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Biosign Technologies Inc. Files FDA Premarket 510(k) Notification for UFIT TEN-10 "Automated Wrist Blood Pressure Monitor"


8/13/2012 8:22:24 AM

TORONTO, Aug. 13, 2012 /CNW/ - Biosign Technologies Inc. (TSXV: BIO) ("Biosign" or the "Company") announced today that it has filed a 510(k) premarket notification application with the United States Food & Drug Administration (FDA) for the UFIT® TEN-10 Automated Wrist Blood Pressure Monitor with Computer Controls and Web Services. The intended use of the product is for the measurement of blood pressure and pulse rate by patients at home as well as healthcare professionals in their respective practices. This product is currently licensed for sale in Canada (Health Canada license 70264) and in the European Union (CE Mark 0120).

The UFIT® TEN-10 Automated Wrist Blood Pressure Monitor measures patient vital signs by acquiring a pulse wave signal at the radial artery. This signal is transmitted instantly and anonymously to Biosign servers in the Cloud, where proprietary algorithms derive systolic & diastolic blood pressure and pulse rate results. These results are transmitted back to the user in real time as well as being stored in the Cloud for later retrieval, analysis and trending. Because each measurement is made via the Internet, Biosign is able to deliver results enhanced with web services, including information that can enable patient education, patient screening and biofeedback. Future iterations may include two-way communication between patient and caregiver via web-based video chat.

Biosign believes it is well poised to enter the US market for Automated Blood Pressure Monitors. According to a new report from iData Research (Vancouver BC), "the US patient monitoring market was worth more than $3.1 billion in 2011 and it is expected to approach $4.2 billion by 2018". Earlier this year, GBI Research (New York NY) predicted, "the global patient monitoring devices market will hit $8 billion in 2017, up from $6.1 billion in 2010." GBI estimated the device market's CAGR at "about 4 percent for the next five years". Like iData, GBI pointed to advancements in wireless and sensor technologies as a key driver of the patient monitoring devices market. Meanwhile a recent report by Global Industry Analysts, Inc. forecast that the global market for blood pressure monitoring will be "driven largely by an expanding proportion of elderly people suffering from blood pressure problems, technological advancements in monitors, growing consumer awareness about benefits of regular measurements and monitoring, intensifying direct-to-consumer advertising and growing stress on healthcare."

The Anson Group, based in Indianapolis, IN, prepared the FDA 510(k) premarket application for Biosign. A response by the FDA is typically expected within about 90 days.

About Biosign Technologies Inc.

Biosign Technologies Inc. (TSXV: BIO) provides automated, computer enabled biomedical systems and devices. Key applications include the noninvasive monitoring of vital signs including blood pressure, pulse rate and breathing rate, enhanced with web services. The Company's UFIT® medical device technology powers quality data collection for clinical decision support, self-care, wellness and disease management, while it's Healthanywhere™ Suite offers industry-leading remote patient monitoring solutions. For more information on Biosign, please visit www.biosign.com

Forward-Looking Statements

This release contains forward-looking statements. Forward-looking statements, without limitation, may contain the words believes, expects, anticipates, estimates, intends, plans, or similar expressions. Forward-looking statements are not guarantees of future performance. They involve risks, uncertainties and assumptions and Biosign's actual results could differ materially from those anticipated. Forward looking statements are based on the opinions and estimates of management at the date the statements are made, and are subject to a variety of risks and uncertainties and other factors that could cause actual events or results to differ materially from those projected in the forward-looking statements. In the context of any forward-looking information please refer to risk factors detailed in, as well as other information contained in, Biosign's filings with Canadian securities regulators (www.sedar.com).

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.



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