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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 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.
Organogenesis announced positive top-line data from its Phase 3 clinical trial of ReNu for knee osteoarthritis, achieving a statistically significant reduction in knee pain and maintenance of function at six months. The results open a transformative opportunity for Organogenesis to enter the pain management market. ReNu addresses a critical unmet medical need for knee OA patients, including the most severe cases. The company plans to request an FDA meeting for a Biologics License Application filing.
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