Shenping Medical Files for IPO: Pioneer in Neurointerventional Device Export with First-Ever CE Certification for Liquid Embolic System

From coronary stents to transcatheter valve interventions, and from cardiac electrophysiology to neurointerventional procedures... whenever a new trend emerges, a wave of Chinese companies simultaneously enters the field.

While this may accelerate the substitution of domestic products for imports in certain niche sectors through cutthroat competition, it also requires companies in the industry to win market share through differentiated competition; otherwise, they will be eliminated by the market.

Taking the neurointerventional field as an example, there are now more than 30 companies in China that have established a presence. Meanwhile,As more products of the same type gain approval, market competition has intensified.。

In addition to the increasingly fierce market competition,The neurointerventional market has also been impacted by “centralized procurement.”. To date, provinces and provincial-level alliances—including Hebei, Jiangsu, Fujian, Zhejiang, Jilin, and the 21-Province Alliance—have implemented centralized procurement for neurointerventional products such as coils and microcatheters.

The previously conducted centralized procurement of neurointerventional products,Although the price reduction is relatively moderate, it will still compress the profit margins of neurointerventional device manufacturers.Faced with intense competition and a complex domestic market landscape, innovative companies are choosing to forge new paths by leveraging differentiated advantages to enter international markets, thereby securing greater revenue and profits in the global arena.

For example, Zhuhai Neurosafe Medical Co., Ltd. (hereinafter referred to as “Neurosafe Medical”) has rapidly entered the markets of more than ten overseas countries, including Russia, Italy, Spain, and Argentina, through its innovative products such as liquid embolization systems, thrombectomy devices, and aspiration catheters, earning recognition from overseas clinical experts and patients.

Zhuhai Neurosafe Medical Co., Ltd., established in 2016, is a high-tech enterprise focused on comprehensive medical solutions for stroke. Its product portfolio includes liquid embolic systems, thrombectomy devices, catheters, andCoil Systemetc., covering three major categories of stroke: ischemic, hemorrhagic, and access-related.

Around 2020, the neurointerventional field became a “hot favorite,” attracting significant attention and favor from the capital market. Consequently, more than 30 domestic companies entered the neurointerventional sector, rapidly making this niche market “crowded.”

Since 2021,Accelerated Approval of Neurointerventional Products Intensifies Market CompetitionAccording to incomplete statistics from VCBeat, more than 25 neurointerventional products were approved in China in 2021, while over 120 products received approval in 2022.

Meanwhile, China's neurointerventional market remains predominantly dominated by multinational medical device companies such as Medtronic, Stryker, and Johnson & Johnson, with domestic manufacturers holding only a small market share. Consequently,Most domestic neurointerventional companies that have launched homogeneous products have chosen to compete fiercely with other Chinese manufacturers.，Engaging in fierce competition through low pricing and other means, yet failing to shake the dominance of multinational medical device companies.。

On the other hand,Domestic neurointerventional companies have also been subjected to centralized procurement, leading to continuous compression of profit margins and gradually increasing revenue pressure.。

Previously, the centralized procurement of coils in Hebei Province reduced the average winning bid price from RMB 12,000 to approximately RMB 6,400, representing an average reduction of 46.82% and a maximum reduction of 66%. The significant decline in end-user prices has placed substantial pressure on the revenue and profits of neurointerventional companies.。

As centralized procurement disrupts the blue-ocean market, the premium pricing potential for innovative products will be significantly reduced. Faced with a complex domestic landscape, many leading Chinese companies are turning their attention to overseas markets. Compared to the fiercely competitive domestic market, which is subject to centralized procurement, the overseas market offers substantial growth opportunities and profit margins, resembling a large cake that attracts numerous Chinese manufacturers to compete for a share.

Zhuhai Neurosafe Medical Co., Ltd. believes: “Internationalization is a common growth path for overseas medical device giants. An international layout can expand growth potential and mitigate risks associated with reliance on a single market, making it an inevitable route for corporate development.”

Compared with the domestic market, the overseas market is larger in scale. In 2019, the global medical device market reached RMB 3.2 trillion, five times the size of the Chinese market.

Unlike the low-price competition and volume-based procurement-driven price reductions in the domestic market, overseas markets feature higher unit prices for medical products, with commercial insurance serving as the primary payer, thereby facilitating product promotion. Taking a certain high-value consumable as an example, since its market launch in 2011 at a price of $32,500, the price remained approximately $32,500 even when its sales revenue reached $3.5 billion in 2022. Moreover, beyond price stability, the product’s price has seen slight increases alongside iterative upgrades and improved clinical outcomes.

Overall, overseas markets hold immense appeal, making the global expansion of medical device companies a path worth exploring.

For Chinese medical device companies, while expanding overseas is promising, they face challenges in market access and sales. In markets such as Europe and the United States, medical devices must undergo more stringent regulatory approvals before they can be marketed and sold. Furthermore, differences between overseas regulations and standards and those in China require companies to develop targeted solutions.

Following product approval, establishing an overseas sales system also requires a considerable amount of time, and medical device companies must also consider how to gain the recognition of overseas experts and customers.

Zhuhai Neurosafe Medical Co., Ltd., which has already achieved certain success in its overseas expansion, stated: “Overseas expert resources serve as a lever to pry open international markets and play a crucial role in the global layout of our products.”Ultimately, gaining recognition from overseas experts hinges on robust R&D capabilities and high-quality innovative products.”

For example, Zhuhai Neurosafe Medical Co., Ltd. rapidly entered the global market through its innovative liquid embolic system (hereinafter referred to as “LAVA”), which features independent intellectual property rights, and quickly captured market share by leveraging LAVA’s clinical and cost-effectiveness advantages.

It is reported that liquid embolic agents are currently the first-line materials for embolizing cerebral vascular malformations. Their mechanism of action involves catheter-based delivery into the target lesion to induce occlusion and interrupt blood supply, thereby achieving therapeutic goals for conditions such as arteriovenous malformations and arteriovenous fistulas.

Compared with conventional therapies, liquid embolic agents can fill the target vessels, thereby reducing the likelihood of recanalization and achieving permanent occlusion. Furthermore, by utilizing liquid embolic materials, physicians can treat arteriovenous malformations (AVMs) and arteriovenous fistulas (AVFs) via interventional embolization alone or in combination with surgical intervention, significantly reducing both procedural complexity and operative time.

To date, only a few companies, including Medtronic and Zhuhai Neurosafe Medical Co., Ltd., have had their liquid embolic systems approved for market launch globally.Among them, Zhuhai Neurosafe Medical’s LAVA received EU CE certification in May 2021, becoming the first Chinese neurointerventional device of its kind to obtain such certification for overseas market entry.

Furthermore, LAVA demonstrates significant advantages in terms of safety, radiopacity, and diffusivity.Specifically, LAVA utilizes non-adhesive materials, resulting in low injection resistance and easier, more convenient, and safer catheter removal. Its material employs a proprietary low-viscosity formulation, and it offers the most comprehensive range of models. LAVA demonstrates superior diffusivity and permeability, enabling deep penetration into lesions and reaching the distal ends of microvessels. Furthermore, LAVA contains finer tantalum powder, which settles more slowly and provides clearer radiographic visibility.

International clinical experts stated: “LAVA demonstrates excellent radiopacity and diffusivity. In particular, LAVA-12 can diffuse into deeper regions to achieve embolization when microcatheters cannot penetrate deeply into the lesion. Regarding handling experience, the LAVA liquid embolic system uses finer tantalum powder, resulting in less resistance during injection and a more comfortable user experience.”

In addition to LAVA,Zhuhai Neurosafe Medical Co., Ltd.’s portfolio of thrombectomy devices, aspiration catheters, and other products all possess differentiated advantages.For example, its thrombectomy device features a unique dual-stent design with movable and variable-mesh characteristics, achieving a higher success rate in thrombus capture. The basket design, incorporating the concept of a distal protection umbrella, provides a containment function to prevent small emboli from escaping and causing re-embolization. Its aspiration catheter boasts an ultra-large aspiration lumen and a multi-segment distal hardness gradient design, delivering both flexibility and support. The catheter body is coated with a leading-edge super-slippery hydrophilic coating, enabling access to more proximal positions.

Leveraging its superior product performance and significant clinical advantages, Zhuhai Neurosafe Medical Co., Ltd. has sold its products to more than ten countries, including Argentina, the United Arab Emirates, Russia, Spain, Greece, Hungary, and Italy. Zhuhai Neurosafe Medical projects: “Over the next three years, the company’s products will enter a period of sales growth. Notably, the LAVA liquid embolic system is expected to capture a 7% market share in select countries this year, rising to 12%–15% within three years.”

Currently, Zhuhai Neurosafe Medical Co., Ltd.’s liquid embolization system, thrombectomy devices, and aspiration catheters have all obtained EU CE certification. Meanwhile, the company has also developed a portfolio of products including mechanically detachable coils, intermediate catheters, distal protection filters, and microcatheters. In the future, it aims to provide comprehensive solutions covering three key segments—hemorrhage, ischemia, and vascular access—to the global market.

It is worth noting that many products in Neurosafe Medical’s portfolio are simultaneously undergoing registration applications in China, with four Class III neurointerventional products expected to obtain NMPA registration certificates in 2024. In the future, Zhuhai Neurosafe Medical Co., Ltd. will provide high-quality comprehensive neurointerventional solutions to patients in China.

As previously mentioned, “gaining recognition from overseas experts essentially relies on solid R&D capabilities and high-quality innovative products.” The reason Zhuhai Neurosafe Medical Co., Ltd. can continuously launch innovative products with clinical advantages is due to its solid and powerful R&D strength.

From a team perspective, Mr. Qiu Haiping, the founder of Neurosafe Medical, boasts over 20 years of experience in the field of neurointervention. He has conducted in-depth research on products from major global neurointervention brands, possesses extensive expertise in the clinical application of neurointerventional devices, and commands substantial networking and channel resources.

Mr. Liu Jian, a medical consultant at Zhuhai Neurosafe Medical Co., Ltd., serves as the Chairman of Qilun Venture Capital. He possesses exceptional capabilities in identifying and evaluating innovative technologies, as well as strong organizational cohesion. Having participated in early-stage investments in numerous high-quality projects, he demonstrates a profound ability to grasp technological innovations.

The core team members of Neurosafe Medical hail from several well-known domestic medical device companies, and each member possesses over 10 years of experience in R&D or quality management of medical devices. For instance, the Vice President of R&D has 18 years of experience in the development and management of implantable and interventional devices, successfully developing and launching six Class III high-value consumable products. The Director of Quality and Regulatory Affairs has 19 years of experience in quality management and domestic and international regulatory affairs for implantable and interventional products, having led NMPA approvals for more than 20 products and CE certifications for over 10 products.

In addition, Zhuhai Neurosafe Medical Co., Ltd. has a clinical advisory team represented by Academician Zhao Jizong, Chief Physician Li Youxiang, and Professor Francis Turjman, and promotes the innovative research and development of Zhuhai Neurosafe Medical through deep integration of medicine and engineering.

Leveraging a team with extensive experience, a practical focus, and strong innovation capabilities, Zhuhai Neurosafe Medical Co., Ltd. has launched multiple innovative products with superior clinical advantages, successfully achieving global market expansion for its medical devices.

In the future, Zhuhai Neurosafe Medical Co., Ltd. plans to use its liquid embolization system as a flagship product to increase market share and leverage established distribution channels to promote and sell other complementary products. In overseas markets, the company intends to focus on expanding its presence in Europe, the Middle East, Asia, South America, and Russia.

In the highly competitive domestic market, further intensified by centralized procurement, Zhuhai Neurosafe Medical Co., Ltd. believes that innovation is the key to breaking through. Therefore, the company plans to provide comprehensive product solutions, continuously innovate while enriching its product portfolio, and adopt differentiated promotional strategies, focusing on specialized and unique therapeutic approaches.

Overall, Zhuhai Neurosafe Medical Co., Ltd. will enhance its market competitiveness through a platform-based product portfolio and create differentiated advantages by innovating medical devices to address unmet clinical needs.