We are a medical device company in China focusing on the research, development and commercialization of innovative transcatheter and surgical solutions for valvular heart diseases. Our mission is to improve the lives of valvular heart disease patients by providing optimal and affordable medical solutions through continuous innovation.
Our self-developed first-generation transcatheter aortic valve implantation (“TAVI”) product, VitaFlowTM, was approved by the NMPA in July 2019 and subsequently commercialized in China in August 2019. As of the Latest Practicable Date, there were five approved or commercialized TAVI products in China, among which, VitaFlowTM is the first one utilizing bovine pericardium as valve tissue, according to Frost & Sullivan. Generally, bovine materials provide better durability and hemodynamic performance as compared to porcine materials. VitaFlowTM also innovatively features a first-in-China double-layer polyethylene terephthalate (“PET”) skirt and the only marketed motorized delivery system worldwide, according to Frost & Sullivan. These unique designs have enabled VitaFlowTM to achieve potentially best-in-class clinical trial results among TAVI products in China, including a low all-cause mortality rate and low incidences of postoperative complications. For details, see “Industry Overview— Competitive Landscape—TAVI Market.” We also launched our first generation in-house developed AlwideTM balloon catheter and AlpassTM catheter sheath as part of the VitaFlowTM offering, making us the only medical device company in China that has a comprehensive offering of in-house developed complementary TAVI procedural accessories, according to Frost & Sullivan. Our second-generation TAVI product, VitaFlowTM II, has completed the Registration Clinical Trial in China and is also under clinical trial in Europe. We submitted the registration application for VitaFlowTM II to the NMPA in October 2020. The application was accepted by the NMPA in November 2020 and is currently under review. We currently expect that we will complete the registration of VitaFlowTM II in China by the end of 2021. In addition, we plan to apply for the CE Mark of VitaFlowTM II by the end of 2021. According to Frost & Sullivan, as of the Latest Practicable Date, VitaFlowTM II was the only TAVI product developed in China that had commenced a clinical trial in Europe. In addition to our TAVI products, we currently have five transcatheter mitral valve (“TMV”) pipeline products strategically targeting all mainstream viable transcatheter valve therapy (“TVT”) options for mitral regurgitation through in- house development and collaboration with our 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 us to penetrate the vast but underserved TMV market.
We are deeply rooted in the vast, rapid-growing and substantially underpenetrated heart valve medical device market. According to Frost & Sullivan, in 2019, approximately 213.2 million patients worldwide suffered from valvular heart disease, which led to 2.6 million deaths. In recent years, transcatheter valve therapy has gradually replaced traditional open-chest surgeries to treat patients with valvular heart diseases in light of its advantages such as less surgical risks, minor trauma and shorter hospitalization time and postoperative recovery period. Our product portfolio strategically focuses on addressing the most prevalent aortic valve and mitral valve diseases, including aortic stenosis and mitral regurgitation.
‧ Aortic stenosis. According to Frost & Sullivan, patients suffering from aortic stenosis globally is expected to grow at a CAGR of 14.3% from 19.7 million in 2019 to 22.1 million in 2025. As a result, the global TAVI market size is expected to increase at a CAGR of 12.9% from US$4.8 billion (or RMB32.3 billion) in 2019 to US$10.0 billion (or RMB67.3 billion) in 2025. Compared to the TAVI market in developed countries, such as the United States, China's TAVI market is significantly under-penetrated. In 2019, there were approximately 2,400 TAVI procedures performed in China with a penetration rate of 0.3%, as compared to approximately 66,800 TAVI procedures performed and a penetration rate of 23.4% in the U.S. It is expected that in 2025 there will be approximately 42,000 TAVI procedures performed in China, representing a CAGR of 60.7% for the next five years and a penetration rate of 4.5% in 2025. It is expected that China's TAVI market will grow from RMB392.0 million in 2019 to RMB5,055.7 million in 2025 at a CAGR of 53.1%.
‧ Mitral regurgitation. In 2019, there were 96.7 million patients worldwide and 10.6 million patients in China suffering from mitral regurgitation. Due to the complexity of TMV therapy, global TMV market is still in a relatively early stage with only six approved TMV repair products and one approved TMV replacement product globally. Most of the existing TMV technologies have certain clinical limitations, such as causing obstructions on the left ventricular outflow tract (“LVOT”), impairing function on the left ventricle and leading to device embolization. As a result, we believe the TMV products that can address these clinical limitations will benefit the most from the vast but unmet medical demands in this area. According to Frost & Sullivan, driven by the increasing market demands of TMV repair/replacement products and emerging innovative TMV technologies, global TMV market is expected to reach US$17.4 billion (or RMB117.0 billion) by 2030 and will eventually grow to three or four times of the global TAVI market.
We have developed a medical device platform focusing on valvular heart disease. The platform covers our four key business functions, namely R&D, clinical trial, manufacturing and commercialization. Leveraging this platform, all the key business functions are integrated to enable smooth collaboration during the whole life-cycle of a product candidate to speed up the product development process in a cost-effective manner. The platform lays a solid foundation and builds the strategic moat for our research, development and commercialization competitiveness. Driven by strong innovation capabilities and supported by stringent quality controls, our platform primarily focuses on (i) technological innovation, product design and biological material processing technique; (ii) efficient design and execution of clinical trials; and (iii) manufacturing efficiency. This platform has enabled us to continuously expand our product portfolio to tackle valvular heart diseases with innovative treatment methods. We have also established a quality control system in accordance with GMP standards required by the NMPA and ISO13485:2016.
We have a proven track record of product commercialization. As of July 31, 2020, we had sold 872 units of VitaFlowTM—an average of over 70 units per month in the first year of its commercialization. As of the Latest Practicable Date, TAVI procedures using VitaFlowTM had been performed at over 120 hospitals in China, most of which are Class IIIA Hospitals located at tier-one and tier-two cities, including 18 of the Top 20 TAVI Hospitals. We have established a dedicated in-house sales and marketing team with professional medical background, primarily focusing on academic promotions. Supported by the potentially best-in-class clinical trial results of VitaFlow with respect to all-cause mortality rate and postoperative complications including moderate/severe PVL, major stroke and vascular complications, the patient-oriented pricing strategy, collaborations with KOLs and hospitals, our enabling distributor network and the brand recognition of “MicroPort” in the cardiology field, we believe we are well-positioned to benefit from the rapid growth of China's TAVI market and to further gain market share.
Complemented by our proven commercialization capabilities, medical device platform focusing on valvular heart disease and experienced management team with continuous support from Shareholders, we have successfully developed and launched a TAVI product with potentially best-in- class clinical trial results with respect to all-cause mortality rate and postoperative complications including moderate/severe PVL, major stroke and vascular complications in China and we are also developing our second-generation TAVI product, which is at near-commercialization stage. We are also dedicated to serving the vast but underserved TMV market, strategically targeting all mainstream viable TVT options for mitral regurgitation through in-house development and collaboration with our 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. We believe these competitive strengths are difficult to replicate and we are well-positioned to capture the tremendous growth potential of the valvular heart disease market. At the same time, we plan to continue to strengthen our presence in China's TAVI market, advance our international strategy, rapidly advance our TMV pipeline and other product candidates and improve operational efficiency and achieve economies of scale to support long-term growth.
Source: CardioFlow-B (02160) Prospectus (IPO Date : 2021/01/26) |