NeuroOne® Medical Technologies Corporation Announces First Human Commercial Use of its Evo™ Cortical Electrode at Mayo Clinic
EDEN PRAIRIE, Minn., Dec. 3, 2020 /PRNewswire/ -- 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.
Forward Looking Statements
"Caution: Federal law restricts this device to sale by or on the order of a physician"
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SOURCE NeuroOne Medical Technologies Corporation
Company Codes: OTC-PINK:NMTC, OTC-QB:NMTC