Breast Cancer Treatment
In the treatment of breast cancer, the APA technology applies the same principal used in the MIT’s “Star Wars” program of detecting missiles.
Medifocus currently holds an exclusive worldwide license to use this technology for medical applications. Using the APA technology, we have developed the APA 1000 breast cancer treatment system intended to destroy localized breast tumors through the application of heat alone or in combination with chemotherapy. The Company has received regulatory approvals to start the APA 1000’s pivotal Phase-III clinical trials. The Company’s goal is to improve outcomes and standards of care in cancer treatment.
APA 1000 Breast Cancer Treatment System
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.
How the APA-1000 Treatment Works
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.
Additional Applications of the APA-1000 Technology
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.