Source of the article: Eye Future ；Editor: SophiaReprint Requirements: Can be reprinted 24 hours after the first publication, source must be credited.
Recently,Wuxi Brisight Nord Medical Technology Co., Ltd.(abbreviation "Brisight Nord") developed byDisposable Vitrectomy HeadHas obtained the approval from the National Medical Products Administration (NMPA) of ChinaMarketing Approval, with the registration number GuoXieZhuZhun 20243161676. This isIn ChinaFirstSelf-developed domestically produced vitrectomy cutter, alsoThe Second GloballyDual-pneumatic vitrectomy cutter with a base cutting speed of 10,000 cuts per minute, which marks that China has reached an internationally advanced level in the field of vitrectomy surgical instruments.Break the oligopoly situation in China。After the vitrectomy probe penetrates the eyeball, it can quickly remove the diseased vitreous body. Based on cutting speed, the mainstream vitrectomy probes currently have cutting speeds of 5000cpm, 7500cpm, and 10000cpm.The higher the cutting speed, the less disturbance to the retina during surgery, and the higher the safety.。The vitrectomy cutter belongs to Class III medical devices., while being included in the list of medical devices exempt from clinical evaluation published by the National Medical Products Administration (NMPA),No clinical trials required。Calculated based on a single set of vitrectomy consumables for each surgical procedure,The current vitrectomy market size in China has reached 3.5 billion yuan, 100% occupied by imported brands.. Among them,The market size of vitrectomy heads is approximately 3.2 billion yuan, with an annual usage of about 800,000 units.；The市场规模 of 玻切机 is approximately 300 million, with an annual sales volume of about 300 units.。In the future, with the increase in surgical coverage and the entry of Chinese manufacturers into the market, the market capacity will further expand.It is reported that the clean production workshop of Brisight Nord located in Wuxi International Life Science Innovation Park is now in place.Chinese-made disposable vitrectomy heads are expected to enter the market next month.，Compatible with the most mainstream vitrectomy machines globally, priced at half the cost of imports.`, which is expected to solve the clinical pain point in China where the high price of imported medical devices limits the promotion of surgeries.`At the same time,The vitrectomy machine independently developed by the company has also entered the application stage and is expected to be approved early next year.。# Research and Development BackgroundFundus diseases generally refer to lesions occurring in the retina, macula, and optic disc within the eyeball.China currently has more than 40 million patients with fundus diseases.。It is estimated that by 2025, the market size related to fundus diseases in China will reach26.9 billion yuan, with a five-year compound annual growth rate of approximately 10.5%. The main treatment methods for fundus diseases are drug therapy, vitrectomy, and laser treatment, among whichVitrectomy is the main method for treating fundus diseases.。With the increase in the number of patients with fundus diseases, the volume of vitrectomy surgeries will grow accordingly.In the field of ophthalmology,Vitrectomy is typically classified as a Level 4 surgery., is in ophthalmic surgeryThe Highest LevelOne of the surgeries. This surgery involves operations on the posterior segment of the eye, including vitrectomy and possible retinal manipulation.Due to itsComplexity, RiskAs well as the technical equipment and doctors' skillsHigh Requirements, vitrectomy is classified as an ophthalmic procedure in China.The Most DifficultOne of the surgeries.But inVitrectomy Machine, Vitrectomy HandpieceWith the assistance of "advanced technologies," ophthalmic treatment has broken through the once unreachable "forbidden zones" within the eye.Nowadays, vitrectomy has been widely used to treat various blinding eye diseases.，Including but not limited to anterior segment and posterior segment diseases such as cortical cataracts, malignant glaucoma, and retinal detachment.Population aging will also create a huge market for vitrectomy devices in China. In 2022, the population aged 65 and over in China reached 200 million, accounting for 14.2% of the total population. It is estimated that by 2025, the population in this age group will reach 247 million.，The prevalence of age-related eye diseases, such as fundus diseases, will expand the patient population and stimulate surgical demand.。 As Chinese manufacturers accelerate the breakthrough of the high pricing restrictions of imported products, the phenomenon of reusing vitrectomy heads will also decrease.. Currently, most hospitals do not have a charge catalog for vitrectomy heads,Due to the high pricing of imported products, it is common for vitrectomy probes to be reused 3-4 times.As domestically produced, cost-effective vitrectomy probes with strong R&D capabilities gradually enter the market competition, the enhancement of market usage standards and the reduction in pricing expectations will further decrease the phenomenon of vitrectomy probe reuse.Currently,The field of vitrectomy instruments is basically monopolized by foreign brands., Global vitrectomy instrument manufacturers includeAlcon (US), Bausch&Lomb (US), DORC (Netherlands), Oteri (Switzerland), Heidelberg AG (Germany)etc. The most commonly used in China are the American Alcon's Constellation vitrectomy machine and the American Baush&Lomb's Millennium vitrectomy machine, among whichAlcon occupies 90% of the market share., which belongs to a typical oligopolistic market.China-produced high-end medical devices started relatively late, and achieving breakthroughs in innovative technology is not an easy task. Taking vitrectomy heads as an example,Each vitrectomy probe is integrated with 32 components, including a handle, reversing valve, blade, and air and liquid tubing., the electromagnetic valve component in the device determines the speed of vitrectomy head cutting iterations.，To fully achieve import substitution, it is necessary to mobilize the entire upstream and downstream industrial chain.According to industry insiders, 30%-40% of the raw materials for vitrectomy probes and components for vitrectomy machines in China still need to be procured from overseas.According to Yang Jianxin, General Manager of Brisight Nord, while independently developing technologies, the company has also been actively supporting and assisting upstream manufacturers in overcoming the "bottleneck" issues of key components. With the R&D demands led by Brisight Nord and through cooperative efforts, a domestic upstream supplier of vitrectomy machines successfully developed a component with a cost of only 1/20 of imported products. Currently...70% of the core components of the vitrectomy cutter developed by Brisight Nord have been replaced with domestically produced alternatives.。Brisight Nord's disposable vitrectomy cutter adoptsDual-pneumatic drive design, providing 23G (needle diameter 0.6 mm), 25G (0.5 mm), 27G (0.4 mm)Three Specifications of Vitrectomy Heads，Cutting speed covers 2500, 5000, 7500, 10000 cpm., andCompatible with mainstream brand vitrectomy machines。This innovative product not only breaks the long-term dependence on imports in China's vitrectomy medical device market but also helpsReduce Related Surgical Costs and Improve the Treatment Rate of Fundus Diseases。Brisight Nord Dual-Channel High-Speed Vitrectomy ProbeHigh-speed Vitrectomy Head:Globally Leading10,000 cpm Cutting Speed，Effectively Reduce Vitreoretinal Traction, reduce surgical complications.The retina is a delicate tissue inside the eyeball responsible for sensing light and transmitting visual signals. In vitrectomy, excessive traction may cause retinal damage or tearing, affecting postoperative visual recovery.Reducing traction force can lower the risk of intraoperative and postoperative complications.Such as retinal detachment, retinal holes, and macular edema, which also help with the smooth adhesion of the retina after surgery.Shorten postoperative recovery time.Dual-pneumatic drive system：The First in China, the Second in the WorldAdopting dual gas path driveThe vitrectomy head.Dual pneumatic drive is controlled by two air source systems for cutting and resetting, respectively.Make the reset of the vitrectomy probe no longer rely on the mechanical elasticity of the spring structure, butEfficiently driven by the air source system，Provided a smoother and more predictable cutting motion,Improved the operating experience for doctors.At the same time, it canMore effectively control the opening and closing ratio of the vitrectomy probe., allowing doctors to perform precise cutting and suction operations based on surgical needs and the patient's condition, optimizing surgical efficiency.Minimally Invasive Surgical Capability:The system is equipped to carry out23G, 25G+, 27G+ Minimally Invasive Vitrectomy, meeting the needs of different minimally invasive surgeries and reducing surgical trauma.Precision Control:Automatic Real-Time Intraocular Pressure Control SystemAccuracy in±2mmHg RangeInternally, to prevent local choroidal or retinal injury caused by high perfusion pressure.
Wuxi Brisight Nord Medical Technology Co., Ltd. was established in April 2021. It is a modern medical technology enterprise that integrates research and development, production, sales, and service.Deeply Cultivate the Field of Ophthalmic Medicine, committed to innovation and breakthroughs, focusing on the research, development, and manufacturing of high-quality, high-precision, and high-safety ophthalmic medical devices, aiming to achieve import substitution and accelerate the development of ophthalmic medical technology in China.
The company has gathered elites and experts in the field of ophthalmic medical technology both in China and abroad, including a specially appointed professor from Tsinghua University as a guiding advisor, and a research and development team centered around PhDs from Beijing Institute of Technology and the Chinese Academy of Sciences.
The company focuses on the research and development of vitrectomy machines and matching consumables with internationally leading standards., and continuously expanding the product areas, now covering products in multiple aspects such as vitrectomy machines, phacoemulsification machines, intraocular lenses, and excimer lasers. At the same time, it pays attention to intellectual property protection, owns multiple patents, and actively lays out intellectual property around the developed products.
2023March,Brisight NordCompleted tens of millions of RMBAngel Round Financing。This investment was exclusively made by Yuanming Xinzhaoyuan. In August 2024, another completion was achieved.Series A FinancingAs of the date of this report, the company's financing history is as follows:
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