Date: Tue, 2 Jan 2001 17:41:51 -0800 (PST)

December 18, 2000

Dow Jones Newswires

NovaMed Recalls NovaGold Breast Implant Product In U.K.

Dow Jones Newswires

WASHINGTON -- The Medical Device Agency of the U.K. Department of Health issued a "device alert" in connection with a recall of NovaMed Inc.'s (NVMD) NovaGold breast implant product on Dec. 11, according to an 8-K form the company filed with the Securities and Exchange Commission Monday.

The decision to issue an alert was made after discussions with the company's subsidiary, Novamedical GmbH, which voluntarily agreed to suspend any further shipment or sale of the NovaGold product in the U.K. until the agency is satisfied that the company has completed an "adequate" biological safety assessment of the company's hydrogel filling material.

The alert doesn't advise that the NovaGold breast implant is unsafe, rather the agency's position is that the company hasn't met the European device regulations for selling breast implants, the filing said.

The device alert says the U.K. agency hasn't identified any definite risk associated with the NovaGold implant and doesn't recommend "explantation" for the about 250 patients identified in the U.K., according to the filing.

The alert also says there is no information to indicate that there are specific risks to women or their children, either during pregnancy or from breast feeding, associated with the NovaGold breast implant.

NovaMed has engaged technical, regulatory and scientific specialists to re-examine all design evidence for the product, including test data, the filing said. The results of this re-examination will determine what further action on the part of the company, including new testing, is required to satisfy the agency mandate.

The NovaGold breast implant is NovaMed's flagship product, according to a company announcement released earlier this year. The product was developed in response to demands for an alternative to silicone-gel filled implants.

The NovaGold filling material is composed of a biocompatible water-based gel in combination with a thickening agent designed to enhance viscosity.

Minneapolis-based NovaMed in late March announced it was resubmitting to the U.S. Food and Drug Administration an "investigative device exemption" for the NovaGold breast implant. FDA clearance of such an application would permit the company to begin a clinical trial of the product in the U.S., according to a company press release.

-Eva-Lotta Jansson, Dow Jones Newswires/Federal Filings Business News; 202-393-7850; eva-lotta.jansson@dowjones.com