EXTON, Pa., April 24, 2012 /PRNewswire/ -- Kensey Nash
Corporation (Nasdaq: KNSY), a leading medical technology company
that provides innovative resorbable biomaterial technology for a
wide range of medical procedures, today announced the achievement
of several milestones for its Meso BioMatrix™ surgical mesh
including the first clinical implant of the product. The Meso
BioMatrix™ product is indicated for use in the United States for implantation to
reinforce soft tissue where weakness exists in patients requiring
soft tissue repair and reinforcement in plastic and reconstructive
surgery. The procedure was performed by Dennis Hammond, M.D. of Partners in Plastic
Surgery in Grand Rapids,
Michigan. "The Meso BioMatrix™ product offers several
advantages for use in plastic and reconstructive surgery including
strength with just the right amount of pliability, and easy
re-draping around corners and complex contours. It will serve as an
excellent adjunct in plastic and reconstructive surgery," commented
Dr. Hammond.
Kensey Nash will be exhibiting the Meso BioMatrix™ product
May 5th-7th at the American Society
of Aesthetic Plastic Surgery Meeting in Vancouver, BC.
The Meso BioMatrix™ surgical mesh is manufactured using Kensey
Nash's proprietary Optrix™ process, which gently disinfects
tissues, inactivates viruses and removes cells while preserving
extracellular matrix (ECM) components. It is a unique tissue
derived from porcine peritoneum, with a thinner profile, and
desirable handling characteristics. Pre-clinical studies have shown
more rapid cellular infiltration when compared to dermis based
xenograft materials[1].
In addition, Kensey Nash has received 510k clearance for its
Meso BioMatrix™ Wound Matrix. This clearance allows for the use of
the Meso BioMatrix™ device in the management of topical wounds.
Next steps for the technology include CE Mark submissions for both
wound and breast surgery applications, and the initiation of an
Investigational Device Exemption (IDE) feasibility clinical study
for the use of Meso BioMatrix™ for soft tissue reinforcement in
two-stage post-mastectomy breast reconstruction surgery. The
Company has received conditional approval on the IDE protocol from
the FDA and has begun clinical site qualifications.
"The Meso BioMatrix™ products and the previously launched
porcine dermis products demonstrate the versatility of the OPTRIX™
processing technology to provide a full spectrum of ECM products
with a diverse range of properties for multiple surgical
applications. Surgeons have responded favorably to now having
an option of biologic materials to meet an array of surgical needs.
We anticipate that these efforts will allow Kensey Nash to explore
various partnership opportunities in these growing biologic
markets," commented Doug Evans,
Chief Operating Officer.
About Kensey Nash Corporation. Kensey Nash Corporation is
a medical device company primarily focused on regenerative medicine
utilizing its proprietary collagen and synthetic polymer
technology. The Company is recognized as a leader for innovative
product development and unique technology in the field of
resorbable biomaterials. The Company has an extensive range of
products, which are sold through strategic partners in multiple
medical markets, including, the cardiology, orthopaedic, sports
medicine, spine, endovascular and general surgery markets.
Cautionary Note for Forward-Looking Statements. This
press release contains forward-looking statements that reflect the
Company's current expectations about its prospects and
opportunities. The Company has tried to identify these forward
looking statements by using words such as "expect," "anticipate,"
"estimate," "plan," "will," "would," "forecast," "believe,"
"guidance," "projection" or similar expressions, but these words
are not the exclusive means for identifying such statements. The
Company cautions that a number of risks, uncertainties and other
important factors could cause the Company's actual results to
differ materially from those in the forward-looking statements
including, without limitation, the Company's continued success in
its research and development efforts in its cartilage repair and
extracellular matrix technologies programs, the Company's ability
to enter into new partnering relationships with respect to its
extracellular matrix products and the success of existing and new
partners in selling the Company's extracellular matrix products,
the completion of additional clinical trials in both the U.S. and
Europe to support regulatory
approval of future generations of its products and competition from
other technologies, current economic conditions, and foreign
currency fluctuations. For a detailed discussion of factors that
could affect the Company's future operating results, please see the
Company's SEC filings, including the disclosures under "Risk
Factors" in those filings. Except as expressly required by the
federal securities laws, the Company undertakes no obligation to
update or revise any forward-looking statements, whether as a
result of new information, changed circumstances or future events
or for any other reason.
[1] Data on file at Kensey Nash
Meso BioMatrix™ and Optrix™ are trademarks of Kensey Nash
Corporation
SOURCE Kensey Nash Corporation