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MacroPore Biosurgery’s FDA Clearance of Expanded Marketing Claims for SurgiWrap
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 of Expanded Marketing Claims for
SurgiWrap
San Diego / Königstein,Ts, September 24, 2003. MacroPore Biosurgery, Inc.
(Frankfurt Stock Exchange: XMP) today announced that it has received United
States FDA clearance to expand its marketing claims for SurgiWrap, MacroPore
Biosurgery’s thin bioresorbable sheet platform technology. The newly cleared
indication is for the minimization of soft tissue attachment to SurgiWrap in
case of contact with the surrounding viscera (all internal organs). This
expanded marketing indication brings SurgiWrap closer to the European
indications that allow MacroPore Biosurgery to market, in Europe, for the
control of postsurgical adhesions. MacroPore Biosurgery will now be marketing
thin sheet products in the US under the name SurgiWrap MAST.
end of ad-hoc-announcement (c)DGAP 24.09.2003
Issuer’s information/explanatory remarks concerning this ad-hoc-announcement:
“Postsurgical complications resulting from uncontrolled tissue healing impacts
one of every two surgeries performed in the world today. There are currently two
major types of products to address these problems: those directed at the tissue
level and those directed at the cellular level,” stated Sharon Schulzki, Senior
Vice President, Marketing and Product Development – Biomaterials. “The
SurgiWrap MAST bioresorbable sheet performs at the tissue level and creates a
physical barrier between healing tissues, thereby minimizing undesired tissue
attachments immediately adjacent to the sheet.” Schulzki continued, “SurgiWrap
also offers surgeons other advantages, including improved handling over
alternative products and the ability to suture the sheet in place to reduce the
potential for migration. In addition, according to Techvest LLC-Equity Research
2002, each year in the U.S. 6.4 million surgical procedures are at risk of
developing uncontrolled healing complications, and a similar amount in Europe.”
According to Gregory Imler, MD, Chairman, Division of General Surgery, Sharp
Rees-Stealy Medical Group, San Diego, CA, “SurgiWrap provides straightforward
application and delivers consistent clinical benefits to my patients.
Additionally, it has been my observation that SurgiWrap minimizes soft-tissue
attachment to the sheet in a site specific manner.”
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 with
surgical therapies using adult stem cells derived from the patient’s own 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 surgeries 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 http://www.macropore.com .
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
240845 Sep 03
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