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

Hexagon Semi’s HX77 AR Display Processor Achieves Ultra-Low Power Consumption with VeriSilicon’s Nano IP Portfolio10.3.2026 01:00:00 CET | Press release

VeriSilicon’s Mature GPU, Display Processing, and DeWarp IPs Collaboratively EnableHighlyIntegrated, Low-Latency AR Display Processing VeriSilicon (688521.SH) today announced that Hefei Hexagon Semiconductor (Hexagon Semi), an image processing SoC provider, has adopted VeriSilicon’s proven IP portfolio in its high-performance HX77 series image processing SoC. The adopted IPs include the GCNanoUltraV 2.5D Graphics Processing Unit (GPU) IP, DW100 DeWarp Processing IP, and DC9200Nano Display Processing IP. The SoC has successfully taped out, achieving a first-pass silicon success. The HX77 series is a highly integrated, low-power image processing SoC based on RISC-V architecture, integrating comprehensive video input/output interfaces, image processing, and system control capabilities. By leveraging an innovative heterogeneous computing architecture and sophisticated power management technology, HX77 has successfully achieved a technological breakthrough that enables 2K@60fps output with

Operio Group Named Distributor for Schaefer Technologies in the United Kingdom and European Union9.3.2026 22:00:00 CET | Press release

Operio Group has signed a distribution agreement with Schaefer Technologies, a manufacturer of semi-automatic encapsulation equipment. Operio Group, a holding company building a global group of brands serving the solid dose manufacturing industry, will be the official distributor of Schaefer Technologies’ products in the United Kingdom and the European Union. Schaefer Technologies develops semi-automatic capsule filling systems, including equipment that produces banded capsules for liquid and pellet formulations used by nutraceutical and pharmaceutical manufacturers. Leadership from both companies worked together to establish the agreement, including Kevin Schaefer, CEO of Schaefer Technologies Inc., and Alastair Sanderson, Chief Business Development Officer at Operio Group. “Schaefer Technologies is looking forward to our new relationship with Operio Group,” said Schaefer. “Their understanding of the pharmaceutical equipment market makes them a strong partner as we combine our experti

Kinaxis Goes All-In on Innovation at Upcoming Kinexions in Las Vegas9.3.2026 19:00:00 CET | Press release

Annual customer conference will bring together global supply chain leaders to explore the latest trends, best practices and technologies in AI-powered planning, decision-making and agentic innovation Registration is officially open for Kinexions North America, the premier global supply chain orchestration conference hosted by Kinaxis® Inc. (TSX: KXS). Taking place June 1–3 in Las Vegas, Nevada, the event brings together supply chain leaders, innovators and practitioners from around the world to explore how organizations can leverage AI-driven strategies and technologies to connect data, people and decisions. After a year defined by market volatility, geopolitical risk and disruption, this year’s conference will focus on how intelligent supply chain orchestration enables organizations to move beyond reactive planning to building true enterprise adaptability. The program promises to be the most immersive and future-forward Kinexions yet, with renowned author, entrepreneur and innovation

InterSystems Appoints Former NHS and Mass General Leader Dr. Tim Ferris as Vice President, Healthcare Practice9.3.2026 17:00:00 CET | Press release

InterSystems, a creative data technology provider powering more than one billion health records globally, today announced the appointment of Tim Ferris, M.D., as Vice President, Healthcare Practice. The announcement comes as healthcare leaders gather for the 2026 HIMSS Global Health Conference & Exhibition. In this role, Dr. Ferris will leverage his comprehensive view of the industry to help drive the clinical and strategic direction of the company’s healthcare solutions worldwide. Drawing on his vast experience, he will serve as a strategic advisor to global health systems and governments, engineer targeted technology solutions based on real-world executive needs, advance his academic research on health data architecture and lead public discourse on the intersection of AI and care delivery. Dr. Ferris brings a unique global perspective to InterSystems that is virtually unmatched in healthcare. His career spans 30 years as a practicing primary care physician, executive leadership at pr

Radial Selects Riskified to Power Payment Fraud and Refund/Return Protection for Merchant Client Portfolio9.3.2026 15:00:00 CET | Press release

The partnership brings Riskified’s AI-powered platform for payment fraud, refund claim, and return abuse protection to Radial’s global network of merchants Riskified (NYSE: RSKD), a leader in ecommerce fraud and risk intelligence, today announced a strategic partnership with Radial, a leading 3PL set to become Paxon later this year. Radial will integrate with Riskified’s AI-powered platform to help its merchants approve more legitimate orders and reduce losses from payment fraud, including many merchants that use Shopify as their ecommerce platform. Radial supports many of the world’s most recognized retail brands with a global ecommerce fulfillment network of more than 20 centers across North America, helping merchants deliver orders quickly and cost effectively. By bringing Riskified’s AI-powered fraud decisioning into its commerce ecosystem, Radial gives merchants the surgical ability to calibrate the checkout experience according to risk—without slowing fulfillment. This also suppo

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