Renerva's Pioneering Step in Neuroma Pain Management: IDE Approval for First-in-Human Study of PNM-CAP Device

Renerva receives FDA IDE approval to open a first-in-human study of its PNM-CAP device aimed at preventing neuroma formation in amputees and reducing opioid reliance.

Renerva has received FDA IDE approval to initiate a first-in-human clinical study of the Renerva PNM-CAP device targeting neuroma prevention in amputees. The study will evaluate the device in surgical settings with the primary intent of determining whether deliberate nerve capping prevents neuroma formation and leads to measurable reductions in pain and opioid use.

The PNM-CAP is designed to occlude transected peripheral nerves and mechanically limit the disorganized axonal sprouting that underlies neuroma formation and persistent neuropathic pain. The implantable cap provides a consistent barrier at the nerve end intended to reduce aberrant regeneration and the painful neuroma phenotype that often follows amputation—addressing the anatomical source of post-amputation nerve pain and positioning the device to affect pain severity, opioid consumption, and global quality of life.

The first-in-human protocol will measure primary endpoints of pain reduction, opioid-sparing effect, and quality-of-life improvement in adults undergoing amputation-related nerve management. The trial is designed to capture early safety signals, device handling metrics, and preliminary patient-reported outcomes using standardized pain scales and validated quality-of-life instruments. As with all IDE studies, this authorization supports human safety and signal-seeking assessment rather than serving as definitive evidence of efficacy; outcomes will inform timing and design of subsequent pivotal trials.

Dr. Amy M. Moore, a plastic and reconstructive surgeon at The Ohio State University Wexner Medical Center, will serve as principal investigator and lead the study—bringing microsurgical expertise and academic trial infrastructure to the FIH protocol. Current practice relies on heterogeneous surgical techniques and symptomatic medical management for neuroma-related pain, leaving an unmet need for standardized, device-based approaches. With IDE approval, sites will begin activation, recruitment, and protocol training to capture early safety and feasibility data under the approved framework.