BioTissue Technologies AG
BioTissue AG english
Corporate-News announcement sent by DGAP.
The sender is solely responsible for the contents of this announcement.
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BioTissue Technologies starts major clinical study on ‘skin from the tube’
Freiburg, July 31st, 2001 – based on the very good findings of monitoring appli-
cation of its product with 79 patients with chronic open wounds, BioTissue
Technologies AG (SIN 618061), which is listed on the Neuer Markt segment of the
Frankfurt Stock Exchange, is now starting an international multi-center study
with BioSeed-S, its ‘skin from the tube’. The study will cover not only medical
data, but also the costs of the treatment and changes in the quality of the pa-
tients’ lives.
In June the green light was given as regards the ethics of the product and now
the first patients are being included in the study. In total, the study encom-
passes 240 patients with chronic venous leg ulcers who are being treated at 25
different centers in Germany and elsewhere in Europe. Only those patients are
included in the study who have suffered from an open ulcer for at least three
months and for whom traditional treatment administered by one of the doctors
included in the study brought no improvement in the state of the wound after
four weeks.
In the case of treatment with BioSeed-S, a small piece of skin is removed from
120 patients, the cells are isolated in the BioTissue labs, cultivated, and
after approx. 18 days transplanted back into the patient in the course of
treatment as an outpatient. As the comparison group, 120 other patients are
treated with wound dressing containing no active substances and compression
therapy. This method conforms with the standard therapy for wound treatment
today. The patients are divided into the two groups by random selection.
The clinical study is being headed by Professor Wolfgang Vanscheidt, Director of
Klinik für Wundbiologie Höchenschwand and President of the Deutsche Ge-
sellschaft für Wundheilung e.V. Vanscheidt explains: “The use of tissue engi-
neering methods, for example of BioSeed-S, in modern wound treatment will
increasingly take the place of conservative forms of treatment.”
The goal of the study: to ensure that BioSeed-S is as swiftly as possible and at
the latest by second-half 2003 approved by health insurance companies for in-
clusion under the coverage they provide. This concurs with the Company’s
internal unit sales targets.
Since April 2001, BioSeed-S is being marketed globally under the terms of an
exclusive, worldwide cooperation with the US Baxter International Group. Each of
the two partners receives an equal share of the proceeds from sales of BioSeed-
S. The cost of all investments such as may be necessary, and the present study
is an example, is likewise borne equally.
Mr. Martin Braendle
Tel.+49 (0) 7 61 76 75-110
martin.braendle@biotissue-tec.com
end of message, (c) DGAP 31.07.2001
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