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St. Jude Medical Announces Exclusive European Co-Promotion Alliance With HemoSense, Inc. To Assist Mechanical Heart Valve Patients With Anticoagulation Therapy Management

Posted on: Thursday, 28 July 2005, 18:01 CDT

St. Jude Medical, Inc. (NYSE:STJ) today announced an exclusive agreement in most European countries with HemoSense, Inc. (AMEX:HEM) to increase awareness and access to self-testing and monitoring the effectiveness of anticoagulation medication or Coumadin(R) (warfarin) for mechanical heart valve patients.

Mechanical heart valve patients take blood-thinning medication to minimize the risk of thrombolic events and, as a result, regularly monitor their anticoagulation levels, a measurement expressed in International Normalized Ratio (INR). INR self-testing may provide major cost savings to insurers, since anticoagulation therapy-related complications - that could potentially be prevented by more frequent and convenient screening at home - can exceed U.S. $10,000 (EUR 8286) per episode if the patient needs to be hospitalized. Studies using other devices have demonstrated that patient INR self-testing is effective in managing Coumadin levels; however, physician and patient awareness of self-testing is still low.

HemoSense's portable INRatio(R) Prothrombin Time (PT) Monitoring System tests PT/INR levels in patients who are taking warfarin, a blood-thinning drug. The St. Jude Medical - HemoSense co-promotion alliance offers a self-testing solution for heart valve patients on anticoagulation therapy.

Under the agreement, St. Jude Medical and HemoSense will develop joint promotional materials, including physician/nurse educational information and patient education programs for physician-directed patient self-testing of anticoagulation therapy. The companies will also sponsor medical symposia and meetings.

HemoSense's portable system allows patients to self-test their anticoagulation levels at home rather than visiting a clinic or a laboratory. Studies have demonstrated that patients who self-test on a regular schedule have fewer anticoagulation-related complications and stay within their therapeutic range more frequently than patients who do not self-test. Increased time in therapeutic range may lead to improved clinical outcomes.

"We are pleased to enter a co-promotion alliance with HemoSense," said Denis M. Gestin, President of St. Jude Medical Europe, Middle East, Africa and Canada. "INRatio offers our heart valve patients a convenient PT/INR testing solution, whether they are testing at home or at their healthcare provider facility."

"Our INRatio monitoring system is a natural fit for St. Jude Medical's mechanical heart valves," said Jim Merselis, President and CEO of HemoSense. "St. Jude Medical's efforts to offer physicians a mechanical heart valve implementation and INR management program reflect their commitment to the highest level of patient care and healthcare cost containment."

St. Jude Medical is the global leader in mechanical heart valve technology and recently implanted its 1.5 millionth mechanical heart valve. Over the past several years, the Company's portfolio has expanded to include a line of tissue valves and repair products, making it one of the most diverse cardiac surgery technology platforms in the market.

In the United States, St. Jude Medical has formed an alliance with Raytel Cardiac Services (www.raytel.com), a wholly owned subsidiary of SHL-Telemedicine Ltd., to promote the benefits of anticoagulation patient self-testing for mechanical heart valve recipients. Raytel's system for remote INR self-testing is called INR@Home(TM).

About HemoSense

HemoSense develops, manufactures and sells the INRatio System, an easy-to-use, handheld blood coagulation monitoring system for use by patients and professionals in the management of warfarin medication. INRatio measures the patient's blood clotting time to ensure that patients with a propensity to form clots are maintained within the therapeutic range with the proper dosage of oral anticoagulant therapy. HemoSense, Inc. is headquartered in San Jose, Calif. For more information, visit www.hemosense.com.

About St. Jude Medical

St. Jude Medical, Inc. (www.sjm.com) is a $2.3 billion global cardiovascular device company headquartered in St. Paul, Minnesota (USA). The company sells products in more than 130 countries and has 20 principal operations and manufacturing facilities worldwide. St. Jude Medical is dedicated to the design, manufacture and distribution of innovative medical devices of the highest quality, offering physicians, patients and payers outstanding clinical performance and demonstrated economic value.

Any statements made regarding St. Jude Medical's anticipated future product launches, regulatory approvals, revenues, earnings, market shares, and potential clinical success are forward-looking statements which are subject to risks and uncertainties, such as those described in the Financial Section of the Company's Annual Report to Shareholders for the fiscal year ended December 31, 2004 (see page 16). Actual results may differ materially from anticipated results.

Source: Business Wire

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