Haiwin Medical Files IPO Prospectus: Solving 'Bottleneck' Challenges in Medical Polymer Materials and Empowering Interventional Catheter Enterprises with One-Stop Procurement Services

Medical polymer materials serve as the cornerstone of the medical device industry, spanning the entire value chain from basic consumables to high-end implants. They play a pivotal role in fostering self-reliance and controllability across the industrial chain, driving technological upgrades and product innovation, and facilitating the clinical adoption of emerging medical technologies. Breakthroughs in their research and development directly contribute to enhanced performance of medical devices.

Haiwang Medical Technology (Suzhou) Co., Ltd. (hereinafter referred to as “Haiwang Medical”) is an emerging player in this sector. Established in 2022, the company’s founding was driven by three key factors: First, during the COVID-19 pandemic, its parent company, Kersail Medical Technology (Suzhou) Co., Ltd. (hereinafter referred to as “Kersail”), encountered significant issues with quality and delivery lead times when procuring raw materials from overseas; second, Kersail already had a strategic plan to expand into the field of polymer materials; and third, a substantial financing round secured by Kersail in 2021 enabled the rapid implementation and launch of this platform.

In this context, Haiwang Medical was established.As a subsidiary of Kossel, Haiwang Medical specializes in the development and production of medical polymer products, dedicated to providing comprehensive solutions for various tubing, as well as medical sheaths and catheters, to customers in the interventional medical device sector.

In 2022, domestically produced medical polymer materials in China saw significant positive developments.

In that year, the Ministry of Industry and Information Technology launched the “Open Competition Mechanism for Innovation in Biomaterials” initiative, encouraging domestic enterprises to overcome key material technology barriers. Meanwhile, in 2022, domestically produced medical-grade PEEK (polyether ether ketone) materials received approval for the first time. This breakthrough not only ended the long-standing monopoly held by European and American companies but also signaled that a strategic window of opportunity had arrived for China to tackle core technologies in high-end medical polymer materials.

Leveraging its strategic groundwork and the opportunities arising from financing, Cosel is determined to break new ground in the sector of medical polymer products. To this end, it swiftly entered the market by establishing its subsidiary, Haiwang Medical. As a well-known platform enterprise in China’s pan-vascular interventional device industry, Cosel had previously accumulated substantial experience and advantages in the research, development, and production of terminal products, yet it faced the challenge of relying on imported core materials. Haiwang Medical has entered the materials sector with a focus on achieving autonomous and controllable supply chains, aiming to reduce supply chain risks through the localization of core raw materials. This strategy empowers Cosel to achieve self-sufficiency in core raw materials and strengthen its industrial chain.

Haiwang Medical’s product portfolio covers precision extruded tubing, reinforced tubing, heat-shrink tubing, PTFE tubing, sheaths & catheters, related value-added services, and CDMO., with the long-term strategic direction of “becoming a global leader in precision medical polymer products and a comprehensive partner for interventional catheter medical device companies.” Its layout in the field of medical polymer material products is backed by clear advantages and resource empowerment.

Haiwang Medical possesses significant advantages in R&D capabilities: First, the company has an experienced scientific research team whose members all have backgrounds in product technology R&D and a deep understanding of market demands; second, the technical foundation and resource advantages accumulated by its parent company, Kossel, over many years in the OEM sector provide Haiwang Medical with important support; furthermore, as this business segment is part of the company’s long-term strategic layout, relevant resources were systematically allocated as early as the initial planning stage.

Haiwang Medical has assembled an R&D team led by more than 30 senior experts, focusing on key technologies such as material modification and biocompatibility, and has established a comprehensive technical reserve system ranging from basic formulation development to application scenario design.. Meanwhile, Haiwang Medical has initiated joint technological breakthroughs through university-enterprise collaborations, such as establishing a practical training base with Sichuan University to conduct research on medical-grade polymer materials.

In terms of commercialization experience, Haiwang Medical is well-versed in the entire process of innovative medical devices from R&D to clinical translation. Its parent company, Kossel, emphasizes the integration of medicine and engineering, possessing a standardized management system and a flexible, efficient mechanism for achievement transformation. This has enabledHaiwang Medical precisely captures frontline clinical needs in its value-added services, translating physicians’ practical pain points into core product design features, thereby ensuring that its products better align with actual clinical usage requirements and exhibit stronger market adaptability., thereby enhancing the product's market competitiveness.

Haiwang Medical centers its business on medical-grade polymer tubing, establishing seven core business segments: precision extruded tubing, reinforced tubing, heat-shrink tubing, PTFE tubing, sheaths, catheters, and value-added post-processing services. Supported by more than 30 specialized production lines, the company achieves full-chain coverage from material forming to finished product manufacturing. In the materials sector, Haiwang Medical strategically focuses on four major product series—extruded tubing, reinforced tubing, heat-shrink tubing, and PTFE tubing—to comprehensively meet clinical demands in peripheral intervention, coronary intervention, neurointervention, and cardiac electrophysiology.

Haiwang Medical’s Four Major Series of Materials

(1) Core Technology: A Full-Dimensional Breakthrough in Material Processing

Polymer Material Processing: Covers molding processes for all categories of medical-grade polymers, establishing integrated production from raw material processing to downstream catheters and sheaths, thereby achieving seamless “material-to-product” manufacturing.

(2) Platform Technology: Seven Major Technical Systems Supporting Customized Solutions

Leveraging six core process platforms—precision extrusion, reinforced tube extrusion, dip coating, heat-shrink forming, fluoropolymer molding, and composite catheter processing—along with post-processing technologies, we provide customers with end-to-end technical support spanning material selection, structural design, and functional optimization.

(1) Precision Extrusion Technology: A Mass Production Breakthrough in Miniaturized Manufacturing

● Ultra-fine catheter manufacturing: Achieved stable mass production of catheters with an inner diameter of 0.2 mm, dimensional tolerance of ±0.01 mm, and wall thickness of 0.005 mm, breaking through the bottleneck in the manufacturing of miniature medical devices.

● Microcatheter Technology: The 2.4F steerable microcatheter achieves clinical-grade precision, with PTFE-lined etched tubing diameters ranging from 0.1 mm to 10 mm; its technical specifications benchmark against leading international enterprises.

(2) Specialized Breakthroughs in the PTFE Field: A Technologically Competitive System with International Competitiveness

Technological Innovation: Developed adhesive layer materials through industry-university collaboration, achieving mass production of etched tubes with adhesive layers; mastered high-strength PTFE tube manufacturing processes, and achieved technological breakthroughs in low-elongation etched tubes and bend-resistant transparent tubes.

Haiwang Medical Heat-Shrink Tubing & PTFE Tubing

In the field of raw materials for high-end medical devices, Haiwang Medical has achieved multiple breakthroughs in critical "bottleneck" areas such as molding and precision machining of medical-grade polymer materials through independent R&D and industry-academia-research collaboration. This has accelerated the domestic substitution of core components and materials, thereby strengthening the autonomy and controllability of the medical device industry supply chain.

(1) System Foundation: Certified under the ISO 13485 medical device quality management system and GMP standards, establishing a standardized production framework;

(2) Talent Support: A professional team of nearly 30 process and materials R&D engineers ensures technology implementation and quality control;

(3) Equipment Assurance: Equipped with high-precision testing instruments such as melt flow indexers and stereomicroscopes to achieve full-process monitoring from raw materials to production;

(4) Closed-Loop Management: Establish a fully closed-loop extrusion inspection system, and form a full-chain quality assurance logic of "R&D - Production - Inspection" through real-time data collection and analysis.

FromProduct DimensionHaiwang Medical has a comprehensive horizontal product portfolio. Meanwhile, it also maintains a vertical layout, spanning from material modification to the manufacturing of products tailored to downstream customer needs, thereby achieving full industry chain coverage.

InSheath & Catheter Product LineHaiwang Medical’s composite tubing is one of its core products. Its production incorporates advanced spring-coiling and braiding equipment, endowing the products with excellent pushability, controllability, kink resistance, and high-strength support performance. Furthermore, Haiwang Medical boasts a comprehensive composite tubing processing production line, enabling customization of sheaths and catheters with diverse structures and functions to meet customer requirements. These products are applied across multiple fields, including cardiac electrophysiology, coronary, peripheral, neurovascular, and natural orifice interventions.

Haiwang Medical: Summary of Catheters & Sheaths in Production

Meanwhile, the company can provide targeted product solutions tailored to the diagnostic and treatment needs of different departments. For instance, it offers sheaths and catheters for cardiovascular interventional departments, among which Pebax-based catheters are commonly used due to their excellent flexibility and biocompatibility that meet clinical requirements. For neurology departments, PTFE-based catheters are provided, satisfying the demands of precise interventional procedures with their superior corrosion resistance and low friction coefficient. In surgical scenarios, the supplied heat-shrink tubing can be utilized for applications such as tissue repair or fixation.

Furthermore, during the manufacturing process, Haiwang Medical strictly controls product precision and quality to ensure consistency and stability, enabling the devices to precisely conform to patients’ anatomical structures across various clinical departments. The company also modifies materials—such as adjusting hardness, toughness, and antimicrobial properties—to meet the specific performance requirements of different departments, thereby better suiting the distinct application scenarios of each.

Haiwang Medical inValue-Added ServicesThe field offers comprehensive "one-stop" solutions. Its core advantages are reflected in two aspects: on the one hand, it provides personalized customization services based on customers' specific needs, performs refined post-processing at the near-finished product stage, and strictly controls production processes, product yield rates, and quality standards; on the other hand, the company remains focused on addressing key pain points in customers' actual business operations, thereby creating tangible value for them.

Haiwang Medical Value-Added Services

In the combinationContract Manufacturing Organization (CMO) ServicesIn this domain, Haiwang Medical has established collaborative mechanisms with partner enterprises to translate cooperation objectives into tangible project outcomes. The company implements a rigorous quality control system during project execution to ensure strong scalability, and employs systematic project management mechanisms to guarantee the on-time delivery of all collaborative projects. In materials development, the company works in close collaboration with customers to develop tailored materials that meet their specific requirements. In catheter extrusion, it offers a full range of polymer materials for single-lumen, multi-lumen, irregular-shaped, multi-layer, and variable-diameter configurations. Furthermore, Haiwang Medical provides comprehensive solutions for injection molding and post-extrusion tube processing, including injection molding, insert molding, heat setting, tip forming, hole punching, diameter variation, thermal bonding, printing, welding, adhesive bonding, and hydrophilic coating.

Notably, Haiwang Medical’s R&D team possesses interdisciplinary expertise, enabling product development and improvement from multiple perspectives, including materials science and biomedical engineering. This provides robust technical support for value-added services, meeting customers’ demands for high-performance and high-quality products. The company offers a comprehensive range of product specifications with broad coverage and outstanding customization capabilities. It can tailor product aesthetics and optimize formulations according to customer requirements, thereby addressing the personalized needs of different departments, surgical procedures, and patients, while reducing customers’ adaptation costs.

Haiwang Medical also undertakes OEM/CDMO/MAH services, with extensive experience in product areas such as vascular stents, balloon catheters, and electrophysiology catheters.To address customized customer requirements, Haiwang Medical can complete sample development within 14 working days and rapidly collaborate with customers to achieve mass-production processes.The company has established a rapid response mechanism covering order placement, drawing and technical requirement reviews, material and fixture preparation, trial production, and post-production meetings. With ample production lines and capacity, the company can flexibly allocate resources, while its stockpile of multi-category materials helps shorten procurement lead times. A professional technical team supports trial production throughout the service process. Furthermore, Haiwang Medical has set up independent R&D and trial production lines to ensure swift responses to sample development requirements.

Based on an assessment of the development trends in medical polymer products, Haiwang Medical’s short-term plan is to achieve a leading position in the domestic market, then expand into neighboring markets such as Japan and South Korea, followed by entry into European and American markets. In the long term, Haiwang Medical aims to become the most specialized expert in the design and manufacturing of sheaths and catheters. Meanwhile, the company strives to become an industry leader in polymer tubing, films, sheets, and wires, dedicated to providing cutting-edge innovative polymer products globally.

Based on this, Haiwang Medical's future development plans will focus on three aspects:

First, accelerate the comprehensive substitution of domestic products, achieving over 90% localization of core raw materials such as precision tubing and sheaths. This will directly reduce reliance on imports, ensure product performance comparable to imported counterparts, and effectively offset the cost pressures arising from increased tariffs.

Second, we will continue to make breakthroughs in the upstream sector, achieve global leadership, and overcome bottlenecks in critical products. In the future, the company will engage in global competition and pursue acquisitions of certain enterprises in Europe and the United States, continuously optimizing its industrial chain layout;

Third, strengthen the one-stop corporate positioning of “R&D + Manufacturing + Services,” promote joint research initiatives with universities and enterprises, collaborate with expert teams from advanced countries, improve rapid response mechanisms, and establish stable production safeguards. Through intelligent production scheduling systems, ensure priority production and delivery services for urgent orders.