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8-K - FORM 8-K - H-CYTE, INC. | mdvx8k_feb172017.htm |
Exhibit 99.1
February
15, 2017 08:30 ET
Medovex Corporation
Completes Phase II CE Mark Audit with Notified Body
LNE/GMED
ATLANTA,
GA--(Marketwired - Feb 15, 2017) - Medovex Corp. (NASDAQ: MDVX), a
developer of medical technology products, today announced that the
Company successfully completed its final CE Mark audit meeting. The
review of the Company's DenerveX™ System was conducted
February 7-9, 2017 by LNE/GMED, a French-based Notified Body firm.
This audit is required to demonstrate compliance with the
regulatory requirements to achieve CE Mark approval.
Patrick
Kullmann, Medovex President and COO, stated, "We're very pleased to
have completed our certification audit of the DenerveX System
February 7-9, 2017 at the Company's Atlanta based offices. Our
in-house development team, along with several representatives from
our world-class suppliers and consultants, contributed extensively
during this process due to their vast expertise in R&D,
manufacturing, electro-surgery, regulatory, quality, and
sterilization processes."
Kullmann
further stated, "Upon successfully completing this audit, the CE
certificate would generally be expected to be issued paving the way
to the future launch of the DenerveX System in the EU and other
countries which accept the CE Mark."
Previously
on January 3, 2017, the Company announced it had successfully
received certification of compliance for its DenerveX System from
SGS S.A. a Swiss based multinational testing and certification
firm. Compliance testing included electrical safety testing for US,
Canada and the European Union.
Prior
to that on November 3, 2016, the Company announced that it held a
successful cadaver lab during NASS 2016. Medical advisory board
members Martin Deeg, MD from Stuttgart, Germany, Vik Kapoor, MD
from Manchester, England, as well as Gabriel Davila, MD from
Colombia, Latin America, highlighted the DenerveX System. Thirty
spine surgeons from Europe and Latin America attended the lab, both
experiencing and using the device.
Jarrett
Gorlin, Medovex CEO, commented, "I'm very proud of our team and how
they prepared for and handled this important event. Together, we
have spent countless hours in anticipation of meeting with
representatives of LNE/GMED. Although a date has not been provided
for the anticipated receipt of the CE certificate or the launch of
the product, we believe we remain well on our way to completing the
final regulatory step in the process of achieving CE
Marking."
The
DenerveX System consists of the DenerveX device, a single use
medical device and the DenerveX Pro-40 Power Generator, both
designed to be less invasive with faster recovery time than current
surgical treatment options, and is expected to provide for a longer
lasting treatment solution while offering potential savings to the
health care system.
DenerveX
system is not yet CE marked or FDA cleared and is not yet
commercially available.
About
Medovex
Medovex was formed to acquire and develop a diversified portfolio
of potentially ground breaking medical technology products.
Criteria for selection include those products with potential for
significant improvement in the quality of patient care combined
with cost effectiveness. The Company's first pipeline product, the
DenerveX device, is intended to provide long lasting relief from
pain associated with facet joint syndrome at significantly less
cost than currently available options. To learn more about Medovex
Corp., visit www.medovex.com
Safe Harbor
Statement
Certain
statements in this press release constitute "forward-looking
statements" within the meaning of the federal securities laws.
Words such as "may," "might," "will," "should," "believe,"
"expect," "anticipate," "estimate," "continue," "predict,"
"forecast," "project," "plan," "intend" or similar expressions, or
statements regarding intent, belief, or current expectations, are
forward-looking statements. While the Company believes these
forward-looking statements are reasonable, undue reliance should
not be placed on any such forward-looking statements, which are
based on information available to us on the date of this release.
These forward looking statements are based upon current estimates
and assumptions and are subject to various risks and uncertainties,
including without limitation those set forth in the Company's
filings with the Securities and Exchange Commission (the "SEC"),
not limited to Risk Factors relating to its patent business
contained therein. Thus, actual results could be materially
different. The Company expressly disclaims any obligation to update
or alter statements whether as a result of new information, future
events or otherwise, except as required by law.
CONTACT
INFORMATION
●
Medovex
Corp.
Jason
Assad
470-505-9905