Latest news with #BioelectronicMedicine
National Post
07-05-2025
- Health
- National Post
Epineuron Announces Topline Pilot Study Results Published in Bioelectronic Medicine Showing the Potential of the PeriPulse® System in Accelerating Nerve Regeneration
Article content TORONTO — A groundbreaking first-in-human trial has revealed the potential of the PeriPulse® Nerve Stimulation System, a wearable temporary nerve stimulator, in enabling electrical stimulation therapy for the regeneration of acutely injured peripheral nerves. In a study published in Bioelectronic Medicine, results showed a significant and sustained improvement in sensation, with 87.5% of treated patients demonstrating clinically meaningful gains 6 months after injury compared to pre-surgery. This highlights the potential of electrical stimulation therapy to drive substantial functional recovery. Article content Article content Treating peripheral nerve injuries remains challenging, particularly in acute trauma scenarios. Surgery, the current standard of care, often results in slow and incomplete recovery, creating substantial burdens for patients and healthcare systems. Epineuron's novel PeriPulse® system provides a simple workflow to improve patient outcomes without prolonging operating room time. 'This publication is an important milestone for Epineuron and a testament to our vision for the future of improving nerve regeneration. The utility of our efficient approach to deploying therapy was validated and we look forward to helping patients recover following nerve surgery,' said Dr. Mike Willand, PhD, Co-Founder and CTO at Epineuron. Article content The system demonstrated a high degree of patient tolerance and safety, underscoring its potential for widespread adoption. The findings offer new hope for patients and provides surgeons the prospect of delivering needed treatment. The study results have paved the way for REGAIN™, the largest multinational medical device trial for nerve regeneration, currently underway across Canada and the US, which is designed to support the company's FDA approval. Article content 'Better nerve regeneration is game changing for patients,' said Dr. James Bain, MD, MSc, Professor of Plastic Surgery, McMaster University and corresponding author of the study. 'The novel system provides a simple and effective way to deliver electrical stimulation therapy that does not impact my workflow and prolong my surgeries. This system and approach have the potential to significantly improve outcomes for patients with peripheral nerve injuries.' Article content Article content Article content Article content Article content Article content
Business Wire
07-05-2025
- Business
- Business Wire
Epineuron Announces Topline Pilot Study Results Published in Bioelectronic Medicine Showing the Potential of the PeriPulse® System in Accelerating Nerve Regeneration
TORONTO--(BUSINESS WIRE)--A groundbreaking first-in-human trial has revealed the potential of the PeriPulse® Nerve Stimulation System, a wearable temporary nerve stimulator, in enabling electrical stimulation therapy for the regeneration of acutely injured peripheral nerves. In a study published in Bioelectronic Medicine, results showed a significant and sustained improvement in sensation, with 87.5% of treated patients demonstrating clinically meaningful gains 6 months after injury compared to pre-surgery. This highlights the potential of electrical stimulation therapy to drive substantial functional recovery. Better nerve regeneration is game changing for patients. The novel system provides a simple and effective way to deliver electrical stimulation therapy that does not impact my workflow and prolong my surgeries. Share Treating peripheral nerve injuries remains challenging, particularly in acute trauma scenarios. Surgery, the current standard of care, often results in slow and incomplete recovery, creating substantial burdens for patients and healthcare systems. Epineuron's novel PeriPulse® system provides a simple workflow to improve patient outcomes without prolonging operating room time. 'This publication is an important milestone for Epineuron and a testament to our vision for the future of improving nerve regeneration. The utility of our efficient approach to deploying therapy was validated and we look forward to helping patients recover following nerve surgery,' said Dr. Mike Willand, PhD, Co-Founder and CTO at Epineuron. The system demonstrated a high degree of patient tolerance and safety, underscoring its potential for widespread adoption. The findings offer new hope for patients and provides surgeons the prospect of delivering needed treatment. The study results have paved the way for REGAIN™, the largest multinational medical device trial for nerve regeneration, currently underway across Canada and the US, which is designed to support the company's FDA approval. "Better nerve regeneration is game changing for patients," said Dr. James Bain, MD, MSc, Professor of Plastic Surgery, McMaster University and corresponding author of the study. "The novel system provides a simple and effective way to deliver electrical stimulation therapy that does not impact my workflow and prolong my surgeries. This system and approach have the potential to significantly improve outcomes for patients with peripheral nerve injuries.' About Epineuron Epineuron is a nerve care company dedicated to advancing bioelectronic solutions for the repair and treatment of damaged nerves. Its flagship technology, PeriPulse®, is Health Canada approved and designated an FDA Breakthrough Device. It uses electrical stimulation to accelerate the recovery of injured peripheral nerves with a seamless perioperative workflow.
Yahoo
31-03-2025
- Health
- Yahoo
Non-Invasive Ultrasound Treatment Shows Promise for Neuropathic Pain Relief, Feinstein Institutes Research Finds
The findings were published in Bioelectronic Medicine MANHASSET, N.Y., March 31, 2025--(BUSINESS WIRE)--Neuropathic pain affects up to 10 percent of the global population and can be challenging to manage effectively with existing medications. As a possible alternative treatment option, scientists at Northwell Health's Feinstein Institutes for Medical Research have discovered that ultrasound precisely targeted at the spinal cord can reduce neuropathic pain and neuroinflammation in preclinical models. The study – published today in Bioelectronic Medicine, an open-access journal distributed by the Feinstein Institutes and BMC, part of Springer Nature -- led by Weiguo Song, PhD, instructor, and Stavros Zanos, MD, PhD, associate professor in the Feinstein Institutes' Institute of Bioelectronic Medicine, demonstrates that trans-spinal focused ultrasound (tsFUS) can reduce sensitivity and suppress spinal microglia activation in neuropathic pain. "This research provides compelling preclinical evidence that tsFUS could offer a safe and effective approach for managing neuropathic pain," said Dr. Zanos. "By targeting the spinal cord directly, we can potentially modulate underlying mechanisms driving pain without the need for invasive procedures or pain medications." Neuropathic pain is a type of chronic pain caused by damage or dysfunction in the peripheral nervous system that can cause burning, shooting, stabbing or tingling within the body. Common causes of neuropathic pain include diabetes, shingles, nerve compression, trauma or surgery, cancer and cancer treatments, or certain infections. In this study of animal models, after nerve injury, tsFUS was aimed precisely at the spinal cord for three minutes a day, for three days. The researchers observed reduced pain sensitivity, which persisted for weeks after the treatment concluded. It also calmed neuroinflammation in the spinal cord, a common complication of nerve injury. "Dr. Zanos and his team are pioneering this non-invasive approach to target the spinal cord and reduce pain signals without the need for surgery or drugs," said Kevin J. Tracey, MD, president and CEO of the Feinstein Institutes and Karches Family Distinguished Chair in Medical Research. "This research suggests the potential to treat nerve pain using focused sound waves that could lead to long-lasting relief for patients." The Feinstein Institutes for Medical Research is the global scientific home of bioelectronic medicine, which combines molecular medicine, neuroscience and biomedical engineering. At the Feinstein Institutes, medical researchers use modern technology to develop new device-based therapies to treat disease and injury. Building upon years of research in molecular disease mechanisms and the link between the nervous and immune systems, Feinstein Institutes' researchers discovered neural targets that can be activated or inhibited with neuromodulation devices, like vagus nerve implants, to control the body's immune response and inflammation. If inflammation is successfully controlled, diseases – such as arthritis, pulmonary hypertension, heart failure, inflammatory bowel diseases, diabetes, cancer and autoimmune diseases – can be treated more effectively. Beyond inflammation, using novel brain-computer interfaces, Feinstein Institutes' researchers have developed techniques to bypass injuries of the nervous system so that people living with paralysis can regain sensation and use their limbs. By producing bioelectronic medicine knowledge, disease and injury could one day be treated with our own nerves without costly and potentially harmful pharmaceuticals. Dr. Zanos was recently awarded $3 million from the National Institute of Neurological Disorders and Stroke (NINDS), part of the National Institutes of Health (NIH), in collaboration with imec, a research and innovation center in nanoelectronics and digital technologies, to pioneer a novel approach to vagus nerve stimulation (VNS). This research aims to develop more precise, safe and effective methods for stimulating specific fibers inside the vagus nerve, potentially transforming treatments for a range of chronic diseases. About the Feinstein InstitutesThe Feinstein Institutes for Medical Research is the home of the research institutes of Northwell Health, the largest health care provider and private employer in New York State. Encompassing 50+ research labs, 3,000 clinical research studies and 5,000 researchers and staff, the Feinstein Institutes raises the standard of medical innovation through its six institutes of behavioral science, bioelectronic medicine, cancer, health system science, molecular medicine, and translational research. We are the global scientific leader in bioelectronic medicine – an innovative field of science that has the potential to revolutionize medicine. The Feinstein Institutes publishes two open-access, international peer-reviewed journals Molecular Medicine and Bioelectronic Medicine. Through the Elmezzi Graduate School of Molecular Medicine, we offer an accelerated PhD program. For more information about how we produce knowledge to cure disease, visit and follow us on LinkedIn. View source version on Contacts Julianne Mosher Allen516-880-4824jmosherallen@ Sign in to access your portfolio
Associated Press
06-03-2025
- Health
- Associated Press
Tivic Health and Feinstein Institute Present New Data Showing Personalized Vagus Nerve Stimulation Method Optimizes Impact on Autonomic Nervous System
Tivic Health ® Systems, Inc. (Nasdaq: TIVC), a diversified therapeutics company, announced today new data that shows personalizing its non-invasive vagus nerve stimulation (ncVNS) method optimized the stimulation's impact on autonomic nervous system activity. Tivic Health believes these findings strongly support its strategy to develop highly personalized neuromodulation devices that can better address inflammatory, cardiac and neurologic disorders compared to current, more invasive treatment options. The data were presented in a poster presentation, titled, ' Autonomic, Cardiac, and Neural Effects from Non-Invasive Cervical Vagus Nerve Stimulation, ' at the Sixth Bioelectronic Medicine Summit, March 4 & 5. The findings were based on Tivic's collaboration with The Feinstein Institute of Medicine, one of the global scientific leaders in bioelectronic medicine. 'These promising findings reinforce Tivic's premise that non-invasive bioelectronic devices can effectively treat inflammatory, cardiac and neurologic disorders without invasive surgeries or pharmaceuticals - both of which carry burdensome side effects,' said Jennifer Ernst, CEO of Tivic Health. 'With these new data secured with pending patents, we believe that we have demonstrated the potential for developing personalized, scalable bioelectronic therapies to treat patients in need.' Tivic Health's poster presentation, titled, ' Autonomic, Cardiac, and Neural Effects from Non-Invasive Cervical Vagus Nerve Stimulation, ' highlighted a novel ncVNS approach and its ability to modulate autonomic nervous system (ANS) function and brain activity. Key results included: Personalized stimulation approach for optimal autonomic modulation: No single stimulation frequency had a universally dominant effect on HRV, highlighting the need for personalized neuromodulation strategies. Choosing the optimal ncVNS stimulation frequency for each study subject resulted in a meaningful increase in effect size of HRV change, paving the way for patient-specific therapy. Significant increase in heart rate variability (HRV), indicating enhanced parasympathetic activity: In 60% of participants (responders), raw HRV nearly doubled on average following ncVNS stimulation. Normalized HRV increased 2.67x post-stimulation, suggesting a strong activation of vagal tone and improved autonomic balance. The data presented resulted from Tivic's ongoing collaboration with the Feinstein Institute of Bioelectronic Medicine to advance high-precision vagus nerve stimulation in a non-invasive form factor. About The Bioelectronic Medicine (BEM) Summit The BEM Summit is a premier gathering of industry leaders, researchers, and clinicians exploring cutting-edge neurotechnologies and neuromodulation therapies. Hosted by the Feinstein Institutes for Medical Research, the event brings together experts in bioelectronic medicine, autonomic neuroscience, and inflammation research to discuss the latest advancements in the field. About Tivic Health Systems, Inc. Tivic Health is a diversified therapeutics company harnessing the power of the immune and autonomic nervous systems to fight disease and restore health. Tivic Health's bioelectronic division is developing non-invasive medical devices that personalize key stimulation parameters for the vagus nerve to deliver meaningfully improved effects on measures of the autonomous nervous system compared to current treatments, which are often invasive, ineffective or both. Tivic Health's biopharma division's lead product candidate is the TLR5 agonist, Entolimod™, which is in late-stage studies to treat acute radiation syndrome. The FDA has granted Fast Track and Orphan Drug designation to Entolimod™. Tivic Health already has an FDA-approved over-the-counter device, ClearUP™ that treats sinus pain and pressure and is available through online retailers and commercial distributors. For more information about Tivic Health, visit: Forward-Looking Statements This press release may contain 'forward-looking statements' that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as 'anticipate,' 'believe,' 'contemplate,' 'could,' 'estimate,' 'expect,' 'intend,' 'seek,' 'may,' 'might,' 'plan,' 'potential,' 'predict,' 'project,' 'target,' 'aim,' 'should,' 'will' 'would,' or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Tivic Health Systems, Inc.'s current expectations and are subject to inherent uncertainties, risks, and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate, including as a result of changes to the company's relationship with the Feinstein Institute, future development of the company's ncVNS treatment, changes to the company's business strategy, clinical trial and study results, consummation of any strategic transactions, the company's need for, and ability to secure when needed, additional working capital, and the company's ability to maintain its Nasdaq listing. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors. Accordingly, you are cautioned not to place undue reliance on such forward-looking statements. For a discussion of risks and uncertainties relevant to the company, and other important factors, see Tivic Health's filings with the SEC, including, its Annual Report on Form 10-K for the year ended December 31, 2023, filed with the SEC on March 29, 2024, under the heading 'Risk Factors'; as well as the company's subsequent filings with the SEC. Forward-looking statements contained in this press release are made as of this date, and Tivic Health Systems, Inc. undertakes no duty to update such information except as required by applicable law. Hanover International, Inc. SOURCE: Tivic Health Systems, Inc. Copyright Business Wire 2025. PUB: 03/06/2025 08:15 AM/DISC: 03/06/2025 08:17 AM
