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EX-99.3 - PRESS RELEASE DATED NOVEMBER 3, 2016 - H-CYTE, INC. | ex-successfullab.htm |
EX-99.1 - PRESS RELEASE DATED NOVEMBER 1, 2016 - H-CYTE, INC. | ex-nasdaqext.htm |
8-K - PRIMARY DOCUMENT - H-CYTE, INC. | mdvx8k_nov2016.htm |
Exhibit
99.2
Medovex Corporation Announces
Successful Largest Living Tissue Population Test to
Date
Successful
Use of DenerveX™ System in Stringent Good laboratory Practice
Setting Confirms System Delivers Intended Treatment and Supports
Already Secured Reimbursement
ATLANTA, GA--(Marketwired – November 2,
2016) - Medovex Corp. (NASDAQ: MDVX), a
developer of medical technology products, today announced that the
company conducted a successful live tissue test of the
DenerveX™ System under the most stringent standards required
by FDA and other regulatory agencies.
Patrick
Kullmann, Medovex President and COO, stated, "This latest testing
of the DenerveX System is the largest living tissue population test
to date. The results confirm that the DenerveX System delivers its
intended treatment and that it supports the type of reimbursement
that the company has already secured in its first targeted country,
Germany.”
The GLP (Good
Laboratory Practice) protocol testing consisted of a 12 porcine
subject clinical evaluation of the DenerveX System at 0, 30 and 60
day time period post procedure. The total subject pool consisted of
144 treatments, of which 48 treatment sites were randomly selected
and initially evaluated per the GLP.
Of the
48 evaluated treatments, 92% of the DenerveX System treatments
reached their targeted facet joint treatment sites. Dorsal nerve
roots and dorsal ganglia did not have evidence of neurodegeneration
at the sites examined. No routinely examined organs had changes
interpreted to be related to the study. All subjects survived the study to term absent
complication.
Martin Deeg MD
of Stuttgart, Germany an advisory board member with experience with
the DenerveX System, reviewed the data and stated, “The
DenerveX System delivered treatments that would be expected and
desired as needed to provide longer term pain relief, and that
would set up the DenerveX System and procedure as a new and unique
therapy for Facet Joint Syndrome.”
Vik Kapoor MD
of Manchester, England, also an advisory board member and equally
experienced with the DenerveX System added, “The DenerveX
System proved out in the data that it will fundamentally change the
way Facet Joint Syndrome will be treated in the
future.”
Jarrett Gorlin,
Medovex CEO commented, “The DenerveX System represents a very
new and creative approach in treating pain associated with the
Facet Joint Syndrome. Our future customers have commented their
clear appreciation for our different approach in performing a new
procedure by way of a posterior calsulectomy of the facet joint,
compared to the less effective standard radio frequency ablation
(Rhizotomy). This gives us cause for continued cautious optimism
going forward.”
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. It consists of two procedures combined into one device and
is expected to provide for a longer lasting treatment solution
while offering potential savings to the health care system.
DenerveX is not yet commercially available.
DenerveX System
is not yet CE marked or FDA cleared and is not yet commercially
available. A full evaluation of the test results continues. The
results of the test have not yet been submitted to, or evaluated
by, the notified body or FDA for consideration and comment. There
can be no assurance that the notified body or FDA will not have
further questions or require additional information when it reviews
the test results.
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
●
CONTACT INFORMATION
Medovex
Corp.
Jason
Assad
470-505-9905
Email
Contact