Sinowares Files IPO Prospectus: Leader in Minimally Invasive Biopsy and Puncture Component Solutions with Over 20% Domestic Market Share

Driven by advantages such as minimal invasiveness, reduced pain, and rapid recovery, minimally invasive surgery has become a mainstream clinical approach, with continuous advancements in minimally invasive techniques. Consequently, China’s market for minimally invasive surgical instruments has expanded to reach a scale of tens of billions of RMB, intensifying competition and testing companies’ capabilities in integrating upstream and downstream resources. Meanwhile, as innovation in the medical device sector becomes increasingly saturated, the industry is shifting its focus toward growth opportunities across the supply chain, particularly in the upstream segment that determines enterprises’ R&D and manufacturing capabilities.

As upstream players, suppliers of structural components for minimally invasive surgical instruments wield considerable pricing power and autonomy. However, given the high technical content and stringent precision requirements of these components, China has historically relied heavily on imports, with only a few domestic companies operating in this space. With innovations in mid-to-high-end minimally invasive surgical instruments, domestic enterprises have increasingly recognized the importance of mastering core component technologies and manufacturing processes. In recent years, the pandemic and import-export regulations have further accelerated the development of the upstream sector.

Long before the sector became a hot trend, Infinio had already been deeply entrenched in the field of minimally invasive surgical instruments for many years.The company specializes in structural component solutions and manufacturing for minimally invasive puncture devices, powered medical instruments, electrosurgical knives, plasma ablation systems, electrocoagulation electrodes, laparoscopic instruments, endoscopic devices, balloon catheters, sports medicine implants, minimally invasive orthopedic devices, minimally invasive stents, minimally invasive suturing devices, flexible powered minimally invasive instruments, and minimally invasive surgical robots. It is committed to continuously overcoming bottlenecks in the craftsmanship and material applications of mid-to-high-end minimally invasive surgical instruments.

Infineo continuously strengthens its original R&D capabilities, holding multiple invention patents in the field of minimally invasive device structures, and was recognized as a National High-Tech Enterprise in 2019. In the biopsy needle and puncture needle business segments, the company commands over 20% of the domestic market share.

The SINOWARES brand has been established for 20 years, but its formal entry into the field of minimally invasive surgical instrument structures was a transformation completed in 2008.

In 2008, Infinio established its Minimally Invasive Surgery Division. At that time, the domestic market for minimally invasive surgical instruments was still in its nascent stage, with a complete void in structural component ecosystems and heavy reliance on imports for core materials and parts. Infinio’s entry into the field was not an overnight success; it had to systematically overcome critical bottlenecks, including raw material supply chains, product structural design, and surface treatment technologies.

Leveraging years of experience and expertise in mechanical engineering and precision structural machining, Infinio is committed to breaking the monopoly on imports by pioneering new equipment, advanced processes, novel materials, and innovative structural solutions.The company has a professional in-house development team with strong technical capabilities in puncture angiography, multi-edge puncture surfaces, surface recognition, and flexible dynamic structures. It independently develops automated multi-edge surface implementation equipment and multifunctional angiography manufacturing equipment, employs instrument surface protection and anti-oxidation processes, and produces various standardized and non-standard instruments.

In China, Infinio is the first company positioned as a structural component supplier for minimally invasive surgical instruments. The company currently employs over 80 staff members, with its core technical talent possessing extensive experience in automated equipment, new material applications, and process engineering. Today,85% of Infinio’s products are sold in the domestic market, while 15% are exported overseas. The company has established partnerships with well-known enterprises such as Double Medical, Kangji Medical, and Kangyou Medical, and has achieved sustained performance growth in recent years.

A review of Infino’s portfolio reveals that biopsy needles account for the largest share in the low-value medical consumables market, the minimally invasive orthopedic device sector is crowded with listed companies, and endoscopy along with surgical robots have emerged as hot tracks in recent years.

In the field of minimally invasive puncture structures, Infinio offers structural solutions for minimally invasive puncture devices, including surgical puncture needles, biopsy needles, microwave ablation probes, ultrasound-visible devices, cranial nerve needles, lumbar puncture needles, bone marrow aspiration needles, hepatic procedure needles, oocyte retrieval needles, and breast biopsy needles. The company enters the market through innovations in new materials, structures, and manufacturing processes.

As conventional biopsy needles on the market typically have one or two bevels,Infineon can develop products with up to seven cutting edges to meet customer needs for precise puncture.. The design of the multi-bevel surface, including bevel angle, roughness, and thickness, all affect its puncture force. Infinio has made significant efforts in material selection and structural design, following months of technical research and development,Development of an Automated N-Blade Puncture Device。

In terms of contrast needle structural design, Infinio leverages its independently developed multifunctional contrast manufacturing equipment to offer contrast needles in various shapes, including circular and triangular configurations. These products meet clinical demands for smoothness, clarity, and diverse geometries, demonstrating originality in the market and securing a stable customer base.

In recent years, the Chinese government has increasingly strengthened policy support for high-end minimally invasive surgical instruments. Market demand has gradually diversified, driving growth in the development of mid-to-high-end products. Energy-based surgical devices, such as plasma scalpels and ultrasonic scalpels, have seen a significantly higher presence in operating rooms, participating in procedures involving tissue cutting, biopsy, and repair.

The Infinio team is capable of developing various types of medical powered handpiece structures, including arthroscopic, ENT (ear, nose, and throat), soft tissue, specialized flexible, and biopsy sampling handpieces, and can design powered surgical tips tailored to the specific needs of different clinical departments and procedural stages.Powered burr heads with different structural designs are suitable for different application scenarios. For example, internal and external beveled blade heads are suitable for soft tissue cutting; toothed powered burr heads at the tip can be used for targeted power work on slightly harder tissues such as ligaments and cartilage.

In addition to its original products, Infinio also places great emphasis on internal management and collaboration. By establishing clear division of responsibilities and optimizing team structures, the company enhances R&D and production efficiency to better serve medical device customers.

General Manager Qin Yongsheng stated, “If we are currently producing smartphone chips, in the future we may engage in advanced process technology development for core components in chip-adjacent fields to enhance our company’s competitive advantage. In recent years, some upstream foundry players in the industry have also attempted to enter the terminal medical device market. However, Infineo’s strategic positioning has always been clear: building on consumables structures and supporting accessories, the company is committed to delivering high-volume, customized products and will not encroach on the market share of terminal brand owners.”

The "14th Five-Year Plan" for the Development of the Medical Equipment Industry mentions that,By 2025, the medical equipment industry will have basically resolved bottlenecks and weaknesses in foundational components and parts, basic software, fundamental materials, core manufacturing processes, and industrial technology infrastructure.

Amid the surge in domestic substitution, innovations are emerging frequently in fields such as minimally invasive orthopedic devices, endoscopes, and surgical robots. Upstream suppliers of core components and supporting solutions play a crucial role in the development and manufacturing of medical devices, particularly for small and medium-sized enterprises (SMEs) that lack the resources to establish their own supply chains. After years of dedicated effort, Infenio has secured its position among the partner network of innovative companies, leveraging its proprietary technologies and robust, reliable production quality, with significant potential for further collaborative development.