Nexeon Receives Research Grant from National Institutes of Health

Company spins out program to focus on development of nanocomposite drug-eluting balloon technology and other intellectual property related to precision medicine

DALLAS, Aug. 9, 2017 /PRNewswire/ -- Nexeon MedSystems (OTCQB:NXNN) today announced that it has been awarded a two-year, Phase II Small Business Research Innovation (SBIR) grant from the National Heart, Lung and Blood Institute (NHLBI), part of the National Institutes of Health (NIH). The Company recently completed the Phase I FastTrack research plan associated with this proprietary system. The Phase II grant was awarded due to successful completion of corresponding Phase I milestones, and it will fund up to $600,000 of critical preclinical research and process development activities, including the completion of a pre-IDE meeting with the U.S. Food and Drug Administration.

Pulsus Medical's leading technology in development features a carbon-nanotube polymer balloon with micro-perforations. These drug-eluting balloons are being tested for precision-pulse delivery of IV drugs.

The SBIR program is a highly competitive, awards-based program that encourages businesses to develop innovative solutions to existing problems and then incentivizes them to commercialize those solutions to achieve profitability. By stimulating high-tech innovation, the government-backed program has created an environment that allows companies of any size to compete based on the value of their ideas, and more importantly, the potential impact these ideas have on improving patient outcomes.  

Nexeon was originally founded in 2005 by Mark C. Bates, MD, DSci (Hon), a thought-leader in interventional cardiology and a medical device inventor with more than 50 issued and pending patents. Dr. Bates formed the Company with the goal of changing how innovative ideas in the medical device industry move from concept to reality. Pulsus Medical, LLC has since been formed as a spinout from Nexeon to focus on the ongoing development and commercialization of its proprietary balloon, catheter, and filter technologies used in precision medicine systems.  

Specific to this Phase II grant, the technology in development is a nanocomposite-based polymer balloon with microperforations that enables precise, pulse delivery of therapeutic drugs directly at the site of an intravascular lesion. Unlike present-day solutions, which are limited to certain drugs and utilize passive delivery only, this approach is hypothesized to enable more efficient drug delivery directly to the diseased site, reducing the potential for systemic toxicity from downstream drug loss. 

Nexeon CEO Will Rosellini explained that early last year, he and Dr. Bates combined teams, IP, clinical programs, shareholders, among other things, because of a shared vision that could be enhanced via shared infrastructure. Their vision, as explained by the CEO, is the automation of closed-loop medical device-based systems that will support healthcare providers in the swift delivery of personalized chronic disease therapy with minimized side effects regardless of where patients are in the world.

"While our management and engineering teams have been focused on executing our commercialization plan for our deep brain stimulation system," said Rosellini, "Dr. Bates and the scientists in our internal R&D program have made great strides in the development of our other proprietary products. This technology has outperformed our expectations. So the spinout allows this now-valuable asset to get the time and attention it needs from a devoted team to reach its next inflection point." 

Separate from the internal R&D team, Nexeon's engineers are finalizing the latest firmware and software upgrades for its deep brain stimulation system prior to submission for regulatory approval. The implantable-device-based system is used in the treatment of symptoms associated with Parkinson's disease and will be eligible for reimbursement under existing EU and US codes. The Company has previously detailed its strategy to achieve initial revenues from the 2018 European commercial launch of this product with a US PMA trial working in parallel. 

About Nexeon MedSystems Inc. -- Nexeon MedSystems Inc. is a global medical device company focused on providing innovative neurostimulation products that improve the quality-of-life of patients suffering from debilitating neurological diseases.  Nexeon has developed and commercialized a neurostimulation system that can be utilized to treat a variety of neurological diseases.

Forward-Looking and Cautionary Statements: Statements in this press release that are not strictly historical may be "forward-looking" statements, which involve risks and uncertainties, and Nexeon undertakes no obligation to update any such statements to reflect later developments. These risks and uncertainties include Nexeon's ability to successfully complete on the terms and conditions contemplated, and the financial impact of, its strategic portfolio repositioning actions, as well as economic and currency conditions, market demand, pricing, protection of intellectual property, and competitive and technological factors, among others, as set forth in Nexeon's subsequent reports filed with the SEC.

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