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 patients are currently enrolling in two Phase 2 multi-center clinical trials.  The first trial is for patients with upper extremity peripheral nerve injury and the second trial is 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.