Broncus is pleased to announce that InterVapor® (including InterVapor Generator and InterVapor Catheter, the “InterVapor®”), the Company’s thermal vapor treatment system, has been granted approval by the National Medical Products Administration of China (the “NMPA”), denoting the official commercialization of the world’s only such product in China. This is the first NMPA-approved thermal vapor energy ablation systems in China and in the world for the treatment of Chronic Obstructive Pulmonary Disease (“COPD”), and it is the only minimally invasive interventional lung volume reduction product that can achieve sequential staged treatment targeting the lung segment level, thereby leading to a new era of interventional pulmonary in China.
InterVapor® is the first thermal vapor energy ablation system in China approved for “Priority Approval” for the treatment of COPD. It is a medical device that is needed imminently in clinics and no similar product has been approved in China. InterVapor® is also safe and effective for patients with complete or incomplete fissure, and offers a solution with minimal invasion and disruption for patients with advanced COPD. The Company has obtained an exclusive patent for the use of thermal vapor for pulmonary treatments with a state-of-the-art technology.
InterVapor® can transport thermal vapor to the targeted lung segment through the bronchial pathway, and deliver energy through air convection, breaking through the original obstacles of energy transmission such as high air content in the lungs, and treating severely diseased lung segments, significantly improving the quality of life of patients and lung function and their exercise tolerance while preserving more healthy lung tissues.
COPD is a comm on chronic respiratory disease and the world’s third leading cause of death. According to Frost Sullivan, in 2021, there were approximately 226 million COPD patients worldwide, and at least 106 million COPD patients in China, with the 5- year survival rate of advanced COPD patients being less than 20%. Currently, the treatment strategy of COPD is still based on drug treatment, which can delay the disease progression to a certain extent, but for severe and acutely severe patients, the effect of drug treatment is very limited. By comparing with other treatments, InterVapor®-based treatment technology is highly innovative and represents a breakthrough, clinically proven to be effective and safe, and fills the gap for treatment of patients with severe emphysema. Currently, InterVapor® has been approved for marketing in major European countries, including the United Kingdom, Germany, Switzerland, Italy, and 12 countries in Asia Pacific. Both the statistics and clinical data of STEP-UP trial (Sequential Segmental Treatment of Emphysema With Upper Lobe Predominance Trial) showed significant improvement in patents’ lung function and improved the quality of life in patients treated with Broncuchoscopic Thermal Vapor Ablation (BTVA) compared to standard treatment of a 12-month follow-up. Such treatment was included in the Guidelines of Global Initiative for Chronic Obstructive Lung Disease (GOLD) for four consecutive years from 2019 to 2022, which is recommended for patients with severe and acutely severe emphysema. In 2019, InterVapor® was awarded the “Breakthrough Device” designation by the U.S. FDA.