Spark Biomedical, the parent company of OhmBody, a women’s wellness division focused on wearable neurostimulation technology, has been selected as one of 13 organizations worldwide to receive funding from Wellcome Leap’s women’s health initiative, The Missed Vital Sign. This recognition highlights Spark Biomedical’s innovative approach and continued scientific pursuit to advancing women’s healthcare.
This award supports Spark Biomedical’s work in heavy menstrual bleeding (HMB), particularly its cutting-edge transcutaneous auricular neurostimulation (tAN) platform. tAN therapy represents a non invasive, non-pharmaceutical approach that engages the nervous system to enhance platelet function and improve hemostasis (i.e. reduced bleeding), addressing a critical unmet need during menstruation.
The funding will enable Spark Biomedical to launch a decentralized nationwide pivotal clinical trial assessing the safety & efficacy of tAN for treating HMB; including women with von Willebrand Disease (VWD).
The upcoming trial will enroll adult women with co-occurring HMB & VWD and adolescents with HMB of unknown cause, aiming to generate robust clinical data to support regulatory approval by the U.S. Food and Drug Administration (FDA). Early feasibility studies have demonstrated promising results, with users experiencing over 50% reductions in blood loss and 20% shorter menstrual periods following daily tAN therapy.
“We’re truly honored to be selected by Wellcome Leap’s The Missed Vital Sign program,” said Daniel Powell, President & CEO at Spark Biomedical. “Being the sole company within a prestigious group of academic institutions this highlights the promise of our innovative technology and our commitment to advancing women’s health.”
“Women’s health has long been understudied, and there is a large unmet need for new treatment options. This funding enables us to move forward with a pivotal clinical trial of our neurostimulation device,” said Dr. Navid Khodaparast, PhD, Co-founder & Chief Science Officer at Spark Biomedical. “It offers a novel, non-invasive treatment for heavy menstrual bleeding and paves the way for FDA approval.”
Spark Biomedical is proud to partner with Wellcome Leap to accelerate advancements in menstrual health and improve quality of life for patients affected by HMB worldwide.
Spark Biomedical, Inc. is a leading U.S.-based medical device developer, committed to unlocking the potential of bioelectronic medicine and bringing to market novel wearable neurostimulation treatment options in neurological health, women’s health, and hemostasis. Spark leverages its neuroscience and engineering expertise to empower healthcare providers and researchers with innovative, evidence based tools designed to address complex care situations which exceed the capabilities of existing treatment options. Spark has received funding from federal institutions, such as the NIH and DoD, and continues to partner with private and academic institutions. Spark Biomedical is empowering a better way forward for the future of patient care and medical technology. For more information, visit www.sparkbiomedical.com.
About OhmBody
At OhmBody, we believe women’s wellness deserves more—more innovation, more understanding, and more solutions designed specifically for the unique needs of the female body. As the women’s wellness division of Spark Biomedical, a leader in wearable neurostimulation, OhmBody is pioneering a new approach to menstrual health, using advanced wearable neurostimulation to support the body’s natural rhythms. Our team understands the challenges women face—because the majority of us have lived them. With a team of women driving exploration and change in clinical research, design, and innovation, we bring both personal insight and deep scientific expertise to our work. The full OhmBody team of experts are dedicated to creating solutions that work with women’s bodies, not against them. For more information, visit www.ohmbody.com.
About Wellcome Leap
Wellcome Leap builds and executes bold, unconventional programs, funded at scale. Programs that aim to deliver breakthroughs in human health over 5 – 10 years. Founded by the Wellcome Trust in 2020 as a US nonprofit, Leap programs target complex human health challenges with the goal of achieving breakthrough scientific and technological solutions. Operating at the intersection of life sciences and engineering, Leap programs require best-in-class, multi-disciplinary, global teams assembled from universities, companies, and nonprofits working together to solve problems that they cannot solve alone. For more information on Wellcome Leap, please visit www.wellcomeleap.org.
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