mBeach Software Inc. (“MBHS”) /quotes/comstock/11i!mbhs (MBHS 0.30, +0.02, +7.14%) today announced its initiation of early stage activities to enter requests for regulatory approvals, required for every Medical Device. The approvals will be for clinical trials and marketing qualifications. The qualifications to be requested at this early stage will include FDA approvals, CE approvals for marketing in the EU, and being recognized by Reimbursement programs.
Completing these regulatory procedures will pave the way for local clinical trials and a full commercial launch of SkinScan 650, SCS’s non-invasive, point-of-care system to detect and identify different types of skin cancers. mBeach expects to receive the initial approvals, for clinical trials mainly, by mid 2011. These requested clinical trial approvals, follow the clinical trials conducted by mBeach wholly owned subsidiary, Skin Cancer Scanning Ltd. (“SCS”), in Israel, with the Ministry of health, Medical Device qualification Department and the international Helsinki approval for conducting clinical trials.
mBeach CEO Yossi Biderman commented, “The early stage regulatory approach, adopted by mBeach, is due to the lengthy regulatory procedures. We expect the approvals to be staggered over a two year period, unless facing unforeseeable obstacles. These requested and required approvals form a basic component in the heath and marketing strategy defined by mBeach. This will help mBeach achieve its two major goals of improving quality of life for millions of people around the world and will greatly increase shareholder value. These approvals combined with a growing market demand and technical innovative approach, will have on the final product what we think will be a boosting impact. We expect our SkinScan 650, a non-invasive, point-of-care, doctors decision supporting device, to provide the Medical practitioner a much needed user friendly diagnostic solution.”