Neuraptive Therapeutics’ Nerve Repair Surgical Kit Wins FDA Breakthrough Designation

The U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to Neuraptive Therapeutics Inc.’s NTX-001 surgical kit for peripheral nerve repair.

The designation follows results from the Phase 2 NEUROFUSE study and several interactions with the FDA. Neuraptive Therapeutics is confident the NTX-001 could potentially be a groundbreaking nerve repair therapy.
 
Neuraptive Therapeutics is preparing to launch a Phase 3 pivotal program for NTX-001 early next year. The program will consist of a single randomized, double-blind, placebo-controlled study assessing the efficacy and safety of NTX-001 in patients with peripheral nerve injury requiring repair. The final protocol for this single Phase 3 study is currently being discussed with the FDA. This follows the promising results from the Phase 2 NEUROFUSE study after 24 weeks. Neuraptive anticipates the full results, including all 48 weeks of data, to be available in the coming weeks and will share the results at an upcoming scientific conference.
 
“The FDA’s Breakthrough Therapy designation for NTX-001 is a major step forward in our mission to provide an innovative treatment for patients suffering from peripheral nerve injuries requiring repair,” Neuraptive Therapeutics Chief Operating Officer/Executive Vice President of R&D Evan L. Tzanis said. “We are eager to continue working closely with the FDA to ensure NTX-001 reaches patients as quickly as possible and to deliver a transformative therapy for nerve repair. We are grateful to the patients, investigators, and our partners who have remained committed to advancing NTX-001.”
 
NTX-001 is a kit comprised of nerve fusion technology and a specialized device intended for use during surgical nerve procedures. The technology in the kit is designed to restore electrical signaling across a severed peripheral nerve intra-operatively, thus preventing Wallerian degeneration in axons distal to injury. NTX-001 has been developed as a surgical product to be used in conjunction with standard suture neurorrhaphy of a severed nerve. Use of NTX-001 is intended to safely accelerate the often slow and diminished return of function in repaired nerves.
 
Neuraptive Therapeutics Inc. is developing medical products and therapeutics to repair and regenerate peripheral nerves. The Chesterbrook, Pa.-based company is focused on addressing the unmet medical needs of patients and physicians dealing with the complex challenges of nerve injuries.