February 4, 2021, Shanghai, China—Today, MicroPort CardioFlow Medtech Corporation (“MicroPort CardioFlow”, stock code: 2160), a subsidiary of Shanghai MicroPort Medical (Group) Co., Ltd. (“MicroPort®”, stock code: 00853) is successfully listed on the Main Board of the Stock Exchange of Hong Kong Limited (SEHK), which is the second listed subsidiary of MicroPort® after the listing of Endovastec™ on the SSE STAR Market.
Founded in 2015, MicroPort CardioFlow specializes in providing total medical solutions for the treatment of the most common aortic and mitral valve diseases, including aortic stenosis and mitral regurgitation.
In recent years, with the development of heart valve prosthesis technology, the treatment of heart valve disease has evolved from traditional surgery, minimally invasive surgery, and finally into the era of transcatheter intervention therapeutics, bringing a last "ray of hope" to patients who cannot undergo surgical open-heart surgery.
Compared to traditional aortic valve replacement, transcatheter aortic valve implantation (TAVI) is a minimally invasive procedure that usually takes only one to two hours to perform, associated with less risk, less trauma, shorter hospital stay, and faster postoperative recovery. Recent studies have shown that for patients with severe aortic stenosis who cannot undergo surgeries, TAVI significantly reduces the morbidity and mortality rate and substantially improves their life quality compared to drug therapy. TAVI can be performed even in elderly patients who are contraindicated for surgery due to advanced age, frailty, severe lesions, or other comorbidities.
Since the world’s first TAVI procedure was performed in 2002, interventional treatment of heart valve disease has achieved remarkable progress. Currently, there are 600,000 patients who have been benefited from TAVI procedures worldwide, and there are around 150,000 completed TAVI cases globally in 2020. Although the interventional treatment of heart valve disease in China started late, it is developing at an extraordinary pace. Despite the impact of the COVID19 in 2020, there were 3,500 TAVI procedures performed in China throughout the year. Currently, more than 6,000 TAVI procedures have been successfully performed in China. With the increasing aging of the population and the expansion of indications, there is a huge clinical demand for TAVI products in China.
Approved by China’s National Medical Products Administration (NMPA) in July 2019, VitaFlow® is the first-generation transcatheter aortic valve product self-developed by MicroPort CardioFlow. This product is the first product that uses bovine pericardium as valve tissue in China, innovatively features the first-in-China double-layer polyethylene terephthalate skirt and the only marketed motorized delivery system worldwide; its stent outflow tract is designed with big cells to allow space for possible subsequent coronary interventions in patients. These unique designs, combined with in-house developed Alwide® balloon catheter and Alpass® catheter sheath, have enabled MicroPort CardioFlow the only medical device company in China that has a comprehensive offering of in-house developed complementary TAVI procedural accessories. It has outstanding clinical trial results in terms of all-cause mortality and post-operative complications, including moderate/severe perivalvular leaks, severe stroke and vascular complications. Over the past year since its launch, VitaFlow® has shown excellent clinical results in nearly 1,000 cases and has been recognized by physicians and surgeons from more than 150 hospitals in China, including leading medical centers such as Zhongshan Hospital Affiliated to Fudan University, Fuwai Hospital of Chinese Academy of Medical Sciences, the Second Affiliated Hospital of Zhejiang University, Xijing Hospital of the Air Force Military Medical University, Wuhan Asia Heart Hospital, and Guangdong Provincial People's Hospital. The price of VitaFlow® is more than 30% lower than any previously available product in the domestic market, significantly reducing the overall cost of TAVI procedure for a greater number of patients.
Currently, MicroPort CardioFlow has submitted the registration application to the NMPA for its in-house developed second-generation TAVI product, VitaFlow® II. The company is also carrying out clinical trials in Europe in order to obtain the EU CE Mark in near future. With retrievable and repositionable features provided by VitaFlow® II, patients will benefit from greatly improved accuracy of valve implantation. According to Frost & Sullivan, a leading global business growth consulting firm, as of January 17, 2021, this is the only TAVI product developed in China that had commenced a clinical trial in Europe.
While committed to innovative research and development, MicroPort CardioFlow has also kept expanding into the global market. It successfully registered VitaFlow® in Argentina and Thailand in July 2020 and November 2020, respectively, enabling more overseas patients and doctors to access a high-quality, cost-effective "Chinese solution" in the field of aortic valve disease.
In addition to the TAVI products, MicroPort CardioFlow currently has five transcatheter mitral valve (“TMV”) pipeline products, strategically providing solutions for all mainstream viable transcatheter mitral valve therapy (TMVT) through in-house development and collaboration with its global partners, namely 4C Medical and ValCare, each being a medical device company focusing on the R&D of mitral and tricuspid valve medical devices, enabling the company to penetrate the vast but underserved mitral regurgitation market.
According to Mr. Chen Guoming, Executive Director and President of MicroPort CardioFlow, “Thanks to the support of controlling shareholders of MicroPort® and all investors from multiple rounds prior to the IPO, the company has achieved rapid and efficient growth. The listing on the Hong Kong Stock Exchange is expected to provide us with ample capital for market expansion and production capacity increase of our next-generation products, and for continued research and development of other product pipelines. It also provides us the possibility to further enrich our product portfolio through mergers and acquisitions. The successful listing on the Main Board of SEHK will provide us ample capital for market expansion and capacity enhancement for our next generation of product as well as continued research and development for our other product portfolio. In the future, we will further accelerate the research and development process, improve market penetration, make efforts to reduce costs and increase efficiency, enhance the sustainable development of our company, and march into a new journey of rapid development.”
“The listing of MicroPort CardioFlow on SEHK is another important milestone in the development of MicroPort® and it brings a broader scope of opportunities for our future development. We will live up to our mission by further strengthening our corporate governance, fulfilling our social responsibility and continuously optimizing and improving our product portfolio through independent innovation and M&As. We are striving to become a global leader of heart valve disease treatment solutions and to bring excellent returns to our investors by continuously improving our business performance and to serve both patients and doctors at the same time”, announced Dr. Luo Qiyi, Chief Technology Officer of MicroPort®, and Non-Executive Director and Chairman of MicroPort CardioFlow.