More than two million people in the U.S. are amputees, and an estimated 500,000 new extremity amputations occur each year because of trauma, disease, or surgical complications. Offering new hope, however, a medical device startup from the University of Pittsburgh has just reached a major milestone to improve care for individuals living with extremity amputations and other conditions causing nerve injury.

Renerva, Inc., a medical device company developing solutions for peripheral nerve repair, today announced it has received Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to initiate a first-in-human (FIH) clinical study for its Renerva PNM-CAP™ device.

Renerva, Inc., a Center for Life Science Ventures client developing medical devices for peripheral nerve repair, has received approval from the U.S. Food and Drug Administration to launch a first-in-human clinical study of its Renerva PNM-CAP™ nerve-cap device.

Neuroma following nerve injury and/or amputation is a debilitating condition with significant impacts on quality of life. Several approaches exist to prevent or treat neuroma and/or reduce associated pain; however, these approaches are not consistently effective, facile, or widely accessible. The present study characterizes a xenogeneic nerve cap graft device (NCGD) composed of decellularized porcine nerve. The NCGD was assessed for its ability to inhibit nerve growth, neuroma formation, and pain in rodent models of sciatic neurectomy and tibial neuroma transposition. The NCGD provided a neuroinhibitory substrate that abated and interrupted nerve growth within 5 mm of the nerve stump and was progressively remodeled into healthy host-derived tissue. The NCGD also resulted in a 3.5-fold reduction in evoked pain and a decrease in pain-associated markers at the dorsal root ganglia. These results suggest that the NCGD may provide a simple and widely accessible alternative for prophylactic treatment of symptomatic neuroma.

The ability to reinnervate a muscle in the absence of a viable nerve stump is a challenging clinical scenario. Direct muscle neurotization (DMN) is an approach to overcome this obstacle; however, success depends on the formation of new muscle endplates, a process, which is often limited due to lack of appropriate axonal pathfinding cues. This study explored the use of a porcine nerve extracellular matrix hydrogel as a neuroinductive interface between nerve and muscle in a rat DMN model. The goal of the study was to establish whether such hydrogel can be used to improve neuromuscular function in this model.