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Biotech / Medical : ASTM-AASTROM BIOSCIENCES: STEM CELL RESEARCH -- Ignore unavailable to you. Want to Upgrade?

To: Bear Down who wrote (389)	12/17/1998 8:51:00 AM
From: Pirate	Read Replies (2) \| Respond to of 1084

Aastrom Biosciences Announces CE Mark Approval For Stem Cell Therapy Kit PR Newswire, Thursday, December 17, 1998 at 08:47 Regulatory Approvals Now in Place to Permit European Market Introduction of the AastromReplicell(TM) System ANN ARBOR, Mich., Dec. 17 /PRNewswire/ -- Aastrom Biosciences, Inc. (NASDAQ:ASTM), today announced that it has obtained approval to affix the CE Mark to the AastromReplicell(TM) Cell Production System (System) liquid products of the SC-I Therapy Kit to produce bone marrow cells for use in stem cell therapy. This announcement follows an earlier approval received by Aastrom to affix the CE Mark to the AastromReplicell(TM) System instrumentation platform, and now allows marketing activities to begin in the European Community. The AastromReplicell(TM) System instrumentation platform is designed to operate different therapy-specific kits including the SC-I Therapy Kit. "The CE Mark approach to regulatory approval provided to the AastromReplicell(TM) System, may set a standard for cell therapy applications in Europe, and we believe will assist in more general therapeutic uses of ex vivo expanded cells. The therapy-specific kit approach not only enables hospitals to have access to needed cells, but also provides both a standardized mechanism and increased reliability for different treatment centers to carry out therapeutic cell production," said R. Douglas Armstrong, Ph.D., President and Chief Executive Officer of Aastrom. "We are proud as well of our rapid progress through the formal review and approval process that has led to the CE Mark which now allows us to initiate product commercialization in Europe," Dr. Armstrong continued. The Company recently reported positive clinical results at the Annual Meeting of the American Society of Hematology from multi-center trials using the AastromReplicell(TM) System SC-I Therapy Kit (bone marrow) and CB-I Therapy Kit (cord blood) to produce cells used in the treatment of patients with cancer and other blood diseases. Data from these and other studies, will be used to support initial marketing efforts for the product line in Europe. Aastrom also recently announced the initiation of the first U.S. pivotal trial evaluating cells produced using the SC-I therapy kit as an alternative method of cell collection for use in stem cell therapy. This kit is designed to enable the production of bone marrow cells and to offer more optimal and standardized patient care. Upon successful completion of this trial, the Company plans to use the data to support a Pre-Market Approval (PMA) application for autologous stem cell therapy in the U.S. The AastromReplicell(TM) System consists of an instrumentation platform designed to operate a family of patient-specific cell therapy kits for a broad range of cell therapy applications. In addition to the currently used stem cell therapies, many emerging cell therapies are being developed at academic centers and other companies. The AastromReplicell(TM) System, an automated clinical system designed for the production of therapeutic cells from small starting quantities, is designed to enable the transition of these laboratory procedures to a standard medical treatment. Once established for use in stem cell therapy, Aastrom plans to leverage the cell manufacturing capabilities of the AastromReplicell(TM) System across multiple cell therapy opportunities by providing a commercialization outlet for these therapies through the AastromReplicell(TM) System product line. Aastrom Biosciences, Inc. is pioneering the development of proprietary clinical systems including the AastromReplicell(TM) System, a first of its kind product, to enable physicians and patients greater accessibility to cells used for therapy. The AastromReplicell(TM) System product line consists of an instrumentation platform that can operate a growing number of patient specific therapy kits tailored to each cell therapy application. Aastrom has received patents covering methods and devices for the ex vivo production of human stem and other types of cells, as well as for the genetic modification of stem cells. The AastromReplicell(TM) System is under development, and is not available for sale at this time in the U.S.