Setting a New Bar for the Clinical Validity of Digital Therapeutics

When I was a kid, I spent most of my free time running out in the potato fields behind our house, collecting flowers and insects. I used to bring home jars of my “findings” back into my room (which drove my parents crazy). To get a closer look at these things, I asked for a microscope for my 6th birthday. But there was more behind this request: I knew at a very young age that when I “grew up,” I wanted to be a scientist.  

Well, here we are in 2021, and while I may not be researching insects in a lab, my passion for knowledge and discovery remains as strong as ever, and has taken me in a profound direction: I am part of an amazing team that is developing technology to help save lives.  

And today, more than 30 years after getting that coveted microscope, I am proud and excited to announce that a study evaluating our company’s clinical achievements has been published in JAMA Network Open—one of the most prestigious clinical magazines in the world.

About the Study

The study followed 28,189 participants with elevated blood pressure (BP) over a three year period. This is the largest and longest-running study ever on the impact of digital therapeutics on hypertension.

The results of the study revealed incredibly positive clinical outcomes, which were sustained over time. 84% of participants with a baseline BP over 140/90 who used Hello Heart’s solution reduced their BP, sustained up to three years. The average reduction in systolic BP was 21 points over three years. In addition, 13% of participants discovered that they had extremely high BP and were able to catch risk on time. Hypertension is a major risk factor for heart disease and stroke, which are leading causes of death in the United States. Many people with this condition are unaware of it until a catastrophe strikes, which is why it is dubbed “the silent killer.” By identifying extreme high blood pressure issues early, we help save lives.

Courage to be Under a Microscope

Publishing data in a peer-reviewed study is something not many companies in the digital therapeutics space feel comfortable or confident undertaking. And I get it—it's scary. Allowing clinicians and statisticians to dig through your dataset and challenge your methodology, while knowing the results may be published regardless of the findings, takes an incredibly high level of courage and confidence in your outcomes.

We were not just willing to take this chance, but were enthusiastic—our goal is to save lives, which means constantly striving to set a new bar for the clinical validity of digital therapeutics. We reached out to the most experienced and reputable independent cardiologist in the digital heart space—Dr. Alexis L. Beatty, MD, MAS, a professor in UCSF’s Department of Epidemiology & Biostatistics and Division of Cardiology—and shipped off three years of data analysis for external review.

Helping Employees While Reducing Cardiac Claims Costs  

Employers know that hypertension is widely spread across their workforce, affecting about 42% of their employees. Yet the vast majority of people with hypertension don’t manage it, and those with extreme blood pressure readings often find themselves in the hospital undergoing unnecessary and invasive surgeries. In fact, new studies estimate that 20% of bypass and stent surgeries are completely unnecessary. So not only do employees go through painful invasive procedures, but their employers are faced with massive claims costs. This lose-lose scenario can be prevented.

Cardiac digital therapeutics are an easy way for employees to manage uncontrolled blood pressure levels, which reduces the risk of cardiac events. At the same time, lowering blood pressure translates to fewer surgeries and other potentially avoidable costs resulting from risky and invasive procedures, emergency room visits, and unnecessary expensive diagnostic imaging, which are the highest cost drivers of cardiovascular spend.  

In recent years, benefits leaders have done a respectable job reducing medical waste in the healthcare system for diabetes management, musculoskeletal management, and cancer treatments. Now, they can do something about reducing unnecessary cardiac spend, knowing the solution they put in place will have large-scale, sustained clinical and cost benefits—and most importantly, help save lives.

And to my mom and dad: all of the jars full of bugs you let me keep in my room to allow me to develop my scientific thinking really paid off!