Peripheral Nerve Injuries

- Interim 24-week data from the NEUROFUSE study highlights the safety and efficacy of NTX-001 for peripheral nerve injuries. CHESTERBROOK, Pa.--(BUSINESS WIRE)--Neuraptive Therapeutics Inc., a leading biopharmaceutical company focused on novel treatments for peripheral nerve injuries, today announced that interim topline results from its ongoing Phase 2 NEUROFUSE Study will be presented at the 2024 American Society for Surgery of the Hand (ASSH) Annual Meeting, held September 19-21 in Minneapolis, MN. The presentation, titled Safety and Efficacy of NTX-001 in the Treatment of Acute Single Transected Peripheral Nerve Injuries: A Phase 2 Randomized Controlled Trial , was awarded a Top 10 Best Paper designation and will be presented by Dr. David Brogan of Washington University during the scientific paper session on Thursday, September 19. The presentation will highlight interim findings from the 24-week analysis of the NEUROFUSE study, which evaluates the safety and efficacy of NTX-001 in patients suffering from acute, single-transected upper extremity peripheral nerve injuries. NTX-001 is a drug-device combination designed to improve the speed and durability of functional recovery when used alongside standard surgical repair. These results represent an important milestone in the continued development of NTX-001 as a novel treatment option for peripheral nerve injuries. Key interim findings at 24 weeks include: NTX-001 demonstrated a significant improvement in MHQ total scores at 8- and 24 weeks post-operation compared to standard of care alone There were no safety findings associated with the use of NTX-001 At all-time points, patients treated with NTX-001 demonstrated significantly reduced post-operative pain compared with SOC alone. These results underscore the potential of NTX-001 to enhance functional recovery in peripheral nerve injury patients and support further development. According to Dr. Brogan, lead author on the paper and primary investigator at Washington University in St. Louis, “traumatic peripheral nerve transections are an unsolved problem in hand and upper extremity surgery, and the potential use of PEG fusion to meet this challenge has gained considerable interest among clinicians who deal with these devastating injuries. This data demonstrating improvement in pain and patient-reported outcomes is an exciting first step in addressing the needs of these patients.” “We are pleased to share these promising interim results from our Phase 2 trial of NTX-001 at such an important Scientific conference, and look forward to sharing full study results at future scientific conferences,” said Evan Tzanis, Chief Operating Officer and Head of R&D at Neuraptive Therapeutics, Inc. “We are immensely grateful to all those involved in this study, including the investigators, supporting staff at the clinical sites, our team, and most importantly, the patients who participated in the study,” said Tzanis. About ASSH The American Society for Surgery of the Hand is the oldest medical society dedicated to the hand and upper extremity. Its mission is to advance the science and practice of hand and upper extremity surgery through education, research, and advocacy on behalf of patients and practitioners. For more information, please visit . About Neuraptive Therapeutics, Inc. Neuraptive Therapeutics, Inc. is dedicated to the innovation and development of medical products and therapeutics to repair and regenerate peripheral nerves. The company is focused on addressing the unmet medical needs of patients and physicians dealing with the complex challenges of nerve injuries. Notice Regarding Forward-Looking Statements This press release contains forward-looking statements subject to various risks and uncertainties. Actual results could materially differ from those anticipated in the forward-looking statements due to various factors. Neuraptive Therapeutics, Inc. disclaims any obligation to update the information contained in these forward-looking statements. Contacts For more information about the NEUROFUSE Study or to inquire about Neuraptive Therapeutics, Inc., please contact: IR@neuraptive.com +1-484-787-3203

Neuraptive Therapeutics chief operating officer and research and development executive vice-president Evan Tzanis. Credit: Neuraptive Therapeutics, Inc./Business Wire. The US Food and Drug Administration (FDA) has granted breakthrough therapy designation (BTD) to Neuraptive Therapeutics’ NTX-001 for the treatment of patients with peripheral nerve injury requiring repair. The BTD status was awarded following the promising results from the Phase II NEUROFUSE study and subsequent discussions with the US regulator. Neuraptive is preparing to initiate a Phase III programme for NTX-001 in early 2025. The programme will include a randomised, double-blind, placebo-controlled trial to evaluate the safety and efficacy of NTX-001 in patients with peripheral nerve injuries. The final study protocol for the prospective Phase III trial is under discussion with the regulator, building on the encouraging data observed after 24 weeks in the NEUROFUSE study. See Also: EASD 2024: Are tetra-agonists the future of metabolic diseases treatment? Cemiplimab by Regeneron Pharmaceuticals for Angiosarcoma: Likelihood of Approval Neuraptive anticipates that the complete set of results, encompassing the full 48 weeks of data, will be available soon. Dedicated to advancing medical solutions for nerve repair and regeneration, Neuraptive Therapeutics continues to focus on the development of innovative products and therapeutics that can improve the lives of patients with peripheral nerve injuries. Neuraptive Therapeutics chief operating officer and research and development executive vice-president Evan Tzanis stated: “The FDA’s breakthrough therapy designation for NTX-001 is a major step forward in our mission to provide an innovative treatment for patients suffering from peripheral nerve injuries requiring repair. “We are eager to continue working closely with the FDA to ensure NTX-001 reaches patients as quickly as possible and to deliver a transformative therapy in the field of nerve repair. We are grateful to the patients, investigators and our partners who have remained committed to advancing NTX-001.” In January 2024, the FDA granted orphan drug designation to NTX-001 for peripheral nerve injury repair.

BOSTON--( BUSINESS WIRE )-- Myomo, Inc. (NYSE American: MYO) (“Myomo” or the “Company”), a wearable medical robotics company that offers increased functionality for those suffering from neurological disorders and upper-limb paralysis, today announced that management will be participating in two investor conferences during the month of September. Paul Gudonis, chairman and chief executive officer, and David Henry, chief financial officer, will present and host one-on-one meetings at the HC Wainwright 26 th Annual Global Investment Conference being held September 9-11, 2024 at the Lotte New York Palace Hotel. Management’s presentation will be available for viewing beginning at 7:00 a.m. ET on September 9 th , and one-on-one meetings with investors will be held virtually on September 9 th and 11 th . Visit www.hcwevents.com/annualconference to register for the conference to view the presentation or request a meeting, David Henry will host one-on-one meetings at the Lake Street 8 th Annual Best Ideas Growth “Big 8” Conference at the Yale Club in New York on September 12, 2024. This conference consists of one-on-one meetings between Company management and investors. Visit https://www.lakestreetcapitalmarkets.com or contact your Lake Street representative to participate in the conference. About Myomo, Inc. Myomo, Inc. is a wearable medical robotics company that offers improved arm and hand function for those suffering from neurological disorders and upper limb paralysis. Myomo develops and markets the MyoPro product line. MyoPro is a powered upper limb orthosis designed to support the arm and restore function to the weakened or paralyzed arms of patients suffering from CVA stroke, brachial plexus injury, traumatic brain or spinal cord injury or other neuromuscular disease or injury. It is currently the only marketed device in the U.S. that, sensing a patient’s own EMG signals through non-invasive sensors on the arm, can restore an individual’s ability to perform activities of daily living, including feeding themselves, carrying objects and doing household tasks. Many are able to return to work, live independently and reduce their cost of care. Myomo is headquartered in Boston, Massachusetts, with sales and clinical professionals across the U.S and representatives internationally. For more information, please visit www.myomo.com .