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About Us
Neuraptive Therapeutics Inc.
Neuraptive Therapeutics is a clinical-stage biotechnology company developing novel therapies and medical technologies for peripheral nerve repair. Our goal is to develop therapies and technologies with the potential to improve the speed and quality of recovery of nerve function and sensation following peripheral nerve injury.
Our lead investigational product, NTX-001, uses polyethylene glycol (PEG) fusion technology designed to reconnect severed nerve fibers and limit degeneration after injury. NTX-001 is being evaluated in a Phase 3 clinical trial as an adjunct to standard surgical repair for upper-extremity peripheral nerve injuries. The program has received Fast Track and Breakthrough Therapy designations from the U.S. Food and Drug Administration. The active polyethylene glycol component of NTX-001 has also received Orphan Drug Designation for peripheral nerve injury requiring repair.
Our pipeline also includes NTX-002, an investigational bioresorbable wireless nerve stimulation device in preclinical development for peripheral nerve injury.
NTX-001 and NTX-002 are investigational products and have not been approved or cleared by the FDA. Their safety and effectiveness in humans have not been established.
Innovation
Nerve PEG-FUSION
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Neuraptive has licensed technology from the University of Texas at Austin (UT) for an investigational PEG-fusion approach to the surgical repair of severed peripheral nerves. NTX-001 incorporates this technology and is being developed with the goal of improving the speed and quality of functional recovery following these injuries.
Bioresorbable Stimulation
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Neuraptive has exclusively licensed a bioresorbable wireless nerve stimulation platform from Washington University in St. Louis, developed in collaboration with Northwestern University. NTX-002 is an investigational device in preclinical development designed to deliver targeted electrical stimulation to an injured nerve, then resorb without a removal procedure.
History
Founded
Seed Funding
Series A Funding
FDA Clearance
of IND for NTX-001
Activate First
Clinical Site
FDA Fast Track Designation
FDA Clearance
for Phase 2 IND
First Patient Enrolled in Phase 2 Trial for the Prevention of Facial Paralysis
Phase 2 Clinical
Proof of Concept
FDA Orphan Drug Designation
Positive 24-Week NEUROFUSE Results
FDA Breakthrough
Therapy Designation
First Patient Enrolled
in Phase 3
Pipeline Expansion into Bioresorbable Nerve Stimulation
2016
Neuraptive Therapeutics was founded in 2016.
2017
$1M of seed funding was completed in September 2017.
2018
Raised $11.5M Series A funding led by New Rhein Healthcare Investors, LLC.
May
2020
U.S. Food and Drug Administration cleared Neuraptive’s Investigational New Drug (IND) application for NTX-001 in patients with acute single transected peripheral nerve injuries.
October
2020
Activation of first clinical site of its Phase 2 Multicenter, Randomized, Controlled Study Evaluating the Safety and Efficacy of NTX-001 versus Standard of Care in Patients with Acute Single Transected Peripheral Nerve Injuries of the Upper Extremities.
May
2021
U.S. Food and Drug Administration granted Fast Track designation for its franchise therapeutic product, NTX-001, in the treatment of patients with peripheral nerve injuries.
April
2021
Phase 2 FDA Clearance U.S. Food and Drug Administration cleared Neuraptive’s Investigational New Drug application for NTX-001 in Treatment and Prevention of Facial Paralysis Requiring Surgical Repair.
July
2022
First patient enrolled in Neuraptive’s Phase 2a clinical trial evaluating the safety and efficacy of NTX-001 compared to the standard of care in the treatment and prevention of facial paralysis.
January 2024
Neuraptive announced initial clinical proof of concept for NTX-001 from the NEUROFUSE study, reporting improvements in patient-reported function and symptoms versus standard surgical repair alone.
January 2024
FDA granted Orphan Drug Designation to polyethylene glycol-3350, the fusogen in NTX-001, for peripheral nerve injury requiring repair.
February
2024
Neuraptive reported statistically significant improvements in patient-reported hand function and pain at 24 weeks, supporting continued clinical development of NTX-001.
September
2024
NTX-001 received Breakthrough Therapy Designation for peripheral nerve injury requiring repair, following results from the Phase 2 NEUROFUSE study.
September 2025
Neuraptive announced first-patient enrollment in its randomized Phase 3 trial evaluating NTX-001 alongside standard surgical repair for transected upper-extremity nerves.
July
2026
Neuraptive secured an exclusive license from Washington University in St. Louis for a wireless, bioresorbable nerve-stimulation device, expanding its peripheral nerve repair portfolio.