Peripheral Nerve Injuries

Company plans to initiate clinical program in mid-2024, followed by a Phase 2 study for the prevention of chemotherapy-induced peripheral neuropathy (CIPN) in patients with breast cancerNEW HAVEN, Conn., March 04, 2024 (GLOBE NEWSWIRE) -- Osmol Therapeutics, a privately held clinical-stage biopharmaceutical company focused on developing preventative treatments for chemotherapy-induced peripheral neuropathy (CIPN) and chemotherapy-induced cognitive impairment (CICI), today announced that it has appointed Ron Weitzman, M.D., as interim Chief Medical Officer, replacing Arthur DeCillis, M.D., who is joining Osmol’s Scientific Advisory Board. “We are pleased to welcome Ron, with his significant oncology drug development expertise, to the Osmol team,” said Bob Linke, MBA, President and CEO of Osmol Therapeutics. “His medical leadership will be invaluable as we advance OSM-0205 into the clinic based on recent U.S. and German regulatory authority feedback on our development program, including clinical plans, nonclinical studies and manufacturing to support the Phase 2 studies.” “We would also like to express our sincere gratitude to Art for his many contributions during the early stages of development for OSM-0205 and look forward to continuing to work together as he joins Osmol’s Scientific Advisory Board,” concluded Linke. “I look forward to working with the Osmol team to guide the clinical development of OSM-0205 for the treatment of chemotherapy-induced peripheral neuropathy and chemotherapy-induced cognitive impairment, debilitating conditions with no approved treatment options,” said Dr. Weitzman. Ron Weitzman, M.D., has held leadership roles at various global biopharmaceutical companies, including Tango Therapeutics, Exelixis, Genentech and Novartis. Most recently he served as Chief Medical Officer at Tango Therapeutics, where he oversaw development of multiple oncology drugs, including three Investigational New Drug (IND) applications, while leading the clinical and clinical operations teams. Prior to Tango, Dr. Weitzman served as Vice President of Clinical Development at Exelixis, where he had overall responsibility for the strategy and execution of the clinical plan for cabozantinib, a drug therapy for prostate cancer. Dr Weitzman is board-certified by the American Board of Internal Medicine in Medical Oncology. About OSM-0205 Osmol’s lead therapeutic candidate, OSM-0205, is based on the research of Barbara Ehrlich, PhD, in neuronal calcium sensor-1 (NCS1) at Yale School of Medicine, which is designed to prevent the off-target calcium surge caused by taxanes and potentially other chemotherapy treatments associated with peripheral nerve damage. Data from non-clinical studies conducted by Osmol show that pre-treatment with OSM-0205 prevents the pathologic damage caused by these chemotherapy agents. About Osmol Therapeutics Osmol Therapeutics is a privately held, clinical stage biopharma company focused on developing a treatment to prevent chemotherapy-induced peripheral neuropathy and chemotherapy-induced cognitive impairment based on the ground-breaking work of Barbara Ehrlich, PhD, Professor of Pharmacology, Yale School of Medicine, and Chief Scientific Officer, Osmol Therapeutics. The company’s lead indication will be for the prevention of CIPN related to taxane treatment. As an example of the extent of this condition, up to 80% of taxane-treated patients with breast cancer have been reported to experience CIPN. For more information, please visit https://osmoltherapeutics.com/. Contact: Gina Nugentgina@nugentcommunications.com

Fees for codes L8701 and L8702 are effective as of April 1, 2024 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 on February 29, 2024, the Centers for Medicare & Medicaid Services (CMS) posted the final Medicare Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) fee schedule payment rates for the MyoPro®. The final average fee schedule rates for the two Healthcare Common Procedures System (HCPCS) codes describing the MyoPro, L8701, our Motion W device, and L8702, our Motion G device, are $33,480.90 and $65,871.74, respectively, and can be found here beginning on page 67. On January 1, 2024, the MyoPro was officially classified in the brace benefit category, which enables reimbursement on a lump sum basis. These final fees become effective on April 1, 2024. “We’re extremely gratified to have reached a successful conclusion with CMS, a process that started in 2018 with the granting of the two HCPCS billing codes,” stated Paul R. Gudonis, Myomo’s Chairman and CEO. “This is an important milestone for qualified Medicare Part B beneficiaries with long-term muscular weakness or partial paralysis, and for Myomo as a company. We extend thanks to the personnel at CMS for their efforts and for appreciating the benefits that powered braces such as the MyoPro can provide to Medicare Part B beneficiaries. " About Myomo 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 certain patients suffering from CVA stroke, brachial plexus injury, traumatic brain or spinal cord injury, ALS 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

NTX-001 continues to be generally safe and well tolerated, with no additional adverse effects NTX-001 demonstrated a clinically and statistically significant improvement in function at 24 weeks. NTX-001 demonstrated a clinically and statistically significant improvement in pain at 24 weeks. WAYNE, Pa.--(BUSINESS WIRE)-- Neuraptive Therapeutics, Inc., a pioneer in nerve repair and regeneration, is proud to announce new 24-week data from the ongoing NEUROFUSE Study for NTX-001, further solidifying the product's status following the previously announced proof of concept results based on the 12-week data in January 2024. This press release features multimedia. View the full release here: Evan L. Tzanis, COO and EVP Head of R&D, Neuraptive Therapeutics, Inc. (Photo: Business Wire) The latest data from the multicenter, randomized, evaluator-blinded, Phase 2a NEUROFUSE Study underscores NTX-001’s sustained safety and efficacy as an adjunct treatment for transected peripheral nerves. At the 24-week mark, NTX-001 continues to demonstrate an encouraging safety profile, with lower treatment-emergent adverse event rates than the standard of care. Regarding efficacy, NTX-001 showed a statistically significant improvement in hand function and symptomatology as measured by the Michigan Hand Questionnaire (MHQ) compared to the standard of care alone, with clinically and statistically meaningful changes observed at eight and 24-week intervals. The secondary endpoints, including the Numerical Pain Rating Scale, also showed statistically significant improvements, favoring NTX-001 at the 24-week timepoint. These results validate the early clinical response reported at the 12-week interim time point and exhibit consistent, supportive trends across multiple secondary endpoints, including multiple assessments of sensory recovery. “Current techniques for the repair of traumatic peripheral nerve injuries often result in disappointing functional outcomes with the potential for significant neuropathic pain. This Phase 2a randomized clinical trial utilizing NTX-001 in nerve repair demonstrates its safety for use in the coaptation of nerves and shows a significant improvement in patient-reported pain scores and patient-reported functional outcome measures. Its potential to improve the care of patients with these devastating injuries using this novel technique is intriguing and holds promise for future clinical application,” said David M. Brogan, MD MSc, Associate Professor of Orthopedic Surgery, Washington University in St. Louis and Lead Author of the study. “We are excited about the results and are rapidly preparing to present these top-line results at an upcoming scientific conference, and we anticipate an End of Phase 2 meeting with the FDA in the near future to discuss late-phase development and the approval pathway,” said Evan Tzanis, Chief Operating Officer and EVP of R&D at Neuraptive Therapeutics, Inc. “We are thankful to the patients, investigators, and their staff for their participation and commitment to this study.” With the continued advancement of NTX-001, Neuraptive Therapeutics, Inc. remains at the forefront of developing novel solutions for a significant number of patients are affected by peripheral nerve injuries globally. 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.