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News Release - December 3, 2020
NeuroOne(R) Medical Technologies Corporation Announces First Human Commercial Use of its Evo(TM) Cortical Electrode at Mayo ClinicEDEN PRAIRIE, Minn., Dec. 3, 2020 -- (Healthcare Sales & Marketing Network) -- NeuroOne Medical Technologies Corporation (OTCQB: NMTC; NeuroOne), a medical technology company focused on improving surgical care options and outcomes for patients suffering from neurological disorders, announced today the first human commercial use of its Evo Cortical Electrode at Mayo Clinic in Rochester, Minnesota.
The procedure was performed by Jamie Van Gompel, M.D., from November 23rd through November 27th on a patient that had drug resistant epilepsy and utilized the NeuroOne Evo electrode technology to perform recording, functional mapping and stimulation of the brain. Three NeuroOne electrodes were also used in addition to four Ad-Tech Medical electrodes during the procedure. In addition to recording a seizure, the NeuroOne electrodes also recorded evidence of pre-seizure activity which may be critical in developing treatments to prevent the onset of seizures.
Dr. Van Gompel stated, "Thin film electrode technology has been in development for years and in addition to its thin film, light weight properties, the electrodes also conformed very securely to the brain. The recordings were sharp and clearly noted evidence of pre-seizure activity. We were also able to visualize the brain under CT imaging which was very useful. We are very excited to continue to explore the potential clinical advantages of this technology for our patients," said Dr. Van Gompel, one of the co-developers of this technology.
Dave Rosa, president and CEO, NeuroOne, says, "After years of development it was exciting to witness the initial validation of our Evo cortical electrode technology at Mayo Clinic. We are grateful to all the institutions that helped provide valuable guidance along the way and look forward to making our technology available to a multitude of centers through our distribution and development partner Zimmer Biomet. We hope to add to this line next year with a family of sEEG electrodes that offer a similar feature set as the Evo cortical product portfolio."
Evo Cortical Electrodes, intended for recording, monitoring and stimulating brain tissue for up to 30 days, may have the potential to change the landscape of neurosurgical procedures offering potential benefit to both physicians and patients. The technology utilizes sophisticated automated manufacturing processes and offers several advantages including a thin-film lightweight design, high resolution capabilities, reduced immunological response—as demonstrated in a pre-clinical study—and the potential to be placed in a minimally invasive manner.
NeuroOne received FDA clearance for its Evo cortical technology in November 2019. It plans to submit a second 510(k) application for its sEEG electrode technology in the first half of 2021 to bolster its product portfolio for use in recording, monitoring and stimulating brain tissue for up to 30 days. In addition, the Company continues developing therapeutic electrodes for use in Parkinson's Disease, epilepsy and back pain due to failed back surgery.
In partnership with Mayo Clinic, Wisconsin Alumni Research Foundation (WARF) and other prominent academic medical centers, the Company began developing its cortical electrode technology in 2015. The Company initially focused its efforts on the epilepsy and intraoperative tumor monitoring markets. NeuroOne intends to continue to develop the technology for use in therapeutic applications for Parkinson's disease, epilepsy and pain management due to failed back surgery procedures.
In July 2020, NeuroOne executed a distribution and development agreement with Zimmer Biomet that provides exclusive rights to distribute NeuroOne's current Evo cortical electrodes and its sEEG electrode product line once it has received FDA clearance.
Mayo Clinic and Dr. Van Gompel have a financial interest in the technology referenced in this news release. Mayo Clinic will use any revenue it receives to support its not for profit mission in patient care, education and research.
NeuroOne Medical Technologies Corporation is a developmental stage 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, dystonia, essential tremors, chronic pain due to failed back surgeries and other related neurological disorders that may improve patient outcomes and reduce procedural costs. For more information, visit https://www.n1mtc.com.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Except for statements of historical fact, any information contained in this presentation may be a forward–looking statement that reflects NeuroOne's current views about future events and are subject to known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. In some cases, you can identify forward–looking statements by the words "may," "might," "will," "could," "would," "should," "expect," "intend," "plan," "objective," "anticipate," "believe," "estimate," "predict," "project," "potential," "target," "seek," "contemplate," "continue" and "ongoing," or the negative of these terms, or other comparable terminology intended to identify statements about the future. Forward–looking statements may include statements regarding the timing and extent of product launch and commercialization of the technology, business strategy, market size, potential growth opportunities, plans for product applications and product development, future operations, future efficiencies, and other financial and operating information. Although NeuroOne believes that we have a reasonable basis for each forward-looking statement, we caution you that these statements are based on a combination of facts and factors currently known by us and our expectations of the future, about which we cannot be certain. Our actual future results may be materially different from what we expect due to factors largely outside our control, including risks that the partnership with Zimmer Biomet may not facilitate the commercialization or market acceptance of our technology; risks that our sEEG electrodes may not be ready for commercialization in a timely manner or at all; risks that our technology will not perform as expected based on results of our pre-clinical and clinical trials, our ability to raise additional funds, uncertainties inherent in the development process of our technology, changes in regulatory requirements or decisions of regulatory authorities, the size and growth potential of the markets for our technology, clinical trial patient enrollment, the results of clinical trials, our ability to protect our intellectual property rights and other risks, uncertainties and assumptions, including those described under the heading "Risk Factors" in our filings with the Securities and Exchange Commission. These forward–looking statements speak only as of the date of this press release and NeuroOne undertakes no obligation to revise or update any forward–looking statements for any reason, even if new information becomes available in the future.
"Caution: Federal law restricts this device to sale by or on the order of a physician"
Source: NeuroOne Medical Technologies
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