Cryoablation

Cryoablation is an FDA-approved treatment for destroying fibroadenomas, and is an alternative to open surgery. It is the use of extreme cold to completely destroy tissue. Cryoablation technology is an established, effective therapy that has been used for decades to destroy benign and cancerous tumors in prostate, liver and other organs. The technology and procedure has now been optimized for breast fibroadenomas.

After local anesthesia and using ultrasound (sonographic) imaging, a small probe (thin hollow needle) is guided into the fibroadenoma. Extremely cold temperatures are used to destroy (ablate) the fibroadenoma. Cryoablation is comfortable and painless, as the cold acts with the local anesthesia to numb the area.

Cryoablation usually takes about 5-15 minutes. No sutures are required; as the procedure is performed using only a small skin nick, just an adhesive steri-strip is needed. As with a needle biopsy, many women can return to work or their normal activity quickly.

 

Fibroadenoma

Fibroadenomas are the most common type of breast tumor (lump) and about 50% of women seek treatment for them. Fibroadenomas are solid (not fluid-filled) masses, have clearly defined edges and are typically round or oval in shape. Fibroadenomas are benign, which means they are not cancerous, and do not turn into cancer. They may increase in size with time, particularly with hormonal changes. Treatment is typically sought because of pain, rapid growth, age, or general discomfort.

What are options for treating a fibroadenoma?

Watchful Waiting

You may choose to observe your fibroadenoma over time, and feel your breast for changes. Your doctor may request follow-up visits every 6-12 months and ultrasound or other imaging to check for any changes in the lump. If the fibroadenoma enlarges or becomes uncomfortable, your doctor may then recommend a treatment option.

Surgery

Fibroadenomas can be removed surgically. This procedure is performed in the operating room and includes surgically removing the fibroadenoma and suturing (stitching) the incision closed. Depending on the size of the fibroadenoma and the location in the breast, healing may result in an indentation or change in the shape and size of the breast. In addition, the size of the scar on the skin will vary depending on the size of the fibroadenoma.

Office–Based Cryoablation

Cryoablation is an FDA-approved treatment for destroying fibroadenomas, and is an alternative to open surgery. It is the use of extreme cold to completely destroy tissue. Cryoablation technology is an established, effective therapy that has been used for decades to destroy benign and cancerous tumors in prostate, liver and other organs. The technology and procedure has now been optimized for breast fibroadenomas. To learn more about the IceSense3™ procedure, click here.

When Will the Lump Go Away?

The fibroadenoma cells will be destroyed (ablated) during the cryoablation procedure. Your body will then reabsorb those destroyed cells over time. You will have a palpable mass (area that can be felt) while your body naturally reabsorbs the treated cells. The time to reabsorb the tissue varies, depending on the initial size of the mass and other factors.

What does the American Society of Breast Surgery say about Cryoablation?

The American Society of Breast Surgeons states, “The FDA has approved the use of cryoablation as a safe and effective therapy for fibroadenomas”. Further, the professional society reports that the results of cryoablation “demonstrate the procedure to be safe, efficacious, and durable.”

What Do Women Say About Their Experiences?

Women who undergo cryoablation as treatment for their fibroadenomas report a high satisfaction from the procedure.

Cancer:

Cryoablation involves using extreme cold to freeze and destroy cancerous and benign tumors. This technique, if successful, may replace traditional surgeries for some women with cancerous tumors.

Dr. Gold has been interested in cryoablation of breast cancer for years and has enrolled patients in the Ice3 Trial:

Cryoablation of Low Risk Small Breast Cancer- Ice3 Trial

National Multi-Center Clinical Trial of Non-Surgical Breast Cancer Treatment Enrolls First Patients – November 18, 2014

October 21st, 2014, MEMPHIS, TENN. — IceCure Medical, Inc. announced today the successful treatment of the first two patients in a multi-centered clinical trial using cryoablation (exposure to extreme cold temperatures) to treat breast cancer without surgery. Dr. Linsey Gold in conjunction with Regional Medical Imaging, Flint, MI – now of Comprehensive Breast Care in Troy, MI and Dr. Richard Fine of The West Clinic, Memphis, TN completed their first cases this week. With these and other leaders in cancer treatment using IceCure’s technology, the ICE3 trial is significantly expanding the data on cryoablation and may create a paradigm shift in the treatment of breast cancer.

“Breast cancer awareness month during October is the perfect time to kick off this important initiative. The treatment of breast cancer has evolved to include not only mastectomy but also breast-conserving lumpectomy. Now cryoablation enables treatment of breast cancer without a surgical scalpel or tissue removal, effectively killing the tumor in place. This promises many clinical and quality of life benefits for patients. We hope to prove them in this study,” states Dr. Gold.

Dr. Fine adds, “Improved screening allows physicians to identify breast cancer earlier, when it’s smaller. Advances in molecular profiling (tumor biology) help us better determine which breast cancers have higher or lower risks of recurrence. We can then individualize approaches to treatment. Now with the ICE3 study, we may have the first effective non-surgical treatment option for some low risk patients.”

IceCure’s clinical trial is recruiting and following women aged 65 years and older diagnosed with luminal A breast tumors measuring less than 1.5 centimeters in diameter. These patients will also receive adjunctive therapy based on local standards of care. Developed by an esteemed and diverse scientific advisory board, the trial is underway at 20 carefully selected sites throughout the United States. These sites already have experience utilizing IceSense3 consoles for the treatment of benign breast tumors, including fibroadenomas. As a market leader in cryoablation treatment of breast disease, IceCure will utilize its resources to provide clinical and technological support to sites during the cancer trial.

“Our study employs the latest generation technology, ensuring that cryoablation is being performed with the coldest, fastest, and most stable equipment available on the market today,” said Hezi Himelfarb, CEO. “This study is the next step in IceCure’s goal of making non-surgical
treatment of breast disease an accepted alternative to the invasive, expensive, surgical approaches today.”

The ICE3 trial has also accelerated IceCure’s commercialization efforts. With treatment of carefully selected cancer patients in view, the market is responding with increased interest in IceCure’s proprietary IceSense3™ technology. The initiation of the ICE3 trial, combined with the recent evolution of IceCure’s business model, establishes the company as the technological leader in the field of breast cancer treatment using minimally invasive, non-surgical cryoablation.

Cryoablation involves use of extremely low temperatures, applied in a targeted manner to “ablate” or destroy tissue in place. The treatment provides numerous benefits compared to traditional surgical removal of tumors. Cryoablation can be performed in a physician’s office with the use of local anesthetic and ultrasound. Additionally, because no tissue is removed, patients endure minimal cosmetic impact with little-to-no scarring or permanent disfigurement. Further, cryoablation is an economically sound alternative to costly surgeries.