) High blood pressure, or hypertension, is an important public health challenge because of its high prevalence and its role in increasing risk for a variety of other diseases. According to the American Heart Association, approximately 1 out of every 3 adults in the United States has hypertension, and the situation is projected to worsen with the percentage rising to approximately 40% of the adult population in the next 15 years. Due to the difficulty of effectively managing hypertension, experts in cardiovascular disease have identified an unmet need to record blood pressures over the long term as a basis for cardiovascular health assessment. There is also a need to determine the effects of external influences such as alcohol, smoking, drugs, exercise, and eating on blood pressure. This contextualized information will ultimately provide insights into how behaviors, medicines, and other drugs impact blood pressure. Unfortunately, there isn?t yet a solution that can provide continuous blood pressure measurements during everyday use. Today, some people persevere with infrequent data points collected using blood pressure monitors at home. Others go through the pain of wearing an ambulatory blood pressure monitor with a cuff that inflates and deflates throughout the day and night. Blumio is developing a revolutionary radar-based blood pressure sensor for anytime, anywhere monitoring. If we succeed, we will be the first to achieve non-contact continuous blood pressure monitoring and address a critical need for personalized medicine for hypertension. The Blumio sensor can be worn next to the body, with no need to form a tight contact, or on top of clothing, which allows for seamless blood pressure measurement without disturbing the user. The goal of this SBIR Phase 1 application is to demonstrate that Blumio?s sensor can satisfy the validation criteria of the ANSI/AAMI/ISO 81060-2:2013 standard of a mean difference of no more than +/- 5 mmHg and a standard deviation of no more than 8 mmHg when compared against a reference device, and therefore be recommended for measurements in the clinical set-up and for research purposes.
Specific Aim 1 will validate Blumio against a clinical grade automated blood pressure monitor for one-time measurement of blood pressure.
Specific Aim 2 will validate Blumio against a clinical grade noninvasive continuous blood pressure monitor. Successful completion of these aims will lay the foundation for a follow-on large, randomized controlled trial that will be performed in Phase 2 of this project.
The aims of Phase 2 will be focused on establishing the Blumio device as a superior technology over existing blood pressure monitors for hypertension management. The Phase 2 study will measure the impact of Blumio?s device on hypertension management with the intent of demonstrating superior effectiveness when compared to cuff-based blood pressure monitors. These studies will lay the groundwork for commercialization of our device, which addresses a significant unmet clinical need with a very large potential market.
PROJECT NARRATATIVE Approximately 30% of adults in the US have high blood pressure, and the situation is projected to worsen with the prevalence rising to 40% of adults in the next 15 years. Blumio is developing a revolutionary radar- based blood pressure sensor for anytime, anywhere monitoring. This device will allow for seamless blood pressure measurement without disturbing the user. Due to the comfort and ease-of-use of the Blumio, the data collected will yield unprecedented insight into short and long-term blood pressure rhythms and will open a brand new window into how we understand and manage cardiovascular health.
