Emerging Markets Report - NeuroOne Medical Technologies Receives FDA 510(k) Clearance
ORLANDO, Fla., Jan. 21, 2020 (GLOBE NEWSWIRE) -- For investors seeking outsized growth, Life Sciences--the more speculative end of the healthcare sector--is certainly one sub-industry that’s hard to beat. Granted, investments in this space might carry a greater degree of risk, but that can be said of almost any prospect in an emerging high-growth industry. When it comes to Life Sciences, the demand for innovation is arguably a key factor. The capacity to disrupt standard industry practice is a critical element that investors focus on to determine a company’s potential for success or likelihood of failure.
But no matter how innovative a company in this space may be, or no matter how well-managed its operations, regulatory clearance is the gatekeeper to a product’s commercial entrance or endpoint. So, when a company receives FDA clearance--the green light that allows a company to commercialize its product--it’s a big deal.
Among the latest emerging healthcare companies to gain FDA clearance is NeuroOne Medical Technologies Corporation (OTC: NMTC), a medical device company committed to providing minimally invasive and hi-definition solutions for EEG recording, brain stimulation and ablation solutions for patients suffering from Epilepsy, Parkinson’s Disease, Essential Tremors and other related neurological disorders such as back pain that may improve patient outcomes and reduce procedural costs.
Turning Brain Signals Into Actionable SolutionsNeuroOne specializes in developing electrodes to record, stimulate, or ablate sections of the brain. Designed as a minimally invasive solution, NeuroOne’s devices are focused on treating and diagnosing patients who suffer from neurological conditions such as epilepsy, essential tremors, Parkinson’s disease, dystonia, pain from failed back surgeries and potentially any pain caused by nerve damage.
For investors who are unfamiliar with this medical practice, neurostimulation works by altering brain signals. It modulates activity in the nervous system. A specialized discipline in the medical industry, neurostimulation exists in many forms, from cochlear implants to deep brain stimulation.
As a therapy for patients suffering from Parkinson’s disease, epilepsy, and dystonia (among others), the use of neurostimulation is still a relatively new field. The problem is there has been zero innovation in electrode therapy in the marketplace for many years. All the focus has been on the impulse generator and software creating a gap for the device that is actually in contact with the problematic area of the body. NeuroOne’s technology is scalable meaning the technology is capable of increasing the number of contacts on a footprint that today has fewer (but larger) contacts. In essence, an electrode today that has 16 contacts could be increased in multiples by making the contacts smaller. This allows the surgeon more precision in what he stimulates, records or ablates.
In limited trials, the Mayo Clinic was able to successfully document pre-seizure activity in epileptic patients using NeuroOne’s technology. The Mayo Clinic tests were conducted as part of a licensing and development agreement between the two companies--a partnership that constitutes a significant first step toward NeuroOne’s commercial adoption.
NeuroOne’s Receives FDA 510(k) Clearance for Its Evo Cortical Electrode Device
On December 2, NeuroOne announced that it received 510(k) clearance from the US Food and Drug Administration (FDA) to begin marketing its Evo Cortical Electrode device for the purpose of short-term brain stimulation, monitoring, and recording.
For those of you who might not be familiar with this term, a 510(k) is a technical document detailing technical, performance, and safety information for a given product. The FDA must review a company’s 501(k) submission and “clear” its product prior to a company commercializing the technology.
NeuroOne’s now-cleared Evo Cortical Electrode product line is the culminating result of the company’s collaboration with the Mayo Foundation and the Wisconsin Alumni Research Foundation, another institution to which the company has an exclusive licensing agreement.
“This is certainly a monumental achievement for the Company,” says Dave Rosa, NeuroOne’s President and CEO. “This 510(k) clearance is a critical step in executing our corporate strategy, and we look forward to working towards our goal of applying this platform to a variety of other devices for recording, monitoring and stimulation for various therapeutic applications such as epilepsy, Parkinson’s Disease, spinal cord stimulation and artificial intelligence.”
NMTC Currently at Market LowsHaving been granted the regulatory green light to begin bringing its product line to market, NeuroOne’s stock is still ranging within its lows (currently at around $2.45 per share). This shouldn’t come as a surprise, as the emerging healthcare space is often too specialized a sub-industry for most mainstream investors to monitor let alone understand.
But for the few who can grasp both the relevance and growth potential of NeuroOne’s product line, the company offers early investors an opportunity to get in on a much-needed medical product that, to date, sees neither comparable solutions nor formidable competition.
About NeuroOne:NeuroOne Medical Technologies Corporation is a medical technology company focused on providing minimally invasive and high-definition solutions for EEG recording, brain stimulation and ablation solutions for patients suffering from epilepsy, Parkinson’s disease, essential tremors, dystonia, back pain and other related neurological disorders that may improve patient outcomes and reduce procedural costs.
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