Around 18 percent of all heart attack victims will wind up readmitted to the hospital within thirty days. For twenty-five percent of all heart attack victims, it is not their first experience with myocardial infarction (MI). This is costly to all concerned, most vitally the at risk patients, but also to the economic health of the hospitals that care for them who are at risk for being penalized for readmission rates over certain levels.

RCE Technologies, winner of the 2019 SEMDA PitchRounds competition, is following a commercialization pathway to reduce those events and costs via remote monitoring that “non-invasively detect[s] protein biomarkers in the blood, and extract[s] a 3D representation of the electrical conductivity of the heart. Continuous streams of critical data points wirelessly enable our cloud based AI models in detecting characteristic learned patterns of heart morphology changes, that affords the cardiologist in making an instant early assessment and proactive intervention”

RCE Technologies’ CEO Atandra Burman

“We have shown high velocity bringing concept to product in nine months, viable clinical alignment and a needed, reimbursement ready opportunity, RCE Technologies’ CEO Atandra Burman told Write2Market VP of Healthcare Paul Snyder. “We believe we have a very clear path forward to de-risking and commercializing our technology.”

Atandra shared with us a few of the insights gained from SEMDA 2019 and some pieces of advice for other early stage medtech innovators and company leaders.

Beyond the “win” what was most valuable about your participation in SEMDA PitchRounds?

Watching the late stage companies gave us a clearer view of our roadmap unfolding. What’s needed to weather the first, or next, round of challenges? Clinical studies and demos. All of the late stage PitchRounds companies had a clear path on reimbursement strategy, regulatory pathways and channel partnerships identified along with optimized operations for production and distribution. One hinted at a clear exit strategy. This I thought was most valuable, because it gives you the end goal, and helps you work backwards from that – time and cost wise, and those are important variables for me as an operator to run a startup and hit within time and budget.

What did you hear from prospective investors?

Are there other markets or monitoring product reimbursement codes for our technology? What we heard inferred a high level of synergy. Our technology is viable and multiple supporting elements exist.

What are the top questions young medtech & device companies need to answer?

Has there been any kind of clinical validation done? This assumes the technology works and the product functions as anticipated towards better patient outcomes. Next, understand your health economics. How will you get paid? Is the hospital paying, is there a reimbursement code? Basically, think beyond the bench. Think economics, exit path and ROI potential at an early point in your journey. That enables a better gauge on a MVP path to market.

What advice would you give young companies considering applying for SEMDA PitchRounds next year?

While working on functionality, you must also work on payer economics. You must be able to explain how your technology is going to make money in time. Furnishing an exit strategy is another important aspect, that keeps young companies focussed, and on target for what is needed. Expect curveballs from investors and strategics. You need to be on top of it to give perspective on how it will work.

We hear more and more that investors, particularly large strategics, are more frequently requiring products in which they invest be 100% de-risked? How accurate is that?

If you are revenue positive and cost effective, that shows some level of viability for strategics to bet on startups/early stage. Sometimes, we might see them engage in M&A with companies in pre-commercialization and clinical trials. An example is Boston Scientific’s acquisition of Millipede for $325 million in structural heart. Millipede has accomplished a great deal on their pathway to commercialization, but haven’t finished their clinical trials. But then, Boston Scientific’s strategy is clear towards innovation in cardiovascular devices, and if there are ones that have clinical viability, commercialization can be addressed effectively by these large strategics.

What’s next for RCE? 

Our goal in 2019 is clinical validation and submit to FDA this fall. As our pilots materialize towards key insights, we look forward to setting up 2020 for commercialization efforts.

What do you need?

As a fast moving business, we are currently raising $800k to support our immediate needs in completing our compliance testing and FDA sub, as well as supporting clinical pilots for 2019.

In parallel, we are evaluating channel partners, and contract manufacturers, to bring our at scale costs down enabling production lines for goto market.

Congratulations again to RCE Technologies. We look forward to seeing how far you’ve come by the SEMDA 2020 Medtech Conference.