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

Donaldson Introduces Alpha-Pore™ Technology Platform for Extended Sterile Filtration Performance2.11.2026 15:35:00 CET | Press release

Donaldson Company, Inc. (NYSE: DCI), a leading worldwide manufacturer of innovative filtration products and solutions, today announced Alpha‑Pore™ technology, a next generation sterile filtration platform engineered to extend filter service life while maintaining critical process performance. Built for critical applications, Alpha‑Pore technology enables longer filter run time compared with competitive single- and dual-layer polyethersulfone (PES) membrane filters, while maintaining flow characteristics, sterility assurance, and process integrity.* The platform is designed to help manufacturers improve operational efficiency through fewer changeouts and more consistent performance over time. Engineered for Extended Performance Sterile filtration processes often require balancing run time with key performance parameters such as flow, differential pressure, and contaminant retention. Alpha‑Pore technology is designed to achieve all three. By optimizing pore structure and filter architect

SBC Medical Forms Capital and Business Alliance with AtomicSoftware, Provider of the medicalforce Clinic Management Platform Used by 800+ Clinics in Japan2.11.2026 15:00:00 CET | Press release

Companies to co-develop AI features, starting with physician documentation support, to enhance medicalforce and SBC Medical’s in-house systems and drive per-clinic productivity and profitability SBC Medical Group Holdings Incorporated (Nasdaq: SBC) (“The Company” or “SBC Medical”), a Medical Services Organization (MSO) providing management support across a wide range of healthcare fields, today announced that it entered into a capital and business alliance agreement on October 26, 2026, with AtomicSoftware Inc. (“AtomicSoftware”), the Tokyo-based provider of medicalforce, an all-in-one software-as-a-service (SaaS) platform for clinics. In connection with the alliance, SBC Medical has invested ¥600 million (approximately US$3.8 million) in AtomicSoftware’s Series C funding round. The two companies will co-develop AI features, beginning with a feature that supports physicians in preparing medical records. Key HighlightsProven platform: medicalforce is used by more than 800 clinics*1 in J

Smartly Launches Intelligence Pro to Connect Campaign Planning, Performance and Incrementality2.11.2026 15:00:00 CET | Press release

The new offering brings together planning, performance benchmarks, headroom analysis and incrementality signals to help marketers make more informed decisions across the campaign lifecycle Smartly, the AI-powered advertising technology company, today launched Intelligence Pro, a premium offering that brings together four capabilities to help marketers plan investment, understand true incrementality and determine where to spend their next dollar. Intelligence Pro connects causal inference models with planning tools to help marketers prove business impact and make faster decisions from increasingly complex data. “Marketing teams are inundated with data, but the challenge is identifying what signals are useful and turning them into a decision they can act on,” said Maxwell Tang, Chief Product Officer at Smartly. “Intelligence Pro brings forecasting, market context and state-of-the-art incrementality signals together to help marketers assess where to invest and what their media is contribu

NetApp Completes Acquisition of PEAK:AIO to Accelerate Zettabyte-scale AI Deployments2.11.2026 14:00:00 CET | Press release

Acquisition strengthens NetApp Novus, high-performance storage, with differentiated metadata technology and a parallel file architecture purpose-built for AI NetApp® (NASDAQ: NTAP), the Intelligent Data Infrastructure company, today announced that it completed the acquisition of PEAK:AIO, a pioneer in next-generation metadata architecture and high-performance parallel file systems. With this acquisition, NetApp can leverage metadata services and parallel namespace innovations to power the fastest storage on the planet, NetApp Novus, to support zettabyte-scale file systems for the most demanding workloads of AI clouds and GPU-as-a-service providers. For the best AI infrastructure economics, organizations need to keep GPU resources continuously supplied with data without bottlenecks. The acquisition advances NetApp’s strategy for the next phase of AI infrastructure by bringing PEAK:AIO’s metadata and parallel file system expertise together with NetApp ONTAP, giving customers a path to AI

Bentley Systems Announces Seequent’s Acquisition of Seismic Interpretation Software Company Eliis2.11.2026 14:00:00 CET | Press release

Strengthens Seequent’s subsurface software portfolio, energy and geophysics capabilities, and expands team of specialists Bentley Systems, Incorporated (Nasdaq: BSY), the infrastructure engineering software company, today announced that Seequent, The Bentley Subsurface Company, has acquired seismic interpretation software company Eliis. The acquisition will enrich Seequent’s capabilities in geophysics with seismic data interpretation and further advance subsurface understanding to help solve complex global challenges. Eliis’ global team of more than 100 geoscientists, technical specialists, and researchers will join Seequent. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20261029964674/en/ 3D view from PaleoScan showcasing recent advancements in seismic interpretation workflows that support prospect evaluation and exploration decision-making Founded in 2007 and with headquarters in Montpellier, France, Eliis develops advanced

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