Attached files
file | filename |
---|---|
8-K - FORM 8-K - H-CYTE, INC. | mdvx8k_june22017.htm |
Exhibit 99.1
Medovex Corporation
Receives ISO 13485 Certification for the DenerveX™
System
ATLANTA,
GA--(Marketwired - June 1, 2017) - Medovex Corp. (NASDAQ: MDVX), a
developer of medical technology products, today announced that it
received ISO 13485 Certification, a globally recognized standard
that specifies the requirements for a quality management system
that can be used by organizations providing medical devices,
components and delivery of related services. This certification
allows Medovex to comply with the ever-changing needs of our
customers 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 customer focus that emanates throughout our company,"
Ms. Schweiger went on to say "This achievement lays the foundation
for the near term announcement 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 internationally recognized quality standard for
medical devices that is awarded when an organization demonstrates
its ability to provide medical devices and related services that
consistently meet customer and regulatory requirements applicable
to medical devices and related services, and is a requirement for
medical device clearance in Canada, the EU and a majority of other
countries that require products meet EU safety, health and
environmental requirements. 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 customer focus, dedication to quality, committed
top management, and continual improvement. 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 indicate
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.
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