Industry Professionals Come to San Francisco for 18th Neurotech Leaders Forum

by Jennifer French, senior editor

October 2018 issue

About 120 management, investment, and research professionals from the neurotechnology industry came to San Francisco for the 18th annual Neurotech Leaders Forum earlier this month. Two keynote speakers set the tone on each day of the event. Frank Fischer, CEO of Neuropace, shared his experience bringing an implanted closed-loop system from the lab to market. “The brain is a beautiful, complex, and extraordinary system,” he said. He told the story of the journey from initial clinical trials in 2004 to PMA approval in 2010 to the gathering of patient ambassadors in the spring of this year. The sensing capabilities of the RNS device provide a “window to the brain” of an individual’s unique neural activity. Using predictive analytics, the data reveals a circadian pattern to aid in the treatment of seizure activity. Neuropace is beginning to use machine learning and AI to make better predictions of seizure activity.

Hunter Peckham, a pioneer in the field of neuroprosthetics, kicked off the second keynote address with the proclamation, “The rehabilitation market has been underserved,” referring to the low level of devices that are commercialized for the paralysis population. Peckham also talked about his journey from the first implanted devices of the 1980s to the most recent design of a networked neural prosthesis. “It’s like a tinker toy—you can piece components together to better serve the patient,” he said. The system has been implanted in five individuals to date. Both keynote speakers expressed the need to interact and understand the people your technology is serving.

This year, two promising start-up ventures chose to offer their first public presentation at the Neurotech Leaders Forum. Manfred Franke, founder and CEO of Neuronoff, Inc., revealed his firm’s innovative injectable electrode technology for the peripheral nervous system. And Isaac Clements introduced BioCircuit Technologies, a spin-off from Axion Biosystems of Atlanta, GA. Pawel Soluch of Neuro Device Group in Poland talked about his company’s latest surface stimulation device for the treatment of aphasia. Dan Rizzuto provided an update on Nia Therapeutic’s 64-channel implanted system for the restoration of memory for people living with traumatic brain injury.

Another start-up, CerebraCell, led by Howard Leonhardt, is also focusing on TBI as well as stroke with a combined stimulation and cellular therapy. Naharika Gajawelli of Voxel Healthcare introduced Click Brain, a new neurodiagnostic tool for children with developmental conditions. Blake Gurfein described a new venture, called Tivic Health, and its Clear Up device for treating sinus pain. FDA clearance is pending and the company plans to pursue OTC sales in the U.S.

A discussion panel focused on new pricing and reimbursement directions in the neurotech industry featured Tom Hughes of Regulatory & Clinical Research Institute and Courtney Lane of Anacapa Clinical Research. What started as an informative discussion about reimbursement soon led to a heated session on the barriers inflicted by the third-party payer system.

Another pain point—literally—for the industry surfaced during a panel on the topic of neuromodulation in the opioid crisis. Several panelists and attendees contended that neuromodulation therapy is not on a level playing field with pharmaceuticals. “Neuromodulation is the best pain solution that no one knows about,” said Michael Leong from the Stanford Pain Center. On the other hand, there are real opportunities for neurotech devices within the pain treatment market in the areas of personalized medicine and data collection. Stephanie Fertig of NINDS described the NIH’s new HEAL initiative, which has received new funding of $70 million to address the ensuing crisis.

Several of the panel discussions displayed a heightened sense of optimism toward the future of neurotechnology. Bashar Badran of the U.S. Army Research Laboratories showed how pairing brain stimulation with rehabilitation can shorten the time to achieve positive outcomes from years to just months. This was echoed by Jose Antonio Tovar of Hocoma.

During a session devoted to bioelectronics medicine, Tony Arnold, former CEO of SetPoint Medical, said that bioelectronic medicine does “more than just treat, but finds cures for diseases using the body’s own mechanisms.” Michael Ackerman, founder of Oculeve (now part of Allergan) added, “It’s our responsibility to deliver on these promises.”

During a panel of financial professionals in the neurotechnology industry, the speakers concurred on two points. The management team is the essential component of any start-up venture and entrepreneurs consistently underestimate the amount of money they will need to get the business running. A similar sentiment emerged in a session devoted to transferring technology out of academia and into the market. Claude Clement, CTO of the Wyss Institute for Bio and Neuroengineering, spoke of the two-stage translation process of educating investigators about translation as well as matching a clinical need with the technology.

A session devoted to regulatory issues in the U.S. and abroad featured an informative talk by Cristin Welle of University of Colorado, Denver, who pointed out that the gap between FDA and European device approval was narrowing. Victor Pikov of startup firm Medipace, Inc. gave an overview of loosened regulation in the Chinese medical device market.

The conference concluded with an all-star cast of innovators in implanted brain devices. Phil Starr of UCSF described recent developments with closed-loop brain stimulation. He stressed the need for devices with higher channel counts. Dan Rizzuto presented the challenges and opportunities in brain stimulation for the restoration of memory. “Sensing is the future. It is neuromodulation 2.0,” he said. BCI pioneer John Donoghue revealed the latest design of a fully implanted brain interface with implanted electrical stimulation to restore natural-like movements for people with paralysis.

Sponsors of this year’s event included Cirtec Medical, MST, imec, Heraeus, Maynard Cooper, Cactus Semiconductor, Senso Medical, RBrooks Group, Cleveland FES Center, Wyss Center, and the International Neuromodulation Society.

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