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Nexeon Receives ISO 13485 Certification

[fa icon="calendar"] April 18, 2017 - by : Company News

Company News

Liege, Belgium -- Nexeon Medsystems Belgium, SPRL ("Nexeon Belgium" or the "Company") announced today that it has received certification from DEKRA Certification B.V. that the Company complies with the European requirements of ISO 13485 and EN ISO 13485 for a comprehensive quality management system for the design and manufacture of the company’s implantable neurostimulation system. Company management has described this as a critical milestone on the path to launching its neuromodulation platform, both for its leading indication in deep brain stimulation ("DBS") for Parkinson's disease as well as follow-on products for other neurological diseases.

"Nexeon has an ongoing commitment to delivering the most advanced and highest quality neuromodulation devices for the treatment of neurologic diseases," said Nexeon VP of Quality Dr. Stéphane Béfahy.  He continued, "We are deliberately investing in our design and production processes in preparation for the commercial launch of our first product as well as the delivery of products for third-party device contracts that are currently in progress."

Since 2013, the team at Nexeon Belgium has received both research grants and commercial contracts to advance the development and manufacture of its neuromodulation platform and related peripherals. The grants include a €3.4M-funded consortium partnership in alignment with Minister Jean-Claude Marcourt's e-health initiative for the Walloon Region in Belgium.  The Company's most notable commercial contract is a multi-year agreement with Galvani Bioelectronics, a joint venture of Google/Verily and GlaxoSmithKline(GSK). After an exhaustive search, Galvani selected Nexeon's platform to conduct its novel preclinical work. The contract is ongoing as Galvani exercised its option to enter the second phase last year.   

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"This is an important step in our goal to becoming a significant player in the future of bioelectronics medicine," said President and Chief Commercial Officer Brian Blischak, who has spent the last 15 years leading all aspects of global commercialization for five different neuromodulation product lines. In addition to his time spent in the neuromodulation division at St. Jude Medical, Blischak's product development experience includes implantable neurostimulation systems for obstructive sleep apnea, three DBS product lines, and an implantable infusion pump.  "We're building a neuromodulation platform with unique capabilities in stimulation and sensing that can be leveraged to spawn multiple neuromodulation solutions for various clinical indications." 

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About Nexeon MedSystems Inc: Nexeon MedSystems is a bioelectronics company focused on the development and delivery of therapeutic solutions for the benefit of patients, healthcare professionals, and healthcare systems throughout the world. The Company’s lead product is a neurostimulation system for the treatment of neurological diseases. The system uses a surgically implanted medical device that delivers pulsed electrical signals to the brain and nervous system.

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. 

Topics: Manufacturing, Engineering

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