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Medifocus reports positive results from Phase II breast cancer treatment study

Study conducted under an investigational device exemption issued by the FDA

Medifocus, a Canada-based capital pool company, has reported positive clinical results from Phase II breast cancer treatment study that demonstrate significant efficacy when using the company’s proprietary focused heat treatment in combination with standard of care preoperative chemotherapy for large breast cancer tumors.

The patient data were obtained from a multi-center, randomized clinical study to demonstrate improvement in tumor shrinkage when focused heat is used in combination with standard of care (SOC) neo-adjuvant chemotherapy. This study was conducted in the US under an investigational device exemption issued by the FDA.

The reported clinical trial results demonstrated that when Medifocus’s focused heat therapy was added to the SOC neo-adjuvant chemotherapy in the treatment of large breast cancer tumors, tumor shrinkage was increased by an additional 50% over that induced by SOC chemotherapy alone.

According to Medifocus, the median tumor shrinkage in the Thermo-chemo arm was 88.4% and for the chemotherapy alone arm, the median tumor shrinkage was only 58.8%. This increase in median tumor shrinkage was statistically significant with a P value equal to 0.048. In addition, the data indicated that for the thermo-chemo treatment arm, almost 80% of all breast tumors treated had a tumor volume reduction of 80% or more compared to only 20% for chemotherapy alone.

The treatment goal of the Medifocus study is to demonstrate that focused heat treatment combined with SOC chemotherapy performed prior to surgery will significantly lower the need for mastectomy and enhance the chance of successful conversion to breast conserving surgery, a treatment outcome desired by both the surgeons and breast cancer patients.