DANVERS, Mass., Nov. 22 /PRNewswire-FirstCall/ -- Medwave, Inc. , the innovator in sensor-based, non-invasive blood pressure measuring solutions, announced today that a 510(k) application has been submitted to the United States Food and Drug Administration for its Primo Non-Invasive Blood Pressure Monitoring System.
(Photo: http://www.newscom.com/cgi-bin/prnh/20051122/CGTU027 )
Medwave, in conjunction with researchers and clinicians at Massachusetts General Hospital in Boston, Massachusetts, have completed the necessary clinical validation studies with the Primo product. These clinical validation studies were conducted according to the American Association for Advancement in Medical Technology (AAMI) SP10 standard that provides labeling, safety and performance criteria for non-invasive blood pressure equipment. The performance of Primo was tested against that of an invasive arterial catheter.
Tim O’Malley, President and CEO of Medwave, Inc., stated, “We are very excited about the Primo product and feel that once it has successfully gone through the FDA review process, the Primo will be able to address a host of market needs in a variety of market segments. The Primo, which has Medwave’s core technology built into it, represents another breakthrough in non-invasive blood pressure monitoring. Primo has undergone rigorous clinical testing in some of the most challenging clinical environments for monitoring a patient’s blood pressure. In addition, Medwave has invested in the creation of a breakthrough look, feel and user interface for Primo. The result is a product that delivers accurate readings that are comparable to an invasive catheter. Primo is non-occlusive, so it comfortably obtains a blood pressure reading in approximately 15 seconds. Primo’s intuitive design promotes ease of use applications, and there are cost benefits for caregivers, as there is no need for calibration for the life of the product. We believe that Primo will have broad appeal in numerous healthcare environments and will have the capability of addressing markets representing approximately $600 million in annual revenue.”
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 latest addition, the Legato(TM) OEM Developers Kit, is designed to introduce the innovative Vasotrac(R) technology to OEM designers. 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 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.
Photo: NewsCom: http://www.newscom.com/cgi-bin/prnh/20051122/CGTU027AP Archive: http://photoarchive.ap.orgPRN Photo Desk, photodesk@prnewswire.comMedwave, Inc.
CONTACT: Investors-Media, Jodie Chastain of Medwave, Inc.,+1-800-894-7601, jchastain@mdwv.com
Web site: http://www.medwave.com/
