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May 28, 2014
08:58 EDTBTXBioTime receives ISO 13485 certification for medical devices
BioTime announced that it has received ISO 13485:2003 certification from British Standards Institution for design, development, manufacture, and distribution of BioTime HyStem hydrogels for cell delivery applications. If Renevia is approved for the treatment of HIV-related facial lipoatrophy, BioTime plans to seek to expand its uses into other cell-based applications in reconstructive surgeries, traumatic injuries, and age-related lipoatrophy. BioTime’s plan is to bring Renevia to the medical market first in the E.U., where the regulatory pathway will allow for faster approval than in the U.S. Once the use of Renevia is established in Europe, BioTime will address an even larger potential market in Asia and the U.S.
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July 31, 2014
09:03 EDTBTXBioTime unit expands clinical development of bladder cancer test
BioTime and its subsidiary OncoCyte announced that OncoCyte has expanded the clinical development of its urine-based bladder cancer diagnostic test by initiating a multi-site clinical trial. The trial, which will involve up to 1,200 patient samples obtained from at least four large urology clinics located throughout the U.S., has received Institutional Review Board approval at multiple sites and should begin enrolling patients within the next week. OncoCyte’s initial clinical study of its bladder cancer diagnostic test began in January and involves pathology specimens being collected at a leading medical institution with an international reputation for excellence and discovery. The multi-site clinical trial is designed to expand the potential use of the PanC-Dx bladder cancer test beyond pathology laboratories and into urologic practices at the point of cystoscopy. Cystoscopy along with urine cytopathology, are the standard methods utilized for bladder cancer screening and diagnosis. The multi-site clinical trial should be completed within 12 months. The goal of the current clinical trial is to compare the performance of OncoCyte’s proprietary PanC-Dx bladder cancer markers to the performance of cystoscopy.

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