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Press Release

Sustained Clinical Benefit After 3 Year Follow Up in Scleroderma Trial

Dec 05, 2016

SAN DIEGO, Dec. 05, 2016 (GLOBE NEWSWIRE) -- Cytori Therapeutics, Inc. (NASDAQ:CYTX) Topline review of early three-year follow-up data from the SCLERADEC I trial shows sustained benefit in treated patients over baseline in major study endpoints. The data indicate the following:

  • Sustained improvement from baseline in all four key endpoints, the Cochin hand Function Score, scleroderma-related disability and pain, and Raynaud’s Condition Score (average scores for each essentially unchanged over than those recently reported for two year follow-up)
  • 83% (10/12) patients in the trial reported no Raynaud’s Phenomenon symptoms in the week leading to the follow up visit
  • Mean hand strength and mobility scores remain substantially improved over baseline
  • Mean follow-up was 3 years, 4 months; range 3 years 1 month to 3 years 7 months

The full data set will be presented by the Investigators at a forthcoming scientific meeting.

“The longevity of the clinical response of a single therapeutic administration of ECCS-50 is an importing finding,” said Dr. Marc H. Hedrick, Cytori President and Chief Executive Officer. “As we prepare for commercial launch and interview payors, duration of effect seems to be one of many potentially attractive aspects of the therapy when compared to current available options.”

The SCLERADEC I trial was a 12-patient, open label, single arm, investigator-initiated study conducted at Assistance Publique Hôpitaux de Marseille (APHM), France led by Drs. Brigitte Granel and Guy Magalon supported by the team of Pr. Florence Sabatier of the Cell Therapy Department of Hôpital de le Conception, APHM, with financial support from the French Scleroderma Research Group (GFRS) and with additional support from Cytori.

Furthermore, Cytori recently announced publication of two-year clinical follow-up of the SCLERADEC I trial. The results were published in the journal Current Research in Translational Medicine, and is accessible online.

Cytori has recently enrolled the STAR trial, a Phase 3, U.S. multi-center, randomized controlled trial of Cytori Cell Therapy™ in the same indication as the SCLERADEC I trial, hand dysfunction and Raynaud’s Phenomenon associated with scleroderma. The STAR trial randomized 88 subjects and completed enrollment in mid-2016.  Data unblinding and analysis will commence once the last enrolled subject has competed their 48 week follow-up visit, anticipated to be in mid-2017.

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.

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 statements regarding availability and publication of clinical data regarding Cytori’s scleroderma therapeutic (ECCS-50), and ECCS-50’s potential duration of effect (as a possibly attractive aspect of the therapy to payers), 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 conduct of clinical trials and clinical trial results (including risks associated with investigator-initiated trials), risks in the collection of clinical data (including collection and accuracy of the limited, open-label 12-patient SCLERADEC I pilot trial data), final clinical outcomes risks, risk regarding protection of intellectual property rights, regulatory uncertainties, risks regarding dependence on third party performance, competitive risks (including potential introduction of superior alternative therapeutic approaches to scleroderma),  and 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 CONTACT

Tiago Girao

+1.858.458.0900

ir@cytori.com

Source: Cytori Therapeutics