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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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September 3, 2015
09:22 EDTCYTXOn The Fly: Pre-market Movers
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07:05 EDTCYTXCytori Therapeutics begins enrollment in Phase III Adresu trial
Cytori Therapeutics announced that the first patient has been enrolled and treated in the ADRESU trial, a late phase, physician-initiated Japanese clinical trial to study the efficacy and safety of Cytori Cell Therapy in men with urinary incontinence after prostatic surgery for prostate cancer or benign prostatic hypertrophy. ADRESU is a multicenter, 45 patient open label controlled trial of the ECCI-50 cellular therapeutic and is based on promising pilot trial data published in the International Journal of Urology in 2014. Details of the pilot trial can be found on clinicaltrials.gov and the MHLW website. The primary endpoint for the ADRESU trial will be the number of patients who experience reduction of urinary leakage volume 52 weeks after treatment. If the endpoint is successfully achieved, the data will be used to seek approval of Cytori Cell Therapy for this indication. The trial costs are substantially supported by Japan's Ministry of Health, Labour and Welfare, with additional support by Cytori. The trial is sponsored by Nagoya University. The ADRESU trial was based on preliminary safety and efficacy data published in 2014 in the International Journal of Urology. Following enrollment and assessment of the results of the trial, Cytori and Nagoya University intend to file for medical device approval for the therapy, which in Japan is typically combined with reimbursement.

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