Breast Health

Endocare Receives 510(k) Clearance From FDA to Market Breast Tumor Treatment

Published in Women's Health Weekly, December 6th, 2001

Endocare, Inc., has been granted 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market, through its alliance partner, privately held Sanarus Medical, Inc., the Visica Treatment System, for the minimally invasive treatment of fibroadenomas, or benign tumors of the breast.

Sanarus and Endocare operate under a strategic alliance that gives Sanarus license to market Endocare's proprietary cryosurgery and ultrasound guidance technologies for breast therapy applications. Under the alliance Endocare will manufacture the Sanarus device and, largely in return for license to the technology, Endocare maintains a minority equity position in Sanarus.

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Source: Women's Health Weekly (2001-12-06)

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