Current Clinical Trial

The Company has received Investigational Device Exemption (IDE) approval from the Food and Drug Administration (FDA) and Investigational Testing Authorization (ITA) from Health Canada’s Medical Device Bureau (MDB) for its pivotal phase III trial with the Microfocus APA 1000 Breast Thermotherapy System for the treatment of breast cancer. A total of 238 patients will be entered into the phase III study in the United States and Canada. Information regarding the Medifocus clinical trial is available on the U.S. National Institutes of Health ClinicalTrials.gov web site at http://www.clinicaltrials.gov/ct2/show/NCT01204801?term=medifocus&rank=1.

Prior Clinical Trials

A 10-patient Phase I clinical feasibility test in 1999/2000 demonstrated that Medifocus’ system can safely heat cancerous breast tumors of 1 to 8 cm diameter using the microwave treatment alone.(Gardner et al, Annals of Surgical Oncology, 2002;9(4):326-332.)

A 25-patient Phase II Columbia Hospital/Harbor UCLA study in 2001/2002 demonstrated that Medifocus’ focused microwave energy delivered to cancerous tissues deep in the breast caused tumor necrosis without causing significant increase in skin surface temperature.(Vargas et al, Annals of Surgical Oncology, 2004;11(2):139-146.)

A Randomized Phase II study in 2002 to 2004 involving 10 clinical sites indicated that Medifocus’ microwave energy used prior to surgery to treat early-stage breast cancer tumors can reduce the rate of positive tumor margins. (Dooley et al, Cancer Therapy,2008,6:395-408. )

A Randomized Phase II study in 2002 to 2004 involving 9 clinical sites indicated that Medifocus’ microwave energy used in combination with chemotherapy to treat large breast cancer tumors can reduce the tumor burden significantly to allow the option of lumpectomy over mastectomy compared to chemotherapy treatment by itself.(Vargas et al, Cancer Therapy, 2007,5:401-408.)

A review article summarizing the above four clinical studies conducted to date by Medifocus were published in the April 2010 issue of Annals of Surgical Oncology (Dooley et al).