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 neurectomy with Axoguard following the non-inferiority analysis.
“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,” said Karen Zaderej, Axogen chair, 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.”