Neuromodulation Professionals Convene in Australia for INS 2019 Meeting
by James Cavuoto, editor
About 1200 clinicians, neural engineers, and neuromodulation industry professionals attended the INS 14th World Congress in Sydney, Australia earlier this month. The meeting, produced by the International Neuromodulation Society, was the first one conducted in Australia.
A preconference session called Innovations in Neuromodulation featured presentations by four early-stage firms, three intermediate-stage firms, and five of the six major players in the spinal cord stimulation market (Nevro chose not to participate). In an opening keynote Josh Makower from VC firm NEA said there was a role for understanding fundamental mechanisms of action for new therapies. He pointed out an often-overlooked signal “right in front of our noses,” the placebo effect. “The placebo effect is a cue that neuromodulation can have a clinical effect on a disease state,” he said. Makower referenced two studies that indicated that the effect is moderated by the autonomic nervous system.
Sjaak Deckers, CEO of the European firm GTX medical, gave an update on the company’s targeted epidural spinal stimulation therapy for SCI pioneered by founder Gregoire Courtine at EPFL. He said that the company’s unique stimulation paradigm, which uses closed-loop feedback and alternates bilateral delivery, can induce growth of new axons at the site of the injury. GTX has implanted 10 chronic SCI patients to date, the last three of which are using the company’s proprietary leads and programmer. The company has raised €36 million to date and is planning a €35 million B round later this year. Deckers reported that there are more than 1000 users on a waiting list to participate in a trial.
Song-Song Liao, the interim CEO of a startup called Aldans Health, described her firm’s noninvasive therapy for traumatic brain injury. The device uses hi-frequency, low-strength magnetic stimulation with gamma rhythm burst embedded in a pillow. Patients would use the device for 20 minutes per day to reverse neurological deficits caused by TBI.
Stephen Popielarski, CEO of a Philadelphia startup called Thermaquil, described his firm’s parallel efforts to develop nerve block technology. One approach uses alternating cooling and heating of nerves to suppress activity without causing neuronal damage. Another approach, derived from the work of Changfeng Tai at Pitt, uses a novel paradigm of high-frequency stimulation. The company is looking for potential licensing agreements with neuromodulation device vendors.
Jonathan Ruais from Nalu Medical described his firm’s compact implanted neurostimulation system. Because the RF-powered device lacks a battery, the implanted stimulator occupies a small fraction of the volume of other IPGs—about the size of four dimes. The externally worn controller can generate a variety of waveforms that the user can control with a smartphone. The company believes that the size and convenience of the system could help increase the percentage of chronic pain patients who become SCS users by about 50 percent.
Chad Andresen from StimRelieve, a unit of StimWave dedicated to occipital nerve stimulation, gave attendees a recap of previous failed ONS trials over the last 15 years and explained how his firm’s injectable device was poised to succeed. The RF-powered therapy does not require tunneling down the neck to an IPG or excessive incisions. Two patients in an occipital neuralgia study reported complete pain relief, Andresen said.
In the session devoted to advanced stage companies, Keith Boettiger from Abbott said the industry needs to understand the psychology of the patient, not just their physiology. “People don’t want to be reminded that they have a chronic disease,” he said. That factor, plus the finding that rechargeable devices are explanted at double the rate of primary-cell SCS devices, leads Abbott to argue against rechargeable systems. Taking a cue from the pharmaceutical industry, Abbott adopted the strategy of using the lowest effective dose for the shortest period of time. That approach could increase longevity of primary-cell SCS from seven to 10 years, Boettiger said.
Marshall Stanton, head of Medtronic’s pain therapies business, offered advice to neuromodulation entrepreneurs approaching large strategics. He advised startups to show off a credible leadership team, including a CMO that comes from the field. When meeting with a company like Medtronic, the CEO shouldn’t answer every question. “Let your team show their experience,” Stanton advised. He also said startups should show a business plan that’s going to “move the needle” for a $10 billion firm. A $10 million market opportunity is not enough.
Paul Hanchin, president of Nuvectra Medical, built the case with attendees for why there was room in the market for a competitor to the big four players. “Are any of the other four offering a panacea?” he asked. “Unmet needs have gone unanswered for two decades.” Nuvectra intends to improve outcomes through product design, Hanchin said, like a 1-mm thick paddle lead instead of a 2-mm lead.
Dirk De Ridder from the University of Otago in New Zealand opened the scientific program with a novel model of brain function that might inform future targeting decisions. Nir Grossman from Imperial College London described his team’s noninvasive DBS alternative using temporal interference [NBR Nov16 p1].
Lawrence Poree from UC San Francisco presented results from Saluda’s Evoke randomized, double-blind, pivotal trial comparing open-loop to closed-loop stimulation in 134 subjects. Closed-loop participants responded at an 82.3 percent rate compared to 60.3 percent for open-loop participants.
At the meeting, a Cambridge-UK firm called BIOS announced findings for its research in which it was able to automatically extract the neural signals regulating physiological biomarkers using an AI-enabled neural interface. This advance creates a new way of investigating conditions, accelerates the discovery of neural biomarkers, and opens the door for a new generation of AI-based neural healthcare treatments.