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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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March 4, 2015
08:13 EDTCYTXCytori Therapeutics sees FY15 product revenue $5M-$8M
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08:11 EDTCYTXCytori Therapeutics reports prelim Q4 revenue $2.5M, two estimates $2.46M
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February 26, 2015
08:02 EDTCYTXCytori Therapeutics says receives FDA approval to expand Scleroderma trial
Cytori Therapeutics announced that it received approval from FDA to expand the number of Scleroderma clinical trial sites from 12 to 20 centers in the United States. The STAR study is an 80 patient pivotal clinical trial approved by FDA in January to study the effects of Cytoriís lead drug ECCS-50 for treatment of patients with hand manifestations of Scleroderma.
February 24, 2015
08:17 EDTCYTXCytori Therapeutics receives positive European opinion on orphan drug status
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