DALLAS, TX and MANHASSET, NY (June 2, 2022) — Spark Biomedical, a leader in wearable neurostimulation solutions, announced today a collaboration with The Feinstein Institutes for Medical Research at Northwell Health — New York’s largest health system — to commercialize a wearable neurostimulation solution focused on lessening excessive blood loss. The collaboration will leverage the Feinstein Institutes’ years of research and patented solution concept in vagus nerve stimulation (VNS) for blood loss reduction and Spark Biomedical’s Food and Drug Administration (FDA)-approved Transcutaneous auricular neurostimulation (tAN) therapy device underpinnings, as well as their experience in clinical trial management, FDA submission, market activation, and commercialization, to advance this patented concept to an on-market therapy.

The new, jointly developed product team will stand on the shoulders of Feinstein Institutes experts Kevin J. Tracey, MD, and Jared M. Huston, MD, and their 15 years of intellectual property development that was initially supported by the Defense Advanced Research Projects Agency (DARPA). Studies conducted by the Feinstein Institutes’ team over the past decade demonstrate that electrical activation of neural pathways to the spleen can prepare the body for clotting — hemostasis — in the event of a wound. A pre-clinical study demonstrated that VNS can effectively modulate coagulation, leading to a 50 percent reduction in bleeding time and volume.¹

Slowing blood loss through neuromodulation has anticipated clinical applications in a range of possible scenarios, including:

• Operating rooms: Surgical teams could apply the device to reduce blood loss and save precious time in the operating room during the more than 50 million planned surgeries in the United States each year.
• Trauma scenes: First responders could apply the device to trauma victims at accident scenes or in ambulances to slow blood loss prior to hospitalization.
• Military missions: Before missions where there is potential for physical trauma, soldiers could apply the device prophylactically to curb blood loss if they are wounded.

Spark Biomedical will manage the collaboration under a new subsidiary named Five Liters (5L) so as to not disrupt the company’s focus in the opioid addiction space.

“By leveraging Spark’s patented Transcutaneous Auricular Neurostimulation (tAN®) platform and our corporate infrastructure, Five Liters is perfectly positioned to begin human trials immediately and move this solution toward commercial application,” said Daniel Powell, Spark Biomedical CEO. “We look forward to working with all of the great scientists at the Feinstein Institutes to realize a life-saving vision set forth over a decade ago.”

“The basic science mechanisms of this strategy have been studied exhaustively, and this is a unique opportunity to translate the science into clinical trials for the treatment of life-threatening hemorrhage,” said Dr. Tracey, president, and CEO of the Feinstein Institutes. “If successful, these trials should represent an important milestone in the history of this long-unsolved clinical situation.”

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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 Therapy System — Transcutaneous Auricular Neurostimulation (tAN®) for Opioid Withdrawal Relief. Sparrow™ 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.

¹ Cite. Czura, C. J., Schultz, A., Kaipel, M., Khadem, A., Huston, J. M., Pavlov, V. A., ... & Tracey, K. J. (2010). Vagus nerve stimulation regulates hemostasis in swine. Shock (Augusta, Ga.), 33(6), 608.

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