Startups and Funders Highlight 2020 Bioelectronic Medicine Forum on Zoom
by Jennifer French, senior editor
With an amended format as an online conference due to the COVID-19 pandemic, the 2020 Bioelectronic Medicine Forum was held on April 7 with more than 100 attendees from the industry, research, and investment communities. Projected to grow to $14 billion by 2025, the field is very quickly gaining ground and building investor interest. This event highlights some of the recent developments, investment activity, and emerging companies.
The Pentagon’s DARPA agency has been a key funding source to accelerate neurotechnology development. The keynote speaker was program manager Al Emondi. He highlighted the current and most recent programs within his portfolio. His most mature program is the HAPTIX program to develop smart upper limb prosthetics that include touch and proprioception interfaces. The technology in this program is now transitioning into humans and some are even in-home use devices.
Neural Engineering System Design is also a neuroprosthetics program with a particular focus on engineering and technology development of high-density, high-fidelity interfaces. The agency selected three performers in this program. N3 is the Next-Generation Non-Surgical Neurotechnology program with a directive of building noninvasive or minutely invasive interfaces designed for able-bodied military personnel. The newest program, is still under investigator selection, is Bridging the Gap Plus. It focuses on spinal cord injury to develop bi-directional devices sensing at the point of injury and stimulating the nervous system to aid in preservation, recovery, and restoration. Emondi also oversees a smaller program with a goal to leverage artificial intelligence to develop high capacity, adaptive, and durable neural interfaces. Emondi concluded his talk with an agency initiative to encourage the translation and commercialization of technologies developed within their programs.
Emily Caporello from the NINDS Small Business Program delivered a targeted presentation specifically for COVID-19 relief funding. NIH does offer special and expedited funding for COVID-19 related research and has extended the deadlines for existing research programs within NINDS. NIH has also issued guidance on both human and animal research that may be delayed due to the current situation. SBIR and STTR programs remain in place and this is a good time to look at this as a source of funding. NIH provides more than $1 billion in funding for small businesses with NINDS accounting for about $75 million per year. Caporello also described how to donate research supplies that may be of use during the crisis.
The conference also featured several discussion panels. One was an investment panel consisting of Manuel Lopez-Figueroa, Bay City Capital, Tony Natale, Aperture Venture Partners, and Imran Eba, Action Potential Venture Capital. The topic of the apparent economic downturn yielded some advice from the panelists. Natale suggested “focusing on what is critical.” Lopez-Figueroa looked back at the beginning of 2020 when $121 billion in capital for investment was available. “So there is money out there,” he said. He cautioned that investors will be much more frugal with their investment in the short term. Eba echoed that message but in a different way: “We need to remember that venture is always a long-term game. Short-term cycles are things that we can look past.” Closing out the session the panelists advised the entrepreneurs in the audience to understand the problem to solve, create a great team, and become resourceful in filling funding needs.
Switching focus to the next generation of treatment developments, panelists Nick Langhals, NINDS, Leigh Charvet, NYU Medical Center, and Marom Bikson, CCNY Neural Engineering Laboratory, gave their input into promising modalities of today and trends for tomorrow. Charvet kicked off the session by stating, “Telemedicine is here and now. That probably will not change going into the future.” As a research clinician, she emphasized that home-use should be part of the technology development pathway.
Concerns about home-based clinical trials surfaced including variability, protocol compliance, and remote monitoring. Charvet’s response was to embrace the technologies and develop conservative and standardized protocols to deliver treatments remotely with considerations for safety adherence. The panel also discussed the challenges of dosing when evaluating new modalities like ultrasound, infrared, and pulsed RF. Bikson recommended breaking down the features of different modalities to define the dosing of treatments to the human body. Focality of noninvasive treatments can be a complicated issue. Langhals mentioned some of the issues but closed with the fact that the identification of biomarkers can be the most efficacious way to develop individualized dosing.
A regulatory and reimbursement panel moderated by Jeremy Koff included input from Courtney Lane, Anacapa Clinical Research, and Abhi Datta, Soterix Medical, two veterans in the neurotech industry. Lane introduced the key components of a clinical trial strategy from the perspective of regulatory agencies and third party payers, along with clinicians and end-users. She advised attendees to consider factors such as safety and efficacy compared to placebo, clinical evidence with feedback from practicing clinicians and patients, device performance, and comparative cost to alternative therapies. She also recommends that for young neurotech companies, consulting experts in regulatory and/or reimbursement can be an effective way to build the strategy.
Datta drew from his experience in industry, including outside the U.S. He said the FDA review process is slow now because of the pandemic. There is also a notion that FDA will require more stringent evidence with 510k applications. From his perspective, “reimbursement equals commercial success.” However there are other sales channels for medical devices that can lead to success. He recommends building both the regulatory and reimbursement strategies into technology development early and also looking to the market for similar and comparable products.
Entrepreneur presenters displayed a diverse array of technologies. Synergia Medical, a Belgium-based company, is developing NAOS technology using optogenetics for therapeutic neural stimulation. Its first area of focus is on vagus nerve stimulation for drug-resistant epilepsy. Neuraura, a Canadian company, is developing a sensing and simulating interface particularly for monitoring brain activity. Micro-Leads [NBR Mar19 p6] is developing a high-density, closed-loop technology, called HD64, with an initial application of spinal cord stimulation for chronic lower back pain. Panaxium is a young neurotech company developing a iontronic platform for the human brain with a development pathway of intra-operative probes, bi-directional stimulators, and closed-loop systems.
NeuroDevice Group is focusing on the development of the Voic System, a noninvasive transcranial electrical stimulation technology for the treatment of aphasia. Spark Biomedical gave an update on their latest development of noninvasive VNS for the treatment of withdrawal symptoms related to addiction. Ash Attia from Bionic Vision Technologies introduced their most recent developments with an implanted retinal prosthesis to treat inherited retinal diseases. Evren Technologies is focusing on noninvasive VNS in the form of an earbud for the treatment of post-traumatic stress disorder. Another noninvasive therapy to improve childhood executive dysfunctions of the brain such as ADHA was presented by Eric Gordon of Atentiv. Thermaquil offers a minimally invasive occipital nerve block technology for head and neck pain. Victor Pikov revealed his new venture, Medipace, and the company’s sacral nerve stimulation therapy for the treatment of IBD and diabetes. Another first publicly revealed company, Defuse Medical, introduced their minimally invasive peripheral nerve stimulation device with a biomimetic porous lead for regional back pain.
The closing session discussed future directions for bioelectronic medicine. Erika Ross, Abbott Neuromodulation, discussed accessing the nervous system with “targeted engagement and measuring of target affects.” Jake Zabara, pioneer of vagus nerve stimulation commented, “The development of VNS has been lateral. But the vagus nerve is a very complex system.” The opportunities for bioelectronic medicine abound and will continue to change the landscape of neurotechnology.
Sponsors of the event included The Mullings Group, Jake Zabara Family Foundation, Evren Technologies, and NeuroDevice Group.