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 renowned 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.