Renerva Inc. approved for first-in-human FDA clinical trials
Pitt-based startup aims to reduce chronic pain in amputees and prevent painful neuroma formation
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.
Led by Chief Technology Officer Bryan Brown (BioE PhD ‘10), professor of bioengineering at the Swanson School of Engineering, and CEO Lorenzo Soletti (BioE PhD ‘08), Renerva, Inc. was founded in 2017 to develop and commercialize transformative implantable technologies for patients affected by peripheral nerve injury. Now, the company has received its first FDA Investigational Device Exemption (IDE) approval to begin a human clinical study of its Renerva PNM-CAP, a device designed to prevent painful neuroma formation.
Putting a cap on chronic nerve pain
When a nerve is damaged during injury or amputation, the axons inside the nerve can form a disorganized nerve growth, called a neuroma, which makes the nerve extremely sensitive and can cause severe chronic pain. Neuroma pain impacts quality of life and is a major driver of opioid use disorder, so Renerva’s PNM-CAP is designed to prevent neuroma formation and pain from the start.
“Our nerve cap is designed to limit how far those axons can grow.” Brown said. “As the cap degrades, it’s replaced with healthy, natural connective tissue. We’ve found that this process stops the axons from becoming entangled, halts their growth, and prevents the formation of painful neuroma.”
IDE approval was supported by preclinical data recently published in npj Regenerative Medicine. “Our preclinical studies demonstrate that PNM-CAP profoundly inhibits nerve growth and leads to a 3.5-fold reduction in average pain behavior observed over a four-month period compared to untreated controls.” Brown said.
Renerva’s earliest technology was jointly developed at Pitt and Cornell University, and early support from Pitt’s Office of Innovation and Entrepreneurship helped connect Brown with Soletti to explore commercialization pathways. With additional funding from success in several campus innovation competitions, the team built the scientific foundation and business strategy that led to Renerva’s 2017 launch — and ultimately to this major achievement.
“This is a pivotal milestone for Renerva, transitioning us into a clinical-stage company and significantly de-risking our business,” Soletti said. “This achievement allows us to proceed with our first-in-human study with a world-class US center for peripheral nerve injury and repair and is a major validation of our rigorous, evidence-based product development.”
The clinical trial will test the nerve cap in 10 patients over the span of one year, hoping to evaluate whether the device can reduce pain, limit opioid use, and improve overall quality of life for patients. Renerva plans to pursue market clearance for the cap once interim clinical data becomes available.