HeartHero is on a mission to save millions of lives from sudden cardiac arrest (SCA), which claims over 350,000 lives annually in the U.S. alone (American Heart Association, 2017). We are revolutionizing the AED, the crucial lifesaving device for SCA, to make it more accessible to more people at their time of need. The use of an AED at the time of an SCA event significantly increases the chance of survival, but currently, AEDs are only used in a small fraction of cases of out-of-hospital SCAs. This gap exists because 70% of out-of-hospital SCA events occur at home, but AEDs are only currently readily available to businesses and institutions. The HeartHero team sees an incredible opportunity to bridge this gap and create a consumer-friendly solution to address these in-home SCA events. We are developing an ultra-portable, affordable, user-friendly AED to make this life-saving technology accessible and attractive to the consumer market, while simultaneously creating a better alternative for the existing institutional market. Over 86 million people in the U.S. have cardiac risk factors. Approximately 12 million of these people are at high risk for SCA. Annually, in this country, two million people are discharged from the hospital each year with high-risk cardiac conditions, leaving family helpless when SCA strikes.HeartHero’s AED is significantly smaller and lighter than any AED currently on the market. “half the weight and half the size”, it is portable and can be carried easily or stored at home by those at increased risk of SCA or their family members. HeartHero’s AED will be introduced at half the cost of currently available AEDs. This affordability makes our AED perfect for home use by a large segment of the population. Unlike conventional AEDs, which use costly, device-specific batteries, our AED uses a standard store-bought battery.
HeartHero is passionate about changing the dismal outcome of Sudden Cardiac Arrest. With a national average of less than 10% survivability, we can do better. HeartHero is on a mission to change that number. What if we empowered everyday families? What if they had an Automated External Defibrillator (AED) at the time of the incident? In a recent BMJ article, the use of an on-site AED increased neurologically intact survivability to 93%. 70% of Sudden Cardiac Arrest happen in the home. HeartHero’s home AED will allow anybody anywhere at any time to improve these dismal outcomes. That’s why HeartHero is developing an ultra-portable, affordable, user-friendly AED that will make this lifesaving technology accessible and attractive to the consumer market, while simultaneously creating a better alternative for the existing business and institutional markets. Our goal is to save more lives from sudden cardiac arrest than all other AEDs combined. To date, HeartHero has completed four working prototypes, demonstrated 20 consecutive shocks from a 9-volt battery, established a relationship with Duracell (through their “powered by” Duracell program), and completed a formative user study to develop our form factor for pre-market approval (PMA) submission. Our team is comprised of Class III medical device regulatory, product development and electrical engineering experts that understand the existing predicate devices and FDA demands for our product. This team, along with our leadership, is rapidly executing a product and quality system for verification and validation in Q4 of 2019 and PMA submission in 2020. Our milestones are measured in months, not years, HeartHero has had multiple interactions with the FDA and have a supported and clear path for approval in 2020.