Renerva Achieves First-in-Human Implant of PNM-CAP™ Device for Neuroma Pain

Rapid clinical execution transitions company to clinical-stage in preparation for commercialization

PITTSBURGH, May 13, 2026 /PRNewswire/ -- Renerva, Inc., a medical device company developing solutions for peripheral nerve injuries, today announced the implantation of the first patient in its first-in-human clinical study of the Renerva PNM-CAP™ device.

The procedure was performed at The Ohio State University Wexner Medical Center, led by Principal Investigator Amy M. Moore, MD. Dr. Moore is the Interim Dean of The Ohio State University College of Medicine and holds the Robert L. Ruberg MD Alumni Endowed Chair of the Department of Plastic and Reconstructive Surgery.

Renerva PNM-CAP™ is an investigational nerve capping device designed to inhibit disorganized nerve growth (neuroma) and associated neuropathic pain when functional recovery of a severed nerve is neither achievable nor desired. Neuromas are a primary source of chronic, intractable pain in amputees and other patients affected by nerve injury, leading to a diminished quality of life and often a reliance on opioids.

"Transitioning to a clinical-stage company with the implantation of our first patient is a monumental milestone," said Lorenzo Soletti, CEO of Renerva. "Our team has executed effectively, moving from FDA Investigational Device Exemption approval of the study to first-in-human implantation in just a few months. We are preparing for regulatory clearance and commercial launch, allowing us to bring this much-needed technology to patients and establish a new standard of care."

The prospective first-in-human pilot study evaluates patients undergoing nerve management procedures for intractable neuropathic pain. Primary endpoints include evaluating the reduction in pain, reduction in opioid consumption, and overall improvement in patient quality of life, each of which are aligned with value-based healthcare metrics.

"Treating the first patient with PNM-CAP is a critical step toward addressing severe chronic pain of nerve origin, which is difficult to manage," said Dr. Moore. "In the operating room, the device proved to be simple to use, integrating into our standard surgical workflow. By evaluating the device in this prospective study, we can isolate its impact on preventing neuroma formation and pain. This study provides an opportunity to investigate a practical definitive solution for patients suffering from nerve pain."

"With approximately 500,000 new extremity amputations unfortunately occurring each year in the United States, there is a tremendous medical need for the use of the PNM-CAP device to prevent disabling pain," said Mark A. Mahan, MD, FAANS, Professor of Neurosurgery and Division Chief of Peripheral Nerve and Pain Surgery at the University of Utah. "Eliminating the development of neuroma pain in amputees translates to improving the quality of life in so many domains, such as allowing for better, more comfortable prosthetics fitting. By avoiding intractable pain, we also have the potential to reduce long-term dependency on painkillers and mitigate the risks of opioid use disorder."

Renerva anticipates achieving U.S. FDA market clearance for the PNM-CAP™ device in the near term, paving the way for a swift commercial launch and broad clinical availability.

About Renerva, Inc.

Renerva is a medical device company committed to developing solutions for peripheral nerve injuries and damage. Renerva's initial therapeutic focus is on patients receiving extremity amputation. Privately held, Renerva is headquartered in Pittsburgh, Pennsylvania. To learn more or stay in touch, please visit www.renerva.com.

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SOURCE Renerva, Inc.