— Study Results Will be Used to Support PMA Application for the RePneu Coil System
MOUNTAIN VIEW, Calif., Oct. 20, 2014 /PRNewswire/ — PneumRx, Inc. (www.pneumrx.com), a leader in the field of interventional pulmonology, today announced completion of enrollment in their RENEW Study, nearly 3 months ahead of schedule. The RENEW Clinical Study is the FDA-approved IDE pivotal trial for the PneumRx RePneu Coil System, a treatment for severe emphysema.
It was anticipated that the study, which began enrolling subjects in the US in February 2013, would take until the end of 2014 to enroll 315 patients. Instead, enrollment was completed nearly 3 months early, with over 70 subjects enrolling in the month of September alone. Such a rapid enrollment rate demonstrates the need for, and interest in, innovative, minimally invasive treatment options for patients with emphysema.
"The patient interest in this trial has been overwhelming," said Dr. Charlie Strange of MUSC, Principal Investigator for the study. "Such a quick enrollment was possible only because of a large commitment of all of the study teams involved in the treatment of severe COPD patients. The RePneu Coil represents a true therapeutic breakthrough in the treatment of patients with severe emphysema, and is the only option for the majority of these patients with homogenous disease. We look forward to being able to offer the RePneu Coil treatment for all severe emphysema patients in the near future."
The RePneu Coil is a minimally invasive device intended to improve exercise capacity, lung function, and quality of life for severe emphysema patients. The implants are designed to compress diseased tissue, increase elastic recoil in the lung, and re-tension the diseased airway network, relieving breathlessness and allowing patients to perform more activities of daily living.
The RePneu Coil has a CE Mark and has been used in Europe for the treatment of emphysema since 2008. The Coil treatment has proven to be effective for a broad range of emphysema patients and adoption of the technique in routine clinical practice is rapidly expanding throughout major emphysema treatment centers across Europe. A key advantage of the Coil is its simple mechanical design which is highly adaptive and has proven effective in treating patients with heterogeneous as well as homogeneous emphysema, and in upper and lower lobes. The RePneu Coil works independently of collateral ventilation, a common condition in emphysema patients which precludes patients from treatment with other types of implants.
"We are thrilled to have completed enrollment in our pivotal trial, bringing us one step closer to PMA approval. PneumRx is eager to bring this ground-breaking technology to the United States," said Erin McGurk, PneumRx’s President and CEO. "It has been so gratifying to support the hard work of our clinical trial sites and witness the excitement of our U.S. principal investigators who have been able to offer the RePneu Coil treatment to their patients. We look forward to submitting the pivotal trial results in support of a PMA application to sell the RePneu Coil System in the United States."
The RENEW clinical trial is a Phase III pivotal trial which enrolled 315 patients in 24 centers across the U.S. and 6 centers outside the U.S., (Netherlands, UK, France, Canada and Germany).
About PneumRx, Inc.
PneumRx, Inc. is a rapidly growing medical device company focused on the development and commercialization of innovative products to treat emphysema using minimally-invasive techniques. It is a privately held company located in Mountain View, California.