Recently, Usightsmed’s independently developed microcatheter surgical system has obtained the NMPA approval, becoming the first domestic glaucoma MIGS surgical product approved for listing in China.
It is reported that the system is an innovative product with independent intellectual property rights built for 6 years. Its research and development process involved a team of well-known domestic experts. It is not only applicable to a wide variety of surgical procedures, but also has the advantages of fewer postoperative complications, no subconjunctival follicle formation, rapid postoperative recovery, and good antihypertensive effect.
In fact, before the official approval of this product, the minimally invasive glaucoma surgery track has been “quietly” hot, attracting many international ophthalmic giants to enter the track. In China, although there were no officially approved local products on the market before, the glaucoma academic community has widely recognized the minimally invasive surgery, and it has also attracted a number of local companies to enter the market. From the perspective of overseas markets, the actions of international giants seem to be more frequent. Obviously, whether it is from abroad to China, or from investment to mergers and acquisitions, there has been a “minimally invasive wind” on the glaucoma surgery track.
To analyze these actions in depth, we need to go back to the most fundamental “origin” – clinical needs. On the one hand, there is a large demand in the field of glaucoma treatment in China. On the other hand, in the face of such a huge demand for treatment, traditional methods have gradually shown drawbacks. Roughly speaking, the technical paths of minimally invasive glaucoma surgery products can be divided into two categories: implantation and intervention, and Usightsmed has chosen the second. There are three main reasons: first, the treatment of glaucoma needs to reduce the damage of the optic nerve by controlling the intraocular pressure. For patients especially with high intraocular pressure, the visual field or optic nerve damage is serious, and intraocular pressure should be fully and effectively reduced. Judging from the actual disease situation in China, most domestic patients only come to the hospital when the symptoms are more obvious. Therefore, when patients come to the hospital for treatment, most of them have developed to middle and advanced glaucoma. According to relevant research results, compared with micro-stent products, the surgical method using micro-catheter products will have a more obvious effect on reducing intraocular pressure. Secondly, judging from the cognition and usage habits of domestic doctors, a considerable number of Chinese doctors are more inclined to use interventional methods. Finally, from the perspective of disease payment, take a foreign brand of glaucoma micro-stent as an example. Its price in the United States is about 1,000 US dollars each, and generally 2 implants are required in each eye, that is, a total of 1,500-2,000 US dollars. That figure is a small percentage of health care payments in the U.S., combined with the more widespread commercial insurance. This price does not cause payment problems for foreign patients. However, the corresponding price of this product in China will be greatly increased (import duty payment plus circulation costs), which will pose a high payment challenge for domestic patients.
Therefore, after comprehensive consideration of the characteristics of clinical indications, antihypertensive effect, prognosis, payment and other aspects, Usightsmed chose the technical path of intervention, that is, microcatheter, for product development.
As a tool for doctors, the biggest highlight of the Usights microcatheter surgical system, in addition to its antihypertensive effect, is its ease of operation. Specifically, the surgical system is mainly composed of a laser fiber optic pointer and a disposable ophthalmic fiber optic catheter. The former mainly provides a laser light source to mark and guide the position of the catheter tip in the Schlemm canal during glaucoma surgery; the latter consists of a viscoelastic injector and a disposable ophthalmic fiber optic catheter. During the operation, the red light emitted by the tip of the microcatheter can penetrate the corneal limbus, thereby helping the doctor determine the location of the catheter and achieve precise navigation.
In addition, in terms of the design of the microcatheter, Usightsmed has also optimized it according to the actual needs of the clinic. For example, compared to imported microcatheters, the Usights microcatheter has a longer length (165mm overall working section and 75mm insertion section), making it more friendly to glaucoma surgery in patients with corneal ectasia.
In addition, the swollen and sleek design of the microcatheter tip enables it to smoothly penetrate the Schlemm canal without damaging the surrounding tissue. Its material design is more ductile, which facilitates the transmission of the pushing force to the tip, making it easier for doctors to operate and push more easily.
Usightsmed not only has established a strong R&D team with members with well-known medical device catheter R&D backgrounds, but also has established an expert team with Beijing Tongren Hospital affiliated to Capital Medical University. Usightsmed has invited Professor Wang Ningli, a well-known glaucoma expert, as the chief scientist.
The cooperation with well-known domestic experts will undoubtedly make Usightsmed’s research and development closer to clinical needs. During the entire product development process, the expert team of Tongren Hospital was deeply involved and gave suggestions and clinical guidance.
Raw materials, manufacturing process, and system stability are the main research and development difficulties of glaucoma microcatheter products, which are inseparable from a significant feature of microcatheter – refinement. The refined characteristics of microcatheter not only make it “must be customized from the catheter to the raw material of the optical fiber”, but also raise the threshold of the manufacturing process and maintain the stability of the system. In this regard, Usightsmed has carried out a lot of experiments and trials so that the current Usights microcatheter surgical system can be successfully launched.
Nowadays, the Usights Microcatheter Surgical System, which has been validated by clinical trials, is about to be officially launched on the market.
For its marketing plan, Usightsmed has long been aware of it. At the marketing level, the company will build an effective technology dissemination system. In the future, Usightsmed will strengthen publicity at the conceptual level to improve the understanding and acceptance of minimally invasive glaucoma surgery among doctors; It is planned to train 500 glaucoma doctors in three years to master Schlemm angioplasty and other related surgical techniques, supplemented by technical support.
In addition to the approved Usights microcatheter surgical system, Usightsmed has also developed micro-stent products in the minimally invasive glaucoma surgery track. At present, the research and development of this product has been basically finalized, and it is planned to start clinical trials next year. At that time, this product will be used in conjunction with the approved microcatheter surgical system.
With an in-depth understanding of the ophthalmology industry, the company will continue to expand its business. In addition to continuing to cultivate in the ophthalmology diagnosis and treatment market, it will further deploy optometry equipment, eye disease management systems, and multi-modal eye disease AI screening systems. Each of its products closely adheres to the concept of “focusing on the needs of ophthalmic diagnosis and treatment, continuously achieving breakthroughs in technology and scenarios, and gradually forming a complete ophthalmic product layout” to extend and expand and strive to create a product platform for the entire eye health industry chain.