SinoNeuro Achieves Over RMB 100 Million Revenue with Three Innovative Products Targeting Intracranial Stenosis in a Crowded Neurointervention Market

“In highly certain tracks, a surge of participants entering simultaneously often leads to rapid ‘involution.’ Innovative companies should instead plan for the future by stepping out of these high-certainty arenas and exploring emerging, immature fields, where they may reap multiplied returns. By the time others recognize the value of these tracks and begin to enter, you will have already established a moat built on time and technological advantage.”

Stenosis-related ischemia in neurointervention, and even the entire neurointervention market, are what Kang Xiaoran, General Manager of Sinomed Neurovita, describes as “an immature field.”

This is indeed the case. Currently, China’s neurointerventional sector remains in its early stages of development, with a low rate of domestic product adoption. Although over 100 neurointerventional devices received regulatory approval in 2022, and Chinese manufacturers have achieved breakthroughs in certain categories such as coils, aspiration catheters, and thrombectomy stents, the market across all product categories continues to be dominated by foreign companies. Meanwhile, the acute ischemic stroke and access device segments within neurointervention are characterized by intense homogeneous competition, whereas there is a lack of safer and more effective therapeutic options for stenosis-related ischemia.

Moving beyond the limitations of domestic substitution, Sinomed Neurovita has carved out a unique path by pioneering the field of intracranial stenosis and ischemia. Its innovative products, including intracranial low-pressure balloons and intracranial drug-eluting stents, have received successive approvals, solidifying its leading position. In 2022, the company’s revenue exceeded RMB 100 million. Meanwhile,The company is committed to innovation-driven comprehensive portfolio layout in neurointervention, implementing the development strategy of "deepening ischemic interventions, innovating hemorrhagic solutions, and breaking through access technologies." Among the seven neurointerventional devices already launched by Sinomed Neurovita, three have achieved global firsts.。

Unlike the coronary intervention market, which can be driven by single products, neurointerventional procedures are complex and the surgical volume remains relatively limited, resulting in a lower ceiling for individual products. At the physician level, a more comprehensive and diverse product portfolio is required to address different pathological conditions such as ischemic and hemorrhagic diseases; at the corporate level, a complete product line facilitates rapid market entry.

Sinomed Neurovita has established a comprehensive product portfolio across four key segments: acute ischemia, stenotic ischemia, hemorrhage, and vascular access. The company aims toProvides 80% of the devices used in neurointerventional procedures. Meanwhile, the company adheres to innovation-driven development, with 80% of its medical devices20% are innovative products with strong differentiated competitiveness.。

Kang Xiaoran firmly believes that only standout flagship products can support a company’s layout across its entire industrial chain; otherwise, doing everything but doing it all similarly will render the company indistinguishable from the crowd.

“Medical devices are not at the forefront of cutting-edge science; they are more about applied science. Companies need to identify clinical needs and integrate their innovative technologies and resources to achieve differentiated innovation.”Sinomed Neurovita has established five core technology platforms: catheter extrusion and precision machining, alloy wire micro-braiding, metal tubing cutting and post-processing, electron beam grafting surface treatment, and drug carrier technology. The company holds over 80 patents, either granted or pending.

Leveraging its foundational technological expertise and drawing on its parent company, Sinomed, years of experience in cardiovascular intervention, Sinomed Neurovita can rapidly respond to clinical needs. Through close collaborations with renowned hospitals in China, such as Beijing Tiantan Hospital, Changhai Hospital, and Xuanwu Hospital, the company identified intracranial stenosis-related ischemia as its first key opportunity.

From a clinical demand perspective, China has approximately 13 million stroke patients, among whom those with ischemic stroke account for about 80%. Within this subgroup, the proportion of cases involving stenotic ischemia is as high as 46.6%.

Kang Xiaoran recalled, “Many years ago, Professor Miao Zhongrong of Beijing Tiantan Hospital expressed to the Sinomed R&D team his envy of the coronary intervention field, which boasts numerous companies and a rich variety of products. In contrast, the neurointerventional landscape for ischemic conditions has been limited, relying solely on bare-metal stents and balloons to address intracranial arterial stenosis. The high rates of in-stent restenosis and recurrent ischemic stroke have often placed clinicians in very challenging situations.”

In coronary intervention, drug-eluting stents rapidly replaced bare-metal stents due to their superior efficacy. Given the shared pathophysiology of ischemic vascular diseases, neurointervention also presents an opportunity for the development of drug-coated stents.

However, the intracranial vascular environment in the human body is complex, with blood vessels being narrow in diameter and fragile. There are also physiological structural differences compared to coronary arteries. Drugs loaded on coated stents may come into contact with cerebrospinal fluid, brain tissue, and other structures. These factors impose higher requirements on stent design, coating technology, drug dosage concentration, and more. Firstly, the drug must reach an effective therapeutic concentration within a controllable timeframe to ensure treatment efficacy; secondly, it should not cause neurotoxicity to brain tissue or other areas due to the drug itself.

Sinomed Neurovita has independently developed the NOVA drug-eluting stent, the world’s first stent specifically designed for the treatment of intracranial stenosis. The NOVA stent platform features a compliant, thin-walled stainless steel body with an open-cell design. Its surface incorporates a composite coating consisting of an electron-grafted underlayer and a biodegradable rapamycin drug coating. Delivered to the lesion site via a rapid-exchange balloon catheter system, the NOVA stent offers advantages including anti-proliferative effects, precise positioning, excellent wall apposition, and a low rate of restenosis.

Pre-market clinical studies of the NOVA intracranial drug-eluting stent demonstrated that, compared with bare-metal stents, implantation of the NOVA stent reduced the 1-year restenosis rate by 68.5% and significantly decreased the recurrence rate of ischemic stroke by 88.4%.The corresponding results were published in JAMA Neurology, a leading international journal in neurology, marking the most academically influential article to date featuring domestically produced neurointerventional devices as the primary subject of research.

In 2021, the NOVA intracranial drug-eluting stent received approval for market launch through the National Medical Products Administration’s Innovative Medical Device Channel. In 2022, it was selected as one of the Chinese Academy of Medical Sciences’ Key Scientific Advances of 2021.

In the field of intracranial stenosis and ischemia, Sinomed Neurovita has never halted its pace of breakthroughs from 0 to 1, continuously deepening its product portfolio. The company’s independently developed world’s first self-expanding drug-eluting stent serves as a complement to the NOVA balloon-expandable drug-eluting stent.

Balloon-expandable drug-eluting stents are more suitable for relatively straight vessels with heavy plaque burden, whereas self-expanding drug-eluting stents can address vessels with abundant perforating branches and tortuous anatomy; these devices are delivered via microcatheters, significantly reducing the technical difficulty of the procedure.The self-expanding drug-eluting stent developed by Sinomed Neurovita simultaneously achieves the combined effects of automatic wall-apposing expansion after delivery via a microcatheter and prevention of restenosis through its drug coating, realizing a “1+1>2” technological breakthrough.

First, the self-expanding drug-eluting stent is available in a wide range of specifications and models, providing more suitable device options for different vessel sizes. Second, the radial strength and vessel compliance of the stent are specially optimized for intracranial stenotic vessels, resulting in favorable angioplasty outcomes. All sizes of Sinomed Neurovita’s self-expanding drug-eluting stents are compatible with 0.021-inch microcatheters, facilitating convenient stent delivery and deployment. This significantly reduces the learning curve for physicians and effectively enhances procedural safety.

According to Kang Xiaoran, “Self-expanding drug-eluting stents undergo significant deformation. Their maximum diameter after free release is 4.5 mm, whereas they must be compressed to 0.5 mm for delivery through a compatible microcatheter during the initial stage, resulting in a deformation ratio as high as 9-fold. If the drug-coating technology is inadequate, issues such as coating fracture, delamination, and particle release are likely to occur due to the substantial mechanical deformation and long-distance transit within the microcatheter. These problems not only compromise therapeutic efficacy but also pose serious safety risks, as fragments of the drug coating may occlude distal vessels or branches.”

Sinomed Neurovita’s self-expanding drug-eluting stent utilizes electron beam grafting base layer technology, spraying the biodegradable drug rapamycin onto the surface of the underlying stent. This process creates a unique “interlocking” physical structure among the coating polymers, significantly enhancing the mechanical integrity of the coating while achieving sustained drug release to prevent vascular restenosis.

In February 2023, the self-expanding drug-eluting stent completed enrollment in its registrational clinical trial. The enrollment process, from the first patient enrolled to completion, took only seven months. The product is expected to receive regulatory approval and be launched on the market next year.

In the leading field of intracranial ischemia, in addition to stenosis-related ischemia, Sinomed Neurovita’s products for acute ischemia—including intracranial thrombus aspiration systems and thrombectomy stents—are progressively gaining market approval.

In line with the development trends of the neurointerventional submarket, Sinomed Neurovita is continuously refining its product strategy. In the hemorrhagic segment, where coils and flow-diverting stents are dominated by two major players, Sinomed Neurovita has independently developed multiple innovative products to achieve category breakthroughs. In the highly competitive access market, the company aims to capture market share through differentiated products.

The advent of flow-diverting stents has shifted aneurysm treatment from “occlusion” to “vascular reconstruction.” Based on a precise assessment of clinical needs,The coated flow diverter stent developed by Sinomed Neurovita features the smallest crossing outer diameter globally; flow diverter stents with diameters of 4.0 mm and below are compatible with 0.017-inch microcatheters.First, it facilitates delivery by physicians without relying on the experience and expertise of seasoned specialists; second, it enables access to distal cerebral vessels, such as the middle cerebral artery and anterior cerebral artery, thereby expanding the application scenarios of flow diverter stents with enhanced safety.

Meanwhile, this coated dense-mesh stent utilizes a novel alloy material that achieves full radiopacity under X-ray imaging, eliminating the need for co-braiding with platinum wires. This approach reduces manufacturing complexity while providing superior mechanical support.

Furthermore, Sinomed Neurovita applies special anticoagulant polymers to flow diverter stents via its electronic grafting surface treatment technology platform. The anticoagulant coating is only approximately 35 nm thick, which can further enhance the safety of flow diverter stents in clinical applications. Following stent implantation, patients may benefit from a shortened duration of postoperative dual antiplatelet therapy (DAPT) or adopt a postoperative antithrombotic strategy involving single antiplatelet therapy (SAPT) alone.

In previous animal studies conducted by Sinomed Neurovita, hundreds of animals did not receive dual antiplatelet therapy postoperatively and required only a single anticoagulant agent. None of the experimental animals experienced in-stent thrombosis. Currently, Sinomed Neurovita’s innovative coated flow diverter stent has entered the clinical enrollment phase.

Furthermore, existing flow-diverting stents are primarily indicated for unruptured aneurysms, and there is currently no clear evidence-based medical support for their efficacy in treating ruptured aneurysms. Once an aneurysm ruptures and causes hemorrhage, the mortality rate can reach as high as 60.2%–73.3%. In addition to breakthroughs in safety and efficacy, Sinomed Neurovita’s coated flow-diverting stent holds promise for expanding its indications to include the treatment of ruptured aneurysms, and the company plans to conduct further expanded clinical trials in this area in the future.

In the vascular access segment, domestic intracranial access catheters were previously administered via the transfemoral artery (TFA) approach. In contrast, the transradial artery (TRA) approach offers superior safety, significantly enhances patient comfort, and shortens hospital stays.

The application of transradial access (TRA) in coronary intervention has become increasingly widespread, with the TRA utilization rate for coronary interventions in China reaching 96.37% in 2020. However, its development in the field of neurointervention lags significantly behind. Sinomed Neurovita’s APEX TRA Guide Catheter is the first intracranial access catheter specifically designed for transradial approach to receive approval from the National Medical Products Administration (NMPA) in China. It was approved for market launch on March 31. The introduction of this new product will further promote the shift toward safer and more comfortable TRA routes in neurointerventional access.

Currently,Sinomed Neurovita Technology Inc. has established a nationwide sales network, with its marketed products being used in over 1,500 clinical centers across China.。

Within Sinomed Neurovita’s “80/20” product strategy, the 20% of innovative products drive incremental profit growth and enhance brand equity, while the 80% comprising the full product portfolio must uphold stringent quality control and cost efficiency to support rapid clinical adoption and translation.

Over the past two years,Sinomed Neurovita Technology Inc. Invested RMB 200 Million to Build a R&D, Production, and Operations Base Covering Over 10,000 Square Meters in Suzhou. The company is gradually extending upstream along the industrial chain, focusing on the core manufacturing processes of its products.Taking access catheters as an example, core processes such as tube extrusion, coil braiding, and heat-covered molding are all independently completed at the Suzhou facility.. Mastering upstream process technologies and core components not only ensures product quality but also enables rapid achievement of economies of scale and meets the clinical demand for rapid iteration of medical device products.

In addition to meeting domestic clinical needs, Sinomed Neurovita attaches great importance to global development. This year marks the company’s “momentum-building” phase, during which it will sequentially initiate overseas regulatory submissions for its series of products.

The parent company, Sinomed, has laid a solid foundation for the global expansion of Sinomed Neurovita through its overseas clinical regulatory resources, marketing teams, and commercialization experience. In the field of coronary drug-eluting stents, Sinomed is the first Chinese company to obtain U.S. FDA Investigational Device Exemption (IDE) approval to conduct large-scale, multicenter, randomized controlled clinical trials globally. Sinomed has established a presence in the United States, Japan, Europe, Southeast Asia, and other countries or regions, achieving a significant business scale.

A comprehensive review of Sinomed Neurovita’s industrial layout and development trajectory reveals the pervasive influence of its parent company, Sinomed. In 2017, Sinomed established a Neurointerventional Business Division. In 2020, as the neurointerventional business continued to expand in scale, Sinomed formally established Sinomed Neurovita in Suzhou, focusing on strategic deployment and growth within the specialized neurointerventional sector.

Kang Xiaoran used a metaphor: “Sinomed is the trunk of a tree, while the company’s emerging businesses, such as neurointervention and valve intervention, are the branches growing from it. The trunk continuously provides nutrients and support to these branches. Without Sinomed’s more than a decade of accumulation in the field of cardiovascular intervention—including core platform technologies segmented into drug coatings, stents, balloons, and surface modification, as well as experience in conducting global clinical trials and building organizational structures—it would have been difficult for us to achieve comprehensive success in the neurointervention field within a short period.”

The core team of Sinomed Neurovita all come from Sinomed, with more than ten years of teamwork experience.Mr. Kang Xiaoran, General Manager, joined Sinomed in 2007 and has gained extensive experience across various functions within the company, including product R&D, quality management, and regulatory and clinical affairs. He has participated in the R&D of multiple innovative products and key projects related to global regulatory and clinical operations management. The Senior R&D Director of Sinomed Neurovita Technology Inc. was involved in the end-to-end development process of multiple innovative products at Sinomed. The Vice President of Production and Operations has over ten years of quality management experience at Sinomed.

Meanwhile, Sinomed’s global technical experts have also formed the expert advisory team for Sinomed Neurovita, providing forward-looking technical guidance for the development of innovative neurointerventional products.

After the explosive growth in 2020, the neurointerventional industry has entered a “slump.” With intensifying competition within the sector and the imminent rollout of centralized procurement, is the survival space for neurointerventional companies shrinking?

According to statistical analysis by Guosen Securities, the market size of neurointervention in China will exceed 30 billion yuan in 2030.

Kang Xiaoran believes that the so-called fierce competition or “involution” stems from either insufficient product barriers to entry or an oversupply. The predicament in neurointervention lies in the latter, where the growth in surgical volume fails to keep pace with the rapid market launch of numerous similar products.The development of neurointerventional devices has been accompanied by continuous optimization and iteration of treatment concepts and surgical techniques. Companies must have the courage to make forward-looking strategic layouts and select high-potential niches that align with their own strengths.

In terms of market maturity, although neurointervention started late, it has developed rapidly. As stroke treatment continues to penetrate grassroots healthcare institutions, China has established more than a thousand stroke centers at various levels, and the number of physicians capable of performing neurointerventional procedures is increasing rapidly. In hospitals that already have a certain volume of coronary interventions, neurointervention will also gradually develop. In the future, the volume of neurointerventional procedures will be sufficient to accommodate the concurrent growth of multiple companies across different niche segments.

As innovative products are rolled out in succession, Sinomed Neurovita is entering its “harvest period,” with a sufficient lead over latecomers in its areas of strength to continuously reinforce its moat built on technology and first-mover advantage. Looking ahead, Sinomed Neurovita will continue to advance along its core positioning as an innovation-driven, full-line supplier of neurointerventional devices, developing more innovative medical devices to meet clinical and patient needs.

Reference Article: "Chinese Expert Consensus on Transradial Approach for Neurointerventional Diagnosis and Treatment"