Entrepreneurs Join Academics at Bioelectronic Medicine Forum

by Sharena Rice, contributing editor

About 80 professionals from the Bioelectronic Medicine industry attended the sixth annual Bioelectronic Medicine Forum, held in New York City earlier this month. The event, produced by Neurotech Reports, was held at the New York Academy of Medicine in Manhattan, with some participants joining via Zoom.

The full-day conference featured several panel discussions on topics related to bioelectronic medicine, as well as presentations from 10 startup firms in the space. Helen Mayberg, director of the Center for Advanced Circuit Therapeutics at the Icahn School of Medicine at Mount Sinai, delivered the keynote address.

A morning session moderated by BBR contributing editor JoJo Platt and featuring Amy Kruse from Satori Capital, Liron Nunez Weissman from Joy Ventures, and Nick Langhals from the NIH focused on the intersection of neuroscience and technology and its potential impact on healthcare.

Kruse highlighted the importance of developing technologies that can accurately monitor brain activity in real-time. Satori Neuro is interested in therapeutics, precision psychiatry, and neurodegeneration and cognition. The goal is to find the right treatment for the right brain.

Langhals, Program Director for Translational Devices at the NIH/NINDS, discussed several of the agency’s funding programs for startups in this space. He emphasized the need for collaboration between industry and academia to ensure that these devices are rigorously tested and proven safe for use in humans.

Weissman discussed the potential of neurotech to revolutionize the treatment of neurological disorders. “We have a unique model which we call lab to life and it spans from funded academic research all the way to investment in existing and growing companies,” he said. Kruse said that it takes time to go out there and “kiss a lot of frogs,” but the landscaping effort is critical to making sort of good investments.

Overall, the session highlighted the exciting potential of bioelectronic medicine to revolutionize healthcare and improve patient outcomes. However, the panelists also emphasized the need for collaboration, transparency, and ethical considerations to ensure that these technologies are developed and deployed responsibly.

A session devoted to the enteric nervous system was moderated by BBR editor James Cavuoto and featured Victor Pikov from Medipace and Jennifer French from Neurotech Network. The enteric nervous system is a complex network of neurons and glia that is embedded in the walls of the gastrointestinal tract. It is often referred to as the “second brain” because it can function autonomously and independently of the central nervous system.

According to Pikov, the ENS is a promising target for bioelectronic medicine. “The ENS is an ideal target for neuromodulation because it has a simple structure and well-defined functions,” he said. “By modulating the activity of the ENS, we can potentially treat a wide range of gastrointestinal disorders, such as irritable bowel syndrome, gastroparesis, and inflammatory bowel disease.”

French discussed the challenges of developing neuromodulation therapies for the ENS. “There’s a lot of anatomical locations where you can stimulate and be able to have a therapeutic effect,” she said. “This is still a frontier that we don’t fully understand but it’s something that we can definitely explore.”

The session also touched on end-user considerations of developing therapies for the ENS. “We need to connect the continuum of the enteric system with the continuum of engagement,” said French. She highlighted guidance from the FDA that accounts for patient preferences in the approval process.

A panel moderated by BBR contributing editor Victor Pikov examined closed-loop systems that integrate sensors and stimulation electrodes, and controllers to form a complete feedback loop. This approach allows for targeted personalized real-time adjustments, minimization of side effects, and improved patient outcomes. Marom Bikson of The City College of The City University of New York and Imanuel Lerman, professor at University of California San Diego and founder of InflammaSense [see article p8] joined Pikov on the panel to explore the challenges and possibilities of closed-loop bioelectronic systems.

Bikson drew important distinctions between biomarkers and clinical endpoints for closed-loop systems. Clinical endpoints respond to the intervention and are the health outcomes underlying the indications for use. In contrast, biomarkers are subjective or objective measures that respond to the intervention but are not clinical endpoints.

Bikson also suggested three different categories of biomarkers. Type 1 biomarkers anticipate the clinical endpoint. An example he gave was if body temperature was the first response that anticipated the effectiveness of a depression symptom.

Type 2 biomarkers show an acute change in the body in response to a treatment dose, indicating the potential mechanism of action. Bikson gave the tingling of some forms of pain neuromodulation as a concrete illustration, as it masks pain through the gate control mechanism.

Type 3 biomarkers indicate the appropriate selection of effective dose while being coincidental to the mechanism or clinical endpoint yet is not a biomarker of Type 1 or Type 2. The finger twitch in transcranial magnetic stimulation is a Type 3 biomarker, as it is used to determine the stimulation strength before being applied to other areas of the brain for depression.

Although researchers may not know which type of biomarker they have because the mechanism of action is unknown and the closed-loop stimulation may be a conjecture of what will help, this categorical framework may help them appraise the signals they collect.

Pikov pointed out that there is an NIH SPARC grant to develop open-source open-architecture systems at two consortia: one based at the University of Southern California and the other at Case Western Reserve University. Although these may eventually become a single system, the consortia are just sharing technology right now. In Pikov’s view, it would be very useful to the field of bioelectronic medicine to develop a database for sharing biomarker and clinical endpoint data.

“There are very heterogeneous populations in these diseases, and it would be good to know what does and does not work, as well as which side effects there are,” said Pikov.

During the Q&A discussion, Cavuoto suggested that new clinical trials incorporate biomarkers of different types, even if their relationship with an underlying disease is not strong, as they may provide valuable insights into therapy responsiveness or side effects in specific patient subpopulations, and new FDA CDRH guidance may allow changing the clinical trial inclusion/exclusion criteria in the middle of the trial based on obtained biomarker evidence.

The session concluded with a discussion on the future potential of bioelectronic medicine. Both Lerman and Bikson expressed optimism about the future of the field, with Lerman stating that “the potential of bioelectronic medicine is truly limitless.” Bikson added that “the possibilities are endless, and the only limit is our imagination.”

The potential of closed-loop systems to revolutionize medical treatment is vast, with the promise of personalized, targeted therapies that can significantly improve patient outcomes. By fostering collaboration between research sites to pool data, considering disease states in interventions, and strategizing with the different types of biomarkers they encounter, the bioelectronic medicine field may improve the effectiveness of treatments for more people faster.

In a closing session devoted to reimbursement issues, Mark Domyahn from the JD Lyman Group, emphasized the importance of considering reimbursement strategy early in the regulatory process for medical technologies, particularly in the field of neural stimulation.

Domyahn also highlighted the differences in reimbursement pathways for implantable devices versus external devices, and noted that the DME reimbursement system is outdated and not built for newer technologies such as the Cala Trio.

In terms of when to start considering reimbursement strategy, Domyahn advised that it should be done as soon as a company begins thinking about their regulatory strategy. He stressed that reimbursement and regulatory considerations should go hand in hand and that early planning is crucial for success.