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Emphasys Medical Announces PMA Submission for Bronchial Valve Therapy

- Data from Positive VENT Trial Presented at ERS 17th Annual Congress -

REDWOOD CITY, Calif., Oct. 1 /PRNewswire/ -- Emphasys Medical Inc. today announced the submission of a pre-market approval (PMA) application to the U.S. Food and Drug Administration (FDA) requesting regulatory approval to market the Emphasys endobronchial valve, the Zephyr(R) EBV, in the United States. The Zephyr EBV is a minimally invasive and potentially reversible treatment option intended to help patients with emphysema breathe easier.

The PMA submission was based on data from the company's pivotal trial, the Endobronchial Valve for Emphysema PalliatioN Trial (VENT). VENT was a randomized, multi-center trial enrolling 321 patients with severe heterogeneous emphysema. This trial was designed based on input from a panel of expert clinicians convened by the FDA in February 2003 to help establish the appropriate clinical endpoints for medical device treatments of emphysema. The VENT study's primary efficacy endpoints were improvement in lung function as measured by forced expiratory volume in one second (change in FEV1) and exercise tolerance as measured by a six minute walk test (6MWT) both at six months. The primary safety endpoint was a composite of major complications at six months.

Data from VENT was recently presented at the European Respiratory Society (ERS) 17th Annual Congress. VENT met both its primary efficacy endpoints showing statistically significant improvements in lung function (p=0.0047) and exercise tolerance (p=0.0073). VENT also showed the Zephyr EBV to have a favorable safety profile in terms of major complications between the treatment and control groups. At the six-month follow-up, protocol-defined major complications occurred in 5.9% of treated patients compared to 1.0% of control patients. The difference did not reach statistical significance. Investigators also reported on select patient subsets. In patients defined as having physiologically isolated target lung zones and correct Zephyr EBV placement, FEV1 was increased by 21% (p<0.0001).

About the Emphasys Zephyr(R) EBV

The Zephyr EBV is a small one-way silicone valve that is inserted into airways to prevent air from entering the diseased portion of the lung during inhalation, while allowing air and fluids to escape during exhalation. The Zephyr EBV is intended to mitigate the effects of emphysema by isolating the targeted diseased portion of the lung, causing a reduction in volume of the diseased region and allowing the healthier portions of the lung to function more normally. The Zephyr EBV has also been used for the treatment of lung air leaks in limited circumstances under a compassionate use protocol approved by the FDA on a case-by-case basis. Procedures using the Zephyr EBV are potentially reversible, if necessary, and the valves can be removed with standard bronchoscopic tools.

The Zephyr EBV system is approved for commercial use in Europe, Australia, Hong Kong and Singapore. The Zephyr EBV system is limited to investigational use in the United States.

About Emphasys Medical

Emphasys Medical is a medical technology company focused on developing and commercializing therapeutic devices for the treatment of patients with emphysema and other debilitating breathing disorders.

This press release contains statements that are forward-looking in nature. Statements preceded by the words believe, expect, anticipate, plan, intend, continue, estimate, may, will, and similar expressions are forward-looking statements. Forward-looking statements are based on the Company's beliefs and assumptions based on information available at the time the assumption was made. Forward-looking statements relate to, among other things, strategies, development timelines, regulatory developments and the timing and likelihood of commercialization of our products candidates, relating to the Company. By its nature, such forward-looking information is subject to various risks and uncertainties which could cause the Company's actual results and experience to differ materially from the anticipated results or other expectations expressed. Readers are cautioned not to place undue reliance on this forward- looking information, which is given as of the date it is expressed in this document, and the Company undertakes no obligation to update publicly or revise any forward looking information, whether as a result of new information, future events or otherwise.

SOURCE Emphasys Medical Inc.
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