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8-K - FORM 8-K - H-CYTE, INC. | mdvx8k_june52017.htm |
Exhibit
99.1
Medovex
Corporation Receives CE Mark Approval for DenerveX™
System
Highly Disruptive
and Patented Less Invasive Device with Faster Recovery Time than
Current Surgical Treatment Options Approved for Sale in
Europe
ATLANTA,
GA--(Marketwired – June 5, 2017) - Medovex Corp. (NASDAQ:
MDVX), (“Medovex” or the “Company”), a
developer of medical technology products, today announced it has
received CE Mark approval for the DenerveX™ System allowing
the Company to market the DenerveX System in Europe.
Patrick
Kullmann, Medovex President and COO, stated, "We are clearly
pleased to have accomplished this important milestone not just for
our shareholders, but for all of those suffering from often
debilitating lower back pain associated with Facet Joint Syndrome.
The CE Mark indicates a product’s compliance with applicable
EU regulations and enables the commercialization of the DenerveX
System in European Countries.”
Kullmann
continued, “We look forward to initiating sales in the future
through our already established international distribution network
being able to offer surgeons, pain management specialists and
patients an alternative, more cost effective and less invasive
treatment option to the current surgical forms of treatment. The CE
Mark is clearly the most significant milestone achieved in the
company’s history to date.”
Facet
Joint Syndrome (FJS), also known as spinal osteoarthritis, spinal
arthritis, or facet joint osteoarthritis, is a significant health
and economic problem in the United States and other countries in
the EU and Rest of World affecting millions each year. Current treatment options are generally
temporary and there is no proven long-lasting option for
FJS.
The
DenerveX System is a highly differentiated technology. It
denervates and removes capsular tissue from the Facet Joint in
one single procedure. Treatment results from the combined
effect of a deburring or polishing action and RF
ablation treatment on the Facet Joint. Using this new
technique, the slowly rotating burr removes the targeted facet
joint synovial membrane and joint surface while the heat ablation
destroys tissue and denudes any residual nervous and synovial
membrane overlying the joint, effectively removing the end
point sensory tissue of the joint.
Jarrett
Gorlin, Medovex CEO, commented, "Design, development and
commercialization of our flagship patented DenerveX System has been
years in the making. It was designed by surgeons for surgeons to be
less invasive with faster recovery time than current surgical
treatment options, and is designed to provide for a longer lasting
treatment solution while offering potential savings to the health
care system. We couldn’t be more pleased to have successfully
reached this most important inflection point and look forward to
moving into the commercialization phase of our
business.”
The
DenerveX System consists of the DenerveX Device Kit, containing a
single use medical device and the DenerveX Pro-40 Power Generator.
The DenerveX system is not yet FDA cleared.
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
jassad@medovex.com
CG
CAPITAL
877-889-1972
investorrelations@cg.capital
www.cg.capital