SOURCE: Cytori Therapeutics, Inc.

Cytori Therapeutics, Inc.

May 25, 2011 09:00 ET

Urinary Incontinence Study Using the Celution® System Approved in Japan

SAN DIEGO, CA--(Marketwire - May 25, 2011) - Cytori Therapeutics (NASDAQ: CYTX) has learned that the Japanese Ministry of Health, Labor and Welfare ("MHLW"), the Japanese health regulatory body, has approved Nagoya University's independent clinical study to assess the efficacy of adipose-derived stem and regenerative cells (ADRCs) in the treatment of stress urinary incontinence.

MHLW approval to proceed with the study reflects Cytori's open operating system model in which hospital-based Celution® Systems may be used by different specialties for their own clinical research. This allows potential applications beyond our core focus to be advanced by independent groups. The study may be used as the basis for a pivotal trial or to apply for regulatory approvals both in Japan and around the world.

"This is an example of a translational medicine application that has evolved into an approved clinical study," said Marc Hedrick, President of Cytori. "Our intention is to leverage this data, should we see positive results, to work towards making this a standard of care for patients around the world."

This open label, non-randomized study will enroll up to 20 patients with mild incontinence, both females and males, at the Nagoya University Graduate School of Medicine and a potential second site. Each patient will receive an injection of Celution® derived ADRCs directly into the urethral sphincter and a periurethral injection of ADRC-enhanced fat graft to act as a bulking agent. Patients will be assessed for incontinence (via 24 hr. pad test), quality of life and sphincter function. The study will be led by Momokazu Gotoh, MD, Ph.D., Professor and Chairman of the Department of Urology and Tokunori Yamamoto, MD, Ph.D., Associate Professor Department of Urology at Nagoya University Graduate School of Medicine.

"We are enthusiastic that this Celution® based treatment could be effective across a broad spectrum of patients who suffer from stress urinary incontinence," said Dr. Gotoh.

Tens of millions of patients around the world today suffer from incontinence. It is estimated that in Japan alone, approximately 4 million patients suffer from urinary incontinence. Stress urinary incontinence (SUI) is characterized by leakage of urine during every day activities. SUI may result from a variety of causes, including surgery, such as radical prostatectomy, effects from childbirth or menopause, as well as from radiation treatment and the effects of certain neurodegenerative conditions.

About Cytori
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 is being sold into the European and Asian cosmetic and reconstructive surgery markets but is not yet available in the United States. Our StemSource® product line is sold globally for cell banking and research applications. Our PureGraft™ products are available in North America and Europe for fat grafting procedures. www.cytori.com

Cautionary Statement Regarding Forward-Looking Statements
This communication includes forward-looking statements regarding events, trends and business prospects, such as statements regarding the potential effectiveness of the therapy in treating stress urinary incontinence, and the the potential usefulness of the study in applying for regulatory approvals or for larger pivotal trials, 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 regulatory and clinical uncertainties, product performance, 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.

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