NovaMed Submits NovaSaline Pre-Filled 510K

NovaMed Submits NovaSaline Pre-Filled 510K

Application for FDA Review

Thursday June 10, 8:00 am Eastern Time

Company Press Release

NovaMed Submits NovaSaline Pre-Filled 510K Application for FDA Review FDA Clearance to Market Expected by End of Third Quarter, 1999

MINNEAPOLIS--(BUSINESS WIRE)--June 10, 1999 Substantial Rise in Sales, Profitability Expected by Year End, 1999

NovaMed, Inc. (OTC BB:NVMD - news) today announced the submission of a 510(k) application for the company's NovaSaline(TM) Pre-Filled breast implant to the U.S. Food and Drug Administration (FDA) for review. Upon FDA clearance to market anticipated by the end of the third quarter of 1999 the company expects a substantial rise in sales that will ensure profitability by year end 1999.

The 510k process requires a manufacturer to submit a formal application to the FDA for permission to market the product in the United States. The submission includes the results of testing the product, design specifications and indications of use. The FDA then has 90 days in which to determine whether the product is substantially equivalent to similar devices currently available.

A positive determination permits the FDA to clear the device for marketing. However, unlike most other devices cleared for market to market through the 510k process, all saline filled breast implant manufacturers are required to conduct a Post-Market Surveillance Clinical Study of the devices to evaluate safety and

efficacy. The company expects to initiate a Post-Market Surveillance Study for the NovaSaline(TM) Pre-Filled product in conjunction with marketing the product.

The NovaSaline(TM) Pre-Filled implant was developed primarily for those countries, such as the United States and France, in which saline filled implants are the only permissible option for cosmetic breast augmentations. Since the FDA ban on the use of silicone gel filled implants for cosmetic augmentations, the only breast implants allowed on the US market for this purpose are saline filled devices. The market for cosmetic breast implant procedures in the United States alone has been estimated at $250 million annually and growing. NovaSaline(TM)

Pre-Filled obtained a CE Mark in November 1996 in compliance with European regulatory standards and now prepares to enter the US market place. Upon FDA clearance to market the NovaSaline(TM) Pre-Filled breast implant, the company will distribute the product in the United States and around the world pursuant to the terms of an exclusive distribution agreement with Inamed, Corp., one of two dominant participants in the sale of breast implants. The company expects its agreement with Inamed Corp. to provide ready access to the US market place for pre-filled breast implants and anticipates significant sales growth to flow from this relationship.

The company develops, manufactures and markets breast implant products from facilities in Minneapolis, Minnesota and Monheim, Germany. Products include, the NovaGold(TM) breast implant, that utilizes an alternative fill material to provide certain beneficial design characteristics not present in other fill materials, and the NovaSaline(TM) Inflatable breast implant, which was developed to provide a superior inflatable saline breast implant to the expanding cosmetic augmentation market in the United States.

This release contains forward-looking statements that are made pursuant to the safe harbor provisions of the Securities Litigation Reform Act of 1995.

Forward-looking statements involve the known and unknown risks and uncertainties that may cause the company's actual results in future periods to differ materially from that which is anticipated.

 

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