Cytori Approved to Initiate Pivotal Stem & Regenerative Cell Heart Attack Trial in Europe; First ADVANCE Trial Site to Begin Enrollment in the Netherlands
SAN DIEGO, CA--(Marketwire - January 20, 2011) - Cytori (NASDAQ:CYTX) received
approval from The Netherlands to initiate a pivotal European trial, named
ADVANCE, to investigate adipose-derived stem and regenerative cells (ADRCs),
processed by the Celution® One System, in the treatment of patients with acute
heart attacks. This is the first country and trial-center approval for ADVANCE.
Additional country and trial-center approvals are anticipated throughout Europe
during the first half of 2011. One of the goals of the trial is to expand the
Celution® System CE Mark to include acute heart attack claims and to provide
economic data to justify its implementation and reimbursement.
ADVANCE is a randomized, placebo controlled, double-blind trial that will enroll
up to 360 patients with ST-elevation myocardial infarction in up to 35 centers,
predominately in Europe. The primary endpoint of the trial is reduction in
infarct size as measured by cardiac magnetic resonance imaging (MRI).
ADVANCE will use the Celution® One, our next generation device manufactured by
Olympus-Cytori Joint Venture. The Celution® One System draws on the same core
technology and scientific innovation as the Celution® 800 System, which is
currently approved in Europe for breast reconstruction, certain aesthetic
procedures and specific types of wounds. The Celution® One System is an
investigational device that is not yet commercially available. The Celution® One
System is specifically designed for use in a hospital setting, processing
greater tissue volumes in less time.
In 2010, Cytori reported results from the APOLLO trial, a pilot study for acute
heart attack patients who underwent ADRC therapy. The study showed that the
harvest and injection of ADRCs were safe and well-tolerated in this patient
population. At 6 months, the procedure was associated with an improvement in
infarct size in ADRC-treated patients, as well as in other measures.
Cytori is a leader in providing patients and physicians around the world with
medical technologies that harness the potential of adult regenerative cells from
adipose tissue. The Celution® System family of medical devices and instruments
are being sold into the European and Asian cosmetic, reconstructive surgery and
wound markets. The Celution® System is not yet available in the United States.
Our StemSource® product line is sold globally for cell banking and research
About Olympus-Cytori, Inc.
Olympus-Cytori, Inc. is a joint venture between Olympus Corporation and Cytori
Therapeutics, Inc. that was formed in 2005 to develop and manufacture future