BioTissue Technologies AG
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Initial data from the clinical study on BioSeed-S
Ad-hoc-announcement transmitted by DGAP.
The issuer is solely responsible for the content of this announcement.
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– Initial data from the clinical study on BioSeed-S
– Excellent clinical results
– BioSeed-S shows its marked superiority over the control group
Freiburg, August 27, 2002 – BioTissue Technologies AG (SIN 618061) is releasing
initial data from the clinical study begun in August 2001 on BioSeed-S, its
autologous skin replacement product or ‘skin from a tube’. The data from the
intermediate evaluation confirm the excellent clinical results BioSeed-S gained
in an earlier open monitoring of the application. Now in this randomized,
prospective clinical study the data read well when compared to the standard
therapy typically used for wound treatment.
After the evaluation of 62 patients with chronic, venous leg ulcers BioSeed-S
already shows its marked superiority over the control group both as regards
frequency of wound healing, and actual healing time required.
The study will gradually be expanded to include 240 patients who are to be
treated at 27 different centers in Germany and other European countries. The
final results of the study are expected by the end of the second quarter, 2003.
Then, in addition to the medical data, also the treatment costs, and the change
in patients’ quality of life will be assessed.
Given such excellent results BioTissue continues to expect health insurance
schemes will agree to reimburse treatment costs as of 2004. As a bridging
solution until the approval of statutory reimbursement, BioTissue is currently
busy setting up special wound treatment centers in Germany in collaboration with
its distribution partner Baxter. With the more extensive data they can now draw
on, Baxter and BioTissue are increasingly seeking out health insurance schemes
to demonstrate to them the efficiency and cost-effectiveness of BioSeed-S.
BioTissue Technologies AG, Martin Braendle, Investor Relations Manager
Phone: +49-761-7676110, martin.braendle@biotissue-tec.com
end of ad-hoc-announcement (c)DGAP 27.08.2002
Issuer’s information/explanatory remarks concerning this ad-hoc-announcement:
– Initial data from the clinical study on BioSeed-S
– Excellent clinical results
– BioSeed-S shows its marked superiority over the control group
Freiburg, August 27, 2002 – BioTissue Technologies AG (SIN 618061) is releasing
initial data from the clinical study begun in August 2001 on BioSeed-S, its
autologous skin replacement product or ‘skin from a tube’. The data from the
intermediate evaluation confirm the excellent clinical results BioSeed-S gained
in an earlier open monitoring of the application. Now in this randomized,
prospective clinical study the data read well when compared to the standard
therapy typically used for wound treatment.
After the evaluation of 62 patients with chronic, venous leg ulcers BioSeed-S
already shows its marked superiority over the control group both as regards
frequency of wound healing, and actual healing time required. “The data from the
intermediate evaluation are an excellent result. I feel completely validated in
my personal experience with BioSeed-S, and it reinforces my opinion that this
modern form of wound treatment will increasingly be favored over the
conservative treatment forms”, says Prof. Wolfgang Vanscheidt, Director of the
Hoechenschwand Clinic for Wound Biology and Vice-President of the German Society
for Wound Treatment, who is leading the clinical study.
The study will gradually be expanded to include 240 patients who are to be
treated at 27 different centers in Germany and other European countries. “We
expect to have the final results of the study by the end of the second quarter,
2003. Then, in addition to the medical data, we will also have assessed the
treatment costs, and the change in patients’ quality of life”, explains Dr.
Volker Kessler, Head of Clinical Research at BioTissue.
Given such excellent results BioTissue continues to expect health insurance
schemes will agree to reimburse treatment costs as of 2004. As a bridging
solution until the approval of statutory reimbursement, BioTissue is currently
busy setting up special wound treatment centers in Germany in collaboration with
its distribution partner Baxter. With the more extensive data they can now draw
on, Baxter and BioTissue are increasingly seeking out health insurance schemes
to demonstrate to them the efficiency and cost-effectiveness of BioSeed-S.
The BioSeed-S clinical study on 120 patients involves extracting a small sample
of the patient’s own skin, before isolating the upper (epithelial) skin cells in
the BioTissue labs, and cultivating them. After around 14 days these cultivated
cells together with a gel-like fibrin glue are transplanted onto the patient’s
open wound.
For the purposes of comparison, the remaining 120 patients are treated using
wound dressings free of any special substance. This complies with the standard
wound treatment therapy typically offered. Patients are divided into the two
groups on a random basis. Both groups are treated with a compression therapy
Patients selected for the study fulfill two criteria: they have suffered from an
open ulcer for at least three months, and one month’s standard treatment by a
doctor involved in the study has brought no visible improvement.
As of April 2001, U.S. Group Baxter International Inc. has been distributing
BioSeed-S in an exclusive, worldwide cooperation agreement.
BioTissue Technologies AG, Martin Braendle, Investor Relations Manager
Phone: +49-761-7676110, martin.braendle@biotissue-tec.com
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WKN: 618061; ISIN: DE0006180615; Index:
Listed: Neuer Markt in Frankfurt; Freiverkehr in Berlin, Bremen, Düsseldorf,
Hamburg, Hannover, München und Stuttgart
271350 Aug 02
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