After a lumpectomy, radiation is administered daily for up to 6 weeks in order to kill any remaining cancer cells that may cause a recurrence. SenoGuard is developing a new way to protect against breast cancer recurrence that does not use radiation fraught with toxicities. Instead of radiating any unseen cancer cells, SenoGuard freezes them to death (literally) in one sitting at the same time as the lumpectomy.

In a market research study* of US women, 28% of those who would qualify for a lumpectomy, chose mastectomy instead. This is because only centers with radiation oncologists and their team with special equipment can deliver radiation; unlike a non-radiation procedure where every hospital has the capability. Unless the patient lives close to a radiation center, can take time off work for almost 6 weeks, can afford to stay in a hotel if they don't live close enough to travel, and has the ability to pay, can they accept a lumpectomy with radiation. The SenoGuard procedure is done at the same time as the breast surgery, by the surgeon, and does not require any---much less many--follow up treatments.

SenoGuard's technology

Breast cancer surgeons want to perform this procedure because they will know that the patient completed their RT therapy; unlike the 33% who do not complete their radiation treatments and then have a 17% chance of recurrence. Surgeons who perform the SenoGuard procedure will also attract more patients, increasing their patient satisfaction and patient volume.

Patients will be able to avoid the hassle, fatigue, and pain associated with radiation therapy. Recently at a pickleball court, a player told me that her sister--after two radiation treatments--told her that she "would rather die from the breast cancer than have any more radiation treatments".

The motivation to avoid radiation is so strong that 93% of patients would pay out of pocket to have a non-radiation procedure.

In addition, there are cosmetic changes to the breast such as a different texture, color, volume and sometimes nipple direction. Patients have claimed that it is very difficult to get a bra that fits both breasts correctly.

The team is comprised of experts in their field with prior experience bringing innovative paradigm-shifting products to market. The team is using the same PR firm they have in the past that provided a 5X return in 2.5 years in spite of the fact that the new product being promoted actually depleted income from the physicians.

SenoGuard has already achieved proof of concept in animal studies, supported by a National Science Foundation grant. A second grant of $1M was awarded by the National Science Foundation to finalize the design, perform human specimen testing, and submit an application to the FDA for 510k clearance. Immediately following the acceptance of the 510k submission, a Breakthrough Technology Exemption will be submitted. Breakthrough Technology Exemptions allow the company to expedite both FDA clearance as well as obtaining reimbursement codes.

With these parameters met, commercialization is possible within 24-36 months of funding.

SenoGuard is seeking $1,235,000 to add to their second National Science Foundation grant of $1M in order to test the final design prototype for FDA submission. We ask for your support of $100 or more to achieve this goal of advancing breast cancer treatment for all women globally.