Cryoablation is a New, Office-based Treatment for Breast Fibroadenomas, Says Study in American Journal of Surgery.

Business Editors and Health/Medical Writers

PLEASANTON, Calif.--(BUSINESS WIRE)--Nov. 12, 2002

Visica(TM) Treatment System Provides Alternative to Surgery

for Benign Breast Tumors

According to a research study published in the November issue of the American Journal of Surgery, cryoablation offers a convenient, office-based treatment option for women with fibroadenomas, the most common form of benign breast tumor(1). The study, "Office-based Ultrasound-guided Cryoablation of Breast Fibroadenomas," documents the success of the Sanarus Visica(TM) Treatment System, the only minimally invasive procedure that enables treatment of a breast fibroadenoma with cryoablation, or extreme cold, in a doctor's office without surgery or stitches. Full text of the study is available online at www.elsevier.com/locate/ajsonline.

The Visica Treatment System is conducted in the comfort of the doctor's office, and involves placing a small needle (about the width of a matchstick) into the center of the breast tumor under ultrasound guidance. The surgeon then activates the Visica system, causing the freezing tip of the needle to deliver extreme cold to the tumor, thereby destroying it. The "iceball" that encompasses and destroys the tumor is easily viewed with ultrasound. Since the treatment is performed under local anesthesia, patients remain awake throughout the procedure. Patients resume normal activity immediately following the procedure.

For this study, doctors used the Visica Treatment System to treat more than 50 fibroadenomas. Initial results indicate that after 12 months, the patients' fibroadenomas had regressed by an average of 92 percent.

"Patients were pleased with this simple procedure and were impressed by how easily their fibroadenomas disappeared," said lead study author Cary Kaufman, M.D., assistant clinical professor of surgery, University of Washington, and medical director of the Bellingham Breast Center in Bellingham, Washington. "Several patients had previously undergone breast surgery and preferred the convenience and comfort of the Visica Treatment procedure. Our research shows that women now have a less invasive, virtually pain-free option for treating their fibroadenomas. This new treatment has the benefits of surgery without going through the operation."

Each year, about 80 percent of breast biopsies result in a benign diagnosis. The most common form of benign breast tumor is a fibroadenoma. Typically, the treatment for fibroadenomas has been surgical excision, a procedure that takes place in an operating room and usually involves sedation or even general anesthesia, stitches and a 2-3 day recovery period. In the American Journal of Surgery, researchers report that the Visica Treatment System offers several advantages over open surgery including excellent visualization under ultrasound, minimal scarring, elimination of the need for any sedation and increased patient comfort.

"Approximately 600,000 fibroadenomas are diagnosed each year, and currently about two-thirds are surgically removed," said study investigator Rache Simmons, M.D., an associate professor of surgery at the Weill-Cornell Breast Center in New York. "Often women develop multiple fibroadenomas and are faced with several operations and resulting scars. Cryoablation offers a better alternative, and now we have demonstrated that a woman can have her benign breast tumor treated without open surgery, general anesthesia, or stitches. This new procedure moves treatment out of the operating room and into the physician's office."

The research study published in the American Journal of Surgery was funded by Sanarus Medical, Inc., a leading developer of minimally invasive solutions for breast disease. The Sanarus Visica Treatment System is the only minimally invasive ablation device currently available in the United States for the treatment of breast fibroadenomas.

The Study: Ultrasound-Guided Cryoablation for the Treatment of Fibroadenomas

Fifty patients with breast fibroadenomas of up to four centimeters in diameter were treated using the Sanarus Visica System. Seven early cases were treated in ambulatory surgery centers. The remaining 43 procedures were completely office-based using only local anesthetic. Each tumor was subjected to two freeze cycles separated by a thaw cycle, which created an iceball that completely engulfed the target tumor in each case. The treatment was completed in six to 30 minutes depending on the size of the tumor. All office-based patients were awake, calm and comfortable during the entire procedure. Some patients chose to observe their tumor being destroyed on the ultrasound monitor during their treatment.

No long-term side effects were seen. The appearance of the skin and breast were excellent and patient satisfaction was exceptional. Ultrasound follow-up over the next three to 12 months showed progressive shrinkage and in most cases, disappearance of the tumors.

The study includes data collected from procedures performed at Bellingham Breast Center, Bellingham, Wash.; Wayne State University, Detroit, Mich.; Rush University, Chicago, Ill.; Executive Surgical Center, Raleigh, N.C.; Penn State University, Hershey, Pa.; Breast Care Specialists of the Blue Ridge, Roanoke, Va.; Alta Bates Summit Medical Center, Oakland, Calif.; Weill Medical College of Cornell University, New York, N.Y.

About Sanarus Medical, Inc.

Sanarus Medical, Inc., headquartered in Pleasanton, Calif., is dedicated to providing truly minimally invasive solutions for the diagnosis, treatment and follow-up of breast disease. The Sanarus technology will transform the way breast disease is managed and treated; from an operating room-based, surgically intensive approach to a more comfortable, cost-effective, office-based care pathway. Privately held, Sanarus Medical, Inc. is funded by leading investors, including Federated-Kaufmann Fund, Forward Ventures, Technology Funding and U.S. Venture Partners. For more information visit www.sanarus.com.

(1) American Journal of Surgery, November 2002, "Office-based Ultrasound-guided Cryoablation of Breast Fibroadenomas"