Pitt-Founded Startup Achieves First-in-Human Implant of Nerve Pain Device

A medical device startup founded by University of Pittsburgh Swanson School of Engineering researchers has implanted its first human patient as part of an FDA-approved clinical study, marking a major step toward commercialization of a technology designed to prevent chronic nerve pain.

Renerva, Inc., led by Chief Technology Officer Bryan Brown (BioE PhD '10), professor of bioengineering at Pitt's Swanson School of Engineering, and CEO Lorenzo Soletti (BioE PhD '08), successfully implanted the first patient with its Renerva PNM-CAP™ device at The Ohio State University (OSU) Wexner Medical Center. The procedure was led by Principal Investigator Amy M. Moore, MD, Interim Dean of the OSU College of Medicine.

"From a bioengineering perspective, we know that simply putting a mechanical block over a severed nerve isn't enough to stop neuroma formation," Brown said. “PNM-CAP is engineered to intervene at the site of the nerve injury, guiding tissue repair in a way that stops uncontrolled nerve growth and entanglement before the onset of pain." 

The Renerva PNM-CAP™ is designed to prevent neuroma formation, a painful, disorganized nerve growth that commonly develops after amputation and other nerve injuries. Neuroma formation is a primary driver of chronic pain and opioid dependence among the more than two million Americans living with limb loss.

"This is a monumental milestone," said Soletti. “We moved from FDA Investigational Device Exemption approval to first-in-human implantation in just a few months."