CardioFlow Announces 2021 Interim Results

Shanghai, China — MicroPort CardioFlow Medtech Corporation (hereafter referred to as the "Company", Stock code: 02160.HK), announced on August 29, 2021 the interim results of the Company and its subsidiaries (hereafter referred to as the "Group"or "CardioFlow") for the six months ended June 30, 2021 (hereafter referred to as the "Reporting Period"). In the Reporting Period, the Group recorded revenue of RMB86.2 million, representing an increase of 121.8% as compared to the corresponding period of last year, with the gross profit margin increased significantly by 11 percentage points to 55.1%.

In the Reporting Period, the Group achieved sustained and rapid growth in revenue, mainly attributable to the rapid growth in sales volume of our first-generation transcatheter aortic heart valve implantation (“TAVI”) product, VitaFlow®. As of June 30, 2021, TAVI procedures using VitaFlow® had been performed at over 220 hospitals in China, most of which are Class IIIA Hospitals located at tier-one and tier-two cities. Among these hospitals, VitaFlow® have obtained market leading position in around 100 hospitals. Meanwhile, VitaFlow® was solely approved by medical reimbursement in Yunnan and Guizhou provinces, which is crucial for VitaFlow® to gain market share advantage in these regions.

With respect to the development of overseas markets, the Company registered VitaFlow® in Argentina and Thailand in 2020, and successfully completed the first overseas commercial implantation in Argentina in August 2021, marking a key milestone for our overseas expansion. Leveraging the worldwide recognition of the “MicroPort” brand and the existing sales network of the MicroPort Group, we will continue to extend our overseas business footprints and lay a solid foundation for the realization of a global business roadmap.

As for the development of new products, our second generation TAVI product VitaFlow LibertyTM received the registration approval from the National Medical Products Administration of the People’s Republic of China (“NMPA”) in August 2021. Besides, VitaFlow LibertyTM is also conducting a pivotal clinical trial in Europe, being the only China-developed TAVI product that commenced clinical trial in Europe. We plan to submit the application for CE Mark registration in 2021 and expect to get approval in 2022. VitaFlow LibertyTM features retrievability and repositioning, enabling deployment and retrieval of the valve in a stable, accurate and fast manner, which will better benefit the patients. In addition, the Group also has another two in-house developed R&D stage TAVI products, i.e. the third-generation self-expanding TAVI product and another balloon-expandable TAVI product. We are also strategically positioned in the transcatheter mitral valve (“TMV”) market with five TMV products, among which, our in-house developed TMV replacement product has completed animal studies, passed safety evaluation and submitted application for compassionate use. In order to further expand our product portfolio, the Company invested in 4C Medical Technologies (the “4C Medical”) and Valcare Medical Ltd. (the “Valcare”) and collaborated with them on pipeline products. Thereinto, the TMV repair product AmendTM, partnership with Valcare, has successfully completed 4 trans-septal implantation cases, and its preliminary results demonstrated significant reduction of mitral regurgitation; and the innovative TMV replacement product AltaValve of 4C Medical is expected to conduct compassionate use in China by the end of 2021. Furthermore, the Group is the only medical device company in China that has a comprehensive offering of in-house developed complementary TAVI procedural accessories having 8 procedural accessory products. Among them, four products are already launched, including Alwide® Plus balloon catheter approved by NMPA in July 2021 and our first-generation tip-preshaped super stiff guidewire Angelguide® approved together with VitaFlow LibertyTM in August 2021. Through continuous in-house development and collaboration with global enablers, we have strategically covered total solutions for the treatment of structural heart diseases.

In July 2021, by virtue of our advantages in the development of high-end interventional medical devices designed for heart valves, the Group was successfully named as one of the third batch of national “Little Giant” enterprises with the features of specialisation, refinement, uniqueness and innovation, which indicates that the innovation capability as well as the leading technology and industry position of the Company have been widely recognized by the society.

With respect to production and operation, the Company is actively upgrading manufacturing capacity to meet the fast-growing market demand. Currently, the Company has two manufacturing facilities in Shanghai in compliance with the GMP standard, and leased a new manufacturing facility in Shanghai with a total GFA of over 15,000 sq.m, which is expected to commence production in 2022. Chengdu Xintuo Biotechnology Co., Ltd., a wholly-owned subsidiary of our Company, completed the construction and opened for operation in May 2021, which will help to secure the supply of key raw materials and improve profitability of the Company.

By leveraging on the strong combination of VitaFlow® and VitaFlow LibertyTM, active expansion of sales network, unremitting development of pipeline products and continuous upgrade of supply chain and capacity, the Company will steadily promote its comprehensive competitiveness and market share to become an innovative leader in total solutions for the treatment of structural heart diseases with stronger strength.

“Relying on VitaFlow®’s unique product design and excellent clinical performance, and thanks to the continuous efforts of our marketing and sales team, the Company further expanded hospital coverage and achieved a sustained high revenue growth. With the approval of VitaFlow LibertyTM, we have every confidence in maintaining high growth, increasing rapidly the hospital coverage and product sales and taking the leading position in domestic market. In the future, we will keep adhering to the Company’s philosophy of “focus, innovation, and globalization” to provide trustworthy and universal access to state-of-the-art total solutions to treat structural heart diseases.” said Mr. Chen Guoming, the executive director and President of the Group.