.
Management will present at the Cantor Fitzgerald Global Healthcare Conference on September 3 at 2:10 p.m. ET and the Morgan Stanley Global Healthcare Conference on September 10 at 2:35 p.m. ET. Both events will take place in New York City and feature fireside chat sessions that will be available via webcast on the company's investor relations website for approximately 30 days after the events.
Organogenesis Holdings (NASDAQ: ORGO) reported Q2 2025 financial results showing a decline in performance. The company posted net product revenue of $100.8 million, down 23% from $130.2 million in Q2 2024. The Advanced Wound Care segment saw a 25% decrease to $92.7 million, while Surgical & Sports Medicine revenue increased 16% to $8.1 million.
The company reported a net loss of $9.4 million ($0.10 per share), an improvement from a $17.0 million loss in Q2 2024. Adjusted EBITDA turned negative at $(3.6) million, compared to positive $15.6 million in the prior year. The company maintained a strong balance sheet with $73.7 million in cash and no debt.
For full-year 2025, Organogenesis updated guidance, projecting revenue between $480-$510 million, representing flat to 6% growth, with net income ranging from $(6.4) million to $16.4 million.
Organogenesis Holdings (Nasdaq: ORGO), a regenerative medicine company specializing in Advanced Wound Care and Surgical and Sports Medicine markets, has scheduled its second quarter fiscal year 2025 earnings release for August 7, 2025, after market close.
Management will host a conference call at 5:00 p.m. Eastern Time on the same day to discuss quarterly results and provide a corporate update. Investors can join via webcast or teleconference using the number 800-715-9871 (646-307-1963 for international) with access code 634899. The webcast will be available on the company's investor relations website for approximately one year.
Organogenesis (Nasdaq: ORGO), a regenerative medicine company, has expressed support for the Centers for Medicare & Medicaid Services' (CMS) proposed new payment methodology for skin substitutes in CY 2026. The proposal introduces a per centimeter square payment system based on FDA classification across both physician office and hospital outpatient settings.
CEO Gary S. Gillheeney highlighted that the new structure aims to reduce system abuse and Medicare spending while ensuring consistent payment across care sites. The proposal notably recognizes PMA products' clinical differentiation and seeks to expand access to innovative wound healing technologies that help reduce amputations and complications.
Organogenesis Holdings (Nasdaq: ORGO) supports the U.S. Centers for Medicare & Medicaid Services' (CMS) decision to delay the implementation of local coverage determinations (LCDs) for skin substitute grafts and cellular tissue-based products (CTP) used in treating diabetic foot ulcers and venous leg ulcers.
The company endorses CMS's move to review coverage policies ensuring patient access to products with high-quality effectiveness evidence, including real-world evidence. CEO Gary S. Gillheeney Sr. recommends CMS implement an integrated coverage and payment policy to address rising Medicare costs while maintaining cost-effective patient care and innovation.
As a four-decade leader in regenerative medicine, Organogenesis pioneers bioengineered living cell products and manufactures advanced wound care therapies, with multiple technology platforms supporting clinically proven solutions that improve outcomes while reducing overall care costs.
Organogenesis Holdings (Nasdaq: ORGO), a regenerative medicine company specializing in Advanced Wound Care and Surgical and Sports Medicine markets, has scheduled its first quarter 2025 financial results announcement for May 8, 2025, after market close.
Management will conduct a conference call at 5:00 p.m. Eastern Time on the same day to discuss quarterly results and provide a corporate update, followed by a Q&A session. The event will be accessible via webcast through the company's investor relations website, where it will remain archived for approximately one year.