#United States #Dallas #Neurostimulation #Biomedical #tAN Technology

Spark Biomedical and Feinstein Institutes Break New Ground in Medical Research

In an exciting advancement for the field of medical technology, Spark Biomedical has recently published the results of a pioneering study that showcases the efficacy of their non-invasive transcutaneous auricular neurostimulation (tAN®) technology in enhancing platelet function. Conducted in collaboration with Northwell Health's Feinstein Institutes for Medical Research, this first-in-human study has the potential to change how severe bleeding conditions are treated, marking a significant milestone in bioelectronic medicine.

The Study and Its Findings

The findings, published in the journal Bioelectronic Medicine, demonstrate that Spark's tAN® platform can safely and effectively stimulate neural pathways that contribute to clot formation. For the first time, clinical evidence indicates that non-invasive electrical nerve stimulation, particularly at the ear, can enhance the body's natural clotting response. This research supports Spark's goal of developing innovative treatments within their Neural Tourniquet™ program—a groundbreaking initiative aimed at creating new, non-pharmacologic solutions for critical bleeding scenarios.

Dr. Navid Khodaparast, Spark Biomedical's Chief Science Officer and co-founder, stated, "This study is a groundbreaking achievement in bioelectronic medicine, demonstrating that our core tAN® technology can modulate neural circuits to enhance platelet readiness. It lays the groundwork for a new class of therapies aimed at controlling bleeding in trauma situations, surgical settings, and for those suffering from bleeding disorders."

Methodology of the Research

To conduct the study, the tAN® platform was tested on healthy human subjects. The technology stimulates both the vagus and trigeminal nerves through the ear, showcasing a dual effect. Notably, both tAN® and a related technique called transcutaneous auricular vagus nerve stimulation (taVNS) resulted in increased platelet function without triggering systemic effects or hypercoagulability. Importantly, no adverse events were reported during the study, indicating a strong safety profile for this non-invasive intervention.

Dr. Jared M. Huston, a professor at the Feinstein Institutes and lead investigator of the study, emphasized the project’s importance. "Spark's wearable tAN® platform presents a portable and non-invasive approach that could optimize patient management in trauma situations, operating rooms, and provide assistance for individuals with bleeding disorders. Our research reinforces the scientific foundation for harnessing targeted neurostimulation methods to aid the body in managing hemorrhage effectively."

The Implications of Enhanced Platelet Function

Severe bleeding continues to be a leading cause of preventable mortality in various scenarios, including trauma, surgical procedures, and postpartum complications. Traditional treatment methods have largely relied on physical interventions or pharmaceuticals. In stark contrast, Spark Biomedical's tAN® technology offers a revolutionary approach that leverages the body's neural pathways to enhance clotting on demand. This shift holds the promise of facilitating quicker responses in critical situations, potentially saving lives that would have otherwise been lost due to excessive blood loss.

The excitement surrounding these findings is palpable, with Anja Krammer, Chief Executive Officer of Spark Biomedical, noting the broad therapeutic horizons now opening up. "This publication underscores the vast potential of our tAN® platform, not only for hemostatic treatment but also for exploring new molecular mechanisms by activating or inhibiting neural targets through neuromodulation devices within the nervous and immune systems."

The Full Study

The comprehensive research titled "Effects of transcutaneous auricular vagus nerve stimulation or combined vagal and trigeminal nerve stimulation on platelet function and laboratory hemostasis parameters in healthy human subjects" is readily available for review in Bioelectronic Medicine. The implications of this research stretch far beyond immediate medical applications, seeding the beginnings of a new era in medical technology that intertwines bioelectronic strategies with physiological response mechanisms.

About Spark Biomedical
Spark Biomedical is a pioneering commercial-stage medical device company that is revolutionizing the field of wearable bioelectronic therapies, focusing on three main pillars: Neurohealth, Hemostasis, and Autoimmune Inflammation. The company is headquartered in Dallas, Texas, with a clear vision of advancing innovative solutions to improve health outcomes.

About the Feinstein Institutes
The Feinstein Institutes for Medical Research serve as Northwell Health's research arm, recognized as New York's largest health care provider. With over 50 research labs and approximately 5,000 researchers across six institutes, the Feinstein Institutes are at the forefront of advancements in bioelectronic medicine on a global scale.