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Cheetah Medical Inc. Announces FDA Clearance and US Release of NIBP Parameter for its NICOM(R) Hemodynamic Monitoring System



1/8/2009 7:15:06 AM

TEL-AVIV, Israel & MORRISVILLE, N.C.--(BUSINESS WIRE)--Cheetah Medical, a leading provider of fully noninvasive hemodynamic monitoring solutions for the comprehensive care of patients in challenging clinical care settings, has been granted 510(k) marketing clearance by the U.S. Food and Drug Administration (FDA) for the NIBP functionality, provided by SunTech Medical, in its NICOM® Reliant® Hemodynamic Monitoring System. The NIBP Option for the NICOM System platform and other feature enhancements add new parameters to provide a comprehensive suite of information for functional cardiac and systemic vascular monitoring – all without the need for invasive cardiovascular monitoring methods that are associated with increased potential costs and patient risks. The new parameters include Noninvasive Blood Pressure (NIBP), Total Peripheral Resistance (TPR), Stroke Volume Variation (SVV), Cardiac Power (CP), and Change in Thoracic Fluid Content (TFCd). The NIBP Option for NICOM Hemodynamic Monitoring Systems sold in the U.S. is the product of an ongoing global OEM agreement between Cheetah Medical and SunTech Medical, the market leader in OEM NIBP clinical grade monitoring technology.

Cheetah Medical’s unique, patented BIOREACTANCE® Technology noninvasively measures stroke volume (SV) and cardiac output (CO) with validated accuracy compared to invasive methodologies. BIOREACTANCE Technology has been used to monitor over 2,000 patients effectively in a variety of clinical settings including medical and surgical intensive care, perioperative care, emergency medicine, heart failure, hemodialysis and exercise testing. Numerous clinical studies validating the performance and clinical efficacy of BIOREACTANCE Technology have been published to-date in peer-reviewed medical publications worldwide, with more studies underway.

“Noninvasive hemodynamic monitoring using the NICOM System is quickly gaining interest as a new standard of monitored care, particularly in hospitals, where the average patient is older, sicker and where accurate clinical decision-making often hinges on knowing the patient’s real-time hemodynamic status,” states Yoav Avidor, MD, CEO of Cheetah Medical. “U.S. market availability of the NICOM® System with integrated Suntech Medical NIBP capabilities furthers our commitment to offer clinicians a complete, continuous noninvasive profile of the patient’s hemodynamic status, while reducing the costs and risks formerly associated with obtaining it,” added Dr. Avidor.

“SunTech Medical is pleased to partner with Cheetah Medical to provide NIBP technology for the NICOM System,” adds Dayn McBee, CEO of SunTech Medical, “Delivering timely and accurate NIBP data is critical to effectively and safely guide patient treatment. We’re proud to be able to deliver that for Cheetah Medical and its customers.”

Cheetah Medical has begun shipment of NICOM Systems equipped with the NIBP Option to its U.S. customers. Live demonstrations of the NICOM System with NIBP capabilities will be available at the 38th Critical Care Congress of the Society of Critical Care Medicine in Nashville, Tennessee, January 31st – February 3rd, 2009, at Cheetah Medical Exhibit #642.

Cheetah Medical

Cheetah Medical delivers accurate noninvasive cardiac output (CO), noninvasive blood pressure (NIBP), thoracic fluid content (TFC) and other vital hemodynamic monitoring parameters to provide continuous, clinically actionable data for fluid and drug optimization in acute and ambulatory care settings, including intensive care, emergency, perioperative care and outpatient cardiology. The NICOM System uses Cheetah Medical’s proprietary BIOREACTANCE® technology which has validated performance accuracy and faster directional changes compared to invasive CO measurement methods, with less potential costs and risks. Cheetah Medical worldwide headquarters are located in Tel-Aviv, Israel and its United States headquarters are located in Portland, Oregon. For more information, visit our website at www.cheetah-medical.com.

For More Information Contact:

Ann Demaree

Executive VP, U.S. Manager Cheetah Medical USA ann@cheetah-medical.com Office: 503-241-5405 Cell: 503-475-2217 Web Site: cheetah-medical.com

About SunTech Medical SunTech Medical provides clinical grade non-invasive blood pressure (NIBP) products and technology. We offer solutions for ambulatory blood pressure monitoring, cardiac stress test blood pressure monitoring, and now a general-use, expandable blood pressure device with temperature and SpO2 upgrades. Its series of OEM blood pressure modules offer customizable NIBP solutions for all clinical applications. Visit SunTech Medical online at www.suntechmed.com.

For More Information Contact: Edward Wright Vice President of Marketing and Business Development SunTech Medical 507 Airport Boulevard, Suite 117 Morrisville, NC 27560-8200 USA Office: 1 (919) 654-2300 Fax: 1 (919) 654-2301 Web Site: suntechmed.com

Contact: Cheetah Medical USA Ann Demaree, 503-241-5405 Executive VP, U.S. Manager ann@cheetah-medical.com Cell: 503-475-2217 cheetah-medical.com or SunTech Medical Edward Wright, 1 919-654-2300 Vice President of Marketing and Business Development Fax: 1 919-654-2301 suntechmed.com

Source: Cheetah Medical


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