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 Inc. (Nasdaq: ORGO) appointed Jon Giacomin to its Board of Directors, effective May 7, 2021, following Wayne Mackie's resignation on the same day. Giacomin brings nearly 30 years of healthcare experience, previously serving as CEO of U.S. Anesthesia Partners and Cardinal Health’s Medical Segment, which generated over $15 billion in revenue. This strategic leadership change aims to enhance the company’s growth potential as it continues to develop its regenerative medicine solutions in wound care and surgical markets.
Organogenesis Holdings Inc. (Nasdaq: ORGO) has announced its participation as a Platinum Sponsor at the upcoming 2021 Symposium on Advanced Wound Care Spring. The company will showcase its advanced wound care product lines, including PuraPly® AM and Apligraf®, with a focus on clinical evidence supporting their efficacy. On May 14, a presentation titled 'Clinical Evidence Outlines the Need for Early Advanced Standard of Care' will discuss a pooled analysis of 434 wounds. Other research highlights include podium and video presentations on the effectiveness of various wound care solutions.
Organogenesis Holdings Inc. (Nasdaq: ORGO) will announce its first quarter fiscal year 2021 financial results after market close on May 10. A conference call is scheduled for the same day at 5:00 p.m. ET to discuss the results and provide corporate updates. Interested participants can join by dialing 866-795-3142, with international callers using 409-937-8908, and using access code 9199306. A live webcast will also be available on their investor relations website, with a replay accessible for two weeks following the call.
Organogenesis Holdings (Nasdaq: ORGO) reported Q4 2020 net revenue of $106.8 million, a 43% increase YoY, driven by strong sales in Advanced Wound Care, which rose 48% to $93.6 million. Net income surged to $18.5 million from a loss of $4.4 million in Q4 2019. For FY 2020, total revenue reached $338.3 million, up 30%, with net income of $17.9 million. Looking ahead, the company expects FY 2021 revenue between $390 million and $405 million, reflecting a projected 15-20% growth.
Organogenesis Holdings (Nasdaq: ORGO) appointed David C. Francisco as Chief Financial Officer, effective February 15, 2021. Francisco, who has over 25 years of finance experience, previously held leadership roles at PerkinElmer, where he oversaw significant revenue growth. CEO Gary Gillheeney expressed optimism about Francisco's strategic insights, aiming to enhance operational performance and profitability amid growth opportunities. However, the company has faced substantial losses and competitive pressures, making its future profitability uncertain.
Organogenesis Holdings Inc. (Nasdaq: ORGO), a leader in regenerative medicine, has announced its participation in several upcoming investor conferences. These include the BTIG Virtual MedTech Conference on February 18 at 1:00 p.m. ET, the SVBLeerink Global Healthcare Conference on February 24 at 8:40 a.m. ET, and the Oppenheimer Healthcare Conference on March 17 at 10:40 a.m. ET. Live audio webcasts will be available on the company's website, with archives accessible for 30 days post-conference.
Organogenesis Holdings Inc. (Nasdaq: ORGO) will announce its fourth quarter and fiscal year 2020 financial results on March 16, 2021, after market closure. A conference call will follow at 5:00 p.m. ET to discuss the financial outcomes and provide corporate updates. Interested participants can join by calling 866-795-3142 (international callers: 409-937-8908) and using access code 6766924. A live webcast will be available on the company's investor relations website, with a replay accessible for two weeks thereafter.
Organogenesis Holdings has initiated a pivotal Phase 3 clinical trial for ReNu®, a cryopreserved amniotic suspension allograft, targeting knee osteoarthritis treatment, with the first patient enrolled. The trial involves 474 subjects in a randomized controlled study comparing ReNu to a saline placebo. The primary endpoint will assess pain reduction over six months using the WOMAC index. The company's RMAT designation from the FDA supports expedited review processes, addressing a significant market demand as knee OA affects over 14 million Americans, with increasing knee replacement surgeries.
Organogenesis Holdings (Nasdaq: ORGO) reported preliminary financial results for Q4 and fiscal year 2020. Q4 net revenue is projected between $104.6 million and $106.0 million, marking a 40% to 42% increase year-over-year. Advanced Wound Care revenues rose by 45% to 47%, while Surgical & Sports Medicine grew by 12% to 14%. For the full year, revenue reached $336.1 million to $337.5 million, up 29% from 2019. The company anticipates reporting positive GAAP net income and adjusted EBITDA for both periods.
Organogenesis announces that the FDA has granted ReNu, a cryopreserved amniotic suspension allograft for knee osteoarthritis management, Regenerative Medicine Advanced Therapy (RMAT) designation. This designation allows closer interactions with the FDA to support accelerated approval, enhancing the therapy's development pathway. The RMAT was granted based on a randomized controlled trial showing a significant reduction in pain and improved function in patients treated with ReNu compared to standard treatments.