I met Jaeson Bang — founder and CEO of Future Cardia (formerly Oracle Health), a heart monitor implant startup — for the first time in 2020. I was facilitating the admissions process of StartX, Standford’s startup accelerator, when Jae was applying. I worked at StartX through four admissions processes until 2021, and I saw Jae go through the same dance every time. He would pass every single interview round, but at the end, judges would have doubts. I would organize an additional interview for them to get one last chance to decide whether to accept Jae, but he was never admitted. I didn’t know much about medtech then, but I could see Jae’s determination and positive attitude every time he applied. He was a passionate and committed founder.
After I joined KingsCrowd, I was pleasantly surprised to run across Future Cardia’s StartEngine raise in 2022. By that time, Future Cardia had earned a recommendation from First Stage Investor and a Deal to Watch rating on KingsCrowd. When I spoke with Jae last year for a Founder Profile, he told me $3.4 million that Future Cardia raised in 2021 convinced StartX judges to accept him into their founder community by the end of that year.
After that update, I personally invested in Future Cardia. When I invest in companies, I look for a great founder with the passion and commitment that will help them handle the ups and downs of leading a startup. This is what I saw in Jae, so I took the opportunity to participate in Future Cardia’s last round on StartEngine.
Many others did the same. And it makes sense. Future Cardia created a precise heart monitor in a space with few competitors, and Jae managed to gather a team of very smart professionals to grow the company.
Now Future Cardia is raising again on StartEngine. So I checked in with Jae to get an update on the company.
How to Make It in Medtech
Let’s cover a bit of background to understand what investors should expect from Future Cardia.
Bringing a new medical device to market in the U.S. requires a lot of capital — $54 million on average — and takes an average of three to seven years.
Any entity creating a medical device must go through the following steps in the FDA’s Device Development Process:
- Device discovery and concept
- Preclinical research and prototype (laboratory and animal testing)
- Pathway to approval (human testing)
- FDA review
- FDA post-market safety monitoring.
Most medical device startups fail to complete this process. Some run out of cash or fail the first tests, and most of the few that are successful get acquired after Step 3.
Future Cardia has passed Step 2 and is currently finalizing its manufacturing setup to ensure high-quality and sterile production of its devices. And it’s about to start Step 3. The company received clearance in Europe to start its human trials on 20 to 50 patients in Croatia around October or November 2023. The funds Future Cardia raises on StartEngine will be applied to completing the trial.
Supply Chain Obstacles
While I’m excited that Future Cardia has reached the trials part of the process, I know that investors aren’t out of the woods yet.
Future Cardia didn’t move as fast as Jae told me it would last year. He wanted to implant in patients in 2022 and receive FDA clearance by mid-2023. Future Cardia did implant in four patients at top universities, including Duke, but won’t start its human trial until the tail end of 2023, which will make it impossible to receive FDA clearance within the next 12 months.
Jae explained that supply chain issues made progress slower. But Future Cardia is still in a good position as it has at least a year of runway in the bank.
The company is working on improving its product. On top of an electrocardiogram and heart sound monitor, it will include an oxygen sensor to measure patients’ blood pressure. To do so, it will integrate a new battery that is 50% smaller than its current one, which will give it extra space on the monitor to include its oxygen sensor.
After its Croatian trial, Future Cardia should launch a larger 300-unit trial in a country that has cheap costs and U.S.-trained doctors, possibly in Europe or Latin America.
An Inflection Point for Investors
Future Cardia’s valuation doubled between its two last rounds. The valuation increase is justified by the company’s progress and development stage. It is now entering Step 3 of the device development process and could be close to proving that its product works.
As with every medical device startup, the risks are high. The device could not work as planned, there could be manufacturing issues, the startup could run out of cash, or it could have difficulty receiving FDA clearance.
But as a previous investor, I still see the same determination and passion that Jae has for the startup he is building, and I’m satisfied with the company’s current progress. Now it just needs a successful human trial.
