Innovative Wearable Device Aims to Detect Postpartum Hemorrhage Early

Armor Medical, a startup co-founded by Kelsey Mayo, Christine O'Brien, and Leo Shmuylovich, is developing a wearable device that could revolutionize the detection of postpartum hemorrhage, the leading cause of maternal death globally. The company recently won MedTech Innovator's Early Stage pitch competition at AdvaMed's The MedTech Conference, securing a $350,000 cash prize to further their groundbreaking technology.

A Personal Mission Driven by Experience

Kelsey Mayo's near-death experience with hemorrhage in 2019 became the catalyst for Armor Medical's mission. After a ruptured ovarian cyst led to internal bleeding, Mayo's symptoms were initially dismissed in the emergency room. This harrowing incident, combined with a prior conversation about postpartum hemorrhage during her Ph.D. studies, inspired Mayo to tackle this critical healthcare challenge.

"That lived experience really is what gives me the fire in my belly, together with all the stories from folks I've talked to who have survived hemorrhage," Mayo said.

Innovative Technology for Early Detection

Armor Medical's wrist-based device utilizes a laser and camera to quantify flowing red blood cells, potentially detecting signs of hemorrhage much earlier than current methods. The technology aims to address a significant gap in maternal care, as early blood loss is often silent and difficult to detect with traditional monitoring techniques.

Mayo explained, "When the body recognizes it's losing blood, it will clamp down on blood vessels in the periphery, such as the hands and feet, to push extra blood supply back to the vital organs. Armor Medical's device keys into these early changes."

Early feasibility studies have shown promising results, with the device reportedly able to detect concerning blood loss five times earlier than the current standard of care. Importantly, the technology has demonstrated accuracy across different skin pigmentations, addressing a crucial aspect of equitable healthcare delivery.

Clinical Trials and Regulatory Pathway

Armor Medical plans to use part of their recent prize money to fund a clinical trial next year. The company is also working on a 510(k) submission for the Food and Drug Administration, aiming to bring the device to market in early 2028.

"You have to be balanced between being a risk taker and being smart with your money, because in today's environment, money is hard to come by," Mayo said, acknowledging the challenges of the current funding landscape.

To support their clinical work and development efforts, Armor Medical is currently raising a $5 million funding round. The company's strategy involves selling the device to hospital systems, including regional perinatal care centers and hospitals serving high-risk patients in both rural and urban settings.

As the medtech startup continues to refine its technology and navigate the regulatory landscape, it remains focused on its core mission: improving maternal health outcomes by providing healthcare providers with crucial, timely information about potential hemorrhage risks. With its innovative approach and recent funding success, Armor Medical is poised to make a significant impact in the field of maternal healthcare.