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Neuraptive Therapeutics Announces FDA Approval of IND Application for New Drug NTX-001 for Treatment of Patients with Peripheral Nerve Impairment

Thursday, April 30, 2020

Neuraptive Therapeutics, Inc. (Neuraptive) is a clinical stage biotechnology company dedicated to the development of new therapies and medical products to address the treatment of peripheral nerve damage (PNI) Unmet needs. The company announced today that the US Food and Drug Administration (FDA) has approved the application of Neuroptive's trial new drug (IND) NTX-001 for patients with acute single truncated PNI.

Evan Tzanis, Executive Vice President and Head of R & D, said: "We are very pleased to receive the company's first IND approval and are pleased to start the trial in the second half of this year. We look forward to working with researchers to bring Neuroaptive NTX-001 to the clinic , Used to treat peripheral nerve damage. "

Damage to peripheral nerves requiring surgery is common. There are more than 600,000 patients in the United States each year, and about 80% of the nerve damage occurs in the upper limbs. Neuraptive's Phase 2 study will evaluate the safety and effectiveness of NTX-001 compared to existing standard treatments for upper limb injuries. In the United States, NTX-001 is being developed through the FDA 505 (b) (2) development path. In this path, the ingredients contained in the product are present in existing approved drugs, which may make the development plan more simplified.

Ivan Gergel, MD, Executive Chairman of Neuraptive, said: "Current interventions cannot prevent irreversibility within 48 to 72 hours after injury. We believe that NTX-001 has the potential to reduce or prevent this degeneration process, thereby allowing the nerve to recover faster, And patients can avoid the disability that would normally result from such nerve damage. We hope NTX-001 can be a disruptive drug that allows doctors to repair PNI for their patients. "

About Neuropive Therapeutics

Neuraptive is developing innovative new nerve repair drugs to improve clinical outcomes for patients and surgeons treating them. The company's licensed treatment product NTX-001 is expected to improve the quality and speed of neurosensory and functional recovery in qualified patients who have sustained trauma or undergo reconstruction surgery. Neuraptive is rapidly advancing its R & D product line and will make full use of its ability to transition to clinical stage companies. Investors include New Rhein Healthcare Investors through its Fund 18 and Ben Franklin Technology Partners. The company is headquartered in Philadelphia, Pennsylvania, with an office near Boulder, Colorado, and a surgical translational medical facility at the University of Colorado Anshutz Medical Center in Aurora, Colorado. For more information, please visit www.neuraptive.com .

About New Rhein Healthcare Investors

New Rhein is a venture capital / early-stage growth fund management company whose investment strategy focuses on the use of proven molecules in new ways, such as new forms of drug administration and potential new uses and indications. As a result, New Rhein limits the risks of scientific fundamentals and focuses on development and execution. Previous investments include drugs and molecular tumor diagnostic reagents used to treat Alzheimer's disease, ophthalmic diseases, and respiratory diseases. New Rhein ’s partners, associates, and consultants are knowledgeable former senior executives in the industry and have an excellent track record in operating, investing, and trading experience. New Rhein combines a wealth of transaction expertise and deep business experience, so that it can tailor the right transaction for the right situation, and cooperate with its subsidiaries to create the maximum value of its products. For more information, please visit www.newrhein.com .

Warning statement regarding forward-looking statements

This press release contains "forward-looking statements" as defined in the safe harbor provisions of the 1995 "United States Private Securities Litigation Reform Act", including statements we made about the timing of initiation of clinical trials. Forward-looking statements are neither historical facts nor guarantees of future performance, but are based on our current beliefs, expectations and assumptions about the future of the business, future plans and strategies, expected events and trends, economics and other future conditions, And subject to inherent uncertainties, risks and environmental changes, the above factors are difficult to predict, many of which are beyond our control.

Disclaimer: The original version of this announcement is the officially authorized version. The translation is for convenience only, please refer to the original text, the original version is the only legally effective version.

Contacts
Investor RelationsNeuraptive Therapeutics, Inc
IR@neuraptive.com

Evan Tzanis
Tel: + 1-484-787-3203

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