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A Near Term FDA Clearance That Could Be The Beginning Of The Brain-Computer Revolution?

  • The FDA recently took a big step towards blessing the emerging field of brain-computer interfacing technology, which has broad application in prosthetics and even enhancing the human brain. Visionaries like Elon Musk are betting on the latter happening quickly, and startups like his are designing software and hardware to capitalize on new technology breakthroughs.
  • This field of neurology, sometimes known as neuromodulation, has only recently come into the pubic markets spotlight with companies like electroCore, Inc. (ECOR) and Nuvectra (NVTR) going public with technology that can assuage pain through electric stimulation of the nervous system.
  • NeuroOne Medical Technologies (NMTC) is another newer company entering the electrode and neuromodulation market as they move towards their first potential FDA clearance in the coming months and plan for a second this year. The company is already exploring BCI applications through a new scientific advisory board, and the Mayo Clinic owns 10% of the company. NeuroOne has flown under the radar since going public, but their first FDA clearance could spotlight their technology.

NEW YORK, NY / ACCESSWIRE / March 13, 2019 / Without much fanfare, the Food and Drug Administration just took a key step towards our cyborg future, and it could bring an influx of new investment dollars to neurological device companies.

In February the regulatory agency released guidance [1] for the life sciences industry on the development of innovative ''brain-computer-interface'' devices, a technology that's seen increased investment over the last few years. Elon Musk launched Neuralink, and Braintree founder Bryan Johnson used $100 million to start Kernel. Both companies are exploring how to implant chips in the brain to improve cognition or restore some kind of function loss. Those were the early adopters, and as the WSJ recently reported [2] the FDA's new guidelines are expected to spur a wave of investment in this early field.

NeuroOne Medical Technologies (NMTC) is one of the few public companies that has this nascent industry on their radar. The company develops electrodes and devices for the treatment of neurological conditions, and they created a hard-hitting scientific advisory board in 2018 to work on the potential of their devices in artificial intelligence and brain-computer-interfaces as the field develops. NeuroOne recently filed for their first FDA clearance [3], which could come this spring, and the company will file for a second device clearance with the FDA in the second quarter of 2019 according to SEC filings. That sets up two influential events for NeuroOne in 2019, and as this subsector of the life sciences heats up it could be a breakout year.

HowNeurostimulation and Interfacing Can Improve Lives

For decades humans have been measuring brain activity, and even modifying it with electrical stimulation, to diagnose and treat neurological disorders. One of the older applications of this ''neuromodulation'' technology has been in the treatment of intractable pain by stimulating the spinal and peripheral nervous system, and in particular parts of the brain directly. Deep brain stimulators (DBS), meanwhile, have been used to treat movement disorders like dystonia and Parkinson's, and destroying small amounts of brain tissue can also be used to treat epilepsy.

New and more precise applications are emerging. The implantable devices used for neuromodulation have improved through the use rechargeable systems, smaller hardware, and much-improved battery life/size. The hardware has become smaller, more user friendly for doctors and patient, and more precise in how they interact with the brain. A research report from Markets and Markets project this global neuromodulation market, including deep brain and spinal cord stimulation, to reach $6.20 billion by 2020. [4]

At the fore of this field are those attempting to merge the human brain with computers, like Neuralink and Kernel. Facebook (FB) recently showed a video of an ALS patient typing with her brain, and some companies are experimenting with prosthetics that are controlled by a person's nervous system.

With their February publication and press statement, the FDA is acting early to present a regulatory framework for these new BCI technologies. FDA Commissioner Scott Gottlieb, M.D. said in his press release, ''The idea that a prosthetic could interact with the brain has been the topic of much imagination, but now we're actually on the verge of realizing this opportunity. The FDA has an important role to play by laying out a path for developers on how to seize this prospect and advance the development of new devices.''

NeuroOneLooks For Their First FDA Clearance Soon, A Second This Year

NeuroOne develops a technology portfolio of electrodes and stimulation technology that could be applicable in this new field, and the company is actively evaluating the opportunities through a new hard-hitting scientific advisory board.

In 2018, NeuroOne announced a new artificial intelligence advisory board. Dr. Kip Ludwig, former Program Director for Neural Engineering at the NIH, chairs the board, which will focus on deploying NeuroOne's electrode technology in artificial intelligence and bioelectronics applications. Dr. Cristin Welle of the Univ. of Colorado and a founder of the Neural Interfaces Program at the FDA's Center for Devices and Radiological Health Office of Science and Engineering Labs joined, and Dr. Doug Weber, a recent Program Manager in the Biological Technologies Office (BTO) at DARPA advises the company. The potential for new translational applications in this field is intriguing, and the caliber of these members suggests there's something to the technology.

First, the company is working on their first two medical devices for regulatory clearance and launch. The company filed a 510(k) application to the FDA in January for the clearance of their proprietary cortical strip and grid electrodes for the diagnosis of epilepsy. NeuroOne's electrodes are intended to have increased recording fidelity over older products on the market, have a lower risk of immunological reaction, and ultimately reduce the time it may take to diagnose patients, possibly from weeks down to days with proper use. Testing of this technology was done at the Mayo Clinic, and this health institute is also a 10% owner of NeuroOne's publicly traded stock. This clearance process can take a few months, thus the company has a key inflection event coming up if they get their first device cleared for sale in the U.S.

A second FDA filing is right on its heels as the company hopes to finalize a design and complete testing imminently for their depth electrodes for recording purposes, and they expect to file for FDA 510(k) marketing clearance in the second calendar quarter of 2019. This sets up another possible clearance event in the next 6 months.

NeuroOne has mostly been off the radar for healthcare investors, but 2019 is when they may have their breakout year. Healthcare companies are known for getting more press when they have big events occur, like regulatory approvals, rejections, or trial results. Trovagene (TROV) and Seelos Therapeutics (SEEL) are recent examples, where no one was paying attention and then they were launched into the public eye over a few days.


1. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm631844.htm

2. https://www.wsj.com/articles/connecting-brains-to-computers-expected-to-get-vc-boost-after-fda-move-11551477446

3. https://www.sec.gov/Archives/edgar/data/1500198/000121390019003697/f424b3030619_neuroonemed.htm

4. https://www.marketsandmarkets.com/PressReleases/neurostimulation-devices.asp

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