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February 25, 2013
09:26 EDTCYTXCytori Therapeutics receives CE Mark in Europe for Intravase
Cytori Therapeutics has received a CE Mark in Europe for Intravase, a reagent intended to be used with Cytori’s Celution System for preparing safe and optimized adipose-derived stem and regenerative cells for intravascular delivery into the same patient.
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September 3, 2015
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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