The Company’s initial commercial development focus is on an APA focused microwave thermotherapy breast cancer treatment system. The first indication of use is in combination with neo-adjuvant chemotherapy for treatment of locally advanced breast cancer (LABC),
LABC involves large size tumors (3-8 cm in diameter), which 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%, a very low percentage.
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 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 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.