Aastrom Biosciences, Inc, a leading developer of expanded autologous cellular therapies for the treatment of severe cardiovascular diseases, and ATEK Medical, a leading medical device manufacturer, have formed 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 programme 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 programmes 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."
Aastrom Biosciences is developing expanded autologous cellular therapies for the treatment of severe cardiovascular diseases.
ATEK Medical is a private, woman-owned contract manufacturer of disposable, implantable, and electromechanical medical devices.