FDA OKs Irvine Firm’s Breast Tumor Treatment

Federal regulators approved a medical device that uses a needle to freeze and destroy benign breast tumors, the Irvine company that developed the procedure said late Tuesday.

With Food and Drug Administration clearance, Endocare Inc. and one of its partners can start marketing the minimally invasive “cryoablation” technology for treatment of benign tumors.

Endocare also is testing the technique as a treatment for breast cancer and said it hopes to get federal approval for that procedure within two years. The company already markets its cryoablation technology to treat prostate cancer, enlarged prostate and cardiac arrhythmias.

“About 700,000 to 800,000 times a year, a woman is diagnosed with a lump in the breast. About 500,000 of those lumps are benign, but right now most women choose to have them surgically removed anyway,” said Paul Mikus, Endocare’s chief executive.

Endocare’s cryosurgical system freezes tumor cells, reducing recovery time and the potential for complications. Most patients can resume normal activities the next day.

The procedure, which is done after a needle biopsy determines whether the lump is malignant, allows women with benign tumors to avoid invasive breast surgery, Mikus said.

Endocare has licensed its cryosurgery and ultrasound guidance technologies to Sanarus Medical Inc. in Pleasanton, Calif., under the brand name Visica. Endocare owns a minority stake in Sanarus.

Endocare also is developing cryosurgical technologies for treating cancer of the kidney and liver, Mikus said.

Information about the FDA approval was released after the stock market closed. Endocare’s stock lost 8 cents to close at $16.87 a share on Nasdaq.