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First U.S. Patients Treated in PneumRx RENEW Pivotal Study for Treatment of Severe Emphysema
Date:2/25/2013

ive devices designed to treat emphysema, the RePneu LVRC is intended to treat a broad range of emphysema patients, including those with heterogeneous and homogeneous disease, in both upper and lower lobes, and it performs independently of collateral ventilation, a common condition in emphysema patients.

The RENEW Study began enrolling patients in the European sites, which are experienced in the technique, late last year.  Up to 315 patients in over 25 medical centers across North America, plus centers in the Netherlands, UK and Germany, will participate in the RENEW Study.  "Bringing relief to the millions of emphysema sufferers was a significant motivation in founding PneumRx, so it is particularly meaningful to me that we have begun treating people with this debilitating disease here at home.  We look forward to submitting the pivotal trial results in support of a PMA application and eventually offering the benefits of LVRC treatment to patients throughout the U.S." stated Erin McGurk , President and CEO of PneumRx.

Qualifying patients must have been clinically diagnosed with severe emphysema and be experiencing increasing difficulty with simple daily tasks. Patients must have stopped smoking for at least eight weeks and must have completed a pulmonary rehabilitation program prior to enrollment.

Although the RePneu LVRC is investigational in the United States and not yet approved for commercial use by the FDA, the device has a CE Mark and has been used in Europe for the treatment of severe emphysema since 2008.

For more information about the RePneu LVRC and the RENEW study, visit www.pneumrx.com or http://www.clinicaltrials.gov/ct2/
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SOURCE PneumRx, Inc.
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