Business Wire

PA-NEURAPTIVE

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

Coolbrook Named on the 2026 Global Cleantech 10015.1.2026 18:14:00 CET | Press release

Coolbrook, a transformational technology and engineering company on a mission to decarbonise major industrial sectors like petrochemicals and chemicals, iron and steel, aluminium, and cement, has been named on Cleantech Group’s 2026 Global Cleantech 100. This annual list recognizes companies poised to deliver market-ready solutions that advance a cleaner, more resilient global future. The report highlights innovators addressing some of the world’s most urgent environmental and infrastructure challenges. The complimentary report introduces you to innovators advancing groundbreaking technologies and business models to enable us to act on the ever-increasing climate and environmental crisis. Following a 2025 marked by geopolitical volatility and shifting economic signals, the global cleantech ecosystem enters 2026 with slightly greater certainty - yet heightened competitive pressure. Growth is concentrating around two dominant themes: AI infrastructure and critical minerals. “The 2026 Glo

World Economic Forum and Salesforce Empower Global Leaders With First-of-its-Kind Agentic Assistant for the 2026 Annual Meeting in Davos15.1.2026 18:01:00 CET | Press release

The Forum activates its vast data stores through Agentforce 360, enabling a level of preparation and decision-making for its over 3,000 attendees previously unachievable by human processing alone Salesforce (NYSE: CRM), the world’s #1 CRM, today announced the activation of the World Economic Forum’s institutional knowledge powered by Agentforce 360 to support over 3,000 of the world’s most influential leaders at the 2026 World Economic Forum Annual Meeting. The Forum has launched a new proactive, high-precision concierge app, “EVA,” built on the Agentforce 360 Platform, Salesforce’s agentic platform. EVA will empower attendees to move beyond traditional information access, with an AI agent that doesn’t just answer questions, but can reason, prioritize, and act on a leader’s behalf for the 2026 Annual Meeting. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260115571119/en/ Scheduled for January 19–23 in Davos, Switzerland, th

Frasca to Supply Four New Flight Training Devices to Global Medical Response15.1.2026 16:05:00 CET | Press release

New Level 7 FTDs will support pilot training for emergency medical operations Frasca International, Inc., a FlightSafety International company, today announced it has signed a contract with Global Medical Response (GMR) to supply four new Level 7 Flight Training Devices (FTDs). The new devices include an Airbus EC135, a Pilatus PC-12, a Beechcraft C90, and a Beechcraft B200. Each FTD will feature Frasca's unique motion system to provide enhanced realism in training. The devices will be installed at GMR’s new training facility currently under construction in Denton, Texas. Frasca has supported GMR’s pilot training efforts for nearly two decades, beginning with the delivery of their first device in 2005 for Air Evac Lifeteam, a GMR company. Since then, Frasca simulators have played a central role in preparing GMR’s flight crews for the complex and high-stakes environments they encounter in emergency medical operations. With the delivery of these new devices, GMR will operate a total of 1

illumynt Reports 60% Revenue Growth and Launches Global Innovation Center to Meet Rising Enterprise Security and Sustainability Demands15.1.2026 15:11:00 CET | Press release

illumynt an intelligent, security-first technology lifecycle partner, today announced significant growth and innovation milestones that position the company as a leader in the next evolution of the IT Asset Disposition (ITAD) industry—an industry increasingly shaped by artificial intelligence, accelerated hardware refresh cycles, and heightened regulatory scrutiny. Under the leadership of CEO Joerg Herbarth, illumynt continues to execute its mission to deliver intelligent, technology-driven lifecycle solutions that maximize sustainability, security, and recovery value for the world’s most compute-intensive organizations. In 2025, ITAD became a strategic imperative. AI-driven workloads have dramatically compressed infrastructure lifecycles, while updates to NIST SP 800-88 Rev. 2, adoption of R2v3, and the expansion of global privacy frameworks have raised expectations for auditability, transparency, and verified data security. As a result, ITAD has evolved from a back-end operational fu

Rimini Street Wins Multiple Industry Awards Recognizing AI Innovation, Client-First Culture, Technical Excellence and Business Impact15.1.2026 15:00:00 CET | Press release

Accolades include Tech Ascension Award for AI-Powered Agent Solution of the Year, Top Tech of the Year Award (Las Vegas), Silver Globee Award in the Customer Service Team of the Year Category and Women Leading IT Award for client, Hitachi Vantara Rimini Street, Inc., (Nasdaq: RMNI), the Software Support and Agentic AI ERP Company™, and the leading third-party support provider for Oracle, SAP and VMware software, has been recognized by top industry award programs for its innovation, technical excellence and client-first culture. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260115632021/en/ Rimini Street Wins Multiple Industry Awards Recognizing AI Innovation, Client-First Culture, Technical Excellence and Business Impact Winner of the AI-Powered Enterprise (Agent) Solution of the Year Category for Fueling Innovation and Driving Business Outcomes Rimini Street earned a 2025 Tech Ascension Award in the AI-powered Enterprise (

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