WAYNE, PA.-- Neuraptive Therapeutics Inc., a leader in innovative medical solutions, is pleased to announce that it has received Orphan Drug Designation from the United States (US) Food and Drug Administration (FDA) for its fusogen contained in the NTX-001 treatment kit. This designation marks a significant milestone in developing NTX-001, a novel treatment for peripheral nerve injury requiring repair.

Dr. Seth Schulman, Chief Medical Officer of Neuraptive Therapeutics Inc., stated, “Receiving the Orphan Drug Designation for NTX-001 is a testament to our commitment to advancing healthcare solutions for patients impacted by peripheral nerve injuries who today have limited options.” The Orphan Drug Designation is granted to drugs intended to treat rare diseases or conditions in the US.

Highlights of Orphan Designation are:

· 7-year marketing exclusivity to sponsors of approved orphan products
· Federal tax credit for expenses incurred in conducting clinical research within the United States
· Waiver of Prescription Drug User Fee Act (PDUFA) fees for orphan drugs
· Ability to qualify to compete for research grants from the Office of Orphan Products Development (OOPD) to support clinical studies for orphan drugs
· Eligibility to receive regulatory assistance and guidance from the FDA in the design of an overall drug development plan.

“The Granting of orphan drug designation by the FDA comes at an important time, as we prepare to meet with regulators in the coming months to seek their input on the future development work and the ultimate path to approval,” said Evan L. Tzanis, Chief Operating Officer and EVP of R&D. “Following this designation, Neuraptive Therapeutics plans to accelerate the development of NTX-001, aiming to bring this promising treatment to patients as soon as possible,” Said Mr. Tzanis.