Brisight Nord Achieves Breakthrough in High-End Ophthalmic Medical Devices with 10,000 CPM Dual-Pneumatic Vitrectomy Probe

China is one of the countries with the largest number of blind and visually impaired patients in the world. Among them, fundus diseases, as a common geriatric condition, had already exceeded 40 million patients in 2022, and the number is showing an increasing trend year by year due to the intensifying issue of population aging in China.

Vitrectomy is the main method for treating various types of fundus diseases. As a revolutionary precision micro-ophthalmic surgery, vitrectomy provides a less invasive and safer surgical treatment option for managing anterior and posterior segment diseases such as cortical cataracts, malignant glaucoma, and retinal detachment, helping to restore patients' visual function.

"The 14th Five-Year Plan for National Eye Health in China (2021-2025)" states that by the end of the "14th Five-Year Plan," the ability for early diagnosis and treatment of eye diseases such as fundus diseases and glaucoma should be improved. Efforts will be made to promote the early detection, early diagnosis, and early treatment of glaucoma, diabetic retinopathy, myopic retinopathy, macular degeneration, retinal vascular occlusion, and hypertensive fundus diseases. Standards for the diagnosis and treatment of key diseases will be formulated, the management model for patients with chronic eye diseases will be improved, and the disease burden and blindness rate will be reduced.

However, China's market for vitrectomy equipment currently relies heavily on imports, with imported devices accounting for 100% of the market. The market is also characterized by an oligopoly, with a single foreign manufacturer occupying about 80% of the market, and there are no domestically produced devices available yet. This not only leads to high procurement costs for hospitals but also drives up the cost of each vitrectomy procedure, which ranges from tens of thousands of yuan, placing a heavy burden on both medical insurance funds and patients. It also hinders the improvement of treatment rates for ophthalmic diseases in China.

In the wave of medical device localization in China, Wuxi Brisight Nord Medical Technology Co., Ltd. (Brisight Nord) has taken the development of internationally advanced ophthalmic surgical treatment instruments and accompanying consumables as its entry point, and was the first to launch import substitution products represented by vitrectomy machines and vitrectomy probes.

Recently, the disposable vitrectomy cutter developed by Brisight Nord has been approved for marketing by the National Medical Products Administration (Registration Certificate No.: 20243161676).As a domestically自主研发的 dual-pneumatic high-speed vitrectomy probe, the main specifications of this vitrectomy probe include 23G, 25G, and 27G, with cutting speeds covering 2500, 5000, 7500, and 10000 CPM. It is compatible with major brands of vitrectomy machines. This is the first domestically-produced and the second globally-produced dual-pneumatic vitrectomy probe with a base cutting speed as high as 10000 CPM, marking that China's vitrectomy surgical medical devices have reached an internationally advanced level.

Brisight Nord Dual-Channel High-Speed Vitrectomy Probe

The structure of the eyeball is extremely complex, requiring high precision in surgery. Once complications occur, the consequences can be severe, especially in the case of intraocular surgeries such as vitrectomy. Vitrectomy involves the removal of cloudy vitreous humor or the excision of vitreoretinal traction to restore a transparent refractive medium and promote retinal reattachment, treating vitreoretinal diseases.

Vitreous cutter surgery has a high level of operational difficulty and is classified as a Level 4 surgery, the highest level in ophthalmic surgical treatments. Therefore, it demands higher safety and performance standards for surgical instruments. This results in the high technical difficulty and long research and development cycle for vitrectomy machines and vitrectomy heads, which are considered advanced ophthalmic surgical medical devices.

Currently, there are six companies globally capable of producing vitrectomy equipment and consumables: Alcon, Bausch + Lomb, German Grieshaber, Swiss Oertli, Dutch DORC, and American Midlabs (Carl Wang). Among them, American Midlabs has been acquired by Japanese Hoya, and Dutch DORC has been acquired by Zeiss. This indicates that globally, the ability to produce vitrectomy equipment and consumables is a "scarce resource."

Especially, the vitrectomy machine and vitrectomy probe are currently evolving towards smaller caliber and faster cutting speed. This trend not only enhances surgical safety and efficiency, broadens the range of indications for surgical equipment, and brings cure possibilities to more patients with eye diseases, but also places higher demands on the development of high-end devices.

Specifically, as a pioneer in the import substitution of vitrectomy machines and vitrectomy heads in China, Brisight Nord's products have the following advantages:

· Globally leading 10000cpm vitrectomy cutter, reducing vitreoretinal traction, enhancing safety

The retina tightly adheres to the outer surface of the vitreous body of the eye. Consequently, when removing a cloudy vitreous, traction on the retina is unavoidable, which can lead to complications such as decreased vision and retinal tears. Therefore, the challenge in developing vitrectomy probes lies in achieving stable and safe cutting of the vitreous while minimizing vitreous traction on the retina to prevent iatrogenic retinal tears.

In terms of surgical application, the faster the cutting speed of the vitrectomy probe, the less traction on the retina. Currently, the cutting speeds of imported vitrectomy probes used in major hospitals are generally 5000 cpm and 7500 cpm. However, the vitrectomy probe approved for use by Brisight Nord is the first domestically produced probe in China with a base cutting speed of 10,000 cuts per minute. It can more effectively liquefy the vitreous body, reducing traction and disturbance to the floating retina, thereby minimizing surgical complications and enhancing the safety of ophthalmic surgeries.

· The second product globally and the first in China to adopt a dual-pneumatic drive system vitrectomy probe

Vitreous cutters generally operate using pneumatic drive, with the types of air sources mainly divided into single-circuit and dual-circuit systems. Traditional single-circuit vitreous cutter heads are driven forward by air pressure actuating a piston, while a spring mechanism assists in retracting the blade. The softness and fatigue resistance of the spring can affect the cutting frequency and pneumatic driving force, thereby influencing surgical efficiency, stability, and even the final surgical outcome.

The vitrectomy probe of the dual-pneumatic drive system is controlled by two pneumatic systems for cutting and resetting respectively, allowing the probe's resetting to no longer rely on the mechanical elasticity of a spring structure but instead be efficiently driven by the pneumatic system. This not only significantly improves surgical efficiency and treatment precision but also enhances the doctor's operational experience.

Moreover, under the same negative pressure conditions, cutting speed and efficiency in vitrectomy often cannot be achieved simultaneously. That is, as the cutting speed increases and the vitrectomy probe size decreases, the flow rate of the vitreous also decreases, thereby reducing surgical efficiency. Controlling and increasing the ratio of the vitrectomy probe's open time to the total time (duty cycle) can enhance the cutting efficiency of the probe.

The vitrectomy probe with a dual-pneumatic drive system enables more effective control of the opening and closing ratio of the probe. Doctors can perform precise cutting and suction operations based on surgical needs and the patient's condition, breaking the previous limitation where cutting speed and surgical efficiency could not be achieved simultaneously. According to publicly available information, Brisight Nord is the second company globally and the first in China to master the dual-pneumatic drive cutting technology.

In addition to the above advantages, the cutting system developed by Brisight Nord is equipped to perform minimally invasive vitrectomies such as 23G, 25G+, and 27G+. The precision of the automatic real-time intraocular pressure control system is within ±2mmHg, preventing potential local choroidal or retinal damage on the opposite side of the infusion port that may be caused by high perfusion pressure, thereby reducing surgical complications.

China’s import substitution strategy for mid-to-high-end medical devices is about to enter a decisive phase. According to procurement announcements released by major hospitals, the price of imported vitrectomy machines generally ranges from over one million Chinese yuan, while the cost of consumables such as vitrectomy kits is approximately six to seven thousand yuan. Additionally, there are further expenses related to long-term equipment maintenance and repair, imposing a heavy cost burden on China's medical services.

"The acquisition cost of the domestically produced vitrectomy machine and vitrectomy probe independently developed by Brisight Nord is expected to be more than 60% cheaper than imported brands. The direct reduction in product costs not only supports equipment configuration and service upgrades for ophthalmic medical institutions at all levels but also provides a strong guarantee for the smooth advancement of healthcare reform in China," said Yang Jianxin, General Manager of Wuxi Brisight Nord Medical Technology Co., Ltd.

Since its establishment in 2020, Brisight Nord has traversed over four years of innovative development "from 0 to 1." Now, its first product is ready to be launched into the market. The courage and capability to tackle the "hard bone" of importing alternatives for high-end ophthalmic surgical instruments lie in the founding team's decade-long dedication to the research, development, and manufacturing of medical devices.

As the founder and general manager of the company, Yang Jianxin holds a Ph.D. in Biomechanics from Beijing Institute of Technology and has over 14 years of experience in medical device R&D. He has held R&D management positions at Lepu Medical and Puhua Heshun, owns more than 50 invention patents, and has led the development of various Class III and Class II active and passive medical devices. In addition, other core members of the Brisight Nord team have also深耕ed in medical R&D, project management, and production for over a decade, making it a highly experienced team in the medical device industry.

In addition to overcoming the core technologies of vitrectomy machines and vitrectomy probes, how to simultaneously establish an efficient and stable supply chain system is one of Brisight Nord's key focuses.

Yang Jianxin stated, "The insufficient localization rate in the midstream and downstream of the vitrectomy machine and vitrectomy probe industry chain has led to lagging development in the upstream raw materials sector. Taking the vitrectomy probe as an example, each probe consists of 31 components, including more than ten types of polymer materials. Achieving complete import substitution for vitrectomy probes requires joint efforts across the upstream and downstream parts of the industry chain. In response, the company is also nurturing and assisting upstream manufacturers in overcoming the bottleneck issues of key components, enhancing the innovation level and resilience of the high-end ophthalmic medical device industry chain."

Under the R&D demand traction and collaborative cooperation of Brisight Nord, an upstream supplier of vitrectomy machines has successfully developed components with a cost of only one-twentieth of imported products. According to reports, 70% of the core components in the vitrectomy machines and vitrectomy heads developed by Brisight Nord have achieved domestic substitution in China, and this proportion is continuously increasing as the domestic supply chain ecosystem in China is established and improved.

Talking about the future, Yang Jianxin said: "With the rapid development of China's medical device industry in recent years and the background of centralized procurement of medical devices, the survival path for low- and mid-range medical device products is becoming increasingly narrow, while high-end ophthalmic surgical instruments have become the next high-growth, high-barrier 'double-high' track. Currently, Brisight Nord has completed a new round of financing. In addition to promoting the registration and market launch of the first generation of domestically produced vitrectomy machines and vitrectomy probes, the company also plans to introduce globally its newly designed and developed second-generation phacoemulsification and vitrectomy integrated machine and other high-end ophthalmic surgical instruments. The company’s unique multiple core technologies have completed patent layout and key algorithm breakthroughs. At that time, the vitrectomy machine developed by the company will go overseas to compete head-on with industry leaders, showcasing to the world the innovative and intelligent manufacturing strength of China's high-end ophthalmic devices evolving from 'fast follow' to 'me better'."