Medifocus Inc. of Health Canada to start Phase III pivotal study in Canada in June 2009 and also received the experimental device exemption to start the same process in the central United States by the FDA in March 2010.Medifocus pivotal phase III clinical trial design is based on the results of four clinical trials in the United States with the Company in 1000 Microfocus APA thermotherapy system cancers. The patient data led to the design of the pivotal study were summarized and published online December 22 September 2009 Annals of Surgical Oncology. Dooley, MD, Hernan I. Vargas, MD, Alan J. Fenn, Ph.D., Mary Beth Tomaselli, MD, and Jay K. Harness, MD.
Pivotal Phase III clinical trials designed to evaluate the safety and efficiency, as measured by tumor shrinkage increased, the Company focused microwave heat energy in combination with neo-adjuvant chemotherapy compared to chemotherapy alone in breast cancer of large tumors. A total of 238 patients will be included in the clinical study of six medical institutions in the United States and Canada as approved by the FDA.S. medical.
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