PA-NEURAPTIVE
28.4.2020 22:17:07 CEST | Business Wire | Press release
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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20200428005968/en/
About Business Wire
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
Aqara Announces the Availability of The Spatial Multi-Sensor FP400, Offering Advanced Spatial Intelligence for Smart Homes16.9.2026 09:00:00 CEST | Press release
Aqara, a global leader and pioneer in IoT, today announced the release of the Spatial Multi-Sensor FP400. The FP400 is designed to bring precise, spatial intelligence to homes without sacrificing the privacy typically compromised by smart cameras. Rather than simply detecting motion or presence, the FP400 enables homes to better understand occupancy, movement, and context for more granular and personalized automations and insight. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260916958372/en/ Aqara Announces the Availability of The Spatial Multi-Sensor FP400, Offering Advanced Spatial Intelligence for Smart Homes The Spatial Multi-Sensor FP400 redefines how smart homes perceive and interact with living spaces by combining high-precision spatial sensing with AI-powered environmental understanding. Powered by a next-generation high-precision 60GHz mmWave radar, the FP400 delivers industry-leading multi-person sensing, precise
Cambridge Associates Opens Italian Office and Expands European Leadership16.9.2026 09:00:00 CEST | Press release
Global investment firm Cambridge Associates (CA) today announced the opening of a new office in Milan and the appointment of two senior hires in Europe. The move reflects the firm’s ongoing commitment to providing bespoke services to current and future institutional and family office investors across the region. Raphael Heynold has joined the Client Solutions team as Head of EMEA and APAC and will serve on the firm’s EMEA Operating Committee. Based in London, Raphael is a key member of the Global Client Solutions Leadership team, responsible for driving growth and market expansion and overseeing client engagement efforts across Europe, the Middle East, and Asia Pacific regions. Heynold brings more than 30 years of experience across client strategy, investment banking and investment management, and has worked with many sophisticated families and institutions around the world. Riccardo Pianeti has joined Cambridge Associates to lead the Italian office. He will serve as Head of the Milan
International Expansion Far Outweighs M&A as a Legal and Compliance Execution Burden, CSC Research Finds16.9.2026 08:49:00 CEST | Press release
International expansion far outweighs M&A as a legal and compliance execution burden, cited by 74% of senior cross-border professionals versus 28%54% often redo work because entity or ownership information is incomplete or outdatedHalf say information gaps can add one to two weeks to cross-border work International expansion is creating a far heavier legal and compliance execution burden than M&A itself, with nearly three quarters (74%) of senior cross-border professionals citing market entry or international expansion as a leading burden, compared with just 28% for M&A transactions, according to new research from CSC, the leading provider of global business administration and compliance solutions. The challenge extends well beyond deal execution. Ongoing entity governance and compliance is cited by 71% of respondents, highlighting the operational burden of establishing and maintaining a presence across multiple jurisdictions. CSC’s new report, The Cross-Border Readiness Gap: Navigatin
Okomera Strengthens Its Leadership Team With the Appointment of Marion Ghibaudo as Chief Technology Officer16.9.2026 08:00:00 CEST | Press release
An expert in scaling medical innovations, Marion Ghibaudo joins Okomera as the company advances toward industrial deployment. Okomera, a TechBio company pioneering next-generation cancer care through the development of a proprietary technology platform combining tumor mini-avatars, microfluidics, and AI-powered imaging, today announced the appointment of Marion Ghibaudo as Chief Technology Officer. She will spearhead the company’s technology and innovation strategy and lead the industrial deployment of its integrated hardware, software, and biological platform. Marion Ghibaudo will join Okomera’s Executive Committee and report to CEO Silvère Lucquin. In parallel, Raphaël Tomasi, Okomera’s co-founder and former CTO, transitions to the role of VP Platform, ensuring continuity in the development of the company’s technology platform. Marion’s appointment comes at a key stage in Okomera’s growth as the company advances toward pilot studies, industrial scale-up, and commercialization. Okomer
Galderma’s Restylane® Volyme™ Demonstrates High Effectiveness, Satisfaction and a Robust Safety Profile in Chinese Patients With Temple Hollowing16.9.2026 07:00:00 CEST | Press release
Positive topline results showed that Restylane Volyme (known as Restylane Contour in the U.S.) was highly effective in the correction of moderate-to-severe temple hollowing, with high responder rates maintained through Month 121 Restylane Volyme was well tolerated, with no incidences of granulomas. Patient and investigator satisfaction were also high1 These data support Galderma’s aim to expand the availability of the Restylane portfolio in China – a market undergoing significant expansion, and further strengthen Restylane’s vast clinical evidence base2,3 Galderma (SIX: GALD) today announced positive topline results from a study of Restylane Volyme for the correction of moderate-to-severe temple hollowing in 162 patients in China.1 The study met its primary endpoint, demonstrating the effectiveness and safety of Restylane Volyme versus a no-treatment control, while also achieving high patient and investigator satisfaction.1 These data further reinforce Galderma's ambition to expand its
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
