Medwave Inc.'s Primo(TM) Granted 510(k) Clearance By FDA

DANVERS, Mass., Feb. 7 /PRNewswire-FirstCall/ -- Medwave Inc. , the innovator in sensor-based, non-invasive blood pressure measuring solutions, announced today that it has received authorization from the U.S. Food and Drug Administration (FDA) to sell and market its Primo(TM) spot blood pressure monitoring product within the United States healthcare markets.

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Primo is a handheld spot blood pressure monitoring device, which is placed on the wrist, with accuracy comparable to an invasive arterial catheter. When on the wrist the user presses a start key, and within approximately 12 seconds, blood pressure and pulse rate values are displayed. Placing Primo on a patient is easy, and in some cases can be completed with just one hand. Also, Primo requires no calibration or routine maintenance. Therefore, the Primo is compact, lightweight, easy to use, very accurate, comfortable for the patient and extremely cost effective.

Tim O'Malley, President and CEO of Medwave, Inc., stated, "Primo is a significant milestone in the development of Medwave as a company, and in the evolution of the non-invasive blood pressure monitoring market. The non- invasive blood pressure monitoring market was introduced to the manual blood pressure cuff in the late 1800's, and frankly this technology has not changed significantly since that time. Medwave has been dedicated to proving that its technology is a better way to measure a person's blood pressure than traditional blood pressure cuff products. This has been consistently validated in 14 clinical studies, which have been published and/or presented regarding Medwave's technology. Through pre-market customer studies and focus groups, Primo has shown that it is easy to use, rapid in its ability to obtain readings, flexible across the various patient populations, and cost effective for the customer. Primo is also comparable in accuracy to an invasive arterial catheter. Our goal when designing Primo was to create technology that was highly disruptive to the industry, while still offering economic advantages for our customers. We are confident that we have accomplished that objective, and we look forward to providing this product to the healthcare markets."

Medwave, Inc. develops, manufactures, and distributes sensor-based non- invasive blood pressure solutions. Its Vasotrax(R) Hand Held Monitor, the Vasotrac(R) APM205A NIBP Monitor, the Vasotrac(R) APM205A Model DS, and the MJ23 OEM Module are new approaches to non-invasive blood pressure monitoring. Medwave's Legato(TM) OEM Developers Kit is designed to introduce the innovative Vasotrac(R) technology to OEM designers. The Primo(TM) Non-Invasive Blood Pressure Monitoring System, Medwave's latest innovation, is designed to be sold into the point of care blood pressure monitoring market, estimated to be in the $600 Million per year range. Medwave has received the necessary regulatory clearances to market its technology in Europe, Asia, and the United States. Medwave's technology is installed in over 500 hospitals and clinics worldwide. Medwave has received the Seal of Acceptance from the Alliance of Children's Hospitals, as well as the Frost & Sullivan Market Engineering Award for Technology Innovation and the Frost & Sullivan Customer Value Enhancement Award. Medwave currently has supply and/or other agreements with Nihon Kohden, Zoll Medical Corporation, Analogic Corporation, and a global electronics company. Medwave trades on the NASDAQ small cap market under the symbol MDWV. For more information, visit http://www.medwave.com.

Statements made in this release that are stated as expectations, plans, anticipations, prospects or future estimates or which otherwise look forward in time are considered "forward-looking statements" and involve a variety of risks and uncertainties, known and unknown, which are likely to affect the actual results. The following factors, among others, as well as factors discussed in the Medwave's filings with the SEC, have affected and, in the future, could affect Medwave's actual results: resistance to the acceptance of new medical products, the market acceptance of the Primo(TM) system, the Vasotrac(R) system and other products of Medwave, hospital budgeting cycles, the possibility of adverse or negative results or commentary from clinical researchers or other users or evaluators of Medwave's products, Medwave's success in creating effective distribution channels for its products, Medwave's ability to scale up its manufacturing process, and delays in product development or enhancement or regulatory approval. Consequently, no forward- looking statement can be guaranteed and actual results may vary materially. Medwave(R), Vasotrac(R), Vasotrax(R), Legato(TM), and Primo(TM) are trademarks of Medwave, Inc.

CONTACT: Jodie Chastain of Medwave, Inc., +1-800-894-7601,jchastain@mdwv.com