TUSTIN, Calif., Dec. 21, 2011 –Uptake Medical® today announced that it received Australian Therapeutic Goods Administration (TGA) approval for its InterVapor™ System for endoscopic lung volume reduction for the treatment of severe emphysema. InterVapor is the first non-surgical, endoscopic lung volume reduction system for the treatment of severe emphysema that uses the body’s natural healing processes without leaving implants or foreign materials in the lung.
Clinical efficacy of InterVapor has been established by the multi-center VAPOR trial which showed a reduction in lung volume as well as statistical and clinical significance in lung function improvement (FEV1) and health-related quality of life (SGRQ) at six months.
“Our involvement with Uptake Medical and InterVapor goes back to the first usage in patients, and we are delighted to see the TGA approval,” commented Professor Gregory Snell, head of lung transplant services at the Alfred Hospital in Melbourne, Australia. “InterVapor has continued to demonstrate clinical efficacy and safety and we look forward to offering InterVapor to our patients.”
VAPOR trial investigator, Dr. Peter Hopkins of Prince Charles Hospital in Brisbane, provided insights into the relevance of new treatment options for emphysema. “Emphysema is a debilitating condition and this patient population is in need of new treatment options. The ability to offer InterVapor to our patients represents an important step in furthering the standard of care for the treatment of severe emphysema.”
“Capping the year by obtaining TGA approval in Australia is another important milestone for Uptake Medical,” said R. King Nelson, President and Chief Executive Officer, Uptake Medical. “We look forward to working with our distributor partner, Aurora BioScience, as we introduce InterVapor in Australia 2012.”
The global incidence of Chronic Obstructive Pulmonary Disease (COPD), which includes emphysema, is on the rise and will become the third leading cause of death by 2030. In the U.S., where nearly 5 million people are diagnosed with emphysema, it already holds this position with one person dying every 4 minutes from COPD. Debilitating and costly, nearly $50 billion was spent addressing the direct and indirect costs associated with COPD in the U.S. in 2010.
About Uptake Medical
Uptake Medical is focused on the development and commercialization of innovative, non-surgical treatments for lung diseases. InterVapor™ is the first and only approach to endoscopic lung volume reduction for people with severe emphysema that uses the body’s natural healing process without leaving any implants or foreign materials in the lung. In clinical studies, InterVapor has demonstrated clinically meaningful improvements in breathing function, exercise capacity and quality of life. Headquartered in Tustin, Calif., Uptake Medical® received the CE mark and TGA approval to commercialize InterVapor. More information can be found at www.uptakemedical.com .
About Aurora BioScience Pty Ltd
Headquartered in Sydney Australia, Aurora BioScience is committed to providing advanced, high quality medical devices and healthcare products to assist medical professionals within Australia, New Zealand and the Asia Pacific healthcare markets contribute to the enhancement of their patients’ quality of life. Our areas of interest include pulmonology, cancer therapies, neurology, haematology and blood products. For more information, please visit www.aurorabioscience.com.au .
Uptake Medical and InterVapor are registered trademarks and trademarks of Uptake Medical.