Research In Brief
This article was originally published in The Gray Sheet
Executive Summary
Medifocus: Vancouver company files a response to FDA's questions on its investigation device exemption application for a pivotal trial of its Microfocus APA 1000 system for the treatment of breast cancer. The application was submitted in Jun,e and FDA's letter was received July 13. The 238-patient pivotal clinical trial will assess the safety and efficacy of focused microwave heat energy delivered by the Microfocus APA 1000 in combination with neo-adjuvant chemotherapy on large breast cancer tumors as measured by tumor shrinkage. A Phase II multicenter randomized study of Microfocus APA 1000 showed that the median tumor shrinkage in the thermo-chemo arm was about 88% compared to about 59% for chemotherapy alone. Almost 80% of all breast tumors treated with Microfocus APA 1000 got substantially smaller versus 20% in the chemotherapy group