[Shalyndria]

Smiths Medical MD Files with FDA for New Infusion Set Product

ST. PAUL, Minn., Aug. 12, 2004--Building on the success of its CozMore(TM) Insulin Technology System, Smiths Medical MD, Inc. announced today it has filed a 510(k) Premarket Notification with the U.S. Food and Drug Administration (FDA) for a new subcutaneous insulin infusion set product, the Cleo(TM) 90 infusion set. Infusion sets are a key element of an insulin pump system, delivering insulin in a flow path connection between the pump and its wearer.

"Smiths Medical's filing for clearance on this new infusion set product demonstrates our commitment to advancing improvements for wearers of insulin pump systems," said Rod Kellogg, Vice President and General Manager of the Diabetes Division. "Many of the features in this new infusion set were gathered from research with existing pump wearers. Their input helped us design the Cleo(TM) 90 infusion set with many significant improvements over existing sets on the market today."

The all-in-one canister design of the Cleo(TM) 90 degree infusion set features an automatic needle retraction system designed to reduce unwanted needlesticks, a skin-like adhesive dressing, and a hidden insertion needle aiding insertions with small children and those with needle-phobia. The 360 (degree) site connectivity option provides total tubing direction control, allowing users to wear what they want, when they want.