Organogenesis Holdings Inc. (NASDAQ:ORGO) shares are up during Tuesday’s premarket session following the company’s announcement of achieving the primary endpoint in a randomized controlled trial evaluating PuraPly AM for managing non-healing diabetic foot ulcers.

Organogenesis Trial Meets Primary Endpoint

The trial demonstrated statistically significant wound closure at 12 weeks when comparing PuraPly AM plus standard of care to standard care alone.

A diabetic foot ulcer is an open sore, commonly on the bottom of the foot. Caused by nerve damage, poor circulation, and high blood sugar, they often start as painless blisters or calluses that do not heal.

Product Profile And Mechanism

PuraPly AM is a skin substitute and combines a native, cross-linked collagen matrix with polyhexamethylene biguanide (PHMB) antimicrobial to manage bioburden within the product and support healing.

Organogenesis plans to publish the study results in a peer-reviewed journal.

FDA Interaction Supports ReNu Filing Plan

The company said on Monday that it completed a planned Type-B meeting with the Food and Drug Administration (FDA), resulting in confirmation to initiate a rolling Biologics License Application (BLA) for ReNu planned before the end of December.

In September 2025, Organogenesis shared topline data from the second Phase 3 randomized controlled trial (RCT) of ReNu, a cryopreserved amniotic suspension allograft (ASA) for the management of symptoms associated with knee osteoarthritis (OA).

The trial did not achieve statistical significance for its primary endpoint, despite the ReNu results demonstrating a numerical improvement in baseline pain reduction over the first Phase 3 trial.

Baseline pain reduction at six months for ReNu was -6.9 for the second Phase 3 study compared to -6.0 in the first Phase 3 study.

ORGO Stock Price Activity: Organogenesis Holdings shares were up 29.91% at $2.91 during premarket trading on Tuesday, according to Benzinga Pro data.

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