By:  Diana Cugliari
President & CEO
Pittsburgh Life Sciences Greenhouse

PLSG partner Forest Devices, an innovative Pittsburgh-based medical device company, has earned high praise for its AlphaStroke™ diagnostic platform that enables first responders to accurately diagnose stroke in the field, pre-hospital. This knowledge provides more accurate triage, which reduces time to treatment and improves outcomes for patients.

The company recently published positive results from the Emergency Data Gathering AlphaStroke Refinement (EDGAR) study of AlphaStroke™ in the America Heart Association Journal, STROKE. We sat down with Forest Devices CEO Matt Kesinger to learn more about this landmark study and what the future holds for Forest Devices.

PLSG: Before attending medical school at the University of Pittsburgh, you worked as an EMT. How did that experience influence your development of AlphaStroke™?

Matt Kesinger: “I didn’t know it at the time, but that experience would shape my future. I learned first-hand how hard it is to identify stroke in the field. In medical school, my research focus was trying to improve the pre-hospital experience for stroke by developing clinical exams beyond the standard, ‘squeeze my finger/what month is it/follow my finger’ assessment. I eventually found that the biggest problem in my work became a research problem, and then later became a business opportunity.

PLSG: Why is it so essential for first responders to accurately determine whether or not a patient is having a stroke before transporting them to the hospital?

Matt Kesinger: The single greatest cause of disability from stoke is pre-hospital misdiagnosis. Wrong decisions delay treatment, and in stroke care shortening time to treatment is essential. If a patient is in fact having a stroke, they will wither need specific medication or a surgical procedure. The problem is, not all hospitals provide these treatments. The wrong assessment could either lead to taking the patient to a hospital that is not equipped to handle the case, which would require a second transport and more time until treatment, or, conversely, a patient could be taken to a hospital much further away for surgical intervention when a local hospital would have been able to manage the case with medication.

PLSG: How does AlphaStoke™ support field triage and improve patient outcomes?

Matt Kesinger: The single most important thing for a stroke patient is what happens pre-hospital. There is too little time to make the most important decision in that patient’s life, and no system was really accurate. There was a need for an objective way to determine whether the patient was having a stroke or not, so six years ago I developed AlphaStroke™ – a compact and portable EKG for the brain – to reduce delays in stroke treatment.

PLSG: How does the AlphaStroke™ device work?

Matt Kesinger: Instead of relying solely on a clinical exam, AlphaStoke™ can determine if a patient is experiencing a large vessel occlusive (LVO) stroke, a type of ischemic stroke that requires surgical intervention, a thrombectomy, which is only available at highly specialized hospitals. The portable AlphaStroke™ device utilizes a single-use disposable head cap that quickly delivers a binary result – stroke or no stroke. Better diagnosis empowers first responders to make the most appropriate transport decision for the patient, shortening the time to treatment and reducing the risk of death and permanent disability.

PLSG: The accuracy of the device has been clinically validated – how was this achieved?

Matt Kesinger: Clinical results have shown that Alpha Stroke™ is 80% accurate. Better diagnosis shortens time to treatment, improving patient outcomes. We recently published positive results from the EDGAR study of our AlphaStroke™ technology in the American Heart Association Journal, STROKE. The study showed that, compared to the clinical exams currently used by medics in the field to make triage decisions, AlphaStroke™ was 28% – 40% superior at correctly identifying patients with LVO, and was equally as good as the clinical exams at correctly ruling out patients with non-LVO diagnoses.

PLSG: What’s next for AlphaStroke™ and for Forest Devices?

Matt Kesinger: For AlphaStroke™, the final test before market launch is in the field and starts in a few weeks. The SEGUE study will test AlphaStroke™ on over 1,000 patients on ambulances in Alberta, Canada. EMS is not a market familiar to most investors in the United States, and that has been the biggest challenge the company has faced. Raising the series-B needed to get AlphaStroke™ to market has been so challenging that I and a large part of the company are planning to move to Europe to obtain financing.

To learn more about AlphaStroke™ and Forest Devices, visit the website or read more about study results.

The Affordable Care Act (ACA) has helped a great many Americans get health insurance and much needed care, but parts of the bill have had less helpful effects. One of these provisions, the medical device excise tax, has been a thorn in the side of life science companies since the beginning of 2013. The tax is meant to help pay for the reforms at the heart of the ACA, but has been derided as a danger to job creation, healthcare innovation, and manageable healthcare costs.

To the delight of many legislators and medical device manufacturers, 2016 looks very different. With the passage of the Consolidated Appropriations Act of 2016, the 2.3% excise tax has been suspended for two years. Advocates for the medical device industry see the suspension as a victory; while others worry it will make it more difficult to fund the reforms of the ACA.

This tax has been projected to bring in $30 billion over a decade to help fund the ACA. In 2013, it brought in $1.4 billion in revenue. According to NPR, that jumped to $2.4 billion in 2014, with some companies paying as much as $10 million.

Opponents of repealing this tax assert that it was created to be balanced. The Center on Budget and Policy Priorities states that the increased business necessitated by the ACA would make up for the revenue lost by the tax. They claim that the tax would have a negligible impact on employment and innovation.

Indeed, as NPR notes in the above referenced story, employment in medical device companies has not been affected by this tax. But the assertion that innovation would not be affected is misguided. It might be true that larger, more established medical device producers have not been hindered by the excise tax, but it’s a different story for medical device startups..

Smaller device manufacturers are often still struggling through startup funding rounds, trying to attract investors and grants to stay afloat. Many investors already see these companies as risky investments. The ACA’s medical device excise tax makes them look even less advantageous as precious investor capital that could go into the company’s development must now go to taxes. This is a real problem for startups, as NPR reports, “because investors balked at putting their money into an industry that’s been singled out to pay a tax.”

2.3% might not be a lot for a big firm, but that can be a significant loss for startups. Funds put toward this tax are funds taken away from research and development, which hurts production, delays testing, and limits market penetration.

We’ve been fortunate to see success over the past year from medical device companies in Pittsburgh, including ALung Technologies and Rinovum Women’s Health. Think about the innovations we could have seen if other young medical device startups were not hampered by this tax.

Do you think it was right to suspend the medical device excise tax? Do you think medical device startups will benefit as expected from this? Share your thoughts in the comments below!

Image Source: https://pixabay.com/en/blood-pressure-blood-pressure-monitor-949093/