StreetInsider.com News Articles

Organogenesis publishes Affinity trial results for venous leg ulcers

Mon, 27 Jul 2026 16:05:14 -0400

Organogenesis Holdings Inc. (Nasdaq: ORGO) announced the publication of results from a randomized controlled trial evaluating its Affinity product in the treatment of complex venous leg ulcers (VLUs), according to a company statement.

The trial, published in the Journal of Wound Care, enrolled 206 patients randomized 1:1 to receive either Affinity plus standard of care (SoC) or SoC alone. Patients were followed for 24 weeks after a four-week run-in period.

The study examined two groups based on baseline wound duration: wounds present for more than six months and wounds present for more than 24 months. In both groups, patients receiving Affinity plus

Organogenesis Announces Publication of Peer-Reviewed Clinical Trial Results Demonstrating Clinical Benefit of Affinity™ in the Most Challenging and Complex Venous Leg Ulcers

Mon, 27 Jul 2026 16:05:00 -0400

CANTON, Mass., July 27, 2026 (GLOBE NEWSWIRE) -- Organogenesis Holdings Inc. (Nasdaq: ORGO), a leading regenerative medicine company focused on product solutions for the Advanced Wound Care and Surgical and Sports Medicine markets, today announced published results from a prospective, multicenter, randomized controlled trial (RCT) evaluating Affinity plus standard of care (SoC) compared to SoC alone in the management of complex venous leg ulcers (VLUs). The results were published in the Journal of Wound Care demonstrating statistically significant improvements in wound closure at weeks 12 and 16 for the Affinity + SoC group across two

Organogenesis Announces Publication of Peer-Reviewed Clinical Trial Results Demonstrating Clinical Benefit of Affinity™ in the Most Challenging and Complex Venous Leg Ulcers

Mon, 27 Jul 2026 16:05:00 -0400

Organogenesis Holdings Inc. to Report Second Quarter of Fiscal Year 2026 Financial Results on August 6, 2026

Thu, 09 Jul 2026 07:30:00 -0400

CANTON, Mass., July 09, 2026 (GLOBE NEWSWIRE) -- Organogenesis Holdings Inc. (Nasdaq: ORGO), a leading regenerative medicine and tissue innovations company focused on empowering healing through the development, manufacturing, and sale of products for the advanced wound care, and surgical and sports medicine markets, today announced that second quarter of fiscal year 2026 financial results will be reported after the market closes on Thursday, August 6th.

Management will host a conference call at 5:00 p.m. Eastern Time on August 6th to discuss the results of the quarter, and to provide a corporate update with a

Organogenesis Holdings Inc. to Report Second Quarter of Fiscal Year 2026 Financial Results on August 6, 2026

Thu, 09 Jul 2026 07:30:00 -0400

Management will host a conference call at 5:00 p.m. Eastern Time on August 6th to discuss the results of the quarter, and to provide a corporate update with a

FDA accepts Organogenesis BLA for knee osteoarthritis treatment ReNu

Mon, 06 Jul 2026 16:05:31 -0400

Organogenesis Holdings Inc. (Nasdaq: ORGO) announced that the U.S. Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for ReNu®, a cryopreserved amniotic suspension allograft intended to treat pain associated with symptomatic knee osteoarthritis.

The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of April 24, 2027.

ReNu consists of amniotic fluid cells and micronized amniotic membrane, containing cellular, growth factor, and extracellular matrix components. The product received FDA Regenerative Medicine Advanced Therapy (RMAT) designation for knee osteoarthritis in 2021 and has been studied in three randomized controlled trials involving more than

FDA accepts Organogenesis BLA for knee osteoarthritis treatment ReNu

Mon, 06 Jul 2026 16:05:31 -0400

The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of April 24, 2027.

Organogenesis Announces FDA Acceptance of Biologics License Application for ReNu® for the Management of Symptomatic Knee Osteoarthritis

Mon, 06 Jul 2026 16:05:00 -0400

PDUFA Target Action Date Set for April 24, 2027

CANTON, Mass., July 06, 2026 (GLOBE NEWSWIRE) -- Organogenesis Holdings Inc. (Nasdaq: ORGO), a leading regenerative medicine company focused on product solutions for the Advanced Wound Care and Surgical and Sports Medicine markets, today announced that the U.S. Food and Drug Administration (FDA) has completed their filing determination and accepted for review the Company's Biologics License Application (BLA) for ReNu^®, a cryopreserved, amniotic suspension allograft developed for the treatment of pain in symptomatic knee osteoarthritis (OA). The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date

Organogenesis Announces FDA Acceptance of Biologics License Application for ReNu® for the Management of Symptomatic Knee Osteoarthritis

Mon, 06 Jul 2026 16:05:00 -0400

PDUFA Target Action Date Set for April 24, 2027

Regenerative Medicine’s Next Chapter: Inside the Race to Make the Body Rebuild Itself

Thu, 18 Jun 2026 12:42:37 -0400

Issued on behalf of Conexeu Sciences Inc.

A sector analysis of regenerative medicine — the science of restoring tissue rather than merely replacing it — and where a new generation of platform companies is trying to fit in.

NEW YORK, June 18, 2026 (GLOBE NEWSWIRE) -- Biotech Insider News Commentary — For most of medical history, the human body’s inability to regrow lost tissue has been treated as a limitation to be managed rather than a problem to be solved. When skin, bone, or soft tissue is destroyed by injury,

Regenerative Medicine’s Next Chapter: Inside the Race to Make the Body Rebuild Itself

Thu, 18 Jun 2026 12:42:37 -0400

Issued on behalf of Conexeu Sciences Inc.

A sector analysis of regenerative medicine — the science of restoring tissue rather than merely replacing it — and where a new generation of platform companies is trying to fit in.

Regenerative Medicine’s Next Chapter: Inside the Race to Make the Body Rebuild Itself

Thu, 18 Jun 2026 12:42:37 -0400

Issued on behalf of Conexeu Sciences Inc.

A sector analysis of regenerative medicine — the science of restoring tissue rather than merely replacing it — and where a new generation of platform companies is trying to fit in.

Regenerative Medicine’s Next Chapter: Inside the Race to Make the Body Rebuild Itself

Thu, 18 Jun 2026 12:42:37 -0400

Issued on behalf of Conexeu Sciences Inc.

A sector analysis of regenerative medicine — the science of restoring tissue rather than merely replacing it — and where a new generation of platform companies is trying to fit in.

Regenerative Medicine’s Next Chapter: Inside the Race to Make the Body Rebuild Itself

Thu, 18 Jun 2026 12:42:37 -0400

Issued on behalf of Conexeu Sciences Inc.

A sector analysis of regenerative medicine — the science of restoring tissue rather than merely replacing it — and where a new generation of platform companies is trying to fit in.

Regenerative Medicine’s Next Chapter: Inside the Race to Make the Body Rebuild Itself

Thu, 18 Jun 2026 12:42:37 -0400

Issued on behalf of Conexeu Sciences Inc.

A sector analysis of regenerative medicine — the science of restoring tissue rather than merely replacing it — and where a new generation of platform companies is trying to fit in.

Regenerative Medicine’s Next Chapter: Inside the Race to Make the Body Rebuild Itself

Thu, 18 Jun 2026 12:42:37 -0400

Issued on behalf of Conexeu Sciences Inc.

A sector analysis of regenerative medicine — the science of restoring tissue rather than merely replacing it — and where a new generation of platform companies is trying to fit in.

Regenerative Medicine’s Next Chapter: Inside the Race to Make the Body Rebuild Itself

Thu, 18 Jun 2026 12:42:37 -0400

Issued on behalf of Conexeu Sciences Inc.

A sector analysis of regenerative medicine — the science of restoring tissue rather than merely replacing it — and where a new generation of platform companies is trying to fit in.

Regenerative Medicine’s Next Chapter: Inside the Race to Make the Body Rebuild Itself

Thu, 18 Jun 2026 12:42:37 -0400

Issued on behalf of Conexeu Sciences Inc.

A sector analysis of regenerative medicine — the science of restoring tissue rather than merely replacing it — and where a new generation of platform companies is trying to fit in.

Regenerative Medicine’s Next Chapter: Inside the Race to Make the Body Rebuild Itself

Thu, 18 Jun 2026 12:42:37 -0400

Issued on behalf of Conexeu Sciences Inc.

A sector analysis of regenerative medicine — the science of restoring tissue rather than merely replacing it — and where a new generation of platform companies is trying to fit in.

Regenerative Medicine’s Next Chapter: Inside the Race to Make the Body Rebuild Itself

Thu, 18 Jun 2026 12:42:37 -0400

Issued on behalf of Conexeu Sciences Inc.

A sector analysis of regenerative medicine — the science of restoring tissue rather than merely replacing it — and where a new generation of platform companies is trying to fit in.

Regenerative Medicine’s Next Chapter: Inside the Race to Make the Body Rebuild Itself

Thu, 18 Jun 2026 12:42:37 -0400

Issued on behalf of Conexeu Sciences Inc.

A sector analysis of regenerative medicine — the science of restoring tissue rather than merely replacing it — and where a new generation of platform companies is trying to fit in.

Form 8-K Organogenesis Holdings For: Jun 15

Tue, 16 Jun 2026 16:33:00 -0400

si-local-file:///var/storage/secattach/20260616/26654595.html

Form 8-K Organogenesis Holdings For: Jun 15

Tue, 16 Jun 2026 16:33:00 -0400

si-local-file:///var/storage/secattach/20260616/26654595.html

The Quiet Revolution in Regenerative Medicine: From Replacing Tissue to Rebuilding It

Tue, 16 Jun 2026 10:30:00 -0400

Issued on behalf of Conexeu Sciences Inc.

A new generation of tissue companies is betting that the future of wound care and reconstruction isn't a better patch — it's a material that helps the body regrow itself. One newly public name just took a concrete step toward proving it.

NEW YORK, June 16, 2026 (GLOBE NEWSWIRE) -- World Street Intelligence News Commentary — For most of medical history, the body's inability to regrow lost tissue has been treated as a fact to be managed rather than a problem to be solved. When skin,

The Quiet Revolution in Regenerative Medicine: From Replacing Tissue to Rebuilding It

Tue, 16 Jun 2026 10:30:00 -0400

Issued on behalf of Conexeu Sciences Inc.