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Medovex Corporation Receives ISO 13485 Certification for the DenerveX System

Medovex Corp. (NASDAQ: MDVX), a developer of medical technology products, today declared that it received ISO 13485 Certification, a internationally acknowledged standard that specifies the needs for a quality management system that can be used by organizations providing medical devices, components and delivery of related services. This certification permits Medovex to comply with the ever-changing requirements of our clients while meeting and maintaining regulatory requirements.

Jill Schweiger, Medovex Senior Vice President Regulatory, Clinical & Quality, stated, "Obtaining the ISO 13485:2003 certification within this timeframe demonstrates the dedication, competency, teamwork and client focus that emanates throughout our company." Ms. Schweiger went on to say, "This achievement lays the foundation for the near term declaration of having also officially received CE Mark, allowing for the marketing of the DenerveX System within the European Union and other markets."

ISO certification is an globally acknowledged quality standard for medical devices that is awarded when an organization demonstrates its ability to provide medical devices and related services that constantly meet client and regulatory requirements applicable to medical devices and related services, and is a necessity for medical device clearance in Canada, the EU and a majority of other countries that need products meet EU safety, health and environmental needs. During the last quarter of 2016, the Company focused its efforts on implementing a quality management system to obtain ISO certification in early 2017.

Dennis Moon, Medovex Executive Vice President, stated, "Receiving the ISO 13485:2003 certificate is a critical milestone for us. The standard is based on a number of quality management principles, including a strong client focus, dedication to quality, committed top management, and constant development. The certification shows our determination to make quality our priority in everything that we do."

The Company's patented DenerveX System, is not yet commercially available, is designed to provide longer lasting relief of pain associated with the facet joint. Lower back pain is the second most common cause of disability in the U.S. for adults. Studies specify that 10% of the U.S. adult population suffers from lower back pain and that 31% of lower back pain is attributed to facet joint pain.

The DenerveX System consists of the DenerveX Kit, consisting of a single use device, and the DenerveX Pro-40 Power Generator. The DenerveX system is designed to provide a minimally invasive treatment option which combines two actions into one device.

DenerveX is not yet CE marked or FDA cleared.

 

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