Axogen, Inc. Announces Positive Topline Results from REPOSE, a Prospective, Randomized Clinical Trial of Axoguard Nerve Cap

REPOSE met its primary endpoint of non-inferiority between the pain visual analog scale outcomes for neurectomy with Axoguard Nerve Cap vs. standard-of-care neurectomy at Month 12.

Axoguard Nerve Cap demonstrated statistical superiority vs. standard-of-care neurectomy in the reduction of total pain reported by participants over the course of follow-up.

ALACHUA, Fla. and TAMPA, Fla., Jan. 18, 2024 (GLOBE NEWSWIRE) -- Axogen, Inc. (NASDAQ: AXGN), a global leader in developing and marketing innovative surgical solutions for peripheral nerve injuries, today announced positive topline results from its REPOSE clinical study comparing standard-of-care neurectomy of symptomatic neuroma to neurectomy and protection of the terminated nerve end with Axoguard Nerve Cap. The post-marketing study met its primary endpoint for reduction in pain as measured by visual analog scale (p-value <0.05).

Additional data analysis found that over the 12-month course of follow-up, the Axoguard Nerve Cap group demonstrated statistical superiority for reduction in the total pain reported by participants compared to the standard-of-care neurectomy group (p-value <0.05).

“We are pleased with the study outcomes and the quality of data gathered in the REPOSE study,” said Lead Investigator Craig Thomajan, DPM, Founder and Managing Partner of Austin Foot & Ankle Specialists. “The data suggest that the addition of Axoguard Nerve Cap to isolate and protect the peripheral nerve ends following a neurectomy is a better treatment option than standard-of-care neurectomy alone for managing symptomatic neuroma pain.”

“This data builds on our body of clinical evidence that supports increased adoption of Axoguard Nerve Cap amongst surgeons and their patients who are seeking solutions that may enhance quality of life following nerve resection to manage chronic neuropathic pain,” commented Karen Zaderej, chairman, CEO, and president. “I am grateful to all study participants and investigators, as well as the Axogen team for their unwavering commitment to delivering improved solutions for patients suffering from peripheral nerve injuries.

About REPOSE

REPOSE is a multicenter, prospective, randomized, subject blinded comparative clinical trial of standard neurectomy and neurectomy followed by placement of Axoguard Nerve Cap, evaluating recovery outcomes for the treatment of symptomatic neuroma. The post-market study is designed to test for non-inferiority between the pain visual analog scale outcomes for neurectomy with Axoguard Nerve Cap and standard neurectomy. The study design also allows for a sequential test for superiority of neurectomy with Axoguard Nerve Cap, following the non-inferiority analysis.