May 2017 issue
May 31, 2017 | Clinicians, neural engineers, and researchers from across the globe attended the 13th World Congress of the International Neuromodulation Society in Edinburgh, Scotland earlier this month. The meeting included a preconference session devoted to noninvasive brain stimulation on May 27 and another devoted to innovations in neuromodulation on May 28.
The theme of the innovations session was “The Challenge of Reimbursement: Can We do Things Smarter?” In the opening session, INS past president Simon Thomson interviewed Axonics Modulation CEO Ray Cohen. Cohen stressed the need for competition and innovation in the space. “Affordable pricing is a critical element these days,” he said. “We have to be on the right side of history.” Cohen said that obtaining reimbursement for a neuromodulation device is achievable if you can demonstrate that you can save the system money. “Long gone are the days when you can have a large premium on your product,” he said.
Cohen also advised startups to avoid the pressure from investors to move their product to the clinic too soon. “Don’t take prototypes to clinical trials,” he admonished. On the other hand, he cautioned entrepreneurs not to bite off more than they can chew in a clinical trial. “The perfect study requires more capital and more risk than is appropriate,” he said. “You have to apply some judgement.”
Another serial entrepreneur, Peter Crosby of Mainstay Medical, highlighted a fundamental challenge in obtaining reimbursement. Entrepreneurs who are not content with building a better mousetrap but instead seek to build an elephant trap in a market where people don’t know about elephants face an uphill battle. The reimbursement system is designed to prevent new categories of products, he said
Crosby called on clinicians to help entrepreneurs explain to agencies the unmet clinical need that a new therapy offers. He also said it’s important for clinicians to speak with one voice. “It’s not good for the pain society to argue with the spine society or the neuromodulation society,” he said.
Founders and executives from several neurotech startup firms presented new modulation therapies during the innovations day. These included Luca Ravagnan, CEO of WISE Srl, who described his firm’s stretchable and flexible electrodes, and Chi-Heng Chang, general manager of Taiwanese firm GiMer Medical, which is developing an ultra high frequency SCS system based on pulsed RF stimulation of the dorsal root ganglion. GiMer’s device is compact and lacks a battery. Chang said that a five-minute treatment session with an external power accessory provides three or more days of pain relief without paresthesia. The company is looking for a marketing partner in the U.S.
Sjaak Deckers, CEO of G Therapeutics, described his firm’s epidural stimulation system to restore function to individuals with paralysis from spinal cord injury. “We provide stimulation at the right place and the right time,” he said, in contrast with some U.S. researchers who deliver continuous stimulation. In addition to the company’s Go-2 implanted device, G Therapeutics is developing a body weight support system that paralyzed individuals will use during the process of functional recovery.
Daniel McDonnall, president of Ripple, described his company’s efforts to develop a blink prosthesis for individuals with facial paralysis. The device is inductively powered and incorporates a conductive polymer electrode and an EMG sensor applied to the contralateral eyelid for timing and synchronization of stimulation. Other firms presenting at the preconference meeting were BlueWind Medical, Bioinduction Ltd., which is developing a skull-mounted DBS system, and NeuroNano Inc., a Swedish firm working on biocompatible neurotech components. John Donoghue from the Wyss Center in Switzerland gave an overview of the organization’s neurotechnology efforts.
At the meeting, Saluda Medical announced that it secured $40 million in an all-equity financing round led by new investor, Action Potential Venture Capital, a GSK fund that invests in companies developing bioelectronic medicines. Existing investors, including Medtronic, also participated in the round. Saluda’s Evoke SCS system is designed to use the patient’s own neural fingerprint to monitor and adapt the dose of electrical stimulation automatically and tailor the therapy to meet each individual patient’s needs in real-time.
Marc Russo from the Neuromodulation Society of Australia and New Zealand presented long-term clinical data from the first chronic implant study of closed-loop SCS conducted in Australia. At six months, subjects with axial back pain experienced an average sustained improvement of 80 percent relief. In addition, the 32-patient cohort showed clinically meaningful improvements in function, disability, and sleep. The data from the Australia clinical study was presented in the morning plenary session on May 29th as part of a larger program on evoked compound action potentials in neuromodulation that included lectures from Robert Levy, editor-in-chief of the journal Neuromodulation: Technology at the Human Interface, Timothy Deer, president of the INS, and Jan Vesper, president of the German Neuromodulation Society. This latest round of funding will support the current U.S. pivotal randomized, double-blinded clinical trial now enrolling patients at 11 sites across the country.
Stephanie Tran, a neuroscience master’s candidate at the University of British Columbia, submitted results of a study that showed non-invasive galvanic vestibular stimulation improved postural stability in 13 patients with Parkinson’s disease. Vestibular stimulation had been shown to affect motor responsiveness in individuals with neurodegenerative disease. She tracked patients’ degree of sway as they stood with their eyes closed, taking measurements while they were on their normal medication to target treatment-resistant symptoms. She compared two stimulation directions and found stimulation from the middle to side was particularly helpful in the patients. By contrast, the stimulation did not change measurements nine healthy control subjects.
