Industry Veterans and Newcomers Take Part in 2015 Neurotech Leaders Forum

by Jennifer French, senior editor

About 85 thought leaders, executives, entrepreneurs, and policy makers gathered at the 15th Annual Neurotech Leaders Forum in San Francisco, November 2-3. This unique forum is a platform for lively discussions around the array of management, investment, and technical issues confronting the growing neurotechnology industry.

The first day of the conference focused on reflection of the year past and discussion of where the industry is going. James Cavuoto, editor of this publication, kicked off the event with an overview of the state of the industry including the significant events of 2015 such as the merger of Cyberonics with Sorin, the regulatory approval of Nevro’s Senza device, and the Stimwave Freedom 4. He also highlighted the numerous venture capital and industry investment activity as well as the emerging competitive segments of the industry leading to the forecasts of the neurotechnology industry into 2020.

Not only is the technology transforming, but the regulatory agencies are as well. This was evident in the presentation provided by Carlos Pena, director of the Division of Neurological and Physical Medicine Devices at the FDA, in which he provided an oversight of how to navigate the regulatory landscape of the agency. Pena described how the FDA, often identified as a bottleneck for industry, is modifying its processes to speed medical innovation and amending the focus for post market surveillance. To that end, the agency is striking a balance between pre-market and post-market data collection. He also highlighted the guidance programs to help industry move devices through the submission procedures toward approval. The agency has set a goal of targeting 30 days for full IDE study approval. The FDA is also hosting more public workshops such as those held on November 19-20 for neurodiagnostic and non-invasive brain stimulation medical devices.

This was not only a time to look forward, but also to reflect the roots of the industry. Jeremy Koff of Colibri Partners delivered a tribute to his uncle Alfred Mann and his impact on the industry over the past 60 years. From the invention of the MiniMed device to the commercialization of the retinal implant, the Mann Foundation has been a driver of innovative solutions that tackle significant unmet medical needs. Rounding out this discussion was Robert Greenberg of Second Sight Medical Products, an AMF spinoff company, and Daryl Kipke of NeuroNexus, each providing their perspectives on moving technical innovations from the laboratory into the marketplace.

The panel discussion on investment included both public and private sources of funding. Stephanie Fertig, director of the NINDS Small Business Program, highlighted the Innovation Research and Technology Transfer programs as well as the emergence of new programs ignited by the BRAIN Initiative such as the SPARC program. Imran Eba of Action Potential Venture Capital, a GSK investment company, discussed the direction of the ElectRx program and John Kim of Aphelion Capital provided his insight on key factors for medical device companies that VCs consider such as the reimbursement pathway.

Innovation was the topic for the afternoon sessions of day one. Mark Stultz of SPR Therapeutics kicked off the Entrepreneur Panel showcasing the single-lead PNS device targeting post-stroke shoulder pain, nerve pain from amputation, as well as acute pain management related to joint replacement surgeries. Marcelo Lima of ImThera highlighted the unmet needs of people suffering from sleep apnea and gave an update of their implantable THN sleep therapy neurostimulation device. Alexandria Haessler presented the new noninvasive device from FemPulse for female incontinence. It is a small vaginally inserted gold-plated ring of electrodes that can be individually programmed by a physician and managed by the user through a smart phone app.

The remaining panel discussions about advancements featured Todd Cushman, CEO of Bioness, and Andrew Cornwell of the Cleveland FES Center, with the forthcoming new release of redesigned devices and the advancement of the implantable network neural prosthesis, respectively. They each provided their insight on the direction of the neurorehabilitation and neural prosthetic marketplace. Margot Puerta, editor of Bioeletronic Medicine, led the discussion on exploring the future, featuring Dan Rizzuto about memory restoration and the identification of neural biomarkers for future brain neuromodulation.

Day two also featured neurotechnologies for the brain but focused on the noninvasive and direct to consumer market. A.K. Pradeep of Smilables delivered a thoughtful and, in some views, controversial talk about stimulating infant brain development. Noninvasive brain stimulation of adults is a rapidly growing space as Blake Gurfein of Rio Grande Neurosciences pointed out along with the alphabet soup of devices, rTMS, tPEMF, and closed-loop TES.

Although these devices are delivered in the clinic, there is a transition of neurotech firms into the consumer wellness space. Chris Berka of Advanced Brain Monitoring, a traditional research- and industry-focused company, demonstrated their entry into the consumer market with a wearable sleep apnea device. Similarly, Walter Greenleaf presented the new application offered by Pear Therapeutics to improve dosage management for psychiatric and addiction disorders.

From using EEG signals to improve diagnoses of the brain (Neuro Assessment Systems) or to improve the efficiency of learning (Nervanix) early entrants are elbowing for position in the marketplace. The Brainwave Optimization device offered by Brain State Technologies reads signals from the brain in order to calibrate audio signals circling back to the consumer. The DOT mobile app from Dynofit uses EMG biofeedback to enhance the rehabilitation process. The variety of devices are entering a turf war for the attention of the end-user.