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 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.
Organogenesis Holdings (Nasdaq: ORGO) announced plans to expand its manufacturing capacity through a long-term lease of a 122,000-square foot state-of-the-art biomanufacturing facility in Smithfield, Rhode Island. The regenerative medicine company, which focuses on Advanced Wound Care and Surgical and Sports Medicine markets, will maintain its existing operations across multiple locations including Massachusetts, Alabama, California, Florida, and Switzerland. The Rhode Island expansion is subject to state and local tax incentives.
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) reported Q3 2024 financial results with net revenue of $115.2 million, up 6% from Q3 2023. Advanced Wound Care revenue increased 7% to $108.0 million, while Surgical & Sports Medicine revenue grew 1% to $7.2 million. Net income reached $12.3 million ($0.09 per share), up from $3.2 million in Q3 2023. Adjusted EBITDA was $13.4 million, down from $16.0 million year-over-year. The company updated its FY2024 guidance, expecting net revenue between $455-480 million, representing 5-11% growth, with projected net loss between $12.3-0.6 million.
Organogenesis Holdings (Nasdaq: ORGO) has secured a $130 million private placement through the sale of Series A Convertible Preferred Stock to Avista Healthcare Partners. The net proceeds will fund strategic growth initiatives, including operating activities, clinical development, working capital, and debt repayment. $23.5 million will be used to repurchase 7.4 million shares of common stock from certain directors. The Preferred Stock is convertible into common stock at $3.79 per share, a 20% premium to recent trading. Investors will receive an 8% annual dividend, and Garrett Lustig from Avista joins the Board of Directors.
Organogenesis Holdings (ORGO) announced positive interim analysis results from its second Phase 3 clinical trial of ReNu for knee osteoarthritis treatment. The analysis, covering 50% of 474 planned patients with moderate to severe knee OA, focused on the 6-month primary endpoint. The independent Data Monitoring Committee recommended proceeding without modifications or sample size increases, confirming favorable results and consistent safety profile. The fully enrolled 594-patient trial is evaluating ReNu versus saline control through intra-articular injection, with the primary endpoint measuring knee pain reduction using the WOMAC pain scale. Knee OA affects nearly 31.1 million Americans, projected to reach 34.4 million by 2027.
Organogenesis Holdings Inc. (Nasdaq: ORGO), a leading regenerative medicine company, has announced that it will report its third quarter fiscal year 2024 financial results after the market closes on Tuesday, November 12th, 2024. The company will host a conference call at 5:00 p.m. Eastern Time on the same day to discuss the quarterly results and provide a corporate update, followed by a question and answer session.
Interested parties can access the live webcast through the company's website at investors.organogenesis.com or via a provided link. A teleconference option is also available. The webcast will be archived on the company's website for approximately one year after the event.
Organogenesis Holdings Inc. (Nasdaq: ORGO) has announced the publication of a randomized clinical trial (RCT) demonstrating the safety and efficacy of NuShield for diabetic foot ulcers (DFUs). The study, published in the Journal of Wound Care, involved 218 patients with Wagner 1 or 2 grade DFUs.
Key findings include:
- NuShield showed statistically superior frequency of wound closure (p=0.04) compared to standard of care (SoC) at weeks 4, 6, 8, 10, and 12
- The NuShield group demonstrated a 48% greater probability of wound closure and decreased median time to complete wound closure
Organogenesis believes this study satisfies requirements for Medicare coverage under proposed Local Coverage Determination (LCDs).
Organogenesis Holdings (Nasdaq: ORGO), a leading regenerative medicine company, has announced its participation in two upcoming investor conferences in September 2024. The company will attend:
1. The Morgan Stanley Global Healthcare Conference in New York, NY, where management will participate in investor 1x1 meetings without a formal presentation.
2. The Cantor Fitzgerald Global Healthcare Conference in New York, NY, featuring a fireside chat on September 18 at 1:20 p.m. Eastern Time. This presentation will be webcast and accessible via the company's website, with a replay available for approximately 30 days.
These conferences provide Organogenesis an opportunity to showcase its focus on developing, manufacturing, and commercializing product solutions for the Advanced Wound Care and Surgical & Sports Medicine markets.