Neurotech Entrepreneurs and Veterans Meet at 20th Annual Leaders Forum

Staff report

More than 110 neurotechnolgy professionals attended the 20th Annual Neurotech Leaders Forum last month. The hybrid event had a handful of attendees on site in San Francisco, but most participated via Zoom video conference. The two-day conference featured two keynote presentations: Nevro founder Konstantinos Alataris spoke on the first day, and Kernel founder Bryan Johnson spoke with NBR editor James Cavuoto on the second day [NBR Nov20 p2].

The event featured several panel discussions plus two sessions with presentations from neurotechnology industry entrepreneurs. It also featured an editorial roundtable, in which NBR editors James Cavuoto, Jennifer French, Jeremy Koff, and Jo Jo Platt discussed issues such as how the industry can help neurotech investigators wean themselves off government research funding, and what the industry could do to make sure that patients with implanted neurotech devices aren’t left in the lurch if the manufacturer goes out of business.

In his keynote talk, Alataris offered some background on the formation of Nevro Corp. and on some themes that he thinks will guide future innovation in the neurotech industry. In particular, he stressed the importance of learning what waveforms and stimulation frequencies were most relevant but also how you deal with adaptation over time. He also highlighted the value of recruiting neural engineers who could think outside the box. “Having people like that when you’re trying something outside the realm of what the big three companies are doing is very important,” he said.

Without formally unveiling his newest venture, Nēsos, which was announced publicly this month [see article, page 5], Alataris offered some hints as to what the startup would be pursuing. He identified immune function as a key area of development and highlighted the work of Theo Zanos at the Feinstein Institute. He said that the cholinergic anti-inflammatory pathway was something very interesting. “Imagine your brain actually being able to modulate immune function—to me that’s exciting,” he said, tantalizingly.

In a session called “Succeeding from Failure,” a panel of industry observes, including NBR editors Koff and Cavuoto, Medipace CEO Victor Pikov, and former FDA official Tim Marjenin, now at MCRA, shared their perspectives on some notable neuromodulation industry commercial or clinical trial failures. Cavuoto mentioned the Northstar Neuroscience EVEREST trial and the St. Jude Medical BROADEN trial as examples. Koff spoke of multiple failures of trials of occipital nerve stimulation for migraine.

Marjenin shared his perspective having been at the FDA for 16 years, and a branch chief for the last seven years. “I can certainly tell you that within the FDA, attitudes have been evolving over a number of years,” he said. Referencing the risk/benefit guidance at the agency for de novo, PMA, and HDE submissions, Marjenin said that it’s still a learning process. Historically, there has been a lot of emphasis on statistics, he said, but now the approval process is a bit more nuanced. “CDRH is a much different place today than it was prior to 2012,” he said.

A session devoted to obtaining funding in the pandemic era, moderated by NBR senior contributing editor Jennifer French, featured VC professionals Trish Costello from Portfolia and Diana Saraceni from the Italian VC firm Panakes SGR. It also featured Faz Bashi from the Angel Capital Association and Emily Caporello, who directs the NINDS Small Business Programs at the NIH.

Costello created the first VC fund focused on women’s health and 28 of Portfolia’s 29 venture partners are women. She said the pandemic has not changed the way they do business much since they have been using Zoom and other online tools for several years. “You can do as great a deal using digital technology as you could in your conference room on Sand Hill Road,” she said. “In times of chaos like this, instead of ducking and covering, people like us need to step up and back these companies with significant dollars but also with all of the networks and expertise we have.”

Saraceni concurred with Costello, pointing out that as a global investor they have traditionally relied on digital tools. She expressed a preference for therapies that could be used in home-based settings.

Caporello, who took over from Stephanie Fertig earlier this year, oversees a program that funds about $77 million per year to startups in the neurology space. A neurophysiologist by training, she co-founded two small businesses herself and worked previously at DARPA supporting neurotechnology development programs.

A session devoted to the SCS market, moderated by NBR senior consulting editor Jeremy Koff featured Josh Boggs from SPR Therapeutics, Rosana Esteller from Boston Scientific, Michelle Byers-Robson from the American Society of Pain & Neuroscience, and Victor Krauthamer, an adjunct professor at George Washington university and former FDA official.

Boggs said that his company’s Sprint PNS device is designed to be nondestructive and avoid the need for a permanent device. Esteller said that precise mapping and steering were highlights of her company’s SCS offerings. Krauthamer mentioned Public Citizen’s recent report on SCS systems, which claimed that the FDA had been lax with the process of approving PMA supplements. He said that SCS vendors need to describe their models more clearly. But he also said the SCS industry was a lot more open about reporting adverse events than other medical device categories. Byers-Robson said that ASPN was created to enable more collaboration among pain clinicians. She advised SCS vendors to submit as many abstracts as they could to journals and conferences and to collaborate with thought leaders in the neuromodulation space.

A panel devoted to neurotech research labs moderated by NBR contributing editor Jo Jo Platt featured Shadi Dayeh from UC San Diego, Hubert Lim from the University of Minnesota, and Andrew Cornell from the Cleveland FES Center.

Entrepreneur presenters at the 2020 meeting included Karen Crow, the CEO of NeuroGeneces, Robert Renneker, the CEO of X-Nerve, Ian Halpern, the CEO of Modular Bionics, and Andreas Forsland, the CEO of Cognixion.


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