Capital Infusion Ignites Eve of Breakthrough: Countdown to First Ophthalmic Surgical Robot Certification in China

Within two months, TIROMU and Oculotronics successively entered the special review channel for innovative medical devices.

Along with Dessight Biomedical, which entered the market first in 2025, three domestic companies are now simultaneously racing to secure China’s first registration certificate for an ophthalmic surgical robot.

Ophthalmic fundus surgery demands extremely high operational precision. Subretinal injection requires stable manipulation at the 10-micrometer level, yet the physiological tremor of the human hand is approximately 100 micrometers, creating an insurmountable gap between the two.

For a long time, there have been very few experienced physicians in China capable of performing such highly complex surgical procedures, while the number of patients with fundus lesions has reached tens of millions, resulting in a persistent and severe mismatch between supply and demand.

The emergence of ophthalmic surgical robots essentially leverages machine stability to compensate for the limitations of human physiological capabilities. Their advent not only signals the birth of a new product category but also serves as a critical milestone in the platformization of super-microsurgery.

Currently, ophthalmic surgical robots have simultaneously initiated the final push for initial regulatory approval and preparations for commercialization.

Following the inclusion of Dessight Biomedical’s ophthalmic surgery device in the Special Review Procedure for Innovative Medical Devices in March 2025, TIROMU’s fundus injection surgical robot and Oculotronics’ ophthalmic surgical robot entered the Green Channel in June and July 2026, respectively.

Who will secure the first registration certificate depends not only on technical strength and clinical progress, but also on a special factor: the lack of established review standards.

As a novel form of high-end ophthalmic equipment, ophthalmic surgical robots involve multiple interdisciplinary fields and represent an entirely new category globally, with no established regulatory review standards available for reference.

Compared with other surgical robots, ophthalmic surgical robots have many unique characteristics.

“While some surgical robots prioritize operational accessibility, surgical efficiency, and reduction of surgeon fatigue, the core performance metric for ophthalmic robots is micron-level intraoperative stability,” introduced Cui Di, founder of Dessight Biomedical. “Given the confined operative space in fundus surgery, even minute device displacements can directly impact surgical outcomes. Therefore, the clinical trial protocol design, data collection, and definition of clinical endpoints are all centered on evaluating the impact of micron-level precision and operational stability on surgical efficacy, employing a multi-endpoint trial design.”

Cui Di revealed to VCBeat that, at this stage, the review department and enterprises are communicating jointly to establish supporting review methods and judgment criteria.

This means that the progress of the first certification depends not only on the standardization and completeness of the company’s submission materials, but also on the collaborative efficiency between the company and regulatory authorities.

Although the exact timing for the approval of the first certification remains uncertain, the company is simultaneously advancing its commercialization preparations.

Dessight Biomedical has primarily focused on three key initiatives:

1. Liaise with relevant institutions in advance to align on the market access process, ensuring rapid clinical implementation upon approval;

2. Establish a tiered physician training system, categorizing training into basic operations, advanced applications, and complex case management, and collaborate with senior ophthalmology department directors to provide mentorship;

3. Establish an after-sales support system, and proactively deploy service teams for post-sale equipment support and intraoperative stability assurance to enable rapid response to hospital needs following market launch.

Oculotronics will also initiate equipment installation and deployment at leading ophthalmic institutions upon completing registration and obtaining certification, while simultaneously advancing large-scale clinical application across hospitals at various tiers.

Initiating commercialization efforts as early as possible helps avoid the post-approval gap, enabling immediate market entry upon certification and rapid scaling thereafter.

The transformation of ophthalmic surgical robots on traditional surgery is mainly reflected in two types of operations: injection and membrane peeling, which are also the mainstream functions of most product designs.

According to VCBeat’s research, subretinal injection is expected to be the first clinical application scenario for ophthalmic surgical robots after regulatory approval.

Previously, in clinical trials conducted by various companies on subretinal injection, the value of robotic assistance was validated across multiple dimensions, including precision, stability, and remote surgical applications.

Research published by Dessight Biomedical in Microsystems & Nanoengineering, a Nature journal, demonstrates that in subretinal injection surgery, its ophthalmic surgical robot-assisted operation offers superior precision and stability compared to manual operation: the drift in the robot-assisted group was only 41.07 micrometers, significantly lower than the 299.66 micrometers observed in the manual group.

“There was no statistically significant difference in postoperative visual acuity between the two groups, but the robotic surgery group showed a trend toward better visual recovery, and no device-related complications occurred during the procedures,” said Cui Di.

Oculotronics completed a remote robotic subretinal injection surgery in 2025. Leveraging low-latency, high-stability 5G technology, the company achieved micron-level precision in surgical operations across a distance of 4,200 kilometers. After the robotic microinjection needle entered the eye in the operating room in Xinjiang, experts in Guangzhou remotely controlled the needle to move to the retinal surface at the lesion site, penetrate to the predetermined retinal depth, and inject the medication. The entire remote procedure took less than seven minutes.

Furthermore, TIROMU has adopted a differentiated strategy by launching a specialized robotic system for fundus injection surgery. This product utilizes a slide-rail Remote Center of Motion (RCM) structure, overcoming the limitations of traditional parallel four-bar linkage mechanisms, which suffer from high cumulative errors in manufacturing and assembly as well as restricted workspaces. The system achieves an execution precision of 2 micrometers.

The revolution in intraocular injection surgery will establish a more precise drug delivery method for ophthalmic gene and cell therapies. The FDA-approved Luxturna, the world’s first gene therapy drug, is administered via subretinal injection.

Schematic diagram of subretinal injection of Luxturna. Image source: company official website

“In recent years, novel therapies for fundus diseases, such as gene therapy and cell therapy, have successively entered late-stage clinical trials. These new drugs must be precisely delivered to the subretinal space to maximize their therapeutic value,” pointed out Xue Mengjun, Managing Partner at Panlin Capital. “During my field research, I operated an ophthalmic surgical robot, which proved convenient and precise, meeting the requirements for drug administration. Robot-assisted technology is a key approach for achieving precise delivery of gene and cell therapy drugs in ophthalmology, significantly enhancing delivery accuracy and stability.”

Cui Di stated that ophthalmic surgical robots performing subretinal injections will be suited for two core scenarios:

First, traditional ophthalmic drug administration has primarily relied on intravitreal injections, predominantly involving anti-angiogenic antibody-based drugs. These are mainly indicated for age-related macular degeneration (AMD) and submacular hemorrhage, requiring repeated, regular injections, thus making them suitable for chronic conditions. However, in cases of acute submacular hemorrhage or significant bleeding volume, timely intervention is necessary, which requires subretinal drug injection to achieve rapid thrombolysis;

Second, gene therapy administration: as the internal limiting membrane serves as a natural barrier within the eye, hindering effective drug penetration, subretinal injection enables precise delivery of viral vectors directly to the target area.

As the pipeline of gene and cell therapy drugs for fundus diseases continues to expand, precise and stable subretinal injection devices will become essential infrastructure. Meanwhile, the direction of technological iteration for fundus injections has also emerged, evolving towards intelligent and autonomous injection systems.

A team from the Institute of Automation, Chinese Academy of Sciences, has validated this direction with its autonomous robotic system for microscopic ophthalmic surgery; the findings were published in Science Robotics in January 2026.

Studies have shown that the system can autonomously perform subretinal and intravascular injections throughout the intraocular space, achieving a 100% injection success rate in experiments involving ocular phantoms, ex vivo porcine eyes, and in vivo animal eyes. Compared with manual surgery performed by physicians, the average positioning error was reduced by 79.87%.

TIROMU has entered into a strategic partnership with leading OCT companies, completed the development of its Fundus Injection Surgical Robot 2.0, and integrated intraoperative OCT imaging to achieve real-time automatic surgical path planning and navigation.

These advancements indicate that ophthalmic surgical robots will evolve along a trajectory of precise manipulation, intelligent assistance, and autonomous execution, with fundus injection being the first key application scenario on this path.

In the past, high-end ophthalmic equipment in China mainly focused on follower-style innovation and domestic substitution. Today, domestically produced ophthalmic surgical robots are generally on par with overseas products, achieving leadership in certain technical dimensions.

“Overseas, only one company’s product has obtained CE certification, while the rest are still in the clinical trial phase,” said Cui Di.

This also means that, the first Chinese ophthalmic surgical robot to receive regulatory approval is also positioned in the top tier globally.

Against this backdrop, not only are companies making all-out efforts to accelerate progress, but capital investors are also heavily increasing their stakes to support regulatory approval and commercialization.

Since 2025, the field of ophthalmic surgical robotics has seen intensive financing activities, with capital allocation highly concentrated on three areas: finalizing clinical trials, regulatory submissions, and building commercialization frameworks. From the perspective of investment institutions, ophthalmic surgical robots have passed the stage of technical validation and are now approaching the "last mile" from laboratory to market.

Since 2025, ophthalmic surgical robots have seen intensive financing activities. Data source: VCBeat Orange Database

The business model of ophthalmic surgical robots is similar to that of other validated surgical robots, offering a comprehensive solution comprising console sales, compatible consumables, and equipment maintenance. The consumables include micro-needles, micro-scissors, micro-forceps, and the like.

The competitiveness of this model lies in the fact that once the equipment is installed in hospitals and physicians develop operational habits, subsequent sales of consumables and services will generate a long-term, stable revenue stream. Since the cost for hospitals to switch equipment is high, this creates a competitive barrier.

This mature business logic has also given investors the confidence to continue increasing their investments.

Xue Mengjun stated that while continuously tracking the surgical robotics sector, his team observed a clustering of regulatory approvals for laparoscopic surgical robots. With the da Vinci system enjoying high market recognition, new entrants face significant challenges in breaking through. Meanwhile, competition in the orthopedic surgical robotics segment has become intense, with companies commanding high valuations. In contrast, the microsurgical robotics sector remains a blue ocean, poised to unlock a new wave of investment opportunities. Characterized by exceptionally high technical barriers, this field has fewer than ten companies globally pursuing its development. With no products yet approved in China, competition remains relatively limited, and ophthalmic surgical robots represent a core category within this domain.

Specifically, there is a significant gap between clinical supply and demand for fundus surgery. Such procedures require operational precision at the 10-micron level, whereas the amplitude of physiological hand tremors can reach up to 100 microns. In China, fewer than 50 physicians are proficient in performing high-difficulty fundus surgeries, such as subretinal injection and retinal vessel cannulation. Meanwhile, the number of patients with fundus lesions in China amounts to tens of millions, highlighting a critical and urgent clinical need. Furthermore, clinical demand continues to expand. In particular, with the future implementation of gene and cell therapies, the market will see new rigid demand for precise drug delivery.

In Xue Mengjun’s view, the industry-wide anticipated first approval is undoubtedly a critical milestone with both formal and substantive significance.

"On the one hand, obtaining the first approval signifies full recognition by the regulatory review authorities of the company's technical capabilities and clinical achievements; on the other hand, by rapidly establishing a commercialization team and initiating academic promotion activities prior to approval, the company can quickly convert this first-to-market advantage into market share, thereby helping it secure a favorable long-term position in the industry."

Beyond its initial approval in ophthalmology, a larger market opportunity is becoming increasingly clear.

The 10-micron-level operational precision required for ophthalmic surgery is among the highest standards in the entire field of microsurgery. Xue Mengjun believes that companies capable of establishing a strong foothold at this level of precision possess inherent technological advantages when expanding into other microsurgical scenarios.

The potential for platform-based technology and expanded application scenarios has already become evident in some companies:

In addition to its developed ophthalmic surgical robot, KouTech’s general-purpose microsurgical robot is equipped with highly flexible wristed instruments featuring a diameter of only 2 mm and seven degrees of freedom, positioning it as a versatile microsurgical platform for cross-anatomical and cross-departmental applications.

Leveraging its robotic microsurgical manipulation technology platform, Dessight Biomedical has concurrently developed a general-purpose microsurgical robot capable of performing lymphaticovenous anastomosis with a precision of 0.1 mm. The company has completed over 20 human clinical cases and has entered the registration clinical trial phase.

The FUNZAR system by Deep Medical adopts a modular split design, covering more than ten surgical scenarios in ophthalmology and non-ophthalmic fields.

TIROMU is simultaneously advancing product development for additional departments, including otolaryngology and neurosurgery.

While Xianwei Medical has initiated multi-center clinical trials for its dual-arm ophthalmic surgical robot, it has also developed a microsurgical robot.

In fact, as ophthalmic surgical robots race toward their first regulatory approval, microsurgical robots have also entered a phase of intense competition.

In the first half of 2026, the microsurgical robots from Angtai Weijing and Deep Medical were included in the special review channel for innovative medical devices.

From the broader perspective of microsurgery, the entire field is exhibiting a posture of collective sprinting.

As multiple companies race neck and neck, capital pours in heavily, and regulation advances prudently, the issuance of the first registration certificate is only a matter of time.

Rather than focusing on when regulatory approval is obtained, what deserves more attention is this: undergoing validation in real-world clinical practice and continuous iteration after product launch is the most critical step for the industry to reach maturity.