Breast Cancer Treatment

The first indication of use of our APA focused microwave thermotherapy breast cancer treatment system is to treat locally advanced breast cancer (LABC), which involves large tumors that are generally treated first with chemotherapy and then by radical surgery if they do not respond to chemotherapy. Our technology can significantly improve the efficacy of neo-adjuvant chemotherapy in shrinking large breast cancer tumors, 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 mastectomy.

LABC with large size tumors (3-8 cm in diameter) represents a large percentage of all newly detected breast tumors in North America. The current Standard of Care (SOC) for LABC is to use neo-adjuvant chemotherapy to induce tumor shrinkage followed by breast conservation surgery (BCS) if the tumor shrinks sufficiently, or complete breast removal surgery (mastectomy) if the tumor does not respond. Currently, the rate of successful conversion to BCS is as low as about 30%.

Medifocus’ focused heat treatment technology has been proven clinically to enhance the effectiveness of neo-adjuvant chemotherapy in tumor shrinkage for LABC significantly enough to allow breast conservation surgery to become an option rather than mastectomy for a better surgical outcome and a more desirable personal outcome. The Company intends to expand the indication of use for its APA breast cancer treatment system to include the treatment for medium size breast tumors (1-3 cm), which is also a large percentage of the newly detected breast tumors. The combination of medium and large tumors represents a majority of the total number of newly detected breast tumors.

The breast cancer treatment sector is currently split between chemical or biological agents, surgery and devices aimed at killing or removing cancerous tumors. Medifocus is well positioned to take advantage in all three treatment modalities, as demand for procedures resulting in cosmetically acceptable outcomes is growing. Medifocus’ minimally invasive, non-toxic, focused microwave technology platform is able to target and treat tumors 1 – 8 cm in diameter, unlike radio frequency devices or laser-induced thermotherapy. Additionally, the system can be used to eradicate microscopic breast tumors that cannot be seen by surgeons.

Microwave is a form of electromagnetic radiation. Microwaves focused on tumors in the breast result in localized heating of the cancer cells. Higher water content of the breast tumor relative to the surrounding fatty tissue means preferential heating of the tumor and minimal damage to healthy tissue. Microwave treatment can result in tumor necrosis, induced apoptosis (programmed cell death), or cell death — and the heat enhances the effects of the chemotherapy drug, resulting in tumor shrinkages within a matter of weeks.

Clinical studies have demonstrated that when used in conjunction with chemotherapy, Medifocus’ patented system can significantly enhance outcome, improving the expected tumor shrinkage rate by about 50 percent. When using Medifocus’ patented focused-microwave technology, a minimally invasive disposable catheter sensor is inserted into the breast under ultrasound guidance to provide feedback signals for microwave focusing and temperature measurement. The breast is then immobilized by compression, which also serves to reduce blood-flow and increase the efficiency of heat delivery for effective treatment, and microwave energy is applied to the breast via two parallel-opposed microwave applicators. A proprietary feedback, tracking, and control mechanism ensures that the microwave energy is focused on the center of the tumor, while a computer algorithm controls the amount of energy applied to the tumor, and monitors the temperature to ensure optimum effectiveness.

The Company also plans to file a supplemental Pre-market Approval (PMA) application to the FDA for using the APA breast cancer system for treatment of Recurrent Chest Wall (RCW) in conjunction with radiation therapy. RCW is a recurrence of breast cancer on the chest wall after breast removal and effective treatment for RCW is an unmet medical need. The APA has already received a PMA as an adjunct to radiation for treatment of surface and sub-surface cancer. Obtaining PMA for RCW will expand the market for the breast cancer system to include radiation oncology.

The Company is exploring using heat with radiation for the treatment of ductal carcinoma in situ (DCIS), an early form of breast cancer that is currently another unmet medical need with no good treatment option. The Company is also examining the use of focused microwave thermotherapy for non-surgical ablation of benign breast tumors, a widely occurring, very painful lesion.

The future goal for Medifocus is to further expand the capabilities of its APA microwave focusing technology platform to develop and commercialize other focused heat treatment systems for surface, subsurface and deep seated tumors anywhere in the body.