Welcome to our dedicated page for Organogenesis Holdings news (Ticker: ORGO), a resource for investors and traders seeking the latest updates and insights on Organogenesis Holdings stock.
Organogenesis Holdings Inc. (Nasdaq: ORGO) is a pioneering company in the field of regenerative medicine. Headquartered in Canton, Massachusetts, Organogenesis offers a diverse portfolio of bioactive and acellular biomaterial products, primarily targeting the Advanced Wound Care and Surgical & Sports Medicine markets. The company's innovative solutions cater to a wide range of patients with repair and regenerative needs.
The company's core products include PuraPly Antimicrobial, Affinity, NuShield, Apligraf, and Dermagraft, which are designed to improve patient outcomes while reducing overall healthcare costs. Organogenesis is recognized for its advancements in both orthopedics and spine treatments, reflecting its commitment to addressing unmet medical needs through cutting-edge research and development.
In recent news, Organogenesis has reported significant milestones and achievements. The company announced that its Phase 3 randomized control trial evaluating ReNu, a cryopreserved amniotic suspension allograft for knee osteoarthritis (OA), met its primary endpoint, demonstrating a significant reduction in knee OA pain. This achievement is poised to introduce new non-surgical treatment options for OA patients, potentially opening a significant market opportunity for Organogenesis.
The company has also faced challenges. Its third-quarter revenue was impacted by local coverage determination (LCD) issues, yet it managed to deliver substantial improvements in operating profitability and adjusted EBITDA. Organogenesis continues to build momentum with commercial support programs aimed at enhancing customer relationships and regaining lost accounts.
Financially, the company reported a net revenue of $99.7 million in the fourth quarter of 2023, reflecting a decrease from the previous year. Despite these hurdles, Organogenesis remains financially robust with $104.3 million in cash and equivalents as of December 2023. Its operating expenses have been carefully managed, showcasing a reduction in selling, general, and administrative expenses.
Looking ahead, Organogenesis has set optimistic projections for 2024, with anticipated revenue growth driven by new product launches and the continued demonstration of value to customers. The company is also planning to further engage with regulatory bodies to secure approvals and expand the clinical indications of its products.
Overall, Organogenesis Holdings Inc. stands out for its commitment to innovation, patient care, and financial stability, making it a significant player in the regenerative medicine landscape. For more information, visit their official website.
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.
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
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