As we recently announced via 8K, we are also working with General American Capital Partners (GACP) to open 10 new clinics in the U.S. called Stem Cell Centers of Excellence. We are excited to help GACP provide stem cell services to new patients in a variety of metropolitan areas over the next three years. In addition, we have entered into an agreement with GACP which will allow for growth of the tissue banking facility. Read more about the agreement with GACP here: https://www.sec.gov/Archives/edgar/data/1388319/000118518517000536/usstemcell8k030817.htm
On regulatory news, following the passing of the 21st Century Cures Act, U.S. Stem Cell, Inc. has applied to the FDA for Regenerative Advanced Therapy or RAT Designation. Thanks to the REGROW component of the Cures Act, The FDA will grant RAT designation for a regenerative medicine therapy that is intended to treat, modify, reverse, or cure a serious or life-threatening disease and demonstrates preliminary clinical evidence that the product has the potential to address unmet medical needs for a disease. We believe that our MyoCell® product meets these requirements as we have demonstrated clinical efficacy in both preclinical and clinical studies including our most recent MARVEL Phase II/III trial. If RAT designation is granted, this could expedite the approval process with the FDA. More information on the FDA’s new RAT Designation can be found here: https://www.fda.gov/BiologicsBloodVaccines/CellularGeneTherapyProducts/ucm537670.htm