Hengsheng Medical Completes Nearly RMB 300 Million Series A Financing to Advance Integrated Precision Cardiovascular Diagnosis and Treatment Solutions

Following the successful bid of Wanrui Feihong’s NOYA sirolimus-eluting stent, a subsidiary under HENG SHENG MEDICAL Group, at the highest price in the 2020 national centralized volume-based procurement of coronary stents, HENG SHENG MEDICAL Group, a leading R&D and manufacturer of coronary medical devices, has recently made new moves.

In January 2021, HENG SHENG MEDICAL announced the completion of its Series A financing round, raising nearly RMB 300 million. The round was jointly invested by prominent healthcare institutions China Merchants Bank International and CITIC Medical Fund, with Xuyi Capital serving as the financial advisor. The proceeds will be used to expand the production of drug-eluting stents, pursue regulatory registration for self-perfusing drug-coated balloons, and support the research, development, and clinical trials of the second-generation 99μm self-perfusing fully biodegradable stent.

The first batch of national volume-based procurement (VBP) for high-value medical consumables, launched in the second half of 2020, has now been finalized. NOYA, the stent product manufactured by Wanrui Feihong, a subsidiary of HENG SHENG MEDICAL Group, was included in the national centralized procurement at the highest price. After more than two decades of development, China’s coronary intervention medical device industry has evolved from initially simply imitating and learning from imported products to its current state of offering high-tech product portfolios driven by independent innovation.

Currently, among domestically produced stent products that have won bids, only two have obtained EU CE certification, with the NOYA stent being one of them. The newly added specifications for the NOYA stent, featuring a minimum diameter of 2.25 mm and a maximum length of 40 mm, have now entered the clinical trial phase. Upon market launch, the NOYA stent is poised to become the Chinese-made stent brand with the most comprehensive range of sizes and specifications.

With the advent of population aging, cardiovascular diseases in China have become increasingly severe, making cardiovascular medical devices the most significant segment of the medical device industry. According to data from the "Report on Cardiovascular Diseases in China 2019," the total number of patients with cardiovascular diseases in China exceeds 300 million, and this figure continues to grow rapidly. The World Health Organization predicts that cardiovascular diseases account for more than 40% of all disease-related deaths among residents, establishing them as the leading cause of death in modern society. In 2019, the number of percutaneous coronary intervention (PCI) procedures performed domestically increased to 1.03 million, showing a clear and consistent year-on-year upward trend. In view of the immense growth potential of the domestic market for cardiovascular interventional medical device consumables, HENG SHENG MEDICAL Group has remained deeply committed to the field of cardiovascular interventional therapy, continuously pursuing innovation, investing in research and development, and manufacturing and promoting cardiovascular interventional consumables.

With the continuous improvement of interventional therapy standards and the ongoing development of interventional devices, the philosophy of interventional treatment is also advancing. At both the 2019 Annual Meeting of the Asian Society of Cardiology (ASSA 2019) and the 14th Oriental Congress of Cardiology (OCC), “Nothing Left” (intervention without implantation), as a novel interventional treatment concept, has gained increasing consensus and recommendation from experts.

One of the flagship products independently developed by Hengyi Medical, a subsidiary of Heng Sheng Medical Group, is the "Self-Perfused Drug-Coated Balloon." The clinical trial for this product is led by Professor Huo Yong, a renowned cardiovascular expert in China, serving as the Principal Investigator (PI). Featuring proprietary self-perfusion technology, this device maintains blood flow during balloon inflation, ensuring that 15% of blood flow continues to pass through. This design not only enhances patient comfort but also extends the balloon's wall-apposition time, significantly improving patient safety. In contrast, standard drug-coated balloons typically have an inflation duration of no more than 60 seconds, resulting in short drug release times, substantial drug loss within the lumen, and low drug uptake.

The unique self-perfusion technology significantly prolongs drug absorption time, allowing more drug to be absorbed by the vessel wall and reducing elastic recoil. The self-perfusing drug-coated balloon utilizes a unique spraying process that ensures excellent uniformity of the drug coating, with complete coverage on the balloon surface, thereby facilitating drug release. Furthermore, the self-perfusing drug-coated balloon features a paclitaxel coating and innovatively eliminates the use of any dispersants, greatly improving the deliverability of the drug-coated balloon. Clinical trials have completed enrollment and officially entered the regulatory submission phase, with market launch expected this year.

HENG SHENG MEDICAL’s independently developed second-generation 99μm self-perfusing, fully biodegradable drug-eluting stent not only ranks among the top in China’s medical device industry but also demonstrates strong competitiveness in the global market. As the world’s first stent to apply self-perfusion technology to biodegradable drug delivery, it utilizes a PLLA scaffold with a strut thickness of 99μm, enabling prolonged expansion, improving stent apposition, and reducing the risk of late thrombosis. The R&D phase for this second-generation 99μm self-perfusing, fully biodegradable stent has been completed, and it is scheduled to enter the First-In-Human clinical trial phase by the end of this year.

Mr. Zhao Xusheng, founder of HENG SHENG MEDICAL Group, stated, “Amid the continuous and vigorous development in the field of coronary intervention, innovation remains the inexhaustible driving force for corporate growth. HENG SHENG MEDICAL has always been committed to exploring internationally leading core technologies. By combining these with high-quality and reliable products, we continuously refine our product portfolio and service capabilities to provide premium solutions for precise diagnosis and treatment in coronary intervention, thereby enabling physicians to deliver more accurate therapeutic regimens. Looking ahead, HENG SHENG MEDICAL will continue to innovate by significantly increasing R&D investment to further expand our product line and enrich our product matrix, elevating our independent R&D capabilities to a new level.”

Zhou Kexiang, Managing Director of China Merchants Bank International Capital, stated, “As the population ages, the incidence of cardiovascular diseases remains high, leading to a continuous increase in demand from both physicians and patients for innovative cardiovascular medical devices. HENG SHENG MEDICAL has established a comprehensive industry chain layout in the cardiovascular field and boasts a top-tier team within the industry, maintaining a steadfast focus on independent innovation and R&D. We believe that under the leadership of its management team, HENG SHENG MEDICAL will fully implement its strategic plans, continue to strengthen and deepen its market presence, align with the national centralized procurement program for high-value consumables, and provide more innovative healthcare options for physicians and patients.”

Cai Hua, General Manager of CITIC Medical Fund, stated, “The development of medical devices in China has just entered the fast lane. Cardiovascular and cerebrovascular intervention is a key niche sector and a primary focus of our fund’s investment strategy. The national centralized procurement of high-value consumables is an inevitable trend that has arrived as expected. We value HENG SHENG MEDICAL’s innovation capabilities and its comprehensive product portfolio advantages. Even more importantly, we recognize the Hengsheng team led by Mr. Zhao, which has cultivated deep expertise in the field of coronary intervention for over two decades. With a profound understanding of both clinical practice and the industry, clear strategic objectives, proactive technological and product planning, strong execution capabilities, and robust clinical resources, we believe HENG SHENG MEDICAL will deliver higher-quality and more accessible products and services to the public.”

Hengsheng Medical Group is a high-end medical device conglomerate dedicated to innovation, with an unwavering focus on the field of cardiovascular interventional diagnosis and treatment. The group’s headquarters is located in the core area of the Zhongguancun Industrial Park in Shunyi District, Beijing, with research and development centers established in Chengdu, China, and Boston, USA. Committed to independent innovation and R&D, the company has been certified as a National High-Tech Enterprise. It has invested over RMB 500 million in cumulative R&D expenditure and currently holds more than 30 patents (including pending applications). Two of its products have entered the special approval "green channel" for innovative medical devices administered by the China Food and Drug Administration (CFDA). The company has obtained six CE certificates from the European Union and nine registration certificates from China’s National Medical Products Administration (NMPA). Hengsheng Medical boasts a team of senior management professionals, along with dedicated production, R&D, and marketing teams. With extensive expertise in product registration, the company has established a comprehensive network encompassing R&D, registration, manufacturing, marketing, and services. Its diverse product portfolio ranges from coronary intervention accessories to balloon dilation catheters, and from NOYA stents to its independently innovated self-perfused drug-coated balloons. Hengsheng Medical remains committed to providing one-stop solutions for Percutaneous Coronary Intervention (PCI) procedures.

CMB International Capital is an equity investment platform established by China Merchants Bank through CMB International. Since its inception, CMB International Capital has adhered to market-oriented principles, with an investment portfolio covering industries such as new energy, healthcare, TMT, culture and entertainment, and high-end consumer goods, forming a comprehensive ecosystem encompassing the entire process of fundraising, investment, management, and exit.

CITIC Medical Fund is CITIC’s equity investment management platform dedicated to the pharmaceutical and broader healthcare sector, committed to building an empowering pharmaceutical industry fund with deep capabilities in industry consolidation. Its core team comprises industry experts with extensive operational experience at multinational pharmaceutical companies and financial experts with deep expertise in the finance sector.