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April 14, 2014
08:12 EDTCYTXCytori announces publication of Cytori Cell Therapy trial outcomes
Cytori Therapeutics announced publication of safety and efficacy data from a 36 month European clinical trial of Cytori Cell Therapy in patients with chronic ischemic heart failure. Final data from the Companyís PRECISE trial, a 27-patient, prospective, randomized, double-blind, placebo-controlled, feasibility trial , or Phase I/IIA, demonstrated statistically significant differences in cardiac functional capacity between treated and placebo groups and will appear in an upcoming issue of the American Heart Journal. Cytori Cell Therapy is a mixed population of adipose derived regenerative cells extracted from a patientís own adipose tissue using Cytoriís proprietary Celution System. Cytori is currently enrolling patients in the U.S. ATHENA and ATHENA II trials, both 45 patient prospective, randomized, double-blind, placebo-controlled trials investigating a lower and a higher dose, respectively, of Cytori Cell Therapy in a similar patient population as PRECISE. In addition, Cytori has received a CE Mark for the Intravase reagent to be used with the Celution System for intravascular delivery. The Intravase CE Mark allows for targeted sales to physicians conducting independent research for intravascular indications.
News For CYTX From The Last 14 Days
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February 3, 2016
07:15 EDTCYTXCytori says Cytori Cell Therapy 'safe' and 'effective' in EU Phase 1 ED trial
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January 25, 2016
07:02 EDTCYTXCytori Therapeutics says Phase 3 STAR trial treats 20th patient
Cytori Therapeutics announced that its U.S. FDA approved Phase 3 STAR trial has enrolled and treated its 20th patient -- 25% of target enrollment. In addition, as per the trial protocol, an independent data monitoring committee has reviewed safety data from the initial 10 patients and recommended that the study continue as planned. The 20 procedures, including the fat harvest from small volume liposuction and the finger injections have all been completed successfully and well tolerated. 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. The trial began enrollment in August 2015 with enrollment expected to be completed by mid-2016. 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 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 one-year post-treatment.

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