TUSTIN, Calif.--(BUSINESS WIRE)--Uptake Medical announced today that it has received CE Mark allowing the commercial sale of its InterVapor system in Europe. InterVapor uses heated water vapor to achieve bronchoscopic lung volume reduction in patients with heterogeneous upper lobe emphysema. According to The Organisation for Economic Co-operation and Development, more than 23 million people in Europe suffer from emphysema, a debilitating and progressive condition that affects the respiratory system1.
“The traditional treatment options for severe emphysema patients have been very limited which is why we have remained committed over the past decade to finding a more meaningful treatment alternative for this progressive disease,” said King Nelson, President and CEO of Uptake Medical. “Gaining CE Mark is a major milestone for our company, but more importantly, represents new hope for emphysema patients. We are eager to begin the commercial launch of InterVapor in Europe allowing more interventional pulmonologists to begin using the system in the months ahead.”
The CE Mark follows results of the STEP-UP study, a prospective, multi-center, multi-national, randomized-controlled study that was completed in late 2014. STEP-UP, which involved patients from 13 centers in Europe and Australia, was designed to evaluate the safety and performance of the InterVapor system in addition to the optimal medical standard therapy in improving lung performance and quality of life of patients with severe emphysema. The STEP-UP trial results will be reported at the European Respiratory Society meeting in Amsterdam in late September 2015.
According to Prof Dr. Med Felix Herth, STEP-UP’s co-principal investigator from ThoraxKlinik in Heidelberg, Germany, “Being granted the CE Mark validates for Uptake Medical the merits of our clinical hypothesis to have for the first time an option where we can treat the most diseased segments and preserve the less diseased segments.”
Professor Greg Snell, STEP-UP co-principal investigator from The Alfred Hospital in Melbourne, Australia, said, “InterVapor provides a new way to offer non-surgical treatment to severe emphysema patients over time as the disease progresses.”
“InterVapor offers emphysema patients who have exhausted their other medical support options another potential solution to improve their lung function and quality of life, and we look forward to making this technology more widely available to patients across Europe,” Nelson said.
About InterVapor and Uptake Medical
Uptake Medical is a privately held company focused on the treatment of lung cancer and emphysema without the risks of surgery and implants or the toxicity of radiation. InterVapor, Uptake’s proprietary targeted vapor ablation technology that received CE Mark approval in 2015, applies energy with heated water vapor via a standard bronchoscope to the lungs. In the 15-minute procedure, lung tissue ablation is performed on the most diseased lung segments. The healthier segments are preserved to provide lung function and quality of life improvements in emphysema patients and to provide potential future targets as the disease inevitably progresses.
The InterVapor platform is now being tested and validated as a possible treatment for lung cancer tumors in a first-in-human study of regional lung tumor ablation in patients with early stage lung cancer and lung metastases. The outside-in bronchoscopic approach eliminates the need for percutaneous access or the need to pierce the tumor in a 10-second ablation during a 15-minute procedure. Founded in 2005, Uptake Medical is located in Tustin, California.