Zenith Medical Serves 13 Million Stroke Patients with High-Quality Devices, Driving Market Penetration in Neurointervention

Zenith Vascular was founded with the mission of leveraging innovative technologies to simplify the treatment of vascular diseases and benefit more patients.

— Xia Jie, Chairman of Zenith Vascular

Cardiovascular and cerebrovascular diseases are the “number one enemy” of Chinese residents.According to the "Report on Cardiovascular Health and Diseases in China 2019," mortality from cardiovascular and cerebrovascular diseases remains the leading cause of death, accounting for 45.91% and 43.56% of all deaths in rural and urban areas, respectively, which is higher than that of tumors and other diseases. The large patient population has generated an urgent demand for clinical treatment; however, as an innovative therapeutic approach, neurointerventional therapy still has a low penetration rate.

According to public data, there are 800,000 new cases of cerebrovascular disease annually in the United States, with over 40,000 mechanical thrombectomy procedures performed each year; however, in China, despite more than 2 million new cases of cerebrovascular disease annually, only 40,000 mechanical thrombectomy procedures are performed.A comparison of new stroke cases and mechanical thrombectomy volumes between China and the United States indicates that China needs to substantially increase the number of mechanical thrombectomies performed to ensure patient survival and recovery rates.

To address the urgent needs of patients in China, Xia Jie returned to the country in May 2018 to establish Suzhou Zenith Vascular Co., Ltd. (hereinafter referred to as “Zenith Vascular”). Zenith Vascular focuses on the research and development of innovative neurointerventional medical devices, committed to addressing clinical challenges in the treatment of cerebrovascular diseases.

Following the successful domestic substitution of medical devices in the fields of cardiac stents and coronary interventions, numerous Chinese healthcare entrepreneurs have reached a consensus on advancing the localization of neurointerventional devices. Xia Jie stated, “In recent years, the market for high-end medical devices such as cardiac stents and those used in coronary interventions has gradually achieved domestic substitution. Judging by this trend, domestically produced neurointerventional devices are poised to replicate this trajectory. Zenith Vascular is committed to contributing actively to this process of domestic substitution.”

To date, Zenith Vascular has established a comprehensive product portfolio for thrombectomy and aspiration, having developed products such as aspiration catheters, stent retrievers, distal access catheters, negative pressure suction pumps, connecting tubes, microguidewires, and microcatheters, demonstrating robust R&D innovation capabilities and strategic product layout. Additionally, Zenith Vascular has received strong support from renowned investment firms, including Juming Venture Capital, Yuanhe Yuandian, and Northern Light Venture Capital.

In the treatment of ischemic stroke, the most effective therapeutic approach currently is rapid vascular recanalization, including intravenous thrombolysis and mechanical thrombectomy. Studies have shown that intravenous thrombolysis has a low rate of vascular recanalization, requires a narrow therapeutic time window, and is subject to strict eligibility criteria for treatment.

In 2015, based on several large-scale clinical trial results, China and the United States updated their guidelines for the management of acute ischemic stroke, recommending the addition ofThrombectomy Stenttechnology as the preferred treatment for patients with acute ischemic stroke. In November 2019, the American Heart Association (AHA), based on the latest clinical data, issued a Class I recommendationThrombus Aspiration Catheter for Thrombectomy, believing it to have the same therapeutic efficacy as stent retriever thrombectomy.

To better serve physicians and patients, Zenith Vascular keeps pace with the latest international developments and has strategically positioned itself inThrombectomy StentandIntracranial Thrombus Aspiration CatheterComprehensive product portfolio across the field. Among these, the distal access catheter, negative pressure aspiration pump, and connecting tube have obtained NMPA registration certificates and commenced commercial sales this year. Clinical trials for the intracranial thrombus aspiration catheter and thrombectomy stent are also scheduled to be completed by the end of 2021.

Xia Jie stated, “Based on existing clinical feedback, Zenith Vascular’s products have demonstrated the capability to compete head-to-head with imported counterparts, exhibiting excellent safety and efficacy in clinical practice.”Taking the distal access catheter as an example, this product features excellent steerability and flexibility, enabling it to reach more distal intracranial vessels and establish vascular access. Furthermore, through structural and material innovations, the product delivers superior trackability and support. In clinical applications, Zenith Vascular’s distal access catheter is fully comparable to high-end imported counterparts, demonstrating the capability to compete with premium imported distal access catheters.

“Zenith Vascular’s thrombectomy aspiration catheters feature a braided-and-coil fused design, enabling a larger lumen and greater resistance to negative aspiration pressure, thereby delivering superior clinical aspiration performance. Material innovations allow the catheters to reach more distal vessels while minimizing vascular injury, effectively ensuring the safety of device use. The overall performance of these thrombectomy aspiration catheters is in no way inferior to that of comparable products from international brands.”

Having refined its product portfolio, Zenith Vascular has begun to formulate its market promotion strategy. Currently, the field of neurointerventional therapy faces a dual challenge: on one hand, neurointerventional devices have long been monopolized by foreign brands, resulting in prohibitively high prices and low penetration rates for thrombectomy procedures in China; on the other hand, a vast number of patients with acute ischemic stroke are unable to access or afford endovascular intervention, leading them to opt for conservative management or even forgo treatment altogether.

To change this situation, Zenith Vascular plans to promote its products to primary care hospitals, driving the penetration of the neurointerventional market into lower-tier segments and enabling more patients to benefit from neurointerventional therapies. Xia Jie stated, “Just as the state promotes centralized procurement, the penetration of the neurointerventional market into lower-tier segments will reduce medical expenses for the majority of patients. Zenith Vascular will also achieve profitability and market share, akin to successful bidders in centralized procurement, ultimately creating a win-win situation.”

“Zenith Vascular’s ultimate goal is to benefit more stroke patients; therefore, with quality comparable to imported products, we are determined to promote our products to the grassroots level.”

In accordance with national policies, the "Healthy China 2030" Planning Outline has elevated stroke prevention and control to a national strategy and promoted the establishment of stroke centers. Currently, the number of stroke centers is growing at an annual rate of 37%, and this rapid growth is expected to continue over the next decade. Driven by factors such as prevalence, market penetration, and policy support, mechanical thrombectomy and aspiration thrombectomy procedures in China are poised for explosive growth.Zenith Vascular’s products will also demonstrate strong market competitiveness through their high cost-performance ratio during this growth phase.

The promotion of high-quality products to the grassroots level is driven by Xia Jie’s desire, as a physician, to serve patients across China; the completion of the R&D and strategic layout for five products within just two years is attributable to Zenith Vascular’s outstanding team.

Chairman Xia Jie has over twenty years of experience as a clinician and in medical device R&D. In 2015, she founded AQURE Medical Inc., leading her team to complete the development and FDA registration of a dual-lumen catheter. As a global first-of-its-kind product, this dual-lumen guiding catheter provides dual channels for vascular interventional therapies, enabling the delivery of various interventional devices, contrast agents, or medications.

CTO Zhang Zhiyong is an expert in the R&D of interventional products, with extensive knowledge in their clinical applications, design, materials, and manufacturing processes. Previously, Mr. Zhang served in Medtronic’s R&D department. With over 30 years of engineering experience, he has led the design of multiple world-first interventional devices, including products in the fields of structural heart disease, peripheral interventions, and neurointerventions.

In both China and the United States, Zenith Vascular has also invited experts such as Dr. Adnan Qureshi to serve as advisors, providing recommendations and assistance for product development.

Dr. Adnan Qureshi is a Professor at the University of Missouri School of Medicine and President of the Society of Interventional Neurology. He began researching endovascular therapy for cerebrovascular diseases as early as 1992, establishing himself as a pioneer in this field in the United States. An early advocate for mechanical thrombectomy in the treatment of stroke, Dr. Qureshi has published numerous landmark academic papers and possesses extensive clinical and theoretical expertise.

In addition, Zenith Vascular has built and cultivated a first-class R&D team. This commitment stems from the company’s prioritization of innovation, with a dedicated focus on addressing unmet clinical needs.Xia Jie stated, “Zenith Vascular will pursue a ‘me-better’ or ‘first-in-class’ strategy. We believe that medical enterprises must avoid homogeneous competition, and proactive innovation is the only way forward. Zenith Vascular will continue to increase its R&D investment in the future.”

In the future, Zenith Vascular will perfect its medical device product line for ischemic cerebrovascular disease within five years. Additionally,Zenith Vascular is planning a new round of financing, with the funds primarily allocated to accelerating product development and advancing clinical trials.