Zhongtian Medical Strengthens Commercialization with Full-Stack R&D as Its Pan-Vascular Intervention Portfolio Enters a Phase of Harvest

VCBeat (WeChat ID: vcbeat) has learned thatZenith Vascular, a Chinese pan-vascular interventional company, has completed a new round of financing.Zenith Vascular operates in the booming vascular intervention sector. In the first half of 2024, China’s vascular intervention industry achieved counter-trend growth.

According to IQVIA data, the national medical device market size in China, measured at ex-factory prices, decreased by 3.2% year-on-year in the first half of 2024, while the market size for vascular interventional devices grew by 10.1% year-on-year. The growth in surgical volume across all sub-segments of vascular interventions remained highly stable, generally outperforming other fields.

In the highly competitive field of vascular intervention, Zenith Vascular has mastered key underlying technology platforms, precision manufacturing, and original design capabilities within the industry chain, leveraging its “full-stack independent R&D” technical strength. Through continuous independent innovation, Zenith Vascular has cumulatively obtained over the past six years19 Registration Certificates, successfully launched multiple exclusive products, among which the carotid artery stent was included in the “green channel” for special review of innovative medical devices. These products from Zenith Vascular have not only achieved widespread adoption in hospitals but also mark the company’s entry into a mature stage of commercialization. In the niche markets of neurointerventional and peripheral interventional procedures, Zenith Vascular has demonstrated significant growth potential.

The recently completed financing has injected new vitality into the sustained development of Zenith Vascular., which also signals that the company will achieve greater accomplishments in the innovative R&D and market promotion of vascular interventional products. To better adapt to the rapid expansion of its product portfolio and business operations,Zenith Vascular completed its business restructuring in the first half of this year, establishing dedicated neurovascular and peripheral vascular business teams.This will help the company meet market demand more effectively and further accelerate its expansion in niche segments.

Since its establishment in 2018, Zenith Vascular has focused on the neurointerventional segment, a niche market characterized by high technical barriers. Among the four major subsegments of neurointervention—acute ischemic, chronic ischemic, hemorrhagic, and access devices—Zenith Vascular has established a presence in three core markets and achieved significant accomplishments. Despite the strong influence of foreign brands and intense market competition, Zenith Vascular has successfully gained market recognition by leveraging its exceptional independent innovation capabilities and robust manufacturing expertise, thereby securing a competitive advantage in the access and ischemic device markets.

Access devices play a pivotal role in neurointerventional procedures, serving not only as the foundation of the surgery but also as a key factor in ensuring its success. Ideal access devices should possess excellent support strength, flexibility, conformability, maneuverability, and kink resistance.

Mr. Li Xiaojian, National Sales Manager for Neurology at Zenith Vascular, stated“Due to the tortuosity of intracranial vessels and their thin, fragile walls, neurointerventional procedures impose higher requirements on access devices. These devices must offer distal flexibility to minimize vascular irritation while reaching as close as possible to the lesion, and simultaneously provide strong proximal support to facilitate the delivery of subsequent therapeutic devices. Given the high technical barriers, there remains a gap between domestic manufacturers and foreign brands in the access device segment, presenting both a challenge and an opportunity for the growth of domestic brands.”

Zenith Vascular has demonstrated particularly outstanding performance in this field. Leveraging its first-mover advantage and technological innovations in the neurointerventional market, the company has established a comprehensive portfolio of access products, including distal access catheters, long sheaths, microwires, and microcatheters. These products not only offer a complete range but have also gained widespread recognition from physicians for their superior performance in clinical applications. Notably, its distal access catheters were successfully awarded in the centralized volume-based procurement of 28 categories of consumables organized by the Beijing-Tianjin-Hebei “3+N” Alliance this year. This achievement not only underscores Zenith Vascular’s competitiveness in the access market but also presents significant opportunities for leapfrog growth.

Ischemic stroke, accounting for approximately 80% of all stroke cases, sees growing treatment demands driven by the establishment of stroke centers and the widespread adoption of therapeutic technologies. In the field of ischemic stroke treatment, Zenith Vascular has introduced a comprehensive acute ischemic stroke (AIS) treatment solution, including Zenith Tianxun®Pro Thrombectomy Aspiration Catheter, Zenith Tianyi^®Thrombectomy Stent, and Zenith Vascular Tianxun^®The Access Series products, through a comprehensive portfolio of access solutions and high-performance therapeutic devices such as thrombectomy stents and aspiration catheters, flexibly address the complexities of endovascular therapy, enhancing the safety and efficiency of vascular recanalization. In this highly competitive market, Zenith Vascular has established its leadership in the field of ischemic stroke products through its innovative offerings and superior performance.

Intracranial Stenosis: A Differentiated Market in NeurointerventionIntracranial stenosis is a condition with high prevalence among the Chinese population, representing a market with substantial potential. However, several studies on endovascular treatment for intracranial stenosis have failed to yield ideal positive results, and the optimal therapeutic approach remains controversial.

The high rate of stroke recurrence with existing pharmacological treatments, coupled with clinical observations that some patients benefit from interventional therapy, has sustained interest in this approach among clinicians and device manufacturers. With advancements in devices and materials, the safety and efficacy of endovascular treatment for intracranial stenosis are poised to improve significantly. This field is emerging as a new blue-ocean market within neurointervention. In addition to its marketed Tianxun Intracranial Balloon Dilatation Catheter, Zenith Vascular has strategically positioned itself with breakthrough innovative products to capitalize on this market opportunity.

Since 2018, China’s neurointerventional market has experienced rapid development, attracting numerous enterprises to enter the field. Competition once became highly homogenized. As the scope of centralized procurement in the neurointerventional sector continues to expand, innovative technologies and high-value-added products have become key drivers of future growth. While providing a comprehensive range of neurointerventional surgical devices, it is essential to ensure that the product portfolio includes a certain proportion of innovative products with significant differentiation, thereby meeting diverse therapeutic needs.

Mr. Chen Chong, Sales and Marketing Director of Zenith Vascular, pointed out“Zenith Vascular’s product pipeline strategy is precisely grounded in this strategic thinking. Whether in establishing vascular access, or providing solutions for acute and chronic ischemic treatments, the company continuously launches products with unique innovative features while offering a comprehensive portfolio. This approach enables Zenith Vascular to maintain its competitive edge in the field of neurointervention and meet the diverse needs of clinical practice.”

As a pan-vascular interventional innovation enterprise, Zenith Vascular has accumulated extensive experience and established market advantages in the field of neurointervention, while also gradually emerging as a notable player in the peripheral intervention sector.

Mr. Chen Chong stated: “Zenith Vascular’s strategy in the peripheral intervention field is to enter the peripheral market with innovative single-product offerings. Its product portfolio covers key areas such as peripheral thrombectomy, treatment of venous stenosis, peripheral embolization therapy, and treatment of carotid artery stenosis. Among these, the core products already launched include Zenith Tianhang.”^®Pro Peripheral Thrombectomy Catheter, Zenith Tianji^®The peripheral aspiration catheter-based embolus removal device, the Zenith Hun Tian Ling® Peripheral Embolization Coils, and the Zenith Inno-Xmart Venous Stent all feature unique product characteristics and innovations, tangibly embodying the corporate mission of “Innovative Technology Simplifies Vascular Therapy.”

Zhongtian Tianhang^®The significance of the Pro Peripheral Thrombectomy Catheter lies in the fact that, with the gradual advancement of thrombus removal technologies, clinical practice of thrombectomy for acute deep vein thrombosis (DVT) is becoming increasingly common; however, traditional thrombectomy methods often yield suboptimal outcomes when addressing subacute or chronic DVT.

To overcome this limitation, Zenith Vascular has launched the SWAM innovative solution for peripheral thrombus removal, a combination featuring the Zhongtian Tianhang aspiration catheter^®Zenith Vascular Peripheral Embolus Removal Device^®It features the SWAM separator-assisted catheter aspiration technique, which can efficiently cut and remove thrombi obstructing blood vessels, significantly enhancing the efficiency of thrombus removal. Through this innovative technology, Zenith Vascular has taken a significant step forward in the field of peripheral interventional therapy, providing clinicians with a more effective therapeutic tool.

In its expansion into the field of peripheral vascular embolization therapy, Zenith Vascular launched the industry’s first fully controllable ciliated peripheral coil—Huntianling.^®Peripheral Embolization Coils, a product that stands out in clinical practice for its controllability and high efficiency. When selecting embolic materials, physicians place particular emphasis on release control, embolization density, and hemostatic efficacy, while Zenith Vascular’s Huntianling^®With its “twisted” filament design and fully controllable detachment mechanism, the coil effectively facilitates precise and dense packing, providing a strong guarantee for the safety and efficiency of the procedure.

Furthermore, in the field of interventional therapy for peripheral venous stenosis, Zenith Vascular provides a comprehensive solution for venous stenosis by exclusively distributing Inflow Medical’s venous stent (the only braided venous stent in China) and combining it with its self-developed thrombectomy products.

Meanwhile, Zenith Vascular has also deployed core differentiated innovative products in the fields of interventional therapy for acute pulmonary embolism and lower extremity arterial interventions to provide superior solutions.

Zenith Vascular has also made strategic inroads into the blue-ocean market of carotid artery stenosis within the field of vascular intervention. Studies indicate that 80%–87% of strokes are ischemic, and approximately 25%–30% of these ischemic strokes are associated with carotid artery stenosis. While larger cell sizes in carotid stents offer superior flexibility, they provide inadequate plaque coverage. Balancing flexibility with plaque coverage area remains a significant challenge. Imported carotid stent products available in the Chinese market have not been updated for an extended period, making it difficult to adequately meet clinical needs.

Zenith Vascular independently developed the Tianmi® Carotid Artery Stent in response to urgent clinical needs, utilizingThe world’s first single-layer microporous hybrid weaving technology, with a mesh area merely 1/30th that of traditional laser-cut stents. It effectively avoids the risk of layering associated with double-layer stents while increasing plaque coverage; compared to traditional braided stents, it offers superior radial support; and compared to laser-engraved stents, it exhibits lower chronic outward force. By fully leveraging the superelastic strain hysteresis energy storage characteristics of nitinol, it ensures effective dilation of stenosis while avoiding excessive vascular irritation. The entire product line utilizes a 5F delivery system, compatible with 6F and larger guiding catheters, offering exceptional compatibility and deliverability for both transradial and transfemoral approaches. Upon market launch, this product is expected to be approved as an exclusive domestic innovative product.

Centered on the treatment of carotid artery stenosis, in addition to carotid stents, Zenith Vascular also offers distal protection devices, carotid balloons, and long sheaths. The company has innovatively upgraded the two major approaches to carotid stent angioplasty—transradial and transfemoral—providing a one-stop innovative solution for carotid artery stenting (CAS) and bringing superior options to the treatment of carotid artery stenosis in China. It is reported that all products within this solution are expected to receive regulatory approval around the end of 2024, paving the way for rapid market adoption and serving as another accelerator for Zenith Vascular’s commercialization efforts.

Vascular diseases impose a significant burden on patients due to their high incidence and mortality rates, a challenge that is expected to intensify with the accelerating aging of the population. To address this issue, there is an urgent need in the field of interventional therapy for vascular diseases for more accessible, highly safe, easy-to-operate, and efficient treatment solutions. Zenith Vascular was established precisely to meet this demand.

Ms. Xia Jie, Chairman and CEO of Zenith Vascular“He pointed out that ‘China ranks first globally in the prevalence of vascular diseases, with new annual cases of cerebral infarction accounting for approximately 40% of the worldwide total. With the implementation of institutionalized and normalized volume-based procurement policies in China’s medical device industry, we are welcoming a valuable opportunity for industry development. I firmly believe that this is a golden period for the growth of Chinese vascular intervention enterprises, as well as an opportunity for me to realize my personal aspirations. We will seize this historic opportunity, continuously strengthen our core competitiveness, increase R&D investment, and promote technological innovation to achieve leapfrog development for the company.’”

Amid the challenging landscape of China’s domestic healthcare financing market, Zenith Vascular’s successful completion of a new round of funding serves as a strong endorsement by the capital markets of its competitiveness in the field of vascular intervention. The key to Zenith Vascular’s steady progress amidst industry volatility lies in its unwavering commitment to the philosophy of “making vascular treatment simpler through innovative technology.” By dedicating itself to solving clinical challenges through innovative products and delivering exceptional quality, the company has earned widespread recognition from the clinical community.

References:

China’s Medical Device Market Dynamics in H1 2024 and Full-Year Trend Insights – IQVIA

Hot Topics in the Treatment of Carotid Artery Stenosis——Chinese Journal of General Surgery