PNM-cap: a novel nerve cap to prevent painful neuroma formation in peripheral nerve injuries and amputations - 2.1M people live with extremity amputation (EA), and >220,000 new EAS are performed…

Renerva, Inc. received a $500,000 project grant award from the National Institute of Neurological Disorders and Stroke under the Drug Use and Addiction Research Programs (CFDA 93.279) for the period of September 1, 2025 through August 31, 2026. The company is developing PNM-CAP (Peripheral Nerve Matrix-Cap), a biodegradable nerve capping device designed to prevent painful neuroma formation following extremity amputations. The device, derived from porcine peripheral nerve tissue through proprietary chemical, mechanical, and physical processes, features an internal neuro-inhibitory matrix that limits axonal sprouting and guides nerve regeneration. By preventing neuroma development, PNM-CAP addresses a critical clinical need affecting the estimated 565,000 nerves annually with neuroma potential and reduces patient reliance on opioid analgesia—a significant concern given that 54.7% of lower extremity amputees currently receive opioid prescriptions.

The device is designed for ease of deployment during amputation procedures, requiring no specialized surgical training or extended operative time. The underlying mechanism allows axons to exhaust their regenerative potential within the device before it biodegrades and remodels into a stable nerve stump. This technology directly supports the federal grant program's mission to develop new approaches for prevention, diagnosis, and treatment of drug use, misuse, and addiction by providing an innovative solution to reduce opioid use disorder risk and overdose potential in this patient population.

PNM-cap: a novel nerve cap to prevent painful neuroma formation in peripheral nerve injuries and amputations - 2.1M people live with extremity amputation (EA), and >220,000 new EAS are performed annually in the US. Each EA transects on average 2.5 nerves, expanding the prevalence to >5M and the incidence to 565,000 nerves with the potential to develop painful neuroma, which occurs in up to 48% of lower extremity amputees. 54.7% of patients who undergo lower EA receive opioid analgesia and 44.6% seek prolonged postoperative opioid use - placing them at high risk for opioid use disorder (OUD) and/or overdose. Despite the existence of different solutions to prevent and/or treat neuroma following EA, these are associated with multiple shortcomings making them unable to satisfactorily resolve a significant unmet clinical need, as demonstrated by multiple statistics. Renerva, LLC has developed a nerve capping device (PNM-cap) to prevent neuroma formation following extremity amputations. PNM-cap is a terminally sterilized biodegradable device obtained from porcine peripheral nerves via proprietary chemical, mechanical, and physical processes. The device can be easily and rapidly secured to each nerve end during an EA procedure without specialized surgical training or procedural extension. PNM-cap has an internal neuro-inhibitory matrix providing a resistive pathway that allows compartmentalized and limited sprouting and extending of axons from the amputated nerve into the device. During this process, the device degrades and remodels into a stable amputated nerve stump in which the internal axons have exhausted their intrinsic regenerative potential in close proximity (