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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.
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October 22, 2014
18:19 EDTCYTXCytori Therapeutics receives FDA approval to resume ATHENA trial enrollment
Cytori Therapeutics has received notification from the FDA that Cytori has provided additional information sufficient to support continuation of enrollment in its ATHENA cardiovascular trials. The FDA has agreed that the submitted data and protocol amendments support the fact that there are no subject protection concerns that preclude continuation of the trials. The ATHENA trials have enrolled a total of 31 patients thus far but enrollment was stopped last May by the company based on meeting the trialsí internal stopping rules related to potential cerebrovascular events affecting both cell and placebo treated patients. Based on consultation with the FDA, Cytori initiated a thorough safety review consisting of evaluating each adverse event in all of its previous and ongoing cardiovascular trials and conducted additional testing of its product and cellular output. In addition, Cytori implemented several protocol changes to enhance the safety of the trial procedures for patients. The FDA response to Cytoriís submission was received on October 22.
October 15, 2014
14:47 EDTCYTXSabby reports 9.99% passive stake in Cytori Therapeutics
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