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) 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.
Organogenesis Holdings Inc. (Nasdaq: ORGO) reported financial results for Q2 2024, ending June 30. Net revenue increased to $130.2 million, up from $117.3 million in Q2 2023. This growth was primarily driven by a 12% increase in revenue from Advanced Wound Care products, totaling $123.2 million. However, revenue from Surgical & Sports Medicine products dropped 3% to $7.0 million.
The net loss for Q2 2024 was $17.0 million, compared to a net income of $5.3 million in Q2 2023. Adjusted net income also fell to $0.2 million, down from $6.1 million. Operating expenses surged by 41% to $114.9 million, primarily due to increased R&D and selling costs.
For the first half of 2024, net revenue was $240.2 million, an increase of 7% from the same period in 2023. The company reaffirmed its 2024 revenue guidance of $445.0 million to $470.0 million and adjusted its profitability guidance.
Organogenesis Holdings Inc. (Nasdaq: ORGO) has provided an update on its ReNu® development program for knee osteoarthritis (OA) symptoms. The company is on track to submit a Biologics License Application (BLA) by the end of 2025. Enrollment in the second Phase 3 trial has been completed ahead of schedule, with 594 patients. Subgroup analysis showed that severe (KL4) patients responded similarly to moderate (KL3) cases.
Key points:
- FDA indicated a second Phase 3 study was needed for BLA submission
- Combined Phase 3 studies will evaluate over 1,100 patients
- First Phase 3 trial showed statistically significant pain reduction and function maintenance
- ReNu could address unmet needs for all knee OA patients, including severe cases
Organogenesis Holdings (Nasdaq: ORGO), a leading regenerative medicine company, has announced it will report its second quarter fiscal year 2024 financial results on August 8, 2024, after market close. The company will host a conference call at 5:00 p.m. Eastern Time on the same day to discuss the results and provide a corporate update. Interested parties can access the live webcast or dial (800) 715-9871 with access code 6679912 to participate. The webcast will also be available on the company's investor relations website and archived for approximately one year.
Organogenesis Holdings (Nasdaq: ORGO), a regenerative medicine leader in advanced wound care and surgical sports medicine, announced its participation in the Truist Securities MedTech Conference on June 18, 2024, in Boston, MA. The company's management team will engage in one-on-one meetings but will not deliver a formal presentation.
Organogenesis Holdings Inc. reported a strong start to 2024 with net revenue of $110.0 million, an increase of $2.3 million compared to the first quarter of 2023. Despite a net loss of $2.1 million, the company is confident in its market leadership and growth opportunities. The company's financials show a mix of positive and negative indicators, with an increase in revenue for Advanced Wound Care products and a decrease for Surgical & Sports Medicine products. Adjusted EBITDA decreased by $1.2 million, but the company remains optimistic about its expansion opportunities in new markets.
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