Data Shows New Cryoablation Treatment Successful for Benign Breast Condition; Sanarus Offers the First Minimally Invasive Alternative to Surgery for Women with Fibroadenomas.

Business Editors and Health/Medical Writers

BOSTON & PLEASANTON, Calif.--(BW HealthWire)--April 25, 2002

Sanarus Medical, Inc., leading developer of minimally invasive solutions for breast disease announced the results of a new clinical study using the Sanarus Visica(TM) Treatment System. The research demonstrates the success of the Visica System in treating fibroadenomas, the most common form of benign breast tumor. The procedure enables a woman to have her fibroadenoma treated with cryoablation, or extreme cold, in a doctor's office, without surgery or stitches. Cary Kaufman, M.D., FACS at the American Society of Breast Surgeons' annual meeting in Boston, Mass. will present the results of the study, on April 27, 2002. Dr. Kaufman is Medical Director of the Bellingham Breast Center, Assistant Clinical Professor of Surgery at the University of Washington and President of the National Consortium of Breast Centers.

The Visica System is the only minimally invasive ablation device cleared by the Food and Drug Administration (FDA) for the treatment of fibroadenomas. This procedure destroys breast tumors using cryoablation without requiring stitches or general anesthesia. The office-based procedure involves placing a small needle, about the width of a matchstick, into the center of the tumor under ultrasound guidance. The system creates very cold temperatures at the needle tip, destroying the tumor.

"Fibroadenomas are the most common form of benign breast tumors. Though benign, these tumors are often palpable and can grow, causing anxiety and distress," said Cary Kaufman, M.D. "Currently about two-thirds of fibroadenomas are surgically removed."

"Now I can offer a minimally invasive treatment alternative to my patients with fibroadenoma," Cary Kaufman, M.D. added. "With the cryoablation procedure, a patient can have her benign breast tumor treated without surgery, general anesthesia, stitches or pain. This new procedure moves treatment from the operating room to my office."

The study included 50 patients with biopsy-confirmed fibroadenomas. Researchers found that the Visica System offers several advantages over open surgery, including less scarring and increased patient comfort. Additionally, due to the inherent anesthetic property of cryoablation, the procedure creates little or no pain.

Open surgery, still the most common treatment for benign tumors, typically involves a day in the hospital, general anesthesia, stitches and 2-3 days of recovery. The Visica System marks a breakthrough in treatment of benign breast tumors through an office-based procedure that involves only local anesthesia and a sterile bandage.

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

Fifty patients with breast fibroadenomas of up to 4-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 ablation procedure was completed in 6-30 minutes dependent on the size of the tumor. All office-based patients were awake, calm and comfortable during the entire procedure. Some patients chose to watch the treatment on the ultrasound monitor during their procedure.

No long-term side effects were seen. The appearance of the skin and breast were excellent and patient satisfaction was exceptional. Follow-up over the next three to twelve months showed progressive shrinkage and eventual disappearance of the tumors under ultrasound.

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, Penn.; and Breast Care Specialists of the Blue Ridge, Roanoke, Va.

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.