Renerva Receives FDA IDE Approval to Commence First-in-Human Study of its Renerva PNM-CAP™ Device for Neuroma Pain
The study will assess PNM-CAP's ability to prevent neuroma, chronic pain, and opioid use
PITTSBURGH, Dec. 3, 2025 /PRNewswire/ -- 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.
The study will be conducted at The Ohio State University (OSU) Wexner Medical Center and led by Principal Investigator Amy M. Moore, MD, who holds the Robert L. Ruberg MD Alumni Endowed Chair of the Department of Plastic and Reconstructive Surgery.
PNM-CAP™ is a novel nerve capping device designed to inhibit disorganized nerve growth (neuroma) after a nerve is transected, a common event in extremity amputations. Neuromas are a primary source of chronic, intractable pain for amputees, often leading to a reliance on opioids and a severe reduction in quality of life. In the U.S. alone, there are over 2 million amputees, with 500,000 new amputations performed annually. Each amputation involves multiple transected nerves, multiplying the risk of neuroma development.
The IDE approval was supported by preclinical data recently published in npj Regenerative Medicine. "Our preclinical studies demonstrate that the Renerva technology has a profound impact on inhibiting nerve growth, a key event in neuroma formation" said Bryan Brown, Chief Technology Officer of Renerva. The study showed up to a 16-fold reduction in nerve growth compared to a standard-of-care control with a 3.5-fold reduction in average pain behavior observed over a four-month period.
The FIH study will enroll patients undergoing nerve management procedures for intractable neuropathic pain. The primary endpoints will evaluate the reduction in pain, reduction in opioid consumption, and overall improvement in quality of life.
"Receiving IDE approval is a pivotal milestone for Renerva, transitioning us into a clinical-stage company and significantly de-risking our technology path," said Lorenzo Soletti, CEO of Renerva. "This achievement, which allows us to proceed with our first-in-human study, is a critical value inflection point for the company. We are honored to partner with Dr. Moore and her world-class team at The Ohio State University, whose unparalleled expertise will be invaluable as we work to establish a new standard of care".
"Chronic neuropathic pain following amputation is a debilitating condition that profoundly impacts my patients' lives, and our current treatment options are limited," said Dr. Moore. "The unique PNM-CAP design addresses the underlying mechanisms of neuroma formation, and we are eager to lead this clinical study to determine its potential impact and hopefully provide a meaningful solution for these patients."
Renerva plans to pursue US market clearance for Renerva PNM-CAP™ once interim clinical data becomes available.
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.
About OSU
The Ohio State University Wexner Medical Center is one of America's top-ranked academic medical centers, committed to improving health through innovations in research, education, and patient care. The Department of Plastic and Reconstructive Surgery at The Ohio State University is a leader in educating future surgeons and providing the highest quality reconstructive and aesthetic care, featuring the largest team of reconstructive microsurgeons in the Midwest.
Media Contact Information
Phone: +1 412-212-6661
Email: media@renerva.com
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SOURCE Renerva, Inc.