Medovex Corporation Receives Regulatory Approval
from Australia's Therapeutic Goods Administration (TGA) for its
Approval Ahead of Schedule and First Order
GA--(Marketwired - Aug 24, 2017) - Medovex Corp. (NASDAQ: MDVX)
("Medovex" or the "Company"), the developer of the DenerveX™
System, a new and novel device designed for enduring relief of
Facet Joint Syndrome related to back pain, today announced it has
received regulatory approval
from the Australian Therapeutic Goods Administration (TGA) for its
DenerveX System allowing the Company to market the device in
Australia, the first country in the Asia Pacific
approval comes ahead of schedule and the Company has also received
its first order for the DenerveX System from Australia. On
September 17, 2017, the Company expects to conduct sales and
product training with its Australia distributor with anticipated
initial procedures to be conducted shortly thereafter, following
receipt of first shipments of the product.
Kullmann, Medovex President and COO, stated, “We’re
clearly very pleased to have received regulatory approval ahead of
schedule for the marketing and sale of our DenerveX Device in
Australia. This paves the way for entry into a very important area
globally, Asia Pacific. Australia is highly regarded market by many
in the global medical community for the quality of care and
delivery of the latest technology for the treatment of chronic
disease such as Facet Joint Pain.”
added, “Since announcing receipt of CE Mark in less than just
three months ago, we have now received orders which include
countries from three continents, the EU, Latin America and now Asia
the Company provided a 30 day post procedure update on one of the
first cases using its DenerveX System.
case was conducted on July 15, 2017 and results were assessed via
visual analog scale (VAS) at 30 days post procedure. According to
the VAS score, the patient reported a 70% reduction in pain.
Currently the Company is working on procuring additional patient
testimonials which it intends to make available to shareholders
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.
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,
removing the end point sensory tissue of the joint.
DenerveX System consists of the DenerveX Kit which contains the
DenerveX Device, a single use medical device and the DenerveX
Pro-40 Power Generator. DenerveX system is not yet FDA
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
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.