Five Liters sets clinical sights on novel bioelectric treatment for von Willebrand Disease
Wearable auricular neurostimulation device could offer a novel treatment option for the most common inherited bleeding disorder.
DALLAS, TX and MANHASSET, NY, July 06, 2023 (GLOBE NEWSWIRE) -- Five Liters, a Dallas-based wearable neuromodulation company, is embarking on a series of groundbreaking first-in-human studies to demonstrate the effectiveness of non-invasive, wearable neurostimulation in reducing blood loss. This significant milestone is made possible through Five Liters' collaboration with the Feinstein Institutes for Medical Research, marking the first translational step from their recently published Nature Communications study titled Vagus nerve stimulation primes platelets and reduces bleeding in hemophilia A male mice.
Five Liters, a subsidiary of Spark Biomedical, is dedicated to exploring the hemostatic effects of vagus nerve stimulation (VNS), specifically transcutaneous auricular neurostimulation (tAN). The focus is on preventing life-threatening bleeding events commonly associated with various conditions, including:
· Blood disorders
· Surgical blood loss
· Traumatic Bleeding
Should the initial human feasibility study yield positive results, Five Liters will prioritize Von Willebrand Disease, the most prevalent inherited blood-clotting disorder worldwide, affecting approximately 0.6 to 1.3% of the global population (equivalent to 1 in every 100 Globally)^1. VWD manifests with varying degrees of bleeding tendency, such as excessive bleeding from injuries, surgical or dental procedures, persistent nosebleeds, heavy or prolonged menstrual bleeding, and bleeding during labor and delivery. Other symptoms include blood in urine or stool, easy bruising, and hematomas.
Dr. Navid Khodaparast, Chief Science Officer of Spark and Five Liters stated “Von Willebrand Disease is an inherited bleeding disorder in which blood does not clot properly, leading to bleeding events and joint problems. In females with VWD, nearly 80% experience heavy menstrual bleeding, also known as menorrhagia. These monthly occurring bleeding events not only can take a toll on their physical health but can also affect their mental health, leading to significant depression and anxiety. At Five Liters, our primary clinical initiative is to demonstrate that tAN therapy can safely alleviate menorrhagia in females with VWD. This clinical trial is scheduled to begin later this year.”
Currently, there is no cure for VWD. However, based on the promising pre-clinical work conducted by the Feinstein Institutes for Medical Research, the recently published Nature Communications article, and Five Liters' affiliation with Spark Biomedical's clinical research, the company remains optimistic about the potential for a non-invasive, non-pharmacological treatment option.
Spark Biomedical, a leader in wearable neurostimulation solutions and the parent company of Five Liters, launched a collaboration with The Feinstein Institutes for Medical Research at Northwell Health to commercialize a wearable neurostimulation solution focused on reducing excessive blood loss in June of 2022. The collaboration leveraged the Feinstein Institutes’ years of research and patented solution concept in VNS for blood loss reduction and Spark Biomedical’s Food and Drug Administration (FDA)-approved tAN therapy device underpinnings. Thanks to this partnership and the Nature article, Five Liters is thrilled to move forward with its mission.
Five Liters' commitment to advancing medical innovation and improving patient outcomes drives their pursuit of groundbreaking solutions. By harnessing the power of wearable neuromodulation, they aim to revolutionize the management of blood loss and provide hope for individuals affected by VWD and other related conditions.
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About Five Liters
Five Liters, a subsidiary of Spark Biomedical, is a U.S.-based wearable neurostimulation solution developer leading the way in exploring and providing novel, non-invasive, non-pharmacological treatment options for those suffering from excessive blood loss. For more information, visit FiveLiters.com or follow us @FiveLiters on LinkedIn and Facebook.
About Spark Biomedical
Spark Biomedical, Inc. is a leading U.S.-based wearable neurostimulation solutions developer devoted to the life-saving work of helping 36.3 million people worldwide overcome withdrawal, heal from addiction, and achieve the better quality of life they deserve. With opioid-related misuse and overdose deaths on the rise, the company’s mission is to eliminate opioid addiction by working to address the full opioid addiction lifecycle, including withdrawal management, opioid-sparing, relapse prevention, and PTSD/trauma abatement.
Spark Biomedical is helping patients take the first step of overcoming acute opioid withdrawal with its FDA-cleared wearable technology, the Sparrow Ascent Therapy System — Transcutaneous Auricular Neurostimulation (tAN®) for Opioid Withdrawal Relief. Sparrow® Ascent Therapy provides an easy, safe, and effective drug-free treatment option supported by clinical evidence. Next steps are underway with the launch of two NIDA-funded clinical trials to improve adult relapse rates and help infants suffering from Neonatal Opioid Withdrawal Syndrome (NOWS).
Learn more at sparkbiomedical.com or on LinkedIn, Twitter, Instagram and Facebook.
About the Feinstein Institutes
The 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 five institutes of behavioral science, bioelectronic medicine, cancer, health system science, and molecular medicine. We make breakthroughs in genetics, oncology, brain research, mental health, autoimmunity and are the global scientific leader in bioelectronic medicine – a new field of science that has the potential to revolutionize medicine. For more information about how we produce knowledge to cure disease, visit http://feinstein.northwell.edu and follow us on LinkedIn.
About Northwell Health
Northwell Health is New York State’s largest health care provider and private employer, with 21 hospitals, 850 outpatient facilities and more than 12,000 affiliated physicians. We care for over two million people annually in the New York metro area and beyond, thanks to philanthropic support from our communities. Our 79,000 employees – 18,900 nurses and 4,900 employed doctors, including members of Northwell Health Physician Partners – are working to change health care for the better. We’re making breakthroughs in medicine at the Feinstein Institutes for Medical Research. We’re training the next generation of medical professionals at the visionary Donald and Barbara Zucker School of Medicine at Hofstra/Northwell and the Hofstra Northwell School of Nursing and Physician Assistant Studies. For information on our more than 100 medical specialties, visit Northwell.edu and follow us @NorthwellHealth on Facebook, Twitter, Instagram, and LinkedIn.
References
1 Du P, Bergamasco A, Moride Y, Truong Berthoz F, Özen G, Tzivelekis S. Von Willebrand Disease Epidemiology, Burden of Illness and Management: A Systematic Review. J Blood Med. 2023 Mar 2;14:189-208. doi: 10.2147/JBM.S389241. PMID: 36891166; PMCID: PMC9987238.
CONTACT: Candace Rempe
Spark Biomedical, Inc.
214.404.4162
candace.rempe@sparkbiomedical.com