From The Editor | January 23, 2017

Missed Diagnosis Motivates Entrepreneurial Response

Bob-Marshall-headshot

By Bob Marshall, Chief Editor

brain

When Forest Devices CEO Matt Kesinger was completing prerequisites for medical school, he spent time working with an emergency medical service (EMS) provider in Boston. During one ambulance ride, Kesinger had an experience that would reshape his life and career. He was evaluating a patient for a possible stroke using standard protocol, which included the Cincinnati Prehospital Stroke Scale. He concluded the patient did not have a stroke. Kesinger would later learn that patient had indeed suffered a stroke.

Flash forward a few years to Kesinger in medical school, performing research. He was working with doctors who were trying to determine how well strokes were identified in pre-hospital situations. It was then that Kesinger realized the mistake he had made years earlier in Boston was not just his problem. It was a national problem, an unmet clinical need. In his final year of medical school, Kesinger also realized that a clinical examination was never going to be good enough for early stroke detection, and he began to develop the technological solution that would become Forest Devices’ ALPHASTROKE.

I spoke with Kesinger as he took a break from tending to his clinical study at the hospital, and asked him about his technology. He explained, “The vast majority of strokes are asymmetric, and we are able to identify the asymmetric brain signature by placing a few electrodes on the forehead and the back of the neck. Basically it’s the same way that an electrocardiograph (EKG) can identify a heart attack. Previously, the paramedic or medical professional would have to interpret the waves, but ALPHASTROKE is a self-interpreting EKG for stroke.”

Kesinger’s personal experience made him keenly aware of the need for such a device, but he also learned about the market for it. Kesinger estimates that about 10 percent of ambulances in the U.S. are owned by hospitals and integrated health systems. He expects this portion of the market in particular to be early adopters of the technology, as they directly bear the risk of not correctly diagnosing stroke patients in the pre-hospital setting.

Urgent care centers are another interesting market. Kesinger stated that about one out of every two lawsuits against urgent care centers involves a neurology patient. This has caused urgent care centers to often turn away people with neurological symptoms, because the potential income does not balance with the potential payout in a lawsuit stemming from the failure to correctly diagnose a stroke. This means the ability to accurately detect a stroke with ALPHASTROKE can offer new revenue opportunities for the more than 7,500 urgent care centers across the U.S.

Kinder, Gentler FDA?

Talking through many of the hurdles that medical device start-ups face (e.g., intellectual property protection, transforming a concept on paper to a functioning prototype, finding the right resources to build the team, finding good partners for support, securing funding to make all of this happen), I was surprised by Kesinger’s upbeat opinion of the FDA. He explained, “We have had great interactions with the FDA so far. We have been able to ask very specific questions. I can schedule a formal meeting time or have informal phone calls. The FDA has also been very clear with the answers to almost every single question that I’ve asked. When their answer has been that they couldn’t comment on something right now, the follow-up question that I’ve always asked is, what do I need to produce in order for you to be able to comment? And FDA has been very clear with what was lacking.” Kesinger added that “working with FDA has been much less difficult than negotiating a contract with a hospital.”

Clinical Enrollment Lags

While much of Kesinger’s experience in guiding ALPHASTROKE through the development process has been positive, he did identify one significant challenge – patient enrollment in the device’s clinical study has not matched the original plan. Kesinger has had to create new plans for both of the study’s clinical sites and focus on program management of the clinical studies.

“We’re treating hospitals like they’re customers. We’re literally using a customer relationship management (CRM) database to manage them. We do have some preliminary data that is very promising, but the sample size is small so it’s not enough for us to make very strong claims yet,” Kesinger said. By adapting to the situation and taking a more active role in managing the program, he has seen improvement, and expects to complete enrollment for at least one of the sites this March.

So, is Kesinger satisfied with his progress in the 21 months that Forest Devices has been a business? When asked about his feelings on the subject, Kesinger exclaimed, “Whoa! This is taking so long. It’s so, so slow.” However, when he talks with prospective investors or his advisors, they are surprised at how far the company has progressed in so short a period of time.

Going Commercial

With many of the developmental challenges behind him and the clinical trial beginning to take shape, Kesinger has to be thinking about competition and commercialization. I asked him directly about the competitive landscape for ALPHASTROKE, and he believes the primary competition is portable ultrasound technology. Either his self-interpreting EKG for stroke or portable ultrasound will become the preferred method of early stroke detection. Still, Kesinger seems to appreciate having a strong competing technology in the space, noting, “It validates our value proposition and it gives us a benchmark.”

Assuming clinical trials conclude with positive results and regulatory clearance is obtained, the final challenge will be commercial adoption. This is one of Kesinger’s favorite things about bringing ALPHASTROKE to market. He explains, “I’m not out there trying to convince people to buy my software or my app because they’re going to like it. There’s an unmet clinical need and if we’re accurate with early stroke detection, we’re the solution to the problem. Accuracy drives adoption.”

Thus, one missed diagnosis years ago may indeed reshape stroke diagnosis for years to come.