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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. BioTimeís 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.
News For BTX From The Last 14 Days
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May 19, 2015
08:04 EDTBTXBioTime says positive interim results of blood-based cancer test to be presented
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May 14, 2015
08:03 EDTBTXBioTime sees OncoCyte funding sufficient for operations into early 2016
BioTime and its subsidiary OncoCyte Corporation announced that OncoCyte has received a new round of financing to fund further development and commercialization activities for its cancer diagnostic products. With completion of the financing, which included a cash investment of $3.3M and conversion of $3.3M of existing debt into equity, OncoCyte has approximately $7M in cash and marketable securities, which should be sufficient to fund current operations into early 2016, the company stated.
May 13, 2015
08:04 EDTBTXBioTime unit awarded $1.6M grand from Israel's OCS
BioTime and its subsidiary Cell Cure Neurosciences announced that Cell Cure has been awarded a grant for 2015 of approximately $1.61M from Israelís Office of the Chief Scientist to help finance the development of OpRegen, a cell-based therapeutic product that consists of animal product-free retinal pigment epithelial cells with high purity and potency. Cell Cure is now enrolling patients at Hadassah University Medical Center in Jerusalem, Israel, in a clinical Phase I/IIa dose-escalation study evaluating the safety and efficacy of OpRegen for geographic atrophy, the severe stage of the dry form of age-related macular degeneration. The Phase I/IIa clinical trial was opened in February 2015 following regulatory clearance from the U.S. FDA and the Israeli Ministry of Health. The trial consists of four cohorts and will evaluate three different dose regimens. Cell Cure expects to report interim data from the cohorts in the coming months.
May 12, 2015
09:38 EDTBTXBioTime management to meet with Oppenheimer
Meetings to be held in New York on May 14 and in Boston on May 15 hosted by Oppenheimer.

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