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SAN DIEGO, Nov. 13, 2017 (GLOBE NEWSWIRE) -- Cytori Therapeutics, Inc. (Nasdaq:CYTX) (“Cytori” or “the Company”) today announced a new investigator initiated U.S. clinical trial for hip osteonecrosis. Details of the trial can be assessed at https://clinicaltrials.gov/ct2/show/NCT03269409.
Cytori Cell Therapy™ technology is approved for use in many countries around the world and has been shown to be safe and clinically useful in many indications. As a result, besides Cytori sponsored clinical trials such as the STAR trial for scleroderma, on a highly selective basis, the Company partners with researchers, academic institutions, and private institutions to support Investigator Initiated Studies (IIS). In these unsolicited, independent clinical or scientific research programs, the sponsor generally provides the majority of the overall trial support while Cytori typically supplies the core cell therapy technology.
In addition to the aforementioned investigator initiated trials, many other investigators are currently conducting research with the Cytori Cell Therapy platform for a broad range of clinical indications:
|Denmark||Erectile Dysfunction (NCT02240823)|
|France||Crohn’s Disease (NCT02520843)|
|France||Diabetic Foot Ulcer (NCT02866565)|
|France||Vocal Cord Scarring (NCT02622464)|
|Japan||Atherosclerosis Obliterans, Buerger’s Disease, Collagen Disease (UMIN000010143)|
|Japan||Heart Failure (UMIN000009066)|
|Japan||Intra Cerebral Hemorrhage|
|Japan||Liver Cirrhosis (UMIN000022601)|
|Poland||Acute Myocardial Infarction (link)|
|Poland||Amyotrophic Lateral Sclerosis (NCT03296501)|
|Poland||Diabetic Foot Ulcer|
|Russia||Anterior Cruciate Ligament Partial Rupture (NCT02469792)|
|Russia||Erectile Dysfunction (NCT02472431)|
|Russia||Knee Osteoarthritis (NCT02219113)|
In summary, these investigator initiated trials, typically performed at leading institutions in the U.S., Japan, and Europe, provide useful preliminary safety and efficacy data into novel therapeutic approaches for Cytori Cell Therapy. In fact, Cytori’s Habeo therapy was developed initially through an investigator initiated clinical trial. For more information about these trials, please visit Cytori’s website at cytori.com/researchers. Furthermore, the results from some of these trials are listed on Cytori’s website at cytori.com/our-technology/#publications.
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, statements regarding potential benefit to Cytori and timing of enrollment of investigator-initiated studies, the potential that improved formation of new bone and blood vessels will lead to more robust bone regeneration in patients with osteonecrosis, Cytori’s intention to work with Nagoya University to submit ADRESU data to Japan’s Pharmaceuticals and Medical Devices Agency for approval to market Cytori Cell Therapy for SUI and Cytori Cell Therapy’s potential to provide benefits across multiple disease states,are subject to risks and uncertainties that could cause our actual results and financial position to differ materially. These risks and uncertainties, which include inherent uncertainties in conduct of clinical studies and trials and the results of such trials (including risks that further studies may not support efficacy or safety of Cytori Cell Therapy), risks associated with clinical use of Cytori Cell Therapy in studies and trials not controlled by Cytori, risks to Cytori’s intellectual property portfolio (including the risk that independent investigators using Cytori’s technology or their employers may file for patent or other intellectual property that would not be owned by Cytori and may be competitive with or conflict with Cytori’s technology and pipeline) are described under the heading "Risk Factors" in Cytori's Securities and Exchange Commission Filings on Form 10-K and Form 10-Q. Cytori assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made.
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