Biopsys Medical Agrees to Alter Promotion of Its Main Product

Biopsys Medical Inc. agreed to quit promoting its key product as a sampling device for detecting breast cancer until regulators approve that use, a spokeswoman for the Food and Drug Administration said Monday.

The Irvine-based biomedical company said it had met all the agency’s objections over the labeling and promotion of the biopsy device that were raised in a warning letter early this month.

The company agreed to change the product’s name from “Mammotome” to “Biopsys Soft Tissue Device” in promotional materials, but is continuing to use “Mammotome” in product packaging, company officials said.

The company also said Monday that, a week after receiving the agency’s warning, it applied for approval to market the item specifically for diagnosing breast cancer.

Though it’s uncertain when the agency might consider the application, Sharon Snider, a spokeswoman, said it takes an average of three months for decisions on requests of its type. “We have asked for an expedited review. Hopefully, we’ll get one,” Steven Gex, the company’s president, said Monday.

Though Biopsys Medical has identified breast-cancer detection as a major market, a spokeswoman said the restrictions on product promotion will “have no affect” on sales.

In a phone interview Monday, Gex said he was in Key Largo, Fla., attending a convention of surgeons and radiologists called “Breast Intervention in the 21st Century.”

Gex said he was there marketing the product as a device for doing biopsies in “soft tissue,” with no reference to the breast.

A Feb. 5 letter from the FDA warned Biopsys that it doesn’t have approval to use its biopsy needle and related items for detecting cancer in the breast. The agency said the product is approved for diagnosing cancer in gastric and urological tissues.

Biopsys shares rose 50 cents a share in Nasdaq trading Monday to close at $31.