PA-22-176, SBIR, Development of a wearable light-based remote monitoring system for early detection of postpartum hemorrhage

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PROJECT SUMMARY There is an urgent need to develop technologies which address preventable causes of maternal deaths and improve maternal health outcomes. In the United States (US) there exist deeply concerning racial and ethnic disparities in maternal health outcomes (with black mothers experiencing a >3x higher mortality rate than non- black mothers). Furthermore, the US has the highest maternal mortality of any high-income country and is one of only two countries in the world where maternal mortality is rising. This SBIR project is focused on addressing postpartum hemorrhage (PPH), defined as severe bleeding after delivery, because it is a leading cause of maternal morbidity and mortality, and >90% of deaths from PPH are considered preventable with early detection and early treatment. The product of this SBIR project, Maternal aRMOR (remote monitoring optical reader), will be a wrist-worn sensor and integrated mobile app that obstetric providers use to detect early blood loss (when inexpensive and accessible treatments like pharmacologic agents and balloon tamponade are most effective). Maternal aRMOR uses laser speckle imaging to quantify peripheral blood flow. Maternal aRMOR works by sensing and alerting providers to the changes in blood flow that occur in early hemorrhage when the body shunts blood to its core to protect vital organs. Unlike visual estimation of blood loss, Maternal aRMOR provides clinicians with real-time, quantitative information about a patient’s hemodynamic state. Aim 1 of this Phase I SBIR will evaluate the potential confounding effects of skin pigmentation and motion on aRMOR signal, to ensure robust and equitable device performance. Aim 2 will establish a subject-specific perfusion range to improve personalized hemorrhage risk assessment. Aim 3 will demonstrate development of a mobile app that interfaces between the wearable Maternal aRMOR device and healthcare providers to provide continuous monitoring for PPH. Phase II of this SBIR project will focus on development of a commercial-grade device and clinical studies to demonstrate the impact of Maternal aRMOR for improving health and decreasing healthcare cost associated with PPH. Initial target customers include the >3,200 US-based obstetric hospitals who serve ~6M patients annually. Ultimately, Maternal aRMOR will set a new clinical standard for early PPH diagnosis enabling rapid treatments to prevent the devastating complications of delayed hemorrhage diagnosis, including transfusion, surgery, and death, that currently impact millions of mothers each year.