As the world continues to change at lightning speed, and the future becomes more unknowable daily, there are some who try to do something that might have both immediate and long-term benefits—while accounting for the changes and the uncertainty. Nicholas Conn, Ph.D., is one such person.
Conn, who earned his Ph.D. at Rochester Institute of Technology (RIT), officially founded Heart Health Intelligence in July 2018. He is now the CEO.
This month, the company announced that it closed its $2.2 million seed round to support attaining FDA approval to commercialize Conn's invention, The Heart Seat™. The device is a cloud-connected toilet seat–based platform that captures clinical-grade and relevant cardiac data from a cardiovascular disease patient’s home, without any change in the user’s habits. Its applications are myriad and far-reaching, as the world scrambles to deal with the COVID-19 pandemic as well as finds ways to reduce the burden on health care systems globally.
Heart Seat’s ability to monitor cardiovascular health in the home could be a step in that direction, says Conn. Especially knowing that, according to the American Heart Association, more than 80% of Americans over the age of 65 will have some form of cardiovascular disease (CVD) by 2035. Elderly people with chronic conditions like coronary heart disease or hypertension are more likely to be infected by coronavirus, according to the AHA.
Conn always knew his path would include both scientific and entrepreneurial elements. He developed the technology and the product while conducting research at RIT, and says that the Heart Seat journey has been a “wild ride” so far.
“I am a programmer, and engineer…and an entrepreneur,” says Conn. “I wanted to build medical devices and develop tech to commercialize, and the Heart Seat seemed like a great device to do that with. In pretty quick succession, I finished the research, came up with a business plan, pitched it, raised capital, formed an advisory group, and made progress with pulling together the business.”
The seed fund round was led by Bemis Manufacturing Company, the largest toilet seat manufacturer in the United States and an innovative company that has significant experience with FDA regulated devices. Additional investors include LaunchNY, RIT Venture Fund, Tech Coast Angels, and Excell Partners.
In Conn’s speedy journey from inception to securing a major investor who will almost surely become a manufacturing partner, he has laid the groundwork for his (much greater) vision.
“As an entrepreneur, I had the confidence that [my product and technology] was going to work,” he says. “I knew it would take time, and hard work, and that there would be challenges with finding the right investor.”
“Entrepreneurs should expect a lot of people to say ‘no,’” Conn advises. “That’s your opportunity to refine your strategy, and keep looking and pitching. When Bemis came to Rochester, it was a dream come true. And it got a lot easier to get more investors after we had our first one.”
The seed money will be used to update the product from a fully functional prototype to meet FDA standards and regulations, and be replicable on a larger scale.
The FDA process can be a lengthy one, says Conn, and his advice to entrepreneurs who may know that they plan to seek FDA approval is to start earlier than they think they need to, while taking advantage of the resources available.
“If you start too late, it’s challenging to go back to meet compliances,” he notes. “The FDA allows you to accelerate the process before you submit your filing, by sending your questions in advance. And you can do it multiple times; it’s called ‘pre-sub,’ or pre-submission, and they will respond with commentary. It helps you reduce your risk and learn if you are doing things correctly.”
Conn brought on Ken Rosenfeld early as an adviser; the experienced executive and entrepreneur is now HHI president and COO. One thing that convinced Rosenfeld was Conn’s approach. “Entrepreneurs tend to be overly optimistic with timeframes, but I saw that Nick had realistic expectations about the entire process,” says Rosenfeld.
In addition to the challenges for any startup around raising capital, Conn says that the solo effort can be daunting. “Doing it ‘by yourself’ is part of what makes being an entrepreneur exciting, but it’s also incredibly difficult,” he says. “I had some great advice to help me go down the right path.”
Rosenfeld says that’s an attribute of Conn’s that makes him and his company worthwhile. “Another special aspect about Nick is his understanding that you need help, and looking for the best help,” says Rosenfeld.
With the seed round funds, Conn and Rosenfeld also plan to add two employees to their growing company: a director of regulatory and clinical affairs, and a cloud software developer.
As for the future, and Conn’s larger goals, he has not scaled back at all.
“Given world events, we want to get this device launched so it can have true impact,” says Conn. “Longer term, I have a vision for transitioning health care from reactive to proactive, being able to monitor and measure things we can capture in the home on a daily basis that were previously available only in a clinical setting. We may be able to predict and prevent many problems—not just related to cardiovascular disease. Who knows what we will find?”