Blue Sail Medical Expands Neurovascular Overseas Distribution Portfolio through Exclusive Partnership with Matrix Medical to Address ICAS Treatment Gap in China

NEWS

Bluesail Dynamics

2026.4

Recently,Bluesail MedicalBluesail Baisheng, its cardiovascular and cerebrovascular business unit, and outstanding domesticInnovative HealthcareMARIX Officially Signs Exclusive Agency Framework Agreement; Both Parties to Engage in In-Depth Cooperation on MARIX’s Self-Developed Intracranial Laser Balloon Dilatation Catheter

This original product received the U.S. FDA Breakthrough Device designation in November 2025 and was successfully included in the National Medical Products Administration (NMPA) of China’s special review green channel for innovative medical devices in January 2026, thereby securing dual authoritative recognition from leading regulatory agencies both domestically and internationally. Under the cooperation arrangement, premised on the provision of substantial support by subsidiaries under Bluesail Baisheng for the research and development, registration, and market access of this product within the three cooperative regions—Mainland China, EMEIA, and APAC—MARIX will accordingly grant Bluesail Baisheng exclusive distribution rights for its approved intracranial laser balloon dilation catheter products within these cooperative regions.

This collaboration fully demonstrates Bluesail Baisheng’s recognition of MARIX’s technological innovation capabilities and the global competitiveness of its products, while also highlighting MARIX Medical’s strong trust in Bluesail Baisheng’s global resource integration and commercialization capabilities. Both parties aim to leverage this opportunity to establish a long-term strategic partnership, jointly advancing the global R&D, regulatory registration, and commercialization of hard-tech innovative products. In the future, through complementary advantages and collaborative innovation, both parties will continuously enhance the clinical diagnosis and treatment standards for intracranial atherosclerotic stenosis (ICAS) in the neurointerventional field, providing more accessible innovative solutions for patients worldwide.

Dual Authority Recognition from China and the United States

Mining the Gold in the Neurointerventional Sector

This intracranial laser balloon dilation catheter product leverages leading energy control technology, refined minimally invasive design, and systematic device innovation advantages.It has successively received the U.S. FDA Breakthrough Device Designation and been accepted into the National Medical Products Administration (NMPA) Green Channel for Special Review of Innovative Medical Devices, thereby earning dual authoritative recognition from top regulatory agencies both domestically and internationally.This is not only a landmark achievement for Chinese enterprises in achieving breakthroughs in core technologies within the high-barrier field of neurointervention, but also a testament to the innovative strength and global competitiveness of domestically produced high-end neurointerventional devices.

Intracranial Atherosclerotic Stenosis (ICAS) is a highly prevalent cerebrovascular disease in China, with an urgent clinical need for effective treatment. Currently, mainstream conservative pharmacological therapy can only control the condition in a subset of patients, while a considerable proportion exhibit poor response to medication. Meanwhile, existing interventional treatments are constrained by technical limitations and have significant shortcomings in improving long-term patient outcomes, making it difficult for patients with severe ICAS to achieve optimal therapeutic results. At the same time,The tortuous and complex structure of intracranial vessels imposes extremely high requirements on device deliverability and operational precision, making it a highly challenging subspecialty with significant technical barriers within the global field of endovascular intervention.

Addressing this critical clinical challenge, MARIX has diligently developed an intracranial laser balloon dilation catheter that precisely targets the therapeutic difficulties associated with intracranial atherosclerotic lesions. By leveraging its proprietary precise energy control technology and selective vascular dilation mode, this innovation successfully overcomes the technical bottlenecks of traditional interventional therapies. It provides a more durable, effective, and safer innovative treatment option for patients with intracranial atherosclerotic stenosis (ICAS) who are refractory to medical therapy, thereby filling a technological gap in this field within China.

A New Starting Point for Platform-Based Collaboration

Building the Optimal Ecosystem in the Cardiovascular and Cerebrovascular Industry

Bluesail Medical has been deeply engaged in the field of cardiovascular and cerebrovascular intervention for many years. It has established an independent commercialization system globally, covering coronary intervention and structural heart disease. Through investment and incubation, it has expanded into neurointervention and peripheral intervention, forming an industrial pattern of multi-track coordinated development. In China, it possesses a comprehensive channel network penetrating medical institutions at all levels nationwide, along with a top-tier academic promotion and clinical service team.Through this collaboration with MARIX to act as the agent for its flagship innovative products, both parties will achieve efficient complementarity between R&D capabilities and channel implementation, thereby accelerating hospital access and clinical adoption, and maximizing the clinical and social value of the products.

This collaboration marks another strategic move in the deepening “platform-based” strategy of Bluesail Baisheng, the cardiovascular and cerebrovascular business unit of Bluesail Medical. The company’s enabling value extends beyond channel sharing in the domestic market, providing open strategic interfaces for global expansion. MARIX’s intracranial laser balloon dilation catheter is expected to leverage Bluesail Medical’s mature overseas operational system and extensive industry resources within its cardiovascular and cerebrovascular business unit, thereby reducing the costs and risks associated with international market entry and achieving a leap in commercial value on a global scale.

Comprehensive Win-Win Cooperation

Empowering Domestic Innovative Medical Devices to Go Global

The “Joint Fleet of Chinese Enterprises Going Global” established by Lanfan Baisheng is not limited to specific single product categories or particular countries and regions; instead, it adopts a global perspective to comprehensively layout across multiple sectors, empowering partners through localized teams.The Company implements the “Global Resources + Local Execution” strategy and has established a comprehensive, end-to-end system covering R&D, clinical trials, manufacturing, regulatory registration, and sales. It maintains localized marketing and sales teams of over 100 employees each in both the APAC and EMEIA regions.Leveraging this competitive barrier, Bluesail Baisheng has successfullyNorth Life, Baixinan, and Wolfman, among other domestic innovative medical device companies, providing end-to-end services spanning product registration, clinical support, and sales promotion, covering the hottest tracks in multiple vascular intervention fields ranging from intravascular imaging to renal artery ablation.

LifeTec

Since 2023, Beijing Lanfan Baisheng Medical Technology Co., Ltd. has served as the distributor for multiple core products of LifeTech Scientific, a company listed on the STAR Market, including its IVUS (Intravascular Ultrasound) Diagnostic System and FFR (Fractional Flow Reserve) Measurement System. Lanfan Baisheng is responsible for multi-country product distribution and marketing promotion in the APAC and EMEIA regions. LifeTech Scientific specializes in precision interventional cardiology, and its imaging diagnostic products have broken the long-standing import monopoly in this niche segment, establishing it as a leading enterprise in domestic substitution within China. Starting in 2024, Lanfan Baisheng became LifeTech Scientific’s second-largest distributor and its largest overseas distributor. According to data disclosed by LifeTech Scientific, the sales revenue generated by Lanfan Baisheng for LifeTech’s products in the first half of 2025 alone surpassed the total for the entire year of 2024, driving significant revenue growth for LifeTech Scientific.

Bai Xin An

Bluesail Baisheng has established a strategic partnership with Antong Medical, a subsidiary of Bai Xin An, serving as its largest overseas business partner in the APAC and EMEIA regions for the Iberis® RDN (Renal Denervation) system under the Borui Shi brand, fully supporting its global commercialization efforts. The Iberis® RDN is currently the only renal denervation product globally approved for both transradial and transfemoral dual access approaches. It obtained EU CE certification in 2016, and its technology is widely recognized by clinical experts worldwide. With the support of Bluesail Baisheng, the product has completed commercial deployment in multiple countries, including Germany, Spain, Italy, the United Kingdom, Switzerland, Portugal, and Singapore, and has been included in medical insurance coverage in countries such as Germany and France. According to data disclosed by Bai Xin An, in 2026, the two parties further completed registrations in Indonesia and Thailand, continuously expanding their collaborative footprint.

Wolffman

Lanfan Baisheng has further deepened its cooperation with Wolfman, a leading domestic enterprise in OCT (Optical Coherence Tomography), becoming the exclusive distributor for Wolfman’s entire OCT product line in key APAC countries. Furthermore, their domestic collaboration has been simultaneously upgraded, expanding the scope of partnership from coronary interventions to neurointerventional and peripheral interventional fields. As a significant shareholder in Wolfman, Bluesail Medical is leveraging a dual-drive strategy of “industrial investment + business cooperation” and, through localized teams, is accelerating the global expansion of high-end Chinese-made imaging technologies.

In addition, Bluesail Baisheng serves as the global distributor for approximately 10 well-known domestic and international brands of cardiovascular and cerebrovascular products, including overseas giants such as Nipro, Kaneka, and Penumbra. In its collaborations with these overseas industry leaders,Both parties achieve full complementarity of channel advantages, distributing each other’s products in their respective strong markets, thereby establishing deep cooperation.

Global Intellectual Property Highlands

Generated hundreds of millions in patent licensing revenue

While continuously expanding its commercial partnership landscape, Bluesail Baisheng’s core competitiveness is also rooted in its substantial accumulation of independent intellectual property rights, thereby establishing a unique patent licensing revenue model that has contributed significant high-quality earnings to the company.

Bluesail Baisheng’s globally exclusive patented drug, Biolimus A9® (BA9™), is one of the most valuable patent assets in the global field of interventional medical devices for cardiovascular and cerebrovascular diseases. The relative lipophilicity of BA9™ is ten times that of conventional sirolimus-based drugs, facilitating greater absorption by vascular tissue and effectively reducing drug loss during device delivery.Over the years, BA9™ and its related drugs have cumulatively generated approximately USD 400 million in patent licensing revenue, with counterparties including Terumo and Guidant (the latter was subsequently acquired by Boston Scientific and Abbott respectively), fully demonstrating the company’s profound expertise and global influence in the internationalization of intellectual property.

This figure is not only a direct reflection of the company's technological value,This is one of the core competitive advantages that distinguish Beijing Lanfan Baisheng Medical Technology Co., Ltd. from ordinary medical device agency sales platforms.Beyond patents related to BA9™-associated drugs and coatings, Bluesail Baisheng’s intellectual property portfolio continues to deepen, with the company and its subsidiaries currently holding nearly 400 global patents.

Bluesail Baisheng’s global partnership landscape is accelerating its penetration across the entire interventional medicine sector. Behind each collaboration lies a practical validation of Bluesail Baisheng’s robust platform capabilities—clinical development, market access, marketing, distribution channels, and brand building are all critical elements in bridging the “last mile” for innovative products. Looking ahead, Bluesail Baisheng will aggregate high-quality innovative resources from both domestic and international markets, empowering more Chinese cardiovascular and cerebrovascular medical devices with global competitiveness to seize opportunities and expand overseas, jointly writing a new chapter in the global expansion of China’s medical device industry.