EDEN PRAIRIE, Minn., Sept. 23, 2021 /PRNewswire/ -- NeuroOne Medical Technologies Corporation (Nasdaq: NMTC) (NeuroOne or the Company), a medical technology company focused on improving surgical care options and outcomes for patients suffering from neurological disorders, today announced that it successfully completed an animal feasibility study of its combination recording and ablation technology at T3 Labs and Georgia State/Georgia Tech Center for Advanced Brain Imaging in Atlanta Georgia under the guidance of Dr. Robert Gross of Emory University. The study evaluated the ability of the NeuroOne Evo® sEEG electrodes to record brain activity and then ablate brain tissue using radiofrequency thermocoagulation in a porcine model.
The Evo ablation electrode represents the Company's first development effort for therapeutic technology and is expected to be the next product offering in its portfolio pending FDA clearance. The product is designed to provide the ability to both identify problematic areas of the brain causing seizures as well as ablate brain tissue to alleviate these symptoms. This would represent a major advancement in neurosurgery, given that patients must first undergo the diagnostic surgery and then schedule a future second surgery to ablate the problematic tissue.
Dr. Robert Gross of Emory says, "This pilot study will provide important data to inform the development of this technological solution that has the potential to improve treatment efficacy and patient comfort."
"We are encouraged and excited by the results of this animal feasibility study. This technology offers the potential to perform two separate procedures using the same device during one hospital stay which we believe is a safer and more cost-effective approach for both the patient, health care provider and health care facility. Today, a patient often needs to have two separate hospitalizations for two separate surgeries typically with months between both procedures. Coupled with our recent partnership with RBC Medical to develop the radio frequency hardware, we are excited about the potential to offer a complete system for our customers" says Dave Rosa, CEO of NeuroOne.
Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.
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 .
The Company previously announced it had successfully met the first performance milestone in the distribution and development agreement signed with Zimmer Biomet on July 20, 2020. In addition to acquiring exclusive global distribution rights to NeuroOne's Evo® (Evo) patented electrode technology, the partnership also offered the potential for NeuroOne to earn back-end milestone payments if certain events were met within a specified time frame.
NeuroOne received FDA clearance for its Evo cortical technology in November 2019. The Company recently announced an FDA clearance for its Evo sEEG electrode technology for temporary (less than 24 hours) use with recording, monitoring, and stimulation equipment for the recording, monitoring, and stimulation of electrical signals at the subsurface level of the brain, and expects to be launch ready by the end of calendar year 2021, pending additional regulatory clearance of sEEG labeling for longer term use.
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.
Forward Looking Statement
This press release may include 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 the Company'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 Company's regulatory submissions, potential regulatory approval of the Evo ablation electrode , commercialization of the Evo ablation electrode, 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 the Company 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 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, our ability to serve those markets, the rate and degree of market acceptance of our products, clinical trial patient enrollment, the results of clinical trials, future competition, the actions of third-party clinical research organizations, suppliers and manufacturers, 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 the Company undertakes no obligation to revise or update any forward–looking statements for any reason, even if new information becomes available in the future.