BTG Regulatory News (BTG)

REVOLENS study of PneumRx® endobronchial coils in severe emphysema meets primary endpoint

London, UK, 19 May 2015: BTG plc (LSE: BTG), the specialist healthcare company, notes the presentation of top line data showing that REVOLENS, a randomized, controlled trial sponsored by the French Ministry of Health, met its primary endpoint. The results show that the PneumRx® endobronchial coil is superior to the standard of care for improving exercise capacity in patients with severe emphysema at 6 months as measured by the 6 minute walk test (6MWT). The results were presented by Professor Gaetan Deslee of the University Hospital of Reims, France at the American Thoracic Society (ATS) International Conference in Denver, Colorado.

The REVOLENS study randomized 100 patients with severe emphysema from 10 centres in France. The primary outcome measure was the rate of patients showing an improvement greater than or equal to 54 metres distance in the 6MWT at 6 months. An intention to treat analysis showed that the rate of patients meeting the primary endpoint was superior in the coil group (36%) compared to the standard of care group (18%) (P

The study has been submitted for publication in a peer-reviewed medical journal.

About REVOLENS

REVOLENS (réduction de volume par voie endobronchique par spirales) was a prospective multicenter randomised controlled superiority trial comparing coil treatment with the standard of care in severe emphysema. The study was funded by the French Ministry of Health 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.

About the PneumRx® Coil

Developed by PneumRx, a BTG group company, the endobronchial coil is a minimally invasive device intended to improve exercise capacity, lung function, and quality of life for severe emphysema patients. The device has a CE Mark and has been used in Europe for the treatment of emphysema since 2010. Coil treatment is being studied under an Investigational Device Exemption (IDE) in the United States and is not yet approved for commercial use by the FDA. The RENEW Clinical Study, a Phase III pivotal trial of 315 patients completed enrolment in October of 2014 and a US regulatory submission is planned for 2016.

About BTG

BTG is a growing international specialist healthcare company bringing to market innovative products in specialist areas of medicine to better serve doctors and their patients. We have a portfolio of Interventional Medicine products to advance the treatment of liver tumours, severe blood clots, varicose veins and advanced emphysema, and Specialty Pharmaceuticals that help patients overexposed to certain medications or toxins. Inspired by patient and physician needs, BTG is investing to expand its portfolio to address some of today's most complex healthcare challenges. To learn more about BTG, please visit: www.btgplc.com

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