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Cytori Cell Therapy Safe and Potentially Effective in EU Phase I Erectile Dysfunction Trial

PSTV | February 3, 2016

Cytori Therapeutics, Inc. (NASDAQ: CYTX) announced today the publication of the results of an investigator initiated Phase I clinical trial using Cytori Cell Therapy™ for the treatment of erectile dysfunction (ED) following radical prostatectomy (RP).

The open-label, single-arm study was conducted in Denmark and enrolled 17 patients who had undergone radical prostatectomy within 5-18 months prior to the study. To qualify for the study, patients were required to have not regained erectile function following surgery despite appropriate pharmacological intervention. All patients received a single intracavernous injection of Cytori Cell Therapy. There were no serious adverse effects reported at six months follow-up, and eight of the 17 patients recovered erectile function within three months of treatment. In the publication, the authors concluded their “…ﬁndings suggest that autologous, freshly isolated ADRCs are safe to use and possess potential efficacy in the treatment of ED after RP.”

A post-hoc analysis was performed in which patients were divided into those who were continent prior to treatment (11 patients) and those who were incontinent (6 patients). Of the 11 in the continent group, 8 (73%) recovered erectile function which remained improved at 6 months. None of the incontinent patients recovered function.

The international index of erectile function-5 score (IIEF) for continent men improved from 7 (baseline) to 17 units at 6 months (p=0.007). The erection hardness score (EHS) improved from 1 (baseline) to 3 units at 6 months (p=0.03). The IIEF and EHS did not improve in the incontinent group.

Dr. Martha Haahr, the lead investigator, stated, "We are very pleased with the results from our Phase 1 study. In this open-label trial, we saw a very good effect on erectile function. It is remarkable, especially as these men had previously seen no effect from traditional medical treatment and continue to have good erectile function after 6 months follow-up. This suggests the possibility of therapeutic options for patients suffering from erectile dysfunction from other causes. We are already planning a double-blind randomized follow-up study.”

This study, published in the journal EBioMedicine, was executed at the Odense University Hospital, Odense, Denmark, by Dr. Martha Haahr and colleagues. Further details can be found on clinicaltrials.gov (NCT02240823).

In addition to this study, Cytori Cell Therapy is currently being studied in the ADRESU trial in Japan for male urinary incontinence following prostatic surgery. This investigator initiated, phase III, multicenter, 45 patient trial of the ECCI-50 cellular therapeutic is based on promising pilot trial data published in the International Journal of Urology in 2014. Details of the pilot trial can be found on clinicaltrials.gov and the Japanese Ministry of Health Labour and Welfare website.

“This recent Danish trial coupled with the ADRESU incontinence trial and related clinical experience in Japan, provide evidence that Cytori Cell Therapy may be able to effectively target two common and important side effects of prostate surgery, incontinence and erectile dysfunction,” said Dr. Marc H. Hedrick, President and CEO of Cytori Therapeutics. “In the future, data from these trials may provide a foundation for broader clinical use of our technology for other urologic diseases.”

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, safety and efficacy of Cytori Cell therapy for certain medical conditions, and conduct of investigator-initiated clinical trials using Cytori Cell Therapy, 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 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.