France’s Ministry of Health will fund €1.3m, under the soutien aux techniques innovantes couteuses (STIC) programme, to support PneumRx‘s RePneu lung volume reduction coil (LVRC) study.
Minimally invasive RePneu LVRC system, which features Nitinol coils, is bronchoscopically implanted into the lungs to improve lung function in emphysema patients, compress diseased tissue (lung volume reduction), restore elastic recoil and adjust lung compliance.
The study will enroll 100 subjects at ten centres throughout France to demonstrate the safety and efficacy of the RePneu LVRC.
Previously, the RePneu LVRC has undergone several clinical studies in Europe, with impressive results in more than 250 treatments.
Subjects who underwent treatment with the RePneu LVRC experienced improvements in lung function, exercise capacity and quality of life at both six months and one year after treatment, with minimal risk.
Clinically significant improvement in exercise capacity at 12 months post-treatment were maintained in 74% subjects, while 96% experienced significant improvement in quality of life.
Gaetan Deslee, study principal investigator professor, said: "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 enrol in this STIC study will enjoy the same benefits, including increased exercise capacity, improved pulmonary function and better quality of life."
Erin McGurk, PneumRx president and CEO, said The French Government agreed to support the study and recognised the benefits of the RePneu LVRC.
"We look forward to bringing the benefits of the RePneu LVRC to growing numbers of emphysema patients in France and throughout the world," McGurk added.
CE marked RePneu LVRC has also received approval from the US Food and Drug Administration to initiate a 315-subject pivotal trial in the US, according to the company.