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About Us
Neuraptive Therapeutics Inc.
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Neuraptive Therapeutics is a biotechnology company developing novel therapies to potentially improve outcomes in peripheral nerve injuries, or PNI. We believe our innovations have the potential to improve the quality and speed of recovery of nerve function and sensation for eligible patients who have sustained traumatic injuries or who are undergoing reconstructive surgical procedures by preventing the degeneration of axons distal to injury.
NTX-001 has received Fast Track Designation from the United States Food and Drug Administration, and we have ended enrollment in two Phase 2 multi-center clinical trials. The first trial was for patients with upper extremity peripheral nerve injury, and the second trial was for patients with clinical evidence of facial paralysis requiring facial nerve repair from conditions or interventions that have or may result in paralysis. We are also developing nerve-specific microsurgical instruments for use in peripheral nerve surgery.
Innovation
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Nerve
PEG-FUSION
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Drug Delivery
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Microsurgical Instruments
Neuraptive has in-licensed technology from the University of Texas at Austin (UT) protecting a novel fusion system for repairing severed peripheral nerves. This technology improves both the speed and outcomes of peripheral nerve injuries (PNI).
A specialized device focusing on the delivery of active agents for topical administration directly on the nerve.
Neuraptive is developing nerve-specific microsurgical instruments that address current product limitations in the field of nerve repair.
History
Founded
Seed Funding
Series A Funding
FDA Clearance
of IND for NTX-001
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.
Capitalize First Clinical Site
FDA Fast Track Designation
FDA Clearance
for Phase 2 IND
October
2020
May
2021
April
2021
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. Top line data expected in the second half of 2023.
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.
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.
First Patient Enrolled in Phase 2 Trial for the Prevention of Facial Paralysis
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.
Neuraptive's team has extensive experience in the biotechnology and pharmaceutical industry. The team is comprised of experts in the field of research and development, manufacturing, and commercialization. The team has a strong commitment to quality and innovation.