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Japanese Approval Trial for Stress Urinary Incontinence Using Cytori Cell Therapy Announced

PSTV | July 30, 2015

Cytori Therapeutics, Inc. (NASDAQ: CYTX) announced that it has recently been informed that a company-supported trial in Japan has received approval to begin enrollment from Japan MHLW (Ministry of Health, Labor and Welfare).

The ‘ADRESU’ trial is a 1-year open-label, multi-center, single arm trial to evaluate the efficacy and safety of periurethral injection of autologous adipose derived regenerative cells for the treatment of male stress urinary incontinence following prostatectomy for prostate cancer. The goal of the investigator-initiated trial will be to gain product approval for Cytori Cell Therapy technology for this indication.

The trial will be led by both 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, and is primarily sponsored and funded by the Japanese Government.

The ADRESU trial will enroll 45 patients and the primary endpoint will assess the improvement in urine leakage volume from baseline by 24-hour pad test. Each patient will serve as his own control in the trial. Key secondary endpoints will include: urine leakage volume at each evaluation time point by 24-hour pad test, improvement in the number of incontinence episodes per day with greater than 50% reduction from baseline, number of incontinence episodes per day, number of pads used per day, key quality of life scores, patient overall satisfaction, key urodynamic parameters, blood flow at the injection site measured by transrectal ultrasonography and evaluation of the injection site by pelvic MRI scan.

The lead site of the trial is Nagoya University and enrollment is expected to begin in 2015 at four centers within Japan. The trial is a follow-up trial to an initial clinical study reporting positive benefits in men with urinary incontinence post-prostatectomy performed at Nagoya University (Gotoh et al. Int Journal Urology. 2014;21(3): 294-300).

For more information on the ADRESU trial, please visit:

https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&type=summary&recptno=R000020539&language=J

About Cytori Therapeutics, Inc.

Cytori Therapeutics is a late stage cell therapy company developing autologous cell therapies from adipose tissue to treat a variety of medical conditions. Data from preclinical studies and clinical trials suggest that Cytori Cell Therapy™ acts principally by improving blood flow, modulating the immune system, and facilitating wound repair. As a result, Cytori Cell Therapy™ may provide benefits across multiple disease states and can be made available to the physician and patient at the point-of-care through Cytori’s proprietary technologies and products. For more information: visit www.cytori.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, including, without limitation, those regarding conduct of clinical trials, are all subject to risks and uncertainties that could cause our actual results and financial position to differ materially. Some of these risks and uncertainties include, but are not limited to, risks related to our history of operating losses, the need for further financing and our ability to access the necessary additional capital for our business, inherent risk and uncertainty in the protection intellectual property rights, regulatory uncertainties, risks in the collection and results of clinical data, final clinical outcomes, dependence on third party performance, performance and acceptance of our products in the marketplace, as well as other risks and uncertainties described under the heading "Risk Factors" in Cytori's Securities and Exchange Commission Filings on Form 10-K and Form 10-Q. We assume no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made.