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March 24, 2014
08:04 EDTCYTXCytori says study using therapy to treat ACL injury underway in Spain
Cytori Therapeutics announces the first investigator-initiated study evaluating Cytori Cell Therapy as a potential concomitant treatment for Anterior-cruciate ligament injury. The study is led by Ramon Cugat, M.D. PhD. Dr. Cugat is President of the Medical Council for the Catalan Soccer Delegation's Health Insurance Company under the Spanish Soccer Federation, President of the Board of Directors of the Council of the Garcia Cugat Foundation for Regenerative Medicine Research, Professor of the Chair of the Garcia Cugat Foundation at CEU Cardenal Herrera University, Director of the Orthopaedic Surgical Department in Hospital Quiron, Barcelona, Spain and Head of Trauma and Orthopaedic Surgery in Mutua Patronal Montañesa. The study is an investigator-initiated study to determine the feasibility of using Cytori Cell Therapy on patients undergoing complete ACL reconstruction. The study is approved to treat 20 patients who will be followed by both clinical and imaging end points. Thirteen patients have been treated thus far, full enrollment is expected this year and data is being evaluated on a rolling basis. The study was initiated in 2013 under an approval from the Spain Ministry of Health, Social Services and Equality. It was organized by a multidisciplinary team of researchers at Hospital Quiron.
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October 23, 2014
09:04 EDTCYTXOn The Fly: Pre-market Movers
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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 trials’ 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 Cytori’s submission was received on October 22.
October 15, 2014
14:47 EDTCYTXSabby reports 9.99% passive stake in Cytori Therapeutics
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