#United States #FDA Approval #Pittsburgh #Renerva PNM-CAP #Neuroma Pain

Renerva's Pioneering Device Approved for Neuroma Pain Study

Renerva, Inc., a pioneering medical device company based in Pittsburgh, has recently announced a significant milestone by receiving Investigational Device Exemption (IDE) approval from the U.S. FDA. This approval allows the company to initiate its first-in-human (FIH) study for the innovative Renerva PNM-CAP™ device, a solution aimed at addressing chronic pain associated with neuromas following extremity amputations.

What is the Renerva PNM-CAP™ Device?

The Renerva PNM-CAP™ is a revolutionary nerve capping device designed to inhibit the disorganized nerve growth, commonly known as neuromas, that often occur after a nerve has been transected during an amputation. Neuromas are a primary source of chronic pain for amputees, contributing to a significant dependency on opioids and adversely affecting their quality of life. Statistics show that there are over 2 million amputees in the U.S., with approximately 500,000 new amputations occurring each year, underscoring the urgent need for effective pain management solutions.

The Clinical Study Details

The upcoming clinical study will take place at the esteemed Ohio State University (OSU) Wexner Medical Center, led by Principal Investigator Dr. Amy M. Moore, MD. Dr. Moore holds the Robert L. Ruberg MD Alumni Endowed Chair of the Department of Plastic and Reconstructive Surgery. The focus of this study will be to assess the capability of the PNM-CAP™ device to reduce neuroma formation, alleviate chronic pain, and minimize opioid consumption, thereby improving the overall quality of life for patients.

Renerva's commitment to advancing nerve repair technology comes further supported by preclinical studies recently published in the academic journal npj Regenerative Medicine, where findings indicated a remarkable 16-fold reduction in nerve growth compared to standard care, coupled with a 3.5-fold decrease in pain behavior over a four-month observation period.

Significance of the Approval

Lorenzo Soletti, CEO of Renerva, emphasized the importance of this FDA approval, describing it as a transformative milestone for the company. “This achievement transitions us into a clinical-stage entity and greatly reduces our technological risks as we move forward,” he stated, expressing gratitude for the collaboration with Dr. Moore and her expert team at OSU, which is recognized for providing top-notch expertise in reconstructive care.

Dr. Moore expressed enthusiasm regarding the PNM-CAP™ design, indicating its potential to significantly impact patients plagued by chronic neuropathic pain following their amputations. She noted the lack of effective treatment options currently available and highlighted the necessity of exploring new methods to address this prevalent issue among amputees.

Future Directions

As the clinical trial unfolds, Renerva aims to collect valuable interim clinical data that could pave the way for market clearance of the PNM-CAP™ device in the U.S. This step holds promise not just for Renerva, but for countless patients who suffer from debilitating pain due to neuromas.

In conclusion, the approval of Renerva's PNM-CAP™ device marks a hopeful advance in pain management for amputees, representing a potential shift towards more effective treatments that directly address the root causes of neuroma formation. The company remains committed to innovating solutions that improve patient outcomes and enhance quality of life.

For more information about Renerva and its groundbreaking work in nerve repair solutions, visit their official website at www.renerva.com.