Bloomer Augmented Garment Platform-Barrier Removal for women in cArdiac rehab (BRA)

PROJECT SUMMARY Bloomer Tech is advancing development of the Bloomer Augmented Garment Platform, a wearable bra with embedded sensors to address cardiovascular healthcare disparities in women. Cardiovascular disease is the leading cause of death in women, resulting in nearly 315,000 deaths in the U.S. in 2020, where women generally experience worse outcomes than men including increased disability, hospitalization, and earlier mortality. Cardiac rehabilitation (CR) is strongly recommended by the American Heart Association and the American College of Cardiology for a variety of indications based on evidence for reduced mortality and morbidity and increased quality of life. Unfortunately, only ~15% to 20% of eligible women participate in this life saving program, compared to 22% to 30% of men. Critically, barriers to participation may differ between women and men and different interventions may therefore be required to increase adherence. Research suggests that supporting women through expanded access to safe, remote access of CR-related exercise routines holds significant potential to improve adherence and broadly improve cardiovascular outcomes in women. Specifically for women, there is an opportunity to increase adherence by catalyzing their motivation and increasing frequency of reinforcing conditions that provide reassurance, supervision, and validation to her achievements in the program and support her adherence within the care continuum. A continuous remote sensing platform that women felt safe and comfortable in holds significant potential to promote adoption and adherence to CR. To address this need, Bloomer Tech has developed the Bloomer Augmented Garment Platform, a female bra with embedded textile sensors that are washable and designed specifically for collecting cardiac biomarker information from women. Bloomer Tech has demonstrated Phase I equivalent proof-of-concept by creating an MVP software platform, establishing device manufacturing best practices, and demonstrating reproducible sensor signal quality in a variety of different bra sizes necessary for continuous monitoring. The goal of this project will be to demonstrate that the Bloomer Tech Platform increases adherence to CR compared to the current standard of care through a robust randomized clinical trial in women prescribed CR at the University of Florida Medical Center and Lakeland Regional Health in Florida. Furthermore, the trial will assess overall participant perception of safety and comfort using the Bloomer Tech bra. Success with these goals will support commercial adoption by both clinicians and patients by demonstrating that patients can safely and comfortably participate in CR both in the clinic and during at-home exercises that are not directly supervised by a clinician.