The phase 3 study is a multicenter, randomized, subject and evaluator blinded, controlled study evaluating the safety and efficacy of NTX-001 compared to standard of care (neurorrhaphy) in the treatment of upper extremity transected nerves requiring surgical repair. The study is expected to enroll approximately 110 patients across approximately 24 clinical sites within the US. Subjects will be randomized in equal numbers to receive either standard of care or NTX-001 as an adjunct to standard of care.

"Enrolling the first patient in our phase 3 trial marks a major milestone for Neuraptive and NTX-001 for patients who have sustained traumatic injuries requiring surgical repair. We believe NTX-001 has the potential to set a new standard of care to address a significant unmet need, and this is another important step forward toward FDA approval," stated Seth Schulman, MD, Chief Medical Officer of Neuraptive.

"Our team is excited to be a part of this clinical trial which represents a significant step forward in developing innovative treatments to accelerate functional recovery for patients with peripheral nerve injuries," said Dr. Katie Liu, Assistant Professor at University of Washington Medical Center, and Principal Investigator for the study site.

NTX-001 has previously received from the United States Food and Drug Administration (FDA) Fast Track Designation for its franchise therapeutics product, NTX-001, as well as Orphan Drug Designation for its fusogen contained in the NTX-001 treatment kit.

The study is supported by an Armed Forces Institute of Regenerative Medicine (AFIRM) Fiscal Year 2024 Clinical Trial Award, granted to Neuraptive through the Wake Forest Institute for Regenerative Medicine (WFIRM), and funded by the Defense Health Agency Research and Engineering Directorate, Department of Defense. This effort is sponsored by the Government under Other Transaction Number W81XWH-15-9-0001.

This funding is specifically directed at advancing regenerative medicine technologies for the treatment of traumatic battlefield injuries that are of critical concern to the military. These include combat-related damage to nerves and extremities, areas where NTX-001 may offer significant clinical benefit.

The views and conclusions contained herein are those of the authors and should not be interpreted as necessarily representing the official policies or endorsements, either expressed or implied, of the U.S. Government.

For more information about the phase 3 clinical trial, visit ClinicalTrials.gov at NTX-001 Phase 3 Trial.

About Neuraptive Therapeutics, Inc.

Neuraptive Therapeutics, Inc. is dedicated to the innovation and development of medical products and therapeutics to repair and regenerate peripheral nerves. The company is focused on addressing the unmet medical needs of patients and physicians dealing with the complex challenges of nerve injuries.

View source version on businesswire.com: https://www.businesswire.com/news/home/20251002748937/en/

Contact

Investor Relations Neuraptive Therapeutics, Inc [email protected]

© 2025 Business Wire, Inc.Disclaimer:This press release is not a document produced by AFP. AFP shall not bear responsibility for its content. In case you have any questions about this press release, please refer to the contact person/entity mentioned in the text of the press release.