Radi Medical Systems Announces 2005 Medicare Hospital Outpatient Payment Classification and Rates For Myocardial Fractional Flow Reserve, FFRmyo.

WILMINGTON, Mass. -- Radi Medical Systems, Inc (Radi), a designer and manufacturer of innovative devices in interventional cardiology, announced today that the Center for Medicare and Medicaid Services (CMS) has approved the proposed 2005 Medicare hospital outpatient payment classifications and rates. The 2005 classification and rates include a new CMS code on reimbursement for Myocardial Fractional Flow Reserve (FFRmyo).

Numerous clinical studies have shown that FFRmyo can be used to accurately assess the functional significance of coronary lesions. Comparative studies have shown that cost savings can be obtained by routinely utilizing FFRmyo to assist in identifying the culprit stenosis via a `tailored' approach in multi-vessel disease.

The new reimbursement codes for FFRmyo that take effect January 1, 2005 are as follows:

--CPT 93571 is assigned to APC group 0670, which is renamed `Level II Intravenous and Intracardiac Ultrasound and Flow Reserve' with a national average payment rate of $1,731.24.

--CPT93572 is assigned to APC group 0416, which is renamed `Level I Intravenous and Intracardiac Ultrasound and Flow Reserve' with a national average payment rate of $274.56.

--The status indicators for CPT 93571 and 93572 have been changed from `N' (signifying that `payment is packaged into payment for other services') to `S' (signifying `separate APC payment' for the service, without multiple service reduction).

Commenting on the new CMS ruling, Jim Archetto, COO, RADI Medical Systems Inc, states "The clinical data and support from the professional organizations, ACC and SCAI, clearly demonstrated to CMS that routine use of myocardial Fractional Flow Reserve, prescribes correct treatment for interventional cardiology patients. While this has been a long process, Radi Medical Systems Inc. is proud to have driven this process that ensures patients receive appropriate therapies, hospitals are reimbursed for procedures performed, and that costs to the healthcare system are reduced."

Radi's physiology platform is the only system on the market that provides measurement of pressure (FFR), flow (CFR) and intravascular temperature using a single PressureWire(R)Sensor and one instrument. The new generation of intravascular assessment products includes the PressureWire(R)5 Sensor coronary guidewire, with significantly improved handling characteristics, and the RadiAnalyzer(R) Xpress, which provides a new level of ease of use for FFR measurements through an intuitive set up sequence.

About Radi Medical AB

Radi Medical Systems AB develops, manufactures, markets and sells medical devices in the field of interventional cardiology. The company is focused on two key areas: Intravascular sensors (coronary physiology) and Hemostasis Management (products to stop bleeding after interventional cardiology procedures). In collaboration with physicians and institutions around the world, Radi Medical Systems is committed to meeting the needs of healthcare professionals and their patients through innovation, technology and expertise. In addition, Radi offers value added support through education and training. Headquartered in Uppsala, Sweden, the company has a total of 200 employees worldwide with subsidiaries in Australia, Germany, Japan, Thailand, Switzerland, BeNeLux, United Kingdom and in the United States.

RadiAnalyzer(R)Xpress pending 510(k) clearance, not available for sale within the United States.

All CPT Codes are Copyright 2004, American Medical Association.