Neurotech Researchers Join with Clinicians and Executives at 2017 NANS Meeting

by James Cavuoto, editor

Nearly 3,000 clinicians, neural engineers, and neurotech researchers attended the 20th Annual Meeting of the North American Neuromodulation Society, held in Las Vegas, NV earlier this month. The meeting moved to January from its previous time slot in December to accommodate physicians’ busy schedule at the end of the year.

As in previous years, the meeting started with a forum devoted to invention, investment, and invigoration led by course directors Ali Rezai from Ohio State University, Ash Sharan from Thomas Jefferson University, and Peter Konrad from Vanderbilt. Gene Civillico, who heads up the NIH’s SPARC program, explained the rationale behind the program. “We need an atlas of the peripheral nervous system,” he said. He referred to the vagus nerve as the “internet of the body,” but said that much of the biophysics involving gastric, cardiac, respiratory, and digestive system neurocircuitry needs to be worked out.

Dan Rizzuto from Penn gave an update on DARPA’s Restoring Active Memory program. Columbia University, Mayo Clinic, UT Southwestern, Lawrence Livermore National Lab, and Medtronic are also involved in the program. Rizzuto’s team has enrolled more that 200 subjects in memory mapping sessions, and has amassed what he called the largest publicly available human intracranial data set. His team has identified an area of the temporal lobe he calls “Region X” that performs better than hippocampal or prefrontal regions as a target for modulating memory impairment. Rizzuto has launched a commercial startup called Nia Therapeutics.

Vanessa Tolosa from LLNL followed up with a description of the lab’s effort to devise new probes for closed-loop brain neuromodulation. Their deposition and photolithographic etching techniques are similar to what Intel uses in semiconductor manufacturing, she said. The lab has a goal of developing a 10,000-channel probe.

Three representatives from the FDA’s Center for Devices and Radiological Health offered their thoughts on neuromodulation device clinical trials and regulatory approaches. Tim Marjenin, chief of the neurostimulation devices branch, described two new branches within the neurological and physical medicine devices division. The five branches in the division also include neurodiagnostic and neurosurgical devices, neurointerventional devices, neurostimulation devices for psychiatry, and physical medicine and rehabilitation devices.

An interactive lunchtime session examined strengths, weaknesses, opportunities, and threats confronting the North American neuromodulation device market. Audience members were generally highly optimistic about growth rates for the industry. A poll asking whether they consider surface stimulation to be a legitimate form of neuromodulation revealed a nearly even split. During discussion, several clinicians reported that they were initially skeptical of TENS as a therapy but became convinced after seeing patients or family members get effective pain relief with devices such as Neurometrix’s Quell system.

An afternoon session led by Kevin Wasserstein of the Neurotechnology Innovations Translator examined challenges impacting medical device growth. Other panelists included Frank Fischer, CEO of NeuroPace, Sami Hamade with AppleTree Partners, and Richard Kuntz, the chief scientific, clinical, and regulatory officer at Medtronic. A closing session looked at neuromodulation device opportunities in Australia, China, and Israel.

This year’s meeting featured a series of thematic abstract sessions from 7 to 8 am on Friday and Saturday. Themes ranged from complex regional pain syndrome to DRG stimulation to novel waveforms to peripheral stimulation. In an opening plenary session, Joshua Prager from UCLA offered his views on what pain neuromodulation would like 10 years from now. He cited the importance of precision medicine and the discovery of “pain genes.” He also took the time to take a swipe at the American College of Occupational and Environmental Medicine, which he says has acted in the interests of the insurance industry to conduct an assault on neuromodulation.

Also in the plenary session, results were presented from two groundbreaking clinical studies. Yaakov Levine from SetPoint Medical offered data from the company’s study of VNS for treating rheumatoid arthritis. Five of seven patients who wore the VNS collar device for several minutes once per week showed marked improvement. And an investigator affiliated with Nevro Corp. presented positive findings from the Senza-ULN study of 48 subjects with upper limb and neck pain.

Investigators affiliated with Bioness presented data surrounding the clinical benefits of its StimRouter system. Porter McRoberts, a physiatrist and interventional spine and pain management specialist from Fort Lauderdale, FL, shared data indicating that the StimRouter is a promising treatment for post-stroke shoulder pain patients when compared to the alternative options for pain management.

In a poster presentation, McRoberts shared data from seven patients who were implanted with the StimRouter in an effort to manage their post-stroke shoulder pain. Using the Visual Analog Scale, patients measured pain both before the procedure and up to four months after implant. The patients received care across four different U.S. hospitals in New York, Florida, and Pennsylvania. McRoberts and his colleagues found that PSSP patients implanted with the StimRouter experienced an average of 70 percent reduction in their chronic pain.

On the show floor, a Dallas, TX firm, Lone Star Neuromodulation showed their fully-featured pulse generator that does not utilize an ASIC, which they say equates to significant cost savings and a technology with increased functional flexibility. The firm’s programmable 17-electrode pulse generator, in a 19.5 cc package, is comprised primarily of easily sourced, “off-the-shelf” components. Lone Star CEO Terry Daglow said the company is seeking to sell the technology platform outright at an asking price of $25 million.

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