AxoGen

Axogen (Nasdaq:AXGN) this week announced the first surgical implantation of its Avive+ Soft Tissue Matrix.

Avive+ is a resorbable, multi-layer, placenta-based allograft that provides temporary protection and tissue separation during the critical phase of nerve healing. The soft tissue matrix is processed and distributed as a 361 tissue product in accordance with FDA Good Tissue Practices under 21 CFR part 1271 regulations.

“We are excited to expand our offering in nerve protection with the introduction of this resorbable barrier to support the critical phases of healing for nerve injuries,” CEO and President Karen Zaderej said in a news release. “We are pleased with initial surgeon feedback and look forward to making Avive+ Soft Tissue Matrix available to more surgeons during our national launch, which is anticipated in the second quarter of 2024.”

Axogen’s nerve protection category covers a wide range of injuries and defects, according to the comp…

Axogen (Nasdaq:AXGN) announced positive topline results from a clinical study evaluating its Axoguard Nerve Cap.

The REPOSE study compares standard-of-care neurectomy of symptomatic neuroma to neurectomy and protection of the terminated nerve end with the Axoguard Nerve Cap.

Axoguard Nerve Cap is a proprietary surgical implant. Derived from porcine submucosal extracellular matrix remodeled during healing, the implant isolates and protects a peripheral nerve end from the surrounding environment to reduce symptomatic or painful neuroma development.

This post-market study met its primary endpoint for reduction in pain as measured by visual analog scale. Additional data demonstrated statistical superiority for pain reduction over the course of 12-month follow-up.

REPOSE aimed to test for non-inferiority between the pain visual analog scale outcomes for neurectomy with Axoguard. The study design also allows for a sequential test for the superiority of …

The Axoguard HA+ nerve protector. [Image from Axogen]Axogen (Nasdaq:AXGN) announced today that it fully launched its Axoguard HA+ nerve protector for peripheral nerve injury protection.

The company designed the proprietary device to provide both short- and long-term protection for those nerve injuries. It features a processed porcine submucosa extracellular matrix base layer with a hyaluronate-alginate gel coating. The gel facilitates enhanced nerve gliding to aid in minimizing soft tissue attachments. The base layer remodels into a long-term protective tissue layer.

According to a news release, nerve injuries for this protection category include a wide range of injuries and defects. Axogen lists nerve compression, crush and complex traumatic injuries. The company aims to optimize outcomes with targeted solutions to adequately address the nerve and the surrounding environment.

Dr. Peter J. Evans of the Cleveland Clinic (Florida Reg…