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. (ORGO) is a leader in regenerative medicine, specializing in advanced wound care and surgical biologics. This page aggregates all official company announcements, press releases, and material developments for investors and industry observers.
Find updates on quarterly earnings, product innovations, regulatory milestones, and clinical trial progress. Our curated feed ensures timely access to information affecting ORGO's position in regenerative therapies and sports medicine markets.
Key areas include bioactive wound care solutions, FDA filings, partnership announcements, and manufacturing updates. All content is sourced directly from company communications to maintain accuracy and compliance.
Bookmark this page for easy access to Organogenesis' latest developments. Check back regularly for updates on their pioneering work in tissue repair technologies and healthcare market strategies.
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.
Organogenesis Holdings (NASDAQ: ORGO) reported strong Q4 2024 financial results with net revenue of $126.7 million, up 27% from Q4 2023. The company achieved Q4 net income of $7.7 million compared to a net loss of $0.6 million in Q4 2023.
For full-year 2024, revenue reached $482.0 million, an 11% increase from 2023, driven by Advanced Wound Care products (+12% to $453.6M) and Surgical & Sports Medicine products (+3% to $28.4M). The company ended 2024 with $136.2 million in cash and no outstanding debt.
For 2025 guidance, Organogenesis expects:
- Net revenue between $480.0-$535.0 million
- Net income between $9.5-$38.8 million
- Adjusted EBITDA between $43.6-$83.2 million
Organogenesis Holdings (Nasdaq: ORGO), a regenerative medicine company specializing in Advanced Wound Care and Surgical and Sports Medicine markets, has announced it will release its fourth quarter and fiscal year 2024 financial results after market close on February 27th, 2025.
Management will host a conference call at 5:00 p.m. Eastern Time on the same day to discuss quarterly and annual results, provide a corporate update, and conduct a Q&A session. The event will be accessible via live webcast through the company's investor relations website, where it will remain archived for approximately one year.
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