Business Wire

PA-NEURAPTIVE

28.4.2020 22:17:07 CEST | Business Wire | Press release

Share
Neuraptive Therapeutics Announces FDA Clearance of IND Application for NTX-001, a Novel Approach for the Treatment of Patients with Peripheral Nerve Injuries

Neuraptive Therapeutics, Inc. (Neuraptive), a clinical-stage biotechnology company dedicated to developing novel therapeutics and medical products to address the unmet needs in the treatment of peripheral nerve injuries (PNI), today announced that the U.S. Food and Drug Administration (FDA) has cleared Neuraptive's Investigational New Drug (IND) application for NTX-001 in patients with acute single transected PNI.

"We are pleased to have received clearance for the company’s first IND, and are excited to initiate the trial later this year," said Evan Tzanis, Executive Vice President and Head of Research and Development. "We look forward to working with investigators as we advance Neuraptive’s NTX-001 into the clinic for the treatment of peripheral nerve injuries."

Peripheral nerve injuries resulting in surgeries are common, occurring in more than 600,000 patients annually in the United States, with approximately 80% of nerve injuries occur in the upper extremities. Neuraptive’s Phase 2 study will evaluate the safety and efficacy of NTX-001 versus the current standard of care in upper extremity injuries. NTX-001 is being developed in the U.S. via the FDA 505 (b) (2) development pathway, in which the components contained in the product are present in existing, approved drug products, allowing for the potential of a more streamlined development program.

"Current interventions do not prevent the irreversible degeneration that occurs within 48 to 72 hours following injury. We believe that NTX-001 has the potential to diminish or prevent this degenerative process so that nerves recover more quickly, and patients can avoid disabilities that commonly result from these types of nerve injuries," said Ivan Gergel, MD, Executive Chairman of the Board of Neuraptive. "We are hopeful that NTX-001 can be a revolutionary treatment for physicians to offer their patients undergoing PNI repairs."

About Neuraptive Therapeutics

Neuraptive is creating innovative novel therapies for nerve repairs to improve clinical outcomes for patients and surgeons who care for them. The company's franchise therapeutic product, NTX-001, has the potential to improve the quality and speed of recovery of nerve sensation and function for eligible patients who have sustained traumatic injuries or who are undergoing reconstructive surgical procedures. Neuraptive is rapidly advancing its pipeline and will leverage its capabilities to transition into a clinical-stage company. Investors include New Rhein Healthcare Investors through its Fund 18 and Ben Franklin Technology Partners. The company is headquartered in Philadelphia, PA, and has offices near Boulder, CO, as well as surgical translational medical facilities at the Colorado University Anschutz Medical Center in Aurora, CO. For more information, see www.neuraptive.com .

About New Rhein Healthcare Investors

New Rhein is a venture capital/early growth stage fund manager whose investment strategy focuses on proven molecules used in new ways, such as new delivery forms and potential new uses and indications. In this way, New Rhein limits science-based risk and concentrates on development and execution. Prior investments have included medicines for Alzheimer’s disease, ophthalmic disorders, respiratory disease, and molecular oncology diagnostics. New Rhein’s partners, associates, and advisors are knowledgeable former industry executives with solid track records of operational, investment, and transactional experience. New Rhein combines significant deal-making expertise with deep operating experience, allowing it to tailor the right deal for the right situation and work with its portfolio companies to achieve maximum value for their products. For more information, see www.newrhein.com .

Cautionary Note on Forward-Looking Statements

This press release contains "forward-looking statements" within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. including, among others, statements we make regarding the time for the commencement of clinical trials. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, anticipated events and trends, the economy and other future conditions and are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control.

About Business Wire

Business Wire
Business Wire
101 California Street, 20th Floor
CA 94111 San Francisco

http://businesswire.com

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

Jefferies Financial Group Inc. Announces Pricing of €850,000,0004.500% Senior Notes Due 20338.7.2026 22:16:00 CEST | Press release

Jefferies Financial Group Inc. (NYSE: JEF) (“JFG”, “we” or “our”) today announced the pricing of its public offering of €850,000,000 aggregate principal amount of 4.500% Senior Notes due 2033 (the “Notes”) with an effective yield of 4.544%, maturing, July 15, 2033. The offering is expected to settle on July 15, 2026, subject to the satisfaction of customary closing conditions. Application is expected to be made for the Notes to be admitted to the Official List of the Irish Stock Exchange plc, trading as Euronext Dublin, and admitted to trading on the Global Exchange Market of Euronext Dublin; any listing is subject to approval by Euronext Dublin. JFG intends to use the net proceeds of the offering for general corporate purposes. Jefferies International Limited served as sole global co-ordinator and joint active book-runner for the offering of the Notes, Banco Santander, S.A., Citigroup Global Markets Limited, Natixis, SMBC Bank International plc and Société Générale served as joint act

KiddeFenwal Launches New Website and Information Hub8.7.2026 18:00:00 CEST | Press release

Enhanced digital platform reflects KiddeFenwal’s legacy, stature and growth trajectory in the fire suppression and safety controls industry KiddeFenwal, the global leader in the fire suppression and safety controls industry, today unveiled a revitalized website, designed to serve as a comprehensive information hub for fire industry practitioners and customers alike. The modernized platform includes features created specifically with the company’s global partners, OEMs and distributors in mind, including: Accelerated asset navigation, pointing users to critical safety documentation, design parameters and product specifications; Seamless solution mapping, helping users quickly locate fire suppression configurations by industry, from data centers to BESS applications to commercial kitchens; and Enhanced resource access, including streamlined pathways to connect with the company’s elite distributor network across 120 countries. It also provides information about the company’s three brands,

Dryad Networks Reaches XPRIZE Wildfire Finals Milestone, Demonstrating Autonomous Detection and Suppression of Wildfires in Alaska8.7.2026 17:00:00 CEST | Press release

Dryad Networks, the leader in ultra-early wildfire detection technology, today announced a major achievement in the finals of the Autonomous Wildfire Response track of XPRIZE Wildfire, a four-year, $11 million global competition accelerating new solutions to end destructive wildfires. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260707802818/en/ The Silvaguard Suppression Drone can deliver a 100 liter liquid suppressant to autonomously suppress small wildfires detected by Silvanet Competing against just two other finalists selected from an original field of nearly 300 teams worldwide, Dryad successfully demonstrated the integrated capabilities of its Silvanet wildfire detection network and Silvaguard autonomous firefighting drone system during final testing in remote Alaska. The XPRIZE Wildfire finals challenged teams to autonomously detect and suppress a wildfire without any human intervention across a vast 1,000 square k

Rigaku Opens "Rigaku Solutions Center Osaka" to Strengthen Global Semiconductor Metrology Service Capabilities8.7.2026 17:00:00 CEST | Press release

- Centralizing and Expanding Practical Training to Strengthen Global Service Capabilities - Rigaku Corporation, a global solution partner in X-ray analytical systems and a group company of Rigaku Holdings Corporation (headquarters: Akishima, Tokyo; CEO: Jun Kawakami; “Rigaku”), has opened the Rigaku Solutions Center Osaka (RSC-Osaka) at its Osaka Plant. The new facility centralizes and expands practical training for field service engineers supporting semiconductor metrology systems, strengthening Rigaku's global service capabilities. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260708402770/en/ Photo: Hands-on training using the TXRF-V310 at RSC-Osaka As semiconductor manufacturing processes continue to advance toward finer geometries, higher layer counts, and more complex three-dimensional structures, semiconductor metrology systems require ever greater precision and operational stability. X-ray analytical technologies pl

Cardiac Dimensions® Announces Three Major Publications Demonstrating Long-Term Durability, Real-World Performance, and Broad Patient Benefit of the Carillon Mitral Contour System®8.7.2026 16:05:00 CEST | Press release

New data highlight multi-center 5-year durability, 10-year survival, and the largest single-center experience across both HFrEF and HFpEF patients with functional mitral regurgitation Cardiac Dimensions, a leader in transcatheter therapies for heart failure, today announced the publication of three major manuscripts that together form the most comprehensive evidence base ever assembled for transcatheter indirect mitral annuloplasty. These publications span a five-year multi-center commercial registry, the largest single-center experience across both preserved and reduced ejection fraction, and long-term survival results through ten years. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260707656796/en/ Carillon Mitral Contour System® The Carillon Mitral Contour System is the only commercially available indirect mitral annuloplasty device, designed to treat a broad and expanding population of patients living with functional mi

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom
World GlobeA line styled icon from Orion Icon Library.HiddenA line styled icon from Orion Icon Library.Eye