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MacroPore Biosurgery Receives FDA Clearance for CardioWrap Pericardial Film
Ad-hoc-announcement transmitted by DGAP.
The issuer is solely responsible for the content of this announcement.
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MacroPore Biosurgery Receives FDA Clearance for CardioWrap Pericardial Film
-First bioresorbable pericardial repair product cleared in the United States-
San Diego/Königstein,Ts, September 9, 2003. MacroPore Biosurgery, Inc.
(Frankfurt Stock Exchange: XMP) today announced that it has received FDA
clearance for MacroPore CardioWrap, a bioresorbable film indicated for the
repair of the pericardium. CardioWrap is the first bioresorbable pericardial
repair product cleared by FDA, marking another industry first for MacroPore
Biosurgery’s thin film platform technology.
end of ad-hoc-announcement (c)DGAP 09.09.2003
Issuer’s information/explanatory remarks concerning this ad-hoc-announcement:
This FDA clearance for CardioWrap further expands the approved applications for
the Company’s thin film technology in the United States. MacroPore Biosurgery’s
thin film technology products are currently cleared in the United States for
soft tissue support, specific pelvic applications, ophthalmology indications,
and adhesion control for specific ear, nose and throat (ENT) procedures.
This FDA clearance positions MacroPore Biosurgery to provide a clinical benefit
to cardiothoracic surgery patients who may require re-operation, and complements
our existing European cardiothoracic approvals for CardioWrap film.
“European surgeons who have been working with CardioWrap, report that it
provides a superior protective covering for the healing heart, because it has
ideal handling characteristics, proven biocompatibility, predictable resorption,
and it is invisible on x-ray,” stated Matthew Scott, Vice President of Sales.
“CardioWrap differs from all existing therapies, in that it is the only
bioresorbable pericardial replacement product on the market, which safely
resorbs once healing has occurred.”
MacroPore Biosurgery, Inc. is a leader in the design, development, and
production of bioresorbable polymer implants for use in a variety of surgical
applications and is pioneering advancement of regenerative medicine for surgical
therapies using adult stem cells derived from adipose (fat tissue). Some
products designed for use in spine, neurosurgical, and musculoskeletal surgeries
are distributed by Medtronic, while other products designed for soft tissue are
distributed through our direct US sales force and an international distribution
network. MacroPore Biosurgery is traded on the Frankfurt Stock Exchange in
Germany under the symbol ‘XMP’. For further information please visit the web
site www.macropore.com.
MacroPore Biosurgery Disclaimer
This press release may include forward-looking statements regarding events and
trends which may affect MacroPore Biosurgery’s future operating results and
financial position. Such statements are subject to risks and uncertainties that
could cause MacroPore Biosurgery’s actual results and financial position to
differ materially. These risks and uncertainties are described (under the
heading “Risk Factors”) in our 2002 Annual Report which is available on our web
site. MacroPore Biosurgery assumes no responsibility to publicly release the
results of any revision of forward-looking statements to reflect events, trends
or circumstances after the date they are made.
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WKN: 940682; ISIN: USU553961025; Index: NEMAX 50
Listed: Geregelter Markt in Frankfurt (Prime Standard); Freiverkehr in Berlin-
Bremen, Düsseldorf, Hamburg, Hannover und Stuttgart
090850 Sep 03
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