Cytori Pivotal ADRESU Incontinence Trial Hits 50% Enrollment Milestone

SAN DIEGO, Dec. 14, 2016 -- Cytori Therapeutics, Inc. (NASDAQ:CYTX) today announced that over half of 45 patients in the ADRESU trial in Japan have been enrolled and treated. ADRESU is a late phase, investigator-initiated Japanese clinical trial to study the efficacy and safety of Cytori Cell Therapy^TM in men with stress urinary incontinence after prostatic intervention for prostate cancer or benign prostatic hypertrophy.

“The enrollment rate is picking up and we now have all four sites enrolling,” said Dr. Momokazu Gotoh, Professor and Chairman of the Department of Urology at Nagoya University and Principal Investigator on the ADRESU trial. “Thus far the therapy has been well-tolerated by the study patients, and we currently anticipate full enrollment in mid-2017.”

ADRESU is a multicenter, 45 patient open label controlled trial of ECCI-50 therapy, comprised of periurethral injection of autologous adipose derived regenerative cells (ADRCs), and a mixture of ADRCs and adipose tissue, and is based on pilot trial data published in the International Journal of Urology in 2014. Details of the ADRESU trial can be found on clinicaltrials.gov and the University Hospital Medical Information Network website. The primary endpoint for the ADRESU trial is the number of patients who experience reduction of urinary leakage by > 50% volume (as measured by the weight of diaper pads for incontinence used over 24 hours) at 52 weeks after treatment.  If the endpoint is successfully achieved, the data will be used to seek approval and reimbursement of ECCI-50 for this indication.  The trial costs are substantially supported by Japan’s Ministry of Health, Labour and Welfare and Japan Agency for Medical Research and Development with additional support (providing the Celution^® system plus all required accessories) by Cytori. The trial is sponsored by Nagoya University.

Cytori has been commercially active in the Japanese market since 2008 through its Japanese subsidiary and has had a full-time office and in-country leadership in Japan since 2005.  Over that period of time, Cytori has built a user base of over 50 sites including leading academic institutions throughout Japan, such as Nagoya University, as well as individual clinics.

About Cytori

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.

About Male Stress Urinary Incontinence

Male stress urinary incontinence is a common side effect of benign prostatic hypertrophy surgeries (BPH) or radical prostatectomy’s with limited treatment options, representing an unmet medical need. In 2015 there were 21,699 BPH procedures and 15,714 radical prostectatomies performed at Diagnoses Procedure Combination (DPC) hospitals in Japan. These DPC hospitals comprise about half of the hospital capacity in Japan.

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, statements regarding completion of ADREU clinical trial enrollment, and possible use of the ADRESU clinical trial data to seek approval and reimbursement of ECCI-50 for men with stress urinary incontinence after prostatic intervention for prostate cancer or benign prostatic hypertrophy, 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, inherent risk and uncertainty in the protection intellectual property rights, regulatory uncertainties, risks in the conduct of investigator-initiated clinical trials, 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.

Cytori Therapeutics, Inc.
Tiago Girao, +1 (858) 458.0900
[email protected]