French Government commits 1.3 Million Euros to fund cost-effectiveness study of the RePneu LVRC in 100 subjects at 10 centers throughout France
MOUNTAIN VIEW, Calif., July 30, 2012 /CNW/ - PneumRx, Inc. (www.pneumrx.com), a leader in the field of interventional pulmonology, today announced that the French Ministry of Health has approved a cost-effectiveness study of the RePneu Lung Volume Reduction Coil (RePneu LVRC) in France. The Ministry of Health agreed to fund the study under the soutien aux techniques innovantes couteuses (STIC) program, which provides government funding for innovative medical technologies that have been validated by prior clinical studies, with a view toward establishing reimbursement for new devices.
The PneumRx study is one of only two STIC projects selected by the Ministry of Health for funding in 2012, and the first in the field of emphysema treatment since 2006. The French Government has committed to paying 1.3 Million Euros ($1.6 Million) to support this PneumRx study. The protocol, entitled "Evaluation Medico-Economique de la Reduction Volumique par Voie Endobronchique au Moyen de Spirales (REVOLENS)" (Medico-Economic Evaluation of Endobronchial Volume Reduction Using Coils), was submitted by Professors Gaetan Deslee of the University Hospital of Reims and Charles-Hugo Marquette of the University Hospital of Nice and is scheduled to begin enrolling patients in France in January, 2013.
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 diseased tissue (lung volume reduction), restore elastic recoil, and adjust lung compliance. This treatment offers a minimally invasive alternative to lung volume reduction surgery to a broad range of emphysema patients.
The RePneu LVRC has already undergone extensive clinical studies in Europe, with impressive results in over 250 treatments. The majority of subjects who underwent RePneu LVRC treatment in PneumRx's European clinical trials experienced significant improvement in lung function, exercise capacity and quality of life at both 6 months and one year after treatment, with minimal risk. 74% of all clinical subjects maintained a clinically significant improvement in exercise capacity at 12 months post-treatment and 96% experienced significant improvement in quality of life. The RePneu LVRC received the CE Mark in October 2010 and is commercially available in select countries in Europe. PneumRx has also received approval from the FDA to commence a 315-subject pivotal trial in the United States.
"We have seen tremendous improvement in most of the patients we have treated with the RePneu LVRC to date, and are confident that the patients we enroll in this STIC study will enjoy the same benefits, including increased exercise capacity, improved pulmonary function, and better quality of life," said Professor Gaetan Deslee, Principal Investigator for the study. Said Professor Charles-Hugo Marquette, "The RePneu LVRC represents an important advancement in the treatment of patients with emphysema, and we are pleased that we will be able to treat additional patients under this new protocol."
"We are thrilled that the French government has recognized the benefits of the RePneu LVRC and agreed to support this important study," noted Erin McGurk, PneumRx's President and CEO. "We look forward to bringing the benefits of the RePneu LVRC to growing numbers of emphysema patients in France and throughout the world."
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.
SOURCE: PneumRx, Inc.
For further information:
Erin McGurk, President & CEO, PneumRx, Inc., PneumRx, GmbH, Mountain View, California, 1-650-625-8910 X110, [email protected]
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