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FDA Events Can Send Stocks Soaring: Here's One That No One Is Talking About

  • Biogen's (BIIG) latest clinical trial failure is a testament to the difficulty in developing drugs for Alzheimer's, which is littered with failures in the last ten years. But other neurology fields have seen major advances recently, one of the leading being with medical devices that use electrical stimulation to improve pain, migraines, movement disorders, and even Parkinson's, and epilepsy.
  • These neurostimulation companies have come to the public markets en masse, with NVRO, NVTR, and ECOR all going public with large market values and stock prices based on moderate sales figures for their ''neuromodulation'' devices.
  • Another small company in the industry could be about to join them with their first commercial device, and few investors are paying attention. NeuroOne Medical Technologies Inc. (NMTC) submitted their first approval application, for a new electrode technology, to the FDA in January and could hear back on this regulatory approval any day. They have a second device they hope to submit to the FDA in Q2, setting up another close possible regulatory clearance. As such, it's on the cusp of joining these bigger players with a compelling commercial-ready device, with more neurology devices in the pipeline. As they join these larger peers with a commercial, approved product, 2019 could be their coming out year.

NEW YORK, NY / ACCESSWIRE / April 2, 2019 / It's been a tough year for the biggest neuroscience biopharma player Biogen (BIIB), and their recent trial failure in Alzheimer's is just one in a long string of blowups around that tough condition. Axovant Sciences' (AXGT) highly anticipated trial of inteperdine failed in 2017, Eli Lilly (LLY) had a failure in 2016, and Neurotrope (NTRP) and vTv Therapeutics (VTVT) are some of the few remaining companies with new mechanisms under development.

But companies with medical devices focused on the nervous system are taking off. ElectroCore (ECOR) and Nuvectra (NVTR) are making progress with new devices that modulate the nervous system with electrical pulses to achieve pain relief. These companies are worth over $200 million in market value each based on early sales with their respective devices, and the market opportunity is immense including the many potential applications for similar technology.

These neuromodulation devices are also commonly used in the treatment of movement disorders, epilepsy, Parkinson's disease, chronic pain, and even depression, sometimes externally and sometimes internally through deep brain stimulation (DBS). The global neurostimulation devices market was valued at $5 billion in 2016 according to Global Markets Insights. [1]

Another neuro device company NeuroOne Medical Technologies Inc. (NMTC) is moving towards their first potential FDA clearance in the coming weeks or months in the same field, and they have bold plans to grow their portfolio of devices in 2019. First, they've submitted an FDA application for a new type of electrode, backed by the Mayo Clinic as a 10% owner of NeuroOne Medical, and they're projecting a second FDA filing in Q2 of 2019. It's a company worth watching as the comparable peers are so much larger, and the company is just getting off the ground with a strong team and potentially their first commercial product - and sales - in 2019.

Electrodes And Neuromodulating Devices A Growing Field

Grand View Research put the global market for electrodes for medical devices - NeuroOne's first focus - at $775.8 million in 2016, and expected to grow at a CAGR of 11.3% through 2025. [2] Electrodes are used for measuring electrical pulses, primarily in cardiology and neurology in the medical field. They play a key role in diagnosing all sorts of neurological conditions, like Parkinson's and Epilepsy. More than 10 million people suffer from Parkinson's disease worldwide, with over 1 million in the U.S. according to the Parkinson's Foundation. [3] Epilepsy affects about 2.2 million people in the U.S. alone and is the 4th most common neurological condition according to the Epilepsy Foundation. [4] It's no wonder that this is such a big market.

The technology behind electrodes hasn't advanced much in the last few decades, although the technology they support has - like neuromodulation products. Small phone-like devices are allowing people to monitor heart conditions at home while newer deep brain stimulation (DBS) devices can be fully implanted in a Parkinson's patient - battery and all - to help improve their symptoms through electrical pulses strategically delivered to the brain. Normally, DBS is reserved for people with late-stage symptoms of Parkinson's as medications have less effect, especially in the hallmark tremors of the disease, but more recent advancements have doctors postulating that they can use them earlier in the disease to slow progression. [5]

NeuroOne May Have The Tech And Team To Capitalize

Even as the technology around neuromodulation has improved, electrodes themselves haven't seen much advancement. NeuroOne Medical Technology (NMTC) has a new solution that could meet some of other electrode tech's shortcomings, and their technology portfolio could provide broad solutions to some of med device's sticking points.

The caliber of leadership attached to the company is intriguing. Their scientific advisory board includes Mayo Clinic's Greg Worrell MD, PhD and Gregory J. Esper, MD, MBA of Emory University. More recently, Dr. Kip Ludwig, former Program Director for Neural Engineering at the NIH, became chair of the company's new "artificial intelligence" advisory board. Dr. Doug Weber, a Program Manager in the Biological Technologies Office (BTO) at DARPA also joined, plus Dr. Cristin Welle of the Univ. of Colorado, a founder of the Neural Interfaces Program at the FDA's Center for Devices and Radiological Health Office of Science and Engineering Labs.

NeuroOne's sheet and depth electrode technology has been tested and developed over the years by the prestigious Mayo Clinic and the Wisconsin Alumni Research Foundation (WARF). The Mayo Clinic is a 10% owner of NMTC's common stock, an apparent vote of confidence that the tech may have a future.

That's because NeuroOne expects their first technology to provide some advantages over older competition when used in neurological diagnoses, like in their first target market epilepsy. They hope to reduce the diagnostic time with smaller, more accurate readings and to eventually be able to implant using a minimally invasive procedure rather than a full craniotomy. In limited human testing, doctors at Mayo Clinic were able to document pre-seizure activity (micro-seizures) during their research using the company's technology. [6]

This is the first tech that NeuroOne is bringing through the pipeline, but they're hoping to bring a whole suite of neurology focused medical devices through development in the next 2-3 years. The first are these cortical strip and grid electrodes, followed by depth electrodes in the second quarter of 2019, according to their recent guidance. A minimally invasive delivery system is slated for testing in the first half of this year, and a depth electrode diagnostic and ablation device, to address the symptoms of epilepsy, are planned for testing in 2019 as well.

What's Next?

NeuroOne made their first 510(k) submission for their cortical electrodes at the end of January 2019, according to SEC filings, and this is typically a 90-day process or less. They could have their first FDA clearance in the coming weeks or months if this timeline holds, which would be a major clearing event for the company. They're also expecting to submit their second 510(k) during Q2, thus by the middle of this year they could have two FDA cleared devices ready for their sales team to take out.

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1. https://www.gminsights.com/industry-analysis/neurostimulation-devices-market-report

2. https://www.grandviewresearch.com/industry-analysis/electrodes-medical-devices-market

3. https://www.parkinson.org/Understanding-Parkinsons/Statistics

4. https://www.epilepsy.com/learn/about-epilepsy-basics/epilepsy-statistics

5. https://www.wndu.com/content/news/Deep-brain-stimulation-calms-Parkinsons-tremors-507366591.html

6. https://www.sec.gov/Archives/edgar/data/1500198/000121390019002106/fs12019_neuroonemedical.htm

SOURCE: One Equity Stocks, LLC

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