[August 27, 2014] |
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CorMatrix® Reports First Human Implant of CorMatrix® CanGaroo™ ECM® Envelope
ROSWELL, Ga. & CLEVELAND --(Business Wire)--
CorMatrix® Cardiovascular announced today that it has
received U.S. Food and Drug Administration (FDA) clearance to market the
CorMatrix® CanGaroo™ ECM®
Envelope for use with cardiac implantable electronic devices (CIED's)
including pacemakers and implantable cardioverter defibrillators (ICD's).
The CorMatrix® CanGaroo™ ECM®
Envelope is intended to securely hold a cardiac implantable electronic
device (CIED) in order to create a stable environment when implanted in
the body. The CorMatrix® CanGaroo™ ECM®
Envelope is a "pouch" which holds a CIED after implantation. It is
constructed from a multi-laminate sheet of decellularized,
non-crosslinked, lyophilized extracellular matrix (ECM®)
derived from porcine small intestinal submucosa. The CorMatrix®
CanGaroo™ ECM® Envelope will be provided in
four sizes to fit an array of device types and sizes.
The first human implant of the CorMatrix® CanGaroo™
ECM® Envelope was performed by Dr. Bruce Wilkoff,
Director of Cardiac Pacing and Tachyarrhythmia evices at Cleveland
Clinic.
Pre-clinical testing of the CorMatrix® CanGaroo™
ECM® Envelope demonstrated that it was replaced with a
vascularized tissue pouch at 90 day follow up that isolated the CIED
within the normal tissue. In pre-clinical trials, the new vascularized
tissue allowed for easy removal of the CIED.
Background of Extracellular Matrix (ECM) Biomaterial
The decellularized matrix material serves as a bioscaffold to allow
vascular ingrowth from adjacent tissues to deliver progenitor cells and
nutrients to the matrix, which then differentiate into tissue-specific
cells and structures. The ECM® material is gradually
replaced as the patient's own cells reinforces and rebuilds the diseased
or damaged site. During repair, the matrix is naturally degraded and
resorbed, leaving remodeled functional tissue where damaged or injured
tissue would normally be expected. The safety of extracellular matrices
has been well established in a number of different clinical applications
and more than 500 published papers. Since 1999, an estimated two million
patients worldwide have received an extracellular matrix implant.
Safe Harbor Statement
This press release includes statements that look forward in time or that
express management's beliefs, expectations or hopes. Such statements are
forward-looking statements within the meaning of the Private Securities
Litigation Reform Act of 1995. These statements include, but are not
limited to, the anticipated approval of pending and future patent
applications related to CorMatrix® ECM®
Technology, the Company's future patent application filings and the
protection of the Company's intellectual property provided by any
patents that issue. These statements are based on current information
and belief, and are not guarantees of future performance. Among the
risks and uncertainties that could cause actual results to differ
materially from those indicated by such forward-looking statements
include that pending and future patent applications related to CorMatrix®
ECM® Technology may not result in issued patent, that the
issuance of any patents may be delayed, that the allowed claims, if any,
may not be in line with the Company's expectations, that the Company may
not be successful in enforcing its patents, and other risk factors for
privately-held companies. By making these forward-looking statements,
the Company does not undertake to update them in any manner except as
may be required.
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