About Medifocus Inc.

Medifocus, Inc. (TSXV-MFS) is in the business of development and commercialization of minimally invasive, focused-heat tumor targeted cancer treatment devices and systems. It plans to raise the standards of breast cancer care and treatment by using focused microwave heating to enhance neoadjuvant chemotherapy to provide better tumor shrinkage and control, leading to improved surgical outcomes and ultimately breast preservation.

Medifocus’ patented adaptive phased array (APA) microwave focusing technology platform licensed from the Massachusetts Institute of Technology (MIT) provides the design of the Company’s unique focused heat treatment systems with the capability to direct precision-focused microwave energy at targeted tumor to induce hyperthermia to shrink or eradicate tumors without undue harm to surrounding tissue.

The Company’s goal is to improve outcomes and standards of care in cancer treatment. Its first indication, locally advanced breast cancer (LABC), involves large tumors that are generally treated first with neo-adjuvant chemotherapy to induce tumor shrinkage and then followed by either radical surgery or breast conservation surgery, depending on the final size of the tumor Medifocus’ focused-heat treatment can significantly improve the efficacy of neo-adjuvant chemotherapy in shrinking LABC, significantly improving the chance of breast conservation, and decreasing the need for radical breast surgery. Focused microwaves can be used to shrink breast tumors up to 8 cm in diameter, vastly improving the chance of breast conservation for these patients who under normal circumstances will have no option but to undergo radical breast surgery.

The company completed the qualifying transaction with Celsion (Canada) Ltd in November 2008 and raised a total of $3 Million as start-up capital. Celsion (Canada) and was resulted from a management buyout from a US listed public company Celsion Corporation. Celsion Canada owns a proprietary Adaptive Phased Array (APA) microwave focusing technology platform and is developing APA focused heat systems that can target cancerous tumors anywhere in the body with precision controlled heat treatment doses reliably and repeatably.  

Early June 2009, the company received the Investigational Testing Authorization (ITA) from Health Canada’s Medical Device Bureau (MDB) for its pivotal phase III clinical study with the Microfocus APA 1000 Breast Thermotherapy System for breast cancer treatment. The ITA application has been reviewed by MDB and has fulfilled Part III of the Medical Devices Regulations which allows conducting the pivotal trial in Canada. The full ITA approval was obtained after the Research Ethics Boards (REB) of the Ville Marie Medical Center and of the St. Mary’s Hospital in Montreal, where a total of 238 patients will be entered into the study.

On June 15, 2009, Medifocus filed an Investigational Device Exemption (IDE) application with the Food and Drug Administration (FDA) in the United States to obtain clearance to initiate its pivotal phase III clinical trial for breast cancer treatment by using its proprietary APA system. The filing of the IDE with the FDA and eventually receiving clearance from FDA to start the pivotal studies in the United States are significant strategic milestones for Medifocus towards global commercialization of the Microfocus APA 1000 thermotherapy system for breast cancer treatment.