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Cytori Announces Timing for Full Enrollment in U.S. Phase III Scleroderma Trial

Apr 27, 2016

SAN DIEGO--(BUSINESS WIRE)-- Cytori Therapeutics, Inc. (NASDAQ: CYTX) today announced that its U.S. FDA approved Phase 3 STAR trial has enrolled and treated its 60th patient (75% of target enrollment). In addition, as per the trial protocol, an independent data monitoring committee has reviewed safety data from the initial 40 patients and recommended that the study continue as planned. The 60 procedures, including the fat harvest from small volume liposuction and the finger injections have all been completed successfully without complications.

“The pace of enrollment has exceeded our original planning and is an indication of the openness and hope from physicians and their patients in the potential for cell therapy as a viable option for scleroderma. Based on screening and scheduling of patients, completion of enrollment will occur by mid-June. We remain exceedingly grateful to the investigators, research staff and especially the patients who have participated,” said Dr. Steven Kesten, Chief Medical Officer, Cytori Therapeutics.

STAR is a randomized, placebo-controlled, double-blind, parallel group phase III FDA approved pivotal study investigating the efficacy and safety of Cytori Cell Therapy (ECCS-50) injected subcutaneously into the fingers of patients with impaired hand function from scleroderma. A total of 80 patients will be randomized with 40 receiving Cytori Cell Therapy and 40 receiving placebo. The double-blind period extends to 48 weeks. After all patients have completed 48 weeks follow-up, the placebo patients will be offered active treatment should they desire treatment and continue to qualify. Details of the STAR trial including inclusion and exclusion criteria can be found at the following link: clinicaltrials.gov

The STAR trial follows the twelve patient SCLERADEC-I pilot trial in which one year post-treatment results were published in the August 2015 edition of the journal Rheumatology. The two year results have recently been presented at the Systemic Sclerosis World Congress in Lisbon, Portugal. The data indicated that a single administration of ECCS-50 was safe and that treated patients exhibited significant improvements in hand symptoms, function and Raynaud’s Phenomena through two years following treatment.

Cytori announced in January 2016 that it entered into an agreement with Idis to establish a Managed Access Program (MAP) for its cellular therapeutic in select countries across Europe, the Middle East, and Africa for patients with impaired hand function due to scleroderma. Managed Access Programs provide biopharmaceutical companies with a way to allow ethical access to their pre-license/unlicensed medicines to help patients with unmet medical needs. Access is provided in response to physician requests in a fully compliant manner, where no alternative treatment options are available. The source of medicine funding varies and may include the hospital’s budget or country’s sickness fund or social security system.

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, without limitation, conduct of Cytori’s STAR trial (including completion of STAR trial enrollment), 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.

Source: Cytori Therapeutics, Inc.

Cytori Therapeutics, Inc.

Tiago Girao, 1 858-458-0900

ir@cytori.com