(PR Wires) DJ: Aastrom Biosciences Announces CE Mark Approval For Stem
DJ: Aastrom Biosciences Announces CE Mark Approval For Stem Cell Therapy Kit
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.
This document contains forward-looking statements, including without
limitation, statements concerning product development objectives, clinical
trial results, commercial introduction, and potential advantages of the
AastromReplicell(TM) System, which involve certain risks and uncertainties.
The forward-looking statements are also identified through use of the words
"anticipates," "believes," "expects," "plans," and other words of similar
meaning. Actual results may differ significantly from the expectations
contained in the forward-looking statements. Among the factors that may
result in differences are the results obtained from clinical trial and
development activities, regulatory approval requirements, the availability
of resources and the degree to which the Company's products achieve market
acceptance. These and other significant factors are discussed in greater
detail in Aastrom's Annual Report on Form-10K and other filings with the
Securities and Exchange Commission.
/CONTACT: Todd E. Simpson, VP Finance & Administration, CFO of Aastrom
Biosciences, Inc., 734-930-5777 or Investor & Media: Francesca T. DeVellis
of Feinstein Kean Partners Inc., 617-577-8110/
08:29 EST
(PR Wires) DJ: Aastrom Biosciences Announces CE Mark Approval For Stem
DJ: Aastrom Biosciences Announces CE Mark Approval For Stem Cell Therapy Kit
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.
This document contains forward-looking statements, including without
limitation, statements concerning product development objectives, clinical
trial results, commercial introduction, and potential advantages of the
AastromReplicell(TM) System, which involve certain risks and uncertainties.
The forward-looking statements are also identified through use of the words
"anticipates," "believes," "expects," "plans," and other words of similar
meaning. Actual results may differ significantly from the expectations
contained in the forward-looking statements. Among the factors that may
result in differences are the results obtained from clinical trial and
development activities, regulatory approval requirements, the availability
of resources and the degree to which the Company's products achieve market
acceptance. These and other significant factors are discussed in greater
detail in Aastrom's Annual Report on Form-10K and other filings with the
Securities and Exchange Commission.
/CONTACT: Todd E. Simpson, VP Finance & Administration, CFO of Aastrom
Biosciences, Inc., 734-930-5777 or Investor & Media: Francesca T. DeVellis
of Feinstein Kean Partners Inc., 617-577-8110/
08:29 EST
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