For 1st Clinical Study of VSEL(NYSE:TM) Technology in Humans …
NBS has been awarded a two year grant totaling $1,221,854 for "Repair of Bone Defects with Human Autologous Pluripotent Very Small Embryonic-Like Stem Cells (VSEL)", grant number 2R44DE022493-02A1, from the National Institute of Dental and Craniofacial Research (NIDCR), a division of the NIH. This peer reviewed grant is to support a P2 investigation and first approved NIH clinical study of VSELsTM in humans. Enrollment for this study is expected to begin in 2013.
The Bottom line: This award will fund the evaluation of VSEL^TM stem cells as a potential treatment for periodontitis. The product candidate, an autologous therapy derived from a patient's own stem cells, is to be developed for use in the regeneration of bone tissue damaged by this disease. The award includes $706,682 for the 1st year and $515,172 for the 2nd year of the project, and will cover the cost of the Investigational New Drug (NYSE:IND) submission to the FDA for the product candidate. NBS has a worldwide exclusive license to VSEL™ technology which uses very small embryonic-like stem cells, a heterogeneous population of stem cells found in adult bone marrow that have properties similar to those of embryonic stem cell. This study will expand NBS' knowledge of how autologous cell therapy can treat periodontitis and other bone defects, and moves development of VSEL technology beyond animal models and into the clinic, paving the way for other potential VSELTM trials.
NBS closed at $0.65 and is UP in the pre-market $0.025 or +3.85 to $0.675 on 10,050 shares traded and continues to be … rated a "BUY"
Periodontal disease is prevalent in the U.S. and affects up to 90% of the world population. The most severe cases of periodontal disease affect between 5% and 15% of the U.S. population, or between 15 and 47 million Americans. The incidence of periodontal disease is estimated to be between 1 and 3 million Americans annually, and growing at a 7% rate each year. Studies have shown that periodontal inflammation could have a role in the initiation or progression of coronary heart disease and stroke. Market research experts have estimated that severe periodontal disease represents a market between $1.25 and $1.5 billion annually.
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