April 22nd, 2016 | BioSpace —
LEXINGTON, Ky., April 21, 2016 /PRNewswire-iReach/ — Nexeon MedSystems Inc (“Nexeon”) announced today that it has acquired a portfolio of neuromodulation patents from NeuroTek Medical, Inc. (“NeuroTek”). NeuroTek was founded by inventor and neuroengineer Alejandro Covalin, PhD, and was a 2013 graduate of the Health Wildcatters program, a mentor-driven seed accelerator focused on improving healthcare.
The NeuroTek portfolio includes innovations related to electrode design and occipital nerve stimulation for the treatment of migraine headaches. Nexeon has existing research programs using similar technology to treat cardiovascular disease, cognitive enhancement, and sepsis; the NeuroTek platform will accelerate and enhance the clinical studies associated with these programs.
In the U.S. alone, more than 45 million people suffer from headaches so severe they seek medical intervention. According to the American Migraine Foundation, pain from migraines alone costs the U.S. more than $20 billion each year. These costs are attributed to direct medical expenses, including doctor visits and medications, as well as indirect expenses, such as missed work and lost productivity.
The NeuroTek device, TONES, is a battery-operated, externally-worn device that stimulates the nerve at the base of a patient’s head. The investigational device is currently being evaluated in a clinical trial for efficacy for both preventive and abortive treatments of migraine headaches while also undergoing final engineering and go-to-market design development. After successful completion of the trial and subsequent FDA clearance, the product will be available to patients in the U.S.
“With this acquisition, Nexeon is well-positioned to have a significant impact in the migraine market,” said Dr. Hubert Zajicek, CEO of Health Wildcatters. “In the headache treatment space, there is a definitive need for non-invasive pharma-alternatives. TONES is undergoing a rigorous clinical trial and engineering development protocol to facilitate FDA clearance, and ultimately, increase patient access to this therapeutic option.”
With this transaction, Covalin will transition from his role at NeuroTek to join Nexeon as Chief Scientific Officer. His background is in physics and biomedical- and neuro-engineering, with more than 15 years of experience in research and development in medical devices. As an inventor on 12 neuromodulation patents, he has served as a consultant in the medical device industry for the last decade, with his most recent role as a consultant for Medtronic and a large pharmaceutical in S. California; he was also a Senior Scientist for CVRx.
“Nexeon has the infrastructure and experience to launch this device successfully,” Covalin said. “We will continue the clinical and engineering momentum we gained while developing TONES at NeuroTek. I am confident that we will have this device in the market by 2017 as we also prepare other Nexeon products for late-stage R&D prior to commercialization.”
About Nexeon MedSystems Inc: Nexeon MedSystems was founded in 2005 by medtech-innovator and interventional cardiologist Dr. Mark C. Bates of West Virginia. Dr. Bates is attributed to innovation of over 60 US and international patents, and over the past decade, Nexeon has experienced several exits and product launches. In early 2016, Nexeon completed a merger with a division of medtech incubator Rosellini Scientific LLC, which brought with it a pipeline of preclinical and clinical projects supported with non-dilutive funding as well as holdings in several existing medtech startup companies. Nexeon has since moved its corporate headquarters to Lexington, Kentucky, and plans to continue the development of its portfolio of medical device products.
About Health Wildcatters: Health Wildcatters, the leading healthcare accelerator in the Southwest, focuses on healthcare innovation, and its first class featured 12 startups, including NeuroTek Medical. Startups receive up to $35,000 in seed money as well as mentors, connections, and other resources. In exchange, the program takes 8 percent equity. For more information, visit http://www.healthwildcatters.com.
Forward-Looking Statements: This news release contains forward-looking statements which may be identified by their use of words like “plans,” “expects,” “will,” “believes,” “intends,” “estimates,” “anticipates” or other words of similar meaning. All statements that address expectations or projections about the future, including statements about the company’s growth strategy, product development, regulatory approval, market position, anticipated benefits of acquisitions, timing of anticipated benefits from restructuring actions, outcome of contingencies, such as litigation and environmental matters, expenditures and financial results, are forward-looking statements. Forward-looking statements are not guarantees of future performance and are based on certain assumptions and expectations of future events which may not be realized. Forward-looking statements also involve risks and uncertainties, many of which are beyond the company’s control. Some of the important factors that could cause the company’s actual results to differ materially from those projected in any such forward-looking statements are: fluctuations in energy and raw material prices; failure to develop and market new products and optimally manage product life cycles; significant litigation and environmental matters; failure to appropriately manage process safety and product stewardship issues; changes in laws and regulations or political conditions; global economic and capital markets conditions, such as inflation, interest and currency exchange rates; business or supply disruptions; security threats, such as acts of sabotage, terrorism or war, weather events and natural disasters; ability to protect and enforce the company’s intellectual property rights; successful integration of acquired businesses and separation of under-performing or non-strategic assets or businesses. The company undertakes no duty to update any forward-looking statements as a result of future developments or new information.
This article appears as it was originally published in BioSpace.0