Healthcare Industry News:  ICU Medical 

Devices Litigation

 News Release - July 10, 2006

Medegen Files Patent Infringement Lawsuit Against ICU Medical

Market Leader in Medical Devices Protects Innovation in Valve Technology

ONTARIO, Calif.--(HSMN NewsFeed)--July 10, 2006--Medegen LLC, a leading provider of medical devices and components to the healthcare industry, today announced that its Medical Manufacturing Services (MMS) division has filed suit in U.S. federal court in California against ICU Medical Inc. (NASDAQ: ICUI ) for infringement on U.S. Patent No. 5,730,418. This covers a number of Medegen's novel inventions in luer-activated valves, including the use of positive displacement technology, which reduces the occurrence of common vascular access device-related complications such as catheter occlusion.

The complaint alleges that two of ICU Medical's valve products, CLC-2000(TM) and TEGO(TM), infringe on Medegen's patent for its proprietary valve technology. This technology is used by Medegen in its Maximus(TM) product line, known on the market as both MaxPlus(TM) and NacPlus(TM). Medegen manufactures and distributes these products to the acute and alternate care provider markets and to its OEM medical device channels. The suit requests that ICU Medical pay damages for infringement to Medegen, and requests the court to issue a permanent injunction preventing the further sale of these products by ICU Medical.

"Medegen was the pioneer in positive displacement valve technology and we are a company committed to innovation in research and development," said Jeff Goble, president for Medegen MMS division. "Our patents are critical to the success of our company and protect our ability to continue to provide enhanced products to hospitals, and ultimately patients. As such we must aggressively enforce our patent portfolio and defend our intellectual property."

Medegen's line of needle-free valves, including the MaxPlus(TM), features Medegen's Tru-Swab(TM) technology, which promotes aseptic technique and proper disinfection of the valve prior to access. Tru-Swab(TM) valves offer a flat smooth surface, free of nooks, crannies, gaps, or slits that typically harbor bacteria even after disinfection. Clinical papers recently presented at the annual meetings of the Society of Healthcare Epidemiology of America and the Association for Professionals in Infection Control reported an increase in blood stream infections with certain valve technology that cannot be adequately disinfected. Tru-Swab(TM) valves provide clean and safe needle-free access to IV catheters and IV administration sets used throughout the hospital.

Medegen MMS division is an emerging market leader in IV therapy components, such as luer locks, luer caps, needleless access ports, anesthesia manifolds and drip chambers which are sold to selected medical device companies under the KippMed(TM) brand name. Medegen MMS also markets its Maximus(TM) brand of IV therapy products, featuring the MaxPlus(TM) valve and a line of IV custom sets. In addition, Medegen MMS offers complete outsourced contract manufacturing solutions to medical device and pharmaceutical companies.

Note to Editors: Examples that graphically depict the Medegen luer-activated valve technology patent are available upon request.

About Medegen

Founded in 2001, Medegen LLC is a market leader in providing superior products and services to the medical community through its two divisions. The Medegen Medical Products (MP) division develops, manufactures and markets disposable medical-surgical products focusing on patient care and laboratory products. The Medegen Medical Manufacturing Services (MMS) division provides branded and OEM specialty infusion therapy disposables as well as cost-effective outsourcing strategies to medical device and pharmaceutical OEMs. Medegen is headquartered in Scottsdale, Ariz., and has operations in Ontario, Calif.; Northglenn, Colo.; Gallaway, Tenn.; and Tijuana, Mexico. For more information, visit

Source: Medegen

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