NovaMed Submits 510(k) Application for its Inflatable Breast Implant

NovaMed Inc. has submitted a 510(k) application for its NovaSaline inflatable breast implant to the FDA for review.

The NovaSaline implant offers an alternative design to other saline breast implants available in the U.S. Unlike other saline inflatable implants, the NovaSaline has a one-piece self-sealing filling valve/patch assembly. This design eliminates the need for a physician to manually seal the implant after filling and also eliminates the straps associated with other saline implants. By incorporating the filling valve and shell patch into a single system, there is only one fused area on the shell.

NovaMed expects to initiate a Post-Market Surveillance Study for the NovaSaline product in conjunction with marketing the product by the third quarter of 1999.

The market for breast implants in the U.S. has been estimated at $250 million annually. More than 80% of that figure represents the use of saline filled breast implants in cosmetic breast augmentation. There are two major manufacturers of these devices in the U.S. and NovaMed intends to become the third significant participant in this growing market, capturing 5% to 8% of the U.S. market within one year of introduction. This forecast is predicated upon the innovative design of the company's NovaSaline device, plus interest generated in the medical community regarding clinical studies expected by the third quarter of 1999 for the company's NovaGold alternative gel-filled breast implant.

NovaGold was approved for sale in Europe and certain other countries outside North America pursuant to the CE Mark process in February 1996, which requires evidence of compliance with international guidelines for testing and manufacturing of this type of device. Since introduction, sales of the product have steadily grown and last year represented 10% of all sales of breast implants in Germany.