THE PRODUCT: The PHOENIX hand piece is the first device specifically designed to combine laser tissue stimulation and physician-directed injections of biologic or pharmacologic agents to pre-determined areas of the heart. The PHOENIX hand piece includes a fiber-optic component and three needles positioned around the fiber-optic, which allow precise delivery of biologic or pharmacologic agents into the stimulated tissue surrounding the channels. Basic research results have demonstrated an advantage in cell survival when delivered in combination with tissue stimulation using PHOENIX.10
PATENTED DESIGN: The combination delivery of laser tissue stimulation and biologic injection into the myocardium is covered by a significant patent portfolio. The method and technology is protected by 8 issued patents, with 168 claims allowed.
CLINICAL UTILITY: The Company has extensive clinical data on the efficacy of stand-alone laser channeling (without stem cells). The preliminary clinical results by Reyes12 of the combination of laser tissue stimulation with direct injection of bone marrow cells, recently published in European Journal of Thoracic Surgery, have demonstrated the feasibility with favorable initial results. The European experience will be the clinical template for our US IDE trial.
