HONG KONG, Aug. 31, 2021 /PRNewswire/ — Shanghai HeartCare Medical Technology Corporation Limited (“HeartCare Medical” or the “Company“, together with its subsidiaries, the “Group“, stock code: 6609), a leading player in China’s neuro-intervention market, announced its interim results for the six months ended June 30, 2021 (the “Period”).
During the period, the Group recorded a revenue of RMB30.13 million, representing a substantial increase of 1,287.4% as compared to the corresponding period of 2020, it was mainly due to the increase in revenue generated by the ExtraFlex™ distal access, and commercialization of Captor™ Thrombectomy Device in December 2020. Gross profit was RMB19.05 million, representing a substantial increase of 1,641.5% as compared to the corresponding period of 2020, while gross profit margin increased to 63.2% from 50.4% in the same period last year. The Group have built an established, extensive and growing distribution network comprising over 80 distributors covering over 1,400 hospitals across 29 provinces in China. The commercialized products of the Group is allowed to be sold in most of the provinces in China, which laid a solid foundation for the revenue increase.
HeartCare Medical is an established leadership position in the neuro-intervention market in China by virtue of our portfolio broadly covering the treatment and prevention of stroke. The Group have a broad portfolio of 7 NMPA approved products and 16 product candidates in China, including the first domestic commercialized full suite of stent retrieving thrombectomy devices and the global-first sirolimus intracranial drug-eluting balloon catheter for intracranial stenosis treatment as of the date of this press release.
Ischemic stroke thrombectomy devices
The Group’s core Product – Captor™ Thrombectomy Device (“Captor”) is used in the minimally invasive thrombectomy procedures to remove the thrombi, or blood clots, in intracranial vessels for patients with acute ischemic stroke (AIS) due to large vessel occlusion (AIS-LVO patients). The Group submitted the registration application for Captor to the NMPA in December 2019 and received the NMPA approval in August 2020, making it the first domestic thrombectomy stent retriever with multi-markers approved by NMPA. Sales in China started in December 2020. As of the date of this press release, the Group were preparing for adding more product models of different lengths and diameters and were also upgrading Captor for indication expansion. The Group is evaluating the opportunities to market Captor overseas and is planning to apply for its registration in the United States and Europe.
Aside from Captor, the Group has 3 commercialized products, namely the ExtraFlex™ distal access, the SupSelek™ microcatheter and Fullblock™ balloon guiding catheter, which together can form a product suite for stent retrieving thrombectomy procedures when used in combination with Captor. Aspiration catheter and pump are used in the aspiration thrombectomy procedure to retrieve the thrombus and restore blood flow in occluded cerebral vessels for AIS-LVO patients. The Group submitted the NMPA registration applications for both the aspiration catheter and aspiration pump in the fourth quarter of 2020. The Group received the NMPA approval for the aspiration pump in July 2021 and the aspiration catheter was in NMPA registration review as of the date of this press release.
Intracranial Stenosis Treatment Devices
Intracranial drug-eluting balloon catheter (intracranial DEB) is designed to deliver an anti-proliferative drug to the lesion to prevent fibrosis and vessel occlusion. The Group initiated registration clinical trial for intracranial DEB in May 2020. As of the date of this press release, the intracranial DEB was in the registration clinical trial and the Group had completed the patient enrollment. The special procedures to the examination and approval for innovative medical devices is applicable to the intracranial DEB. The Group is aimed to complete the trial, submit NMPA registration application and receive NMPA approval in 2022.
Ischemic stroke prevention devices
The Group’s core Product – LAA Occluder is a stroke prevention device designed to be permanently implanted at the opening of the LAA of patients with non-valvular atrial fibrillation (AF) to prevent thrombus escaping from the LAA, thus causing embolization. LAA occlusion is a one-time surgical therapy with proven efficacy, in particular for the patient who is not suitable for long-term oral anticoagulation therapy and has a higher risk for bleeding complications. The Group had completed the clinical trial in December 2020 and it was submitted for NMPA registration review in May 2021. The Group is expected to receive NMPA approval in the fourth quarter of 2021 and commence sales in the second quarter of 2022.
Hemorrhagic Stroke Treatment Devices
Embolic coil can be released at the location of the aneurysm, filling the aneurysm to isolate the aneurysm from normal blood circulation and prevent the aneurysm from further expanding and breaking. As of the date of this press release, the embolic coil was in the registration clinical trial. The Group is expected to submit NMPA registration application and receive the NMPA approval in 2022.
Vascular reconstruction stent is designed for bridging the neck of aneurysm to support the coils placed in the aneurysm. The Group had completed product design and type testing for the vascular reconstruction stent as of the date of this press release. The Group is expected to submit NMPA registration application and aim to receive NMPA approval in 2022.
Vascular Access Devices
The Group is also developing various vascular access devices for use in interventional procedures, including the vascular closure device. The Group expect to receive NMPA approvals for vascular closure device, micro guidewire and support catheter in 2021. In addition, the Group had seven other product candidates in design stage covering different product categories of neuro-interventional medical devices, which further supplements the full-set product portfolio for the treatment and prevention of stoke, including the flow diverter device and embolization assisting balloon.
The Five Technology Platforms Cover Product R&D, Manufacturing and Quality Control
HeartCare Medical leveraging the advanced technologies and engineering techniques for the development of neuro-interventional devices. The R&D platforms comprehensively cover the product development, manufacturing and quality control. Aside from the five technology platforms, namely the stent forming and processing platform, catheter technology development and manufacturing platform, balloon technology development and manufacturing platform, braiding technology development and manufacturing platform and interventional products quality platform, the Group plan to build and develop additional technology platforms including combinatory drug and device platform and active medical device platform. As of the date of this press release, the Group had 42 registered patents in China, including 8 invention patents and 34 utility models. As of the same date, the Group had 58 pending patent applications in China, including 53 invention patents, 4 utility models and 1 industrial design patent.
Continuous Expansion of Manufacturing Facilities
As of the date of this press release, the Group had carried out manufacturing activities at the manufacturing facility located in the leased properties in Zhangjiang, Shanghai, with an aggregate gross floor area of approximately 1,784.1 sq.m. As of the date of this press release, the general headquarters office in Lin-gang Special Area had commenced operation, and the Group is planning on applying for the production permit for the commercialized products at the Lin-gang manufacturing facility in the next few months. The Group plans to construct additional production facility in Lin-gang Special Area to accommodate the growing demand for the products going forward.
Well-Developed and Solid Commercial Layout
As of June 30, 2021, the Group has built an in-house sales and marketing team of highly experienced sales personnel, which including 65 employees, the Group is continuing to expand the sales and marketing team.
As of the date of this press release, the Group has built an established, extensive and growing distribution network comprising over 80 distributors covering over 1,400 hospitals across 29 provinces in China. The commercialized products are allowed to be sold in most of the provinces in China, which laid a solid foundation for the revenue increase.
Chairman of the Board, Chief Executive Officer and Executive Director of HeartCare Medical, Mr. WANG Guohui, said, “HeartCare Medical are aims to become an undisputable leader in the global neuro-interventional medical device market. In future, the Group will continue to grow sales of our product suite of stroke thrombectomy devices and rapidly advance our registration-stage product candidates into commercialization, advance and supplement our product pipeline to further enrich our full-set product offering for stroke care, and further enhance our integrated R&D infrastructure and manufacturing capabilities as well as selectively engage with potential partnership and global collaborations to capture market opportunities.”
About Shanghai HeartCare Medical Technology Corporation Limited
Shanghai HeartCare Medical Technology Corporation Limited was founded in 2016, is a China-based neuro-interventional medical device pioneer with the aim of redefining the therapeutic and preventive paradigm of stroke. Leveraging the integrated capabilities in R&D, manufacturing and commercialization, HeartCare Medical strive to reduce the mortality rate and improve prognosis of stroke in China and worldwide through the commercialization of our innovative product candidates. HeartCare Medical has a one-stop product portfolio extends from the treatment and prevention of ischemic stroke, covering the entirety of the massive, fast-growing and under-penetrated neuro-interventional market in China, to meet the unmet and differentiated needs of stroke patients. As of the Latest Practicable Date, HeartCare Medica have a broad portfolio of 7 NMPA approved products and 16 product candidates in China. The core products of HeartCare Medical, namely Captor™ thrombectomy device (“Captor”) and left atrial appendage (LAA) occluder, which Captor has been commercialized in China.