Spark Biomedical Launches Phase II LUNA Trial Testing Wearable Neurostimulation for Heavy Menstrual Bleeding
核心洞察
Spark Biomedical (搜索) has initiated the pivotal Phase II LUNA Trial, a randomized, double-blind, sham-controlled study evaluating transcutaneous auricular neurostimulation (搜索) for reducing heavy menstrual bleeding (搜索) in 80 participants aged 14-45.
The trial will test whether daily 2-hour sessions of wearable neurostimulation during menstruation can achieve clinically meaningful reductions in menstrual blood loss compared to sham treatment over three treatment cycles.
Heavy menstrual bleeding (搜索) is one of the most common reasons for gynecologic consultation and a major contributor to iron-deficiency anemia (搜索) globally, with current treatment options remaining limited for many women.
Spark Biomedical (搜索) has launched the pivotal Phase II LUNA Trial, a prospective, randomized, double-blind, sham-controlled, decentralized clinical trial evaluating transcutaneous auricular neurostimulation (搜索) (tAN) for the reduction of heavy menstrual bleeding (搜索) (HMB). The Dallas-based medical device company announced the trial initiation on March 10, 2026, marking a significant milestone in bioelectronic medicine for women's health.
Trial Design and Participants
The LUNA Trial will enroll 80 participants across the United States, including adolescents aged 14-21 and adults aged 22-45 with a history of heavy menstrual bleeding (搜索) of no known structural cause. Participants will be recruited from hospitals affiliated with Oregon Health & Science University (OHSU), the University of Michigan, and Yale University (搜索), among other institutions.
The trial follows a comprehensive design spanning approximately five months. Participants will undergo two baseline menstrual cycles with no neurostimulation treatment, followed by three consecutive treatment cycles. During the treatment phase, participants will self-administer one 2-hour session of either active or sham stimulation daily during menstruation.
Primary and Secondary Endpoints
The primary efficacy endpoint focuses on achieving a significantly greater proportion of participants with clinically meaningful reduction in menstrual blood loss from baseline in the active stimulation group compared to the sham group. Secondary assessments will evaluate changes in menstrual cramp pain, overall symptom burden, and quality of life.
"The launch of the LUNA Trial marks an important milestone in advancing women's health and the field of bioelectronic medicine," said Navid Khodaparast, PhD, Co-founder and Chief Science Officer at Spark Biomedical (搜索) and Principal Investigator of the LUNA Trial. "Heavy menstrual bleeding (搜索) is not only one of the most common reasons women seek gynecologic care, but it is also a major contributor to iron-deficiency anemia (搜索) globally."
Clinical Significance and Unmet Need
Heavy menstrual bleeding (搜索) remains one of the most common reasons for gynecologic consultation and is frequently normalized despite its significant impact on daily functioning, school attendance, work productivity, and overall quality of life. The condition represents a substantial unmet medical need, with many women having limited treatment options available.
"Through this pivotal trial, we aim to generate the clinical evidence needed to support regulatory pathways and ultimately make this non-pharmaceutical, wearable therapy accessible to more women who currently have limited treatment options," Khodaparast explained.
Investigator Perspectives
Maureen Katherine Baldwin, M.D., M.P.H., Associate Professor of Obstetrics and Gynecology at the School of Medicine at OHSU, expressed enthusiasm for the trial's inclusive approach. "I am excited to launch the LUNA Trial at OHSU, which will help determine whether a wearable neurostimulation device can help with heavy periods," Baldwin said. "I'm particularly excited that we are going to be including a wide range of ages, including teens as young as 14 years old, and that participants can stay on their current therapies during the trial."
Funding and Strategic Goals
The study receives funding from Wellcome Leap (搜索) through its program "The Missed Vital Sign," which aims to reduce the time it takes for women to receive effective treatment for heavy menstrual bleeding (搜索) from five years to five months. This funding aligns with the trial's objective to accelerate access to innovative treatment options for women's health conditions.
Company Background
Spark Biomedical (搜索) positions itself as a leading U.S.-based medical device developer committed to unlocking the potential of bioelectronic medicine. The company focuses on bringing novel wearable neurostimulation treatment options to market across multiple therapeutic areas, including behavioral health, women's health, hemostasis, pediatrics, and chronic pain. The company has received funding from federal institutions such as the NIH and DoD, and continues to partner with private and academic institutions.