Entrepreneurs and Executives Present at 2021 Bioelectronic Medicine Forum

Staff report

About 85 professionals from the bioelectronic medicine industry participated in the 2021 Bioelectronic Medicine Forum, held online earlier this month. The fourth annual event will return to New York City in 2022.

Keynote speaker at this year’s event was Murthy Simhambhatla, CEO of SetPoint Medical. He started by offering SetPoint’s definition of bioelectronic medicine: “Stimulating nerves and tapping into the body’s innate mechanisms as an adjunct or alternative to drug therapies.” Compared to drug therapies, bioelectronic medicine can offer improved efficacy, safety, patient compliance, and/or cost effectiveness, he said.

Simhambhatla traced the evolution of the space from cardiac devices to traditional neuromodulation to today’s goal of modulating molecular pathways, for example immune response or metabolic function. He described the role of the inflammatory reflex in the evolution of SetPoint’s product line.

Despite that key scientific advance, Simhambhatla said he doesn’t believe that new drug or device interventions should be required to understand the mechanism of action to that degree, so long as there’s strong empirical evidence. But the advantage of knowing the mechanism of action is that you maximize your chance of getting a response, he said.

A session devoted to investment in bioelectronic medicine featured input from DARPA ElectRx program manager Eric Van Gieson, Emi Gonzalez from Joyance Partners, Diana Saracini from Panakes SGR, and Juan Cueva from Action Potential Venture Capital. Van Gieson explained that his job at DARPA is to de-risk in a four- to five-year timeframe technology that could take 20 years to develop otherwise. He also described DARPA’s embedded entrepreneur program, which teams up experienced entrepreneurs with performers funded by DARPA.

A session devoted to commercialization and moderated by NBR contributing editor Jo Jo Platt featured Dan Brounstein from Saluda Medical, Lorenzo Rossi from Newronika, and Cameron McIntyre, a DBS pioneer who recently accepted a new position at Duke University.

McIntyre explained his goals in moving from Case Western Reserve to Duke. “I consider myself a prototype maker that has close collaboration with startup companies in the deep brain stimulation industry,” he said. “Our goal is to build some prototypes, see if they have any legs, and do some clinical testing of them before they roll out into a full-on startup company. And then hopefully help shepherd them through that startup process.”

McIntyre explained that that’s something not typically integrated into a professorship. “I see a huge opportunity in neurosurgical robot assistance,” he said. “And I see a huge need for software peripheral development in that arena. And that last thing is really what I do. That’s my special skill, I would say.” He also highlighted the integration of advanced imaging with advanced visualization technologies.

“If you’ve seen me talk anytime in the last few years, you’ve heard me talk about the work that we’re doing in holographic visualization. And I really see that as a key component of the future of surgical planning and figuring out how we’re going to integrate that kind of technology with robotics. So I’m looking for those kinds of partners and I’m hoping to assemble that kind of testbed center.”

Brounstein said that one of the biggest problems facing the neuromodulation industry is that there hadn’t been any sensing going on within neuromodulation for chronic pain. “There’s a huge explant rate,” he said, “and we’re all trying to solve that problem with different approaches.”

Rossi said that attracting investment in his Italian startup was not that big of a deal. He had personal connections with some family offices in Europe. He said it took a year to fund the first seed round. But he acknowledged that Newronika needs to put the company in a brighter spotlight in order to penetrate the U.S. market.

NBR senior consulting editor Jeremy Koff moderated a panel devoted to regulatory and reimbursement issues. On the panel with him were Tim Marjenin, senior vice president of neurology regulatory affairs at MCRA and Christopher Salmen, director of global market access strategy and reimbursement at NAMSA.

Koff, who is the nephew of the late neurotech entrepreneur Alfred Mann, related his uncle’s five factors for a successful medtech startup. Numbers 1, 2, and 3 were capital, followed by team and then technology. Koff suggested that regulatory and reimbursement would necessarily follow as the number 6 and 7 priorities.

Salmen said that when planning the product development process, he thinks in terms of three stages: product design stage, pre-commercialization stage, and commercialization stage. “It’s very important to identify the predicate, not just for the FDA clearance or approval, but also for payment,” he said. “A lot of times when you get to the payment space, if you get a 510(k), they’re going to look at that predicate product and probably give you the same payment coverage and coding.” Salmen said it’s also important to understand payer perceptions and evidence requirements.

Marjenin offered four pieces of advice from a regulatory standpoint: “First, engage early,” he said. “You want to understand what the FDA’s expectations are.” Second, he said, is not to make too many assumptions. Third, have a vision for what you want to achieve, and fourth, show your work.

Entrepreneur presenters at the conference included Blythe Karow, president and CEO, Evren Technologies; Anuj Bhardwaj, founder & CEO, SecondWave Systems, Inc.; Peter Schlecht, founder & CEO, Braingrade; Richard Hanbury, CEO, Sana Health; Nicolas Vachicouras, CEO, Neurosoft Bioelectronics; Stephen Popielarski, CEO, Thermaquil, Inc.; Balder Onarheim, founder and CEO, Plato Science; Aaron Bromberg, CEO, StimScience Inc.; and Victor Pikov, CEO, Medipace Inc.

Gold sponsor at this year’s event was Micro Systems Technologies. The Cleveland FES Center was Silver sponsor.


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