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Tensys’ TL-300 Receives SFDA Approval for Chinese Market

2013年08月21日 PM04:25
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SAN DIEGO

Tensys Medical, Inc., a leader in the development and commercialization of continuous, non-invasive hemodynamic patient monitoring systems, has been informed that the State Food & Drug Administration (SFDA) has approved the sale and marketing of Tensys’ TL-300 monitoring system in the People’s Republic of China. The approval will permit Tensys’ local partner, Zhejiang Shanshi Medical Device Co., LTD (Shanshi), to begin immediate commercialization of the company’s TL-300 throughout the People’s Republic of China. Under terms of the 5-year exclusive supply relationship, Shanshi has committed to Tensys a minimum of $US 40 million in TL-300 sales.

Shanshi will initially target the TL-300 into the Chinese operating room (OR) and intensive care unit (ICU) markets. The TL-300 technology platform accurately and continuously captures a patient’s beat-to-beat waveform and blood pressure in a completely non-invasive fashion, providing physicians with a stream of real-time hemodynamic data that is not possible using traditional non-invasive blood pressure (cuff) devices. Avoiding the blind-time associated with a deflated or inaccurate cuff can enhance hemodynamic monitoring, which has been definitively linked to improved clinical outcomes.

“We are pleased to have received SFDA approval so we can immediately begin selling and capitalizing on the high level of interest in the TL-300 seen throughout our pre-commercial marketing efforts. We are confident that the TL-300 represents the future of hemodynamic monitoring in the Chinese market,” commented Dr. Xiaodong Du, Shanshi’s General Manager.

The newest generation TL-300 features a touch screen control and displays a patient’s key hemodynamic parameters. In addition to continuous beat-to-beat blood pressure and arterial waveform, the operator is readily able to view trend data for up to a 12-hour period. The tablet displays data coming from an integrated bracelet, sensor, and wrist frame placed over the patient’s radial artery. The wrist frame is disposed at the end of the case and the bracelet and sensor are immediately available for the next patient.

“We are delighted that our TL-300 system has received marketing and sales approval for the Chinese market,” commented Dr. Eric Daniels, Tensys’ Vice President, Sales & Marketing. According to Dr. Daniels, “This approval represents a significant achievement in our expansion to the Asian markets and strengthens our leadership position in the field of non-invasive hemodynamic monitoring.”

About Tensys Medical, Inc.

Tensys Medical, Inc. is a leader in the development and commercialization of continuous, non-invasive, hemodynamic monitoring systems. Without a single needle stick, the company’s FDA approved and CE-Marked T-line technology is used today in hospital operating rooms, ICUs and electrophysiology labs to provide a patient’s real-time pulse pressure waveform and blood pressure. With the future addition of advanced hemodynamic parameters, Tensys is positioned to continue its leadership in the growing, non-invasive, hemodynamic marketplace.

Cautionary Statement Regarding Forward-Looking Statements

This press release may include “forward-looking statements” intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. These forward-looking statements generally can be identified by phrases such as “will,” “can,” “represents,” “believe,” “positioned,” “provide,” or other words or phrases of similar import that are intended to identify forward-looking statements. Similarly, statements herein that describe Tensys Medical’s business strategy, outlook, objectives, plans, intentions, or goals also are forward-looking statements. All such forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially from those in forward-looking statements, including: the clinical and commercial potential and success of the company’s TL-300 product and T-Line product line; general economic and business conditions; and other risks and important factors that could cause actual results to differ materially from the forward-looking statements. The forward-looking statements included in this press release are made only as of the date of this announcement, and Tensys Medical undertakes no obligation to update the forward-looking statements to reflect subsequent events or circumstances after the date on which they were made.

CONTACT

Tensys Medical, Inc.
Eric J. Daniels, MD, MBA
Vice President,
Sales & Marketing
TEL: 858.552.1941
FAX: 858.552.1944
edaniels@tensysmedical.com

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