Five Liters Studying Wearable Neurostimulation Tech to Reduce Blood loss

Wearable neuromodulation firm Five Liters is embarking on a series of first-in-human studies to demonstrate the effectiveness of non-invasive, wearable neurostimulation in reducing blood loss.

This 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, and 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 one 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. 
 
“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,” Spark Biomedical/Five Liters Chief Science Officer Dr. Navid Khodaparast said. “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, an article published Nature Communications, 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 developer of wearable neurostimulation solutions and the parent company of Five Liters, launched a collaboration with The Feinstein Institutes for Medical Research at Northwell Health in June 2022 to commercialize a wearable neurostimulation solution focused on reducing excessive blood loss. The collaboration leveraged the Feinstein Institutes’ years of research and patented solution concept in VNS for blood loss reduction and Spark Biomedical’s U.S. Food and Drug Administration (FDA)-approved tAN therapy device underpinnings. 
 
Five Liters, a subsidiary of Spark Biomedical, is a U.S.-based wearable neurostimulation solution developer exploring and providing novel, non-invasive, non-pharmacological treatment options for those suffering from excessive blood loss. 
 
Spark Biomedical Inc. is a U.S.-based wearable neurostimulation solutions developer devoted 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).
 
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 has five institutes of behavioral science, bioelectronic medicine, cancer, health system science, and molecular medicine. The Institutes work to 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. 
 
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. 

Reference
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.