Investors Join Entrepreneurs and Strategics at Bioelectronic Medicine Forum in NYC

by Jennifer French, senior editor

About 85 executives and entrepreneurs took part in the second annual Bioelectronic Medicine Forum held in New York City earlier this month. The agenda featured four discussion panels covering topics like investments, digital health, regulatory and reimbursement, and future technology. More than a dozen entrepreneurs presented their ventures and technology innovations at the event and NBR editor James Cavuoto presented newly released data from the market research report: The Market for Bioelectronic Medicine 2020-2025.

Headlining the event was Sue Siegel of GE Ventures, which has been investing in this field for quite some time, including companies like SetPoint Medical and Neuronetics. She opened her keynote by ringing a Tibetan singing bowl, commenting that stimulating the body dates back to ancient acupuncture in eastern cultures. Today, we are taking a western approach to the same theories. “We are in the fourth industrial revolution,” said Siegel, describing this radical transformation of unconventional partnerships targeting consumers.

She mentioned that a typical therapeutic treatment will take an average of 12 to 13 years and about $1.3 billion to bring to market, but in the future, it will be one-tenth the price and take one-third of the time. She also advised that the marriage between therapeutics and diagnostics could be very attractive to third party payers. When asked to give advice to the entrepreneurs in the room, Sue provided this, “Grow thick skin.” More specifically, she advised entrepreneurs to understand what is attractive to each specific investor. “In 10 slides or less describe what problem you are trying solve, how big is the opportunity, what will it take to get to breakeven, and what is your regulatory and reimbursement strategy.”

These points dovetailed into the investment panel moderated by NBR contributing editor Margo Puerta and featuring Evan Norton of Abbott, Eric van Gieson from DARPA, Adam Fine of Windham Ventures, and Jeff Erb from Medtronic. Fine kicked off the discussion. “A lot of work still needs to be done to know mechanisms of action and dosing.” For them, implantables to wearables is attractive. Conversely, Norton mentioned that Abbott is a big manufacturer and their main customers are hospital systems. “If we take on wearables, then we have to change our value proposition,” he explained. Erb added that there is high consumer compliance with implantables. Van Giesen switched gears, stating that NIH and DARPA spend millions of dollars to understand mechanisms. “We reach out to the investment community but the investment community does not come to us and ask about the mechanisms for a specific device. We will tell you.”

A regulatory and reimbursement panel chaired by NBR senior consulting editor Jeremy Koff featured Peter Staats from eletroCore, Victor Pikov, formerly of Galvani, and Corey Hunter from Mount Sinai Hospital. Panelists painted a bleak picture for the reimbursement landscape to the point that regulatory approval seems easy. Staats advised attendees to establish cost dominance and engage in discussions with insurers. Hunter highlighted the inequitable treatment of data for devices versus pharma and the biases by claims reviewers. Pikov addressed the device market in China. “By 2030, China will be the leading market worldwide for medical devices,” he said.

The wearables panel addressed the issues of marketing and distributing devices directly to consumers. Gozani spoke of his experience with the Quell device for pain management, which entered the market in 2015. Sam Hamner from start-up Cala Health addressed their perspective on direct to consumer. The consensus was if it works then consumers will use it.

In a luncheon talk, Jacob Zabara, the pioneer behind vagus nerve stimulation, discussed some of the lessons learned developing that technology.

There is a reason for this enthusiasm from investors to researchers and from clinicians to consumers. Bioelectronic medicine is a growing market that has the potential to change medical treatments.

Several presenting entrepreneurs touted wearable or noninvasive therapies. Daniel Powell from Spark Biomedical described a novel VNS therapy for addiction. Don Deyo from FemPulse discussed his intravaginal device for the treatment of OAB in women. Ana Maiques from Neuroelectrics demonstrated her firm’s tDCS headset for epilepsy. Nader Yaghoubi of PathMaker Neurosystems presented his firm’s clinical device for treating spasticity in movement disorders. Sam Hamner from Cala Health described a wearable for hand tremors. And Jennifer Ernst of Tivic Health highlighted her firm’s launch of a treatment for sinus pain and congestion.

Four new ventures described new platform technologies, including Synergia Medical, Qura Inc., Synchron Inc., and Orchestra BioMed. Orchestra CEO David Hochman featured their “add-on” device to a traditional pacemaker to treat hypertension. New this year were some translational entrepreneurs who are researchers seeking efforts to move new therapeutics out of the laboratory. Shelley Fried of Harvard Medical School featured a new cortical implant. Michael Jenkins from Case Western Reserve University presented his novel work using infrared and ultrasound stimulation, and Gaurav Sharma from Battelle spoke about their new business unit dedicated to bioelectronic medicine.

In a lively closing session, Elliot Krames, a pioneer in this field, stated, “The future of medicine is neuromodulation.” Kip Ludwig from the University of Wisconsin said that bioelectronic medicine offers potential of moving neuromodulation therapies away from being the treatment of last resort to being a front line therapy. He also stressed the importance of understanding mechanisms of action, but also recognizing the inherent limitations of animal models. “When you get to humans the side effects can be very different,” he said. Jeff Kramer of Medtronic closed the session highlighting the need for sensing in adaptive therapies.


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