
PneumRx recently established a subsidiary in Germany, PneumRx GmbH, and has begun selling its innovative RePneu Lung Volume Reduction Coil (LVRC) System in Europe. It plans to use the funds to expand European commercialization and to conduct an FDA-approved pivotal clinical trial to support a PMA application. PneumRx expects to begin its pivotal clinical trial in early 2011 and intends to submit its pivotal trial results to support a PMA application to be able to sell the RePneu LVRC System in the United States.
The RePneu LVRC System is a minimally invasive device intended to improve lung function in emphysema patients by bronchoscopically implanting Nitinol coils into the lungs to compress damaged tissue (lung volume reduction) and restore elastic recoil to the lung. This treatment offers a minimally invasive alternative to lung volume reduction surgery, and works independently of collateral ventilation. More than 1500 LVR Coils have been implanted to date in over 170 procedures. The LVRC System is CE Marked and is currently available in select markets in Europe, with plans for broader expansion... [PDF] PneumRx's Press Release -