FDA Review Seeking Permission to Start U

FDA Review Seeking Permission to Start U.S. Clinical Trial

Date: Wed, 29 Mar 2000 10:42:02 EST

From: SusanS3733@aol.com

NovaMed Resubmits NovaGold IDE Application for FDA Review Seeking Permission to Start U.S. Clinical Trial

MINNEAPOLIS--(BUSINESS WIRE)--March 29, 2000--NovaMed, Inc. (OTCBB:NVMD) announced today the resubmission to the U.S. Food and Drug Administration of an Investigative Device Exemption (IDE) for its NovaGold(TM) breast implant. FDA clearance of the IDE application would permit the Company to commence a clinical trial of NovaGold(TM) in the United States.

The IDE process requires NovaMed to conduct an FDA mandated clinical trial of the NovaGold(TM) breast implant that is designed to collect data on the product's safety and efficacy over an extended period. NovaMed expects the clinical trial to be conducted in concert with Inamed Corporation pursuant to a Strategic Alliance Agreement. The clinical trial is expected to include breast augmentation, reconstruction and revision patients. Upon FDA clearance of the IDE submission, NovaMed will be responsible for qualifying prospective clinical sites, prior to enrolling patients in the study. NovaMed anticipates that after 24 months of clinical trial experience, sufficient data will have been collected to submit a Pre-Market Approval application to the FDA. Once the data has been reviewed the FDA can decide to clear the product for general sale or seek additional data from the clinical studies before rendering a decision. NovaMed anticipates a start to the NovaGold(TM) clinical trial before the end of this year subject to FDA approval.

NovaMed has had commercial and clinical success with the NovaGold(TM) breast implant outside of North America since 1996. NovaGold(TM) is currently marketed in Europe, Asia, Central and South America, where some 12,000 units have been sold. The product has already received a CE Mark from European regulatory authorities, which permits sale in Europe and is accepted by many other health regulatory authorities worldwide.

The NovaGold(TM) breast implant utilizes a patented alternative filling material that is not found in other breast implants that are currently available, such as silicone (only permitted for reconstructive purposes in the U.S., but allowed for general sale in most other countries) and saline. The NovaGold(TM) filling material is based upon a biocompatible polymer which has been used in medical products for decades, including as a plasma expander, in pharmaceutical products and topically in cosmetics in combination with a rheological control agent that is generally recognized as safe. The control agent is added to the water based fill material to enhance feel and consistency. The resulting product appears to be radiolucent, permitting better x-rays for mammograms than either silicone or saline.

NovaMed operates from facilities located in Minneapolis, Minnesota and Monheim, Germany. The component parts of the NovaGold(TM) implant are manufactured in the Minneapolis facility and shipped to Monheim for final manufacture, assembly and distribution. Research and development is conducted from both facilities. NovaMed has invested heavily over the last five years in the development of the NovaGold(TM) breast implant and looks forward to beginning a clinical trial in the U.S. market.

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 known and unknown risks and uncertainties that may cause NovaMed's actual results in future periods to differ materially from that which is anticipated.

CONTACT:

Martin E. Janis & Company, Inc., Chicago

Public Relations

Hal Schweig, 312/943-1100

or

NovaMed, Inc., Minneapolis

Ruairidh Campbell, 612/378-1437

President




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