Nexeon Announces Submission for FDA Innovation Challenge
Dallas, TX, Oct. 11, 2018 (GLOBE NEWSWIRE) -- Nexeon MedSystems Inc (”Nexeon”) (OTCQB: NXNN), a neurostimulation medical device company, announces that it has submitted an application in response to the FDA Innovation Challenge: Devices to Prevent and Treat Opioid Use Disorder.
Opioid Use Disorder (OUD), characterized by problematic symptoms of addiction to and withdrawal from opioids, is part of a public health crisis affecting more than 2 million Americans with significant physical, emotional, and cognitive impairment. Nexeon is developing the Zero PointTM Stimulation System, a non-invasive neurostimulation device designed to provide low-levels of electrical stimulation to activate nerves for the treatment of a number of diseases and disorders, including opioid withdrawal.
Through the Innovation Challenge, Nexeon is requesting the FDA’s early involvement in the regulatory plan with the goal of making Zero Point available over-the-counter. Nexeon is in early stages of clinical investigation but believes that Zero Point will provide an effective and rapid improvement in opioid withdrawal symptoms. If made available over-the-counter, recovering addicts will be able to find the relief that they need to persist through the detoxification phase and transition to maintenance therapy without relapse to recurrent opioid use to alleviate withdrawal symptoms.
“The opioid epidemic is a public health crisis that necessitates any and all innovation that can curb the devastation that opioid abuse is causing to individuals, friends, family members, and loved ones,” said Will Rosellini, CEO of Nexeon. “Given the promising signs that neurostimulation can relieve the symptoms associated with opioid withdrawal, we believe it is necessary to respond to the FDA’s innovation challenge and do all we can to provide treatment options. We applaud the FDA’s efforts to address the epidemic of opioid misuse and abuse.”
About Nexeon MedSystems Inc: Nexeon MedSystems, Inc. is a global medical device company focused on providing innovative neurostimulation products that are designed to improve the quality-of-life of patients suffering from debilitating neurological diseases. Nexeon is developing and is commercializizing a neurostimulation system that can be utilized to treat a variety of neurological diseases.
Forward-Looking Statements: Forward-looking statements in this press release and all other statements that are not historical facts are made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements involve factors, risks, and uncertainties that may cause actual results in future periods to differ materially from such statements. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks arising from prevailing market conditions and the impact of general economic industry or political conditions in the United States or globally. A list and description of these and ,other risk factors can be found in the Company's most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K filed with the Securities and Exchange Commission which can be reviewed at www.sec.gov. We make no representation or warranty that the information contained herein is complete and accurate, and we have no duty to correct or update any information contained herein.
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Released October 11, 2018