First Patient Treated in Adipose Stem & Regenerative Cell Study for Stress Urinary Incontinence

Fri Jan 30, 2009 9:29am EST
 
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NAGOYA, Japan--(Business Wire)--
Cytori (NASDAQ: CYTX) announced that the first patient was enrolled in an
investigator-initiated safety and feasibility study using adipose-derived stem
and regenerative cells to treat stress urinary incontinence. The 10-patient
study is being conducted independently by Nagoya University Hospital in Japan.
Cytori's Celution 800 System is being used to process and extract the patients'
own adipose tissue-derived stem and regenerative cells at the time of surgery. 

"The Celution System is uniquely able to provide real-time access to clinical
grade stem and regenerative cells to meet the growing demand Cytori is seeing
from physicians seeking regenerative medicine-based treatments," said Seijiro
Shirahama, President, Cytori Asia Pacific. "As a result, hospitals are
increasingly interested in a Celution purchase to fill this need in the
marketplace. This demand is partially reflected in the seven
investigator-initiated clinical studies taking place in Japan which use the
Celution System." 

As part of the study, stem cells were injected intra-muscularly into the
sphincter as well as in combination with a measured volume of the patient`s own
fat tissue to create a bulking agent to support the urethra. The study will
evaluate safety, functional endpoints including intraurethral pressure and leak
point pressure, as well as subjective assessments of patient and physician
satisfaction. Current treatments include use of collagen as a bulking agent to
provide pressure against and support the urethra. 

"There are a growing number of scientific publications that show adipose derived
stem and regenerative cells can ameliorate urinary incontinence," said Momokazu
Gotoh, M.D., Ph.D., Professor and Chairman, Department of Urology, Nagoya
University Graduate School of Medicine. "Celution is the only feasible way to
derive the cells in a clinically practical manner. This first case could not
have gone better and the Celution System performed flawlessly." 

Stress urinary incontinence can have a significant impact on a patient`s quality
of life, resulting in involuntary release of urine due a weakened urethral
sphincter. The condition is more common in women and often comes about following
child birth or menopause. It is estimated that approximately 9 million people in
Japan, and more than 13 million women in the U.S., are affected by stress
urinary incontinence. 

About Cytori

Cytori's (NASDAQ: CYTX) goal is to be the global leader in regenerative
medicine. The company is dedicated to providing patients with new options for
reconstructive surgery, developing treatments for cardiovascular disease, and
banking patients' adult stem and regenerative cells. The Celution(R) 800 System
is being introduced in Europe into the reconstructive surgery market while the
Celution(R) 900 System is being commercialized globally for cryopreserving a
patient's own stem and regenerative cells. Clinical trials are ongoing in
cardiovascular disease and planned for spinal disc degeneration,
gastrointestinal disorders, and other unmet medical needs. www.cytoritx.com

Cautionary Statement Regarding Forward-Looking Statements

This press release includes forward-looking statements regarding events, trends
and business prospects, which may affect our future operating results and
financial position. Such statements are subject to risks and uncertainties that
could cause our actual results and financial position to differ materially. Some
of these risks and uncertainties include our history of operating losses, the
need for further financing, regulatory uncertainties regarding the collection
and results of, clinical data, dependence on third party performance, and other
risks and uncertainties described under the "Risk Factors" in Cytori's
Securities and Exchange Commission Filings. We assume no responsibility to
update or revise any forward-looking statements to reflect events, trends or
circumstances after the date they are made. 





Cytori Therapeutics
Tom Baker
Direct: 858-875-5258
tbaker@cytoritx.com

Copyright Business Wire 2009

 

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