The US Food and Drug Administration (FDA) has granted investigational device exemption (IDE) approval for Renerva to initiate the first human clinical trial of the Renerva PNM-CAP nerve capping device.
The trial will take place at The Ohio State University Wexner Medical Center, US, with Amy Moore serving as principal investigator.
The device is intended to cap nerves following transection, a frequent occurrence in amputations, to prevent the formation of neuromas.
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Neuromas, which result from disorganised nerve growth, are a significant cause of persistent pain in amputees and can lead to increased opioid use and diminished quality of life.
Each amputation is said to typically involve several nerves being cut, which raises the likelihood of neuroma formation.
The FDA approval was based on preclinical data.
Renerva chief technology officer Bryan Brown said: “Our preclinical studies demonstrate that the Renerva technology has a profound impact on inhibiting nerve growth, a key event in neuroma formation.”
The trial showed up to a 16-fold nerve growth reduction against a standard-of-care control with a 3.5-fold decline in average pain behaviour which was observed for four months.
The upcoming trial will enrol patients who are undergoing nerve management procedures for severe neuropathic pain.
Key endpoints will include assessment of pain reduction, decreased opioid use, and overall quality of life improvements.
Renerva will seek clearance for the PNM-CAP device in the US market following the availability of interim clinical data.
Renerva CEO Lorenzo Soletti said: “Receiving IDE approval is a pivotal milestone for Renerva, transitioning us into a clinical-stage company and significantly de-risking our technology path.
“This achievement, which allows us to proceed with our first-in-human study, is a critical value inflection point for the company.”
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