Aastrom and ATEK Medical Form Strategic Manufacturing and Development Partnership
October 26 2010 - 7:30AM
Aastrom Biosciences, Inc. (Nasdaq:ASTM), a leading developer of
expanded autologous cellular therapies for the treatment of severe
cardiovascular diseases, and ATEK Medical, a leading medical device
manufacturer, today announced the formation of a new strategic
partnership in which ATEK Medical will supply key components and
technology for use in Aastrom's proprietary cell manufacturing
process. This partnership is intended to replace a previous
supplier relationship with a more comprehensive arrangement to
strengthen Aastrom's long-term manufacturing capabilities. Aastrom
plans to initiate its Phase 3 CLI program in 2011 and is also
developing its cell therapy for the treatment of dilated
cardiomyopathy (DCM).
"Aastrom is a leader in developing new, proprietary cell
therapies to treat severe cardiovascular diseases. Their
development programs and automated cell manufacturing system all
require components that meet the highest standards of cGMP and FDA
compliance. Our technology expertise and manufacturing experience
for regulated products at ATEK make us an ideal partner to support
the technology needs of their advanced development programs," said
Dave Mabie, ATEK Medical vice president of business
development.
ATEK Medical specializes in product development and launch based
on advanced technology applications. Aastrom operates a cGMP
facility in Ann Arbor where the company's automated, proprietary
cell-manufacturing system is used to produce expanded autologous
cellular therapies based on a sample of a patient's bone marrow.
The cell therapy produced by this process is then delivered back to
the same patient to promote regeneration of damaged tissues.
"ATEK has an outstanding track record in leveraging its
technology expertise to produce high-quality components and medical
devices and to improve and upgrade procedures used in the
manufacture and processing of novel therapies," said Tim Mayleben,
president and CEO of Aastrom. "We expect that this collaboration
will be a critical advantage for Aastrom as we move our
cardiovascular programs into the final stages of clinical
development. We are also very pleased to be joining with another
Michigan-based company in this collaboration. We believe that this
partnership will result in the creation of high-paying jobs in
Michigan."
About Aastrom Biosciences
Aastrom Biosciences is developing expanded autologous cellular
therapies for the treatment of severe cardiovascular diseases. The
company's proprietary cell manufacturing technology enables the
production of cellular therapies expanded from a patient's own bone
marrow and delivered directly to damaged tissues. Aastrom has
advanced its cell therapies into late-stage clinical development,
including a planned Phase 3 clinical program for the treatment of
patients with critical limb ischemia and two ongoing Phase 2
clinical trials in patients with dilated cardiomyopathy. For more
information, please visit Aastrom's website at www.aastrom.com.
The Aastrom Biosciences, Inc. logo is available at
http://www.globenewswire.com/newsroom/prs/?pkgid=3663
About ATEK Medical
ATEK Medical is a private, woman-owned contract manufacturer of
disposable, implantable, and electromechanical medical devices. The
company specializes in product life-cycle management and
full-service manufacturing and has launched more than 400 unique
products. Clinical focus areas include cardiovascular, gynecologic,
orthopedic, spinal, wound management and emerging technologies.
ATEK Medical is ISO 13485:2003 certified, FDA registered, and
certified by the Women's Business Enterprise National Council. The
company maintains headquarters in Minneapolis, Minnesota, and a
main facility in Grand Rapids, Michigan.
This document contains forward-looking statements, including
without limitation, statements concerning the partnership and
supply agreement with Atek Medical, employment opportunities,
clinical trial plans and progress, objectives and expectations,
clinical activity timing, intended product development, disease
treatment and progression, operating results, spending activities,
patient symptoms and responses to treatment, treatment options and
expected timing of collecting and analyzing treatment data, all of
which involve certain risks and uncertainties. These statements are
often, but are not always, made through the use of words or phrases
such as "anticipates," "intends," "estimates," "plans," "expects,"
"we believe," "we intend," and similar words or phrases, or future
or conditional verbs such as "will," "would," "should,"
"potential," "could," "may," or similar expressions. Actual results
may differ significantly from the expectations contained in the
forward-looking statements. Among the factors that may result in
differences are the inherent uncertainties associated with clinical
trial and product development activities, regulatory approval
requirements, competitive developments, and the availability of
resources and the allocation of resources among different potential
uses. These and other significant factors are discussed in greater
detail in Aastrom's Annual Report on Form 10-K, Quarterly Reports
on Form 10-Q and other filings with the Securities and Exchange
Commission. These forward looking statements reflect management's
current views and Aastrom does not undertake to update any of these
forward-looking statements to reflect a change in its views or
events or circumstances that occur after the date of this release
except as required by law.
CONTACT: Aastrom Biosciences
Investor Contact
Kimberli O'Meara
734 930-5777
ir@aastrom.com
Berry & Company
Media contact
Stephen Zoegall
212 253-8881
szoegall@berrypr.com
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