Wuhan VicoMed's Atrial Shunt Device Granted National Innovative Medical Device Designation, Company Files IPO Prospectus

Recently, the Center for Medical Device Evaluation (CMDE) of the National Medical Products Administration released the "Announcement of the Review Results for Special Review Applications for Innovative Medical Devices (No. 4, 2022)." A total of seven products passed the special review application for innovative medical devices and entered the special review process. Among them, the "Atrial Septal Puncture Atrial Shunt" developed by Wuhan Vickor Medical Technology Co., Ltd. ("Vickor") ranked first. This is also the first innovative medical device company in Hubei Province this year to enter the special review process for innovative devices.

Heart failure is a global challenge, often referred to as the "stumbling block of life." According to epidemiological data, there are approximately 10 million people in China currently suffering from heart failure. These patients have poor exercise tolerance, low survival rates, and require repeated hospitalizations each year, with a prognosis worse than cancer. Vickor's independently developed "Atrial Septal Puncture Atrial Shunt Device" reduces left atrial pressure by implanting a shunt device through a minimally invasive percutaneous interventional procedure. This method does not significantly reduce left ventricular output or substantially increase right heart load while alleviating pulmonary congestion and dyspnea, thereby improving heart failure symptoms and prognosis. In April 2020, this product completed the first human implantation in China, marking a breakthrough achievement in this field for the country.

"The Ceiling of the Medical Device Field, Innovation at the National Level," Vickor, founded in 2018, is a company focused on the research and development of innovative devices for minimally invasive interventions in structural heart disease and heart failure. Speaking about the company's successful application for special review of innovative medical devices, Wang Xueli, Co-founder and General Manager of the company, was very excited. She introduced that the product is expected to complete clinical trial enrollment by the end of this year and be approved for registration and market launch in 2024.

According to reports, up to now, Vickor Medical has had 5 products enter clinical trials, of which 4 are the first and original in China. They have successively completed 4 rounds of financing totaling hundreds of millions of yuan, and a new round of financing is also underway. In the future, the entire product line for heart failure will be fully accelerated, entering the fast track of research and development, providing strong support for Vickor Medical to build an integrated platform for structural heart disease.

It is reported that from 2014 to now, nine products (including two reagent kits) from eight biopharmaceutical companies in Hubei Province, including the "Atrial Septal Puncture Atrial Shunt Device" and the "Three-layer Bionic Small-diameter Artificial Blood Vessel" developed by Yangsen Biotech, have passed the special review for innovative medical devices.