Chinese Ophthalmologists Develop Novel Implant to Combat Myopic Macular Retinal Detachment, File IPO Prospectus

Did you know that high myopia can lead to blindness?

According to data from the World Health Organization, high myopia has become the fourth leading cause of low vision globally. In East Asia, where the prevalence of high myopia is highest, this threat is silently and rapidly eroding the bright futures of millions.

Asia, the world’s most populous continent, is home to more than half of the global population and is widely recognized as a “myopia hotspot.” Here, particularly in China, wearing glasses is hardly novel—childhood and adolescent myopia rates rank among the highest worldwide, and more than half of adults rely on corrective lenses for clear vision.

However, lurking within this “myopia hotspot” is an even more at-risk population:Patients with High Myopia。

Patients with myopia exceeding 600 degrees are classified as having high myopia. In addition to requiring corrective lenses with higher prescriptions, they also need regular examinations, as they must remain vigilant against a more serious complication—Tractional Maculopathy in High Myopia:namely, macular schisis, macular hole, tractional retinal detachment, and retinal detachment associated with macular hole.

This is a blinding eye disease that is extremely easy to mistake for "ordinary vision loss." Patients typically have high myopia, and the probability of retinal detachment occurring in those with high myopia is that of normal people'sApproximately 10-fold。

In some patients with high myopia, continuous axial elongation exerts persistent traction on the retina and choroid. As the retina gradually thins and atrophies, the compensatory capacity of the macular region declines. Concurrent vitreous liquefaction leads to partial separation of the vitreous from the inner retinal surface, generating additional traction. The resulting combined internal and external mechanical forces continuously act upon the vulnerable macula. The pathogenesis of myopic traction maculopathy is the cumulative result of fundus degenerative changes induced by high myopia, along with the progressive mechanisms underlying macular hole formation and retinal detachment.

With persistent traction, the neurosensory retina in the macular region initially develops macular retinoschisis and localized retinal detachment, which subsequently progresses to a full-thickness macular hole and more extensive, severe retinal detachment.

The Harm Caused by This Category of Diseases Far Exceeds Imagination:

First, it directly damages the macular region of the retina, which is responsible for fine central vision, leading to a sharp decline in central visual acuity, metamorphopsia (distorted vision), and fixed scotomas in the visual field. If treatment is delayed, retinal photoreceptor cells will undergo irreversible apoptosis due to nutritional deprivation, resulting in permanent vision loss. More critically, even with surgical intervention, there remains a high probability of recurrence, and evenFrom “Manageable Daily Living” to “Only Light Perception Remaining” in Just a Few Yearsthe abyss of darkness.

“Patients with high myopia have inherent pathological changes in the fundus. As the axial length increases, the eyeball becomes like an over-stretched balloon, and the retina can no longer adequately ‘cover’ the expanded scleral wall. Traditional pars plana vitrectomy is difficult to completely eliminate the tractional forces on the retina.” From Zhongshan Ophthalmic Center, Sun Yat-sen UniversityProf. Liu BingqianThis is how it is explained.

As Chief Physician at Zhongshan Ophthalmic Center, Professor Liu Bingqian has performed thousands of fundus surgeries and has witnessed recurrence in multiple patients with myopic traction maculopathy.

Furthermore, he and his colleagues in the department once handcrafted patient-specific implants using available materials, aiming to prevent disease recurrence. After achieving successful outcomes in the operating room, he spearheaded the technological translation of this approach in 2019, with the goal of extending this expertise beyond Zhongshan Ophthalmic Center to provide solutions for a broader patient population.

In the field of ophthalmic clinical practice,Macular Hole Retinal Detachment in High Myopia: A Challenging Clinical Dilemma

Currently, the core treatment regimen for this condition in clinical practice is based onVitreoretinal Surgeryas the primary approach, which has long been the main “weapon” for ophthalmologists in managing retinal detachment.

The surgical rationale involves removing the vitreous humor that exerts traction on the retina, peeling off the internal limiting membrane from the retinal surface, and filling the eye with specialized gas or silicone oil. The tamponade effect of the gas or silicone oil facilitates the reattachment of the detached retina to the eyeball wall, while simultaneously promoting the closure of the macular hole.

Adjuvant regimens include traditionalMacular Scleral Buckling, the concept of this surgical procedure originates from international medical research. Its core principle involves suturing an implant onto the sclera on the external surface of the eyeball, using the supportive force of the implant to counteract the tendency for retinal detachment; theoretically, it can directly act on the site of the staphyloma.

However, in clinical practice, the concept of macular buckling has not gained widespread adoption and is used only as an adjunctive technique in select specific cases.

Neither mainstream vitrectomy nor traditional scleral buckling has addressed the underlying etiology of “staphyloma.” Relying solely on the “passive repair” offered by conventional surgical approaches will never break the vicious cycle of “surgery–recurrence–reoperation–functional decline.”

The key to breaking the deadlock lies in findingAn Innovative Solution That Precisely Conforms to Staphyloma Morphology While Ensuring Stability and Biocompatibility, shifting treatment from "passive reduction" to "active correction."“Since we know that the staphyloma is the root cause, let’s design the implant ourselves.”Professor Liu Bingqian recalls.

Professor Lin LvandProf. Liu BingqianIn the team’s initial explorations, they used routinely procured ophthalmic consumables. During surgery, physicians manually cut and polished the materials based on the patient’s ocular morphology, incrementally adjusting the size and curvature of the implants.

“Just like doing needlework, each one had to be precisely fitted, but manual craftsmanship could never guarantee consistent standards,” recalled Professor Liu Bingqian. Even so, this approach spared most patients from undergoing secondary surgeries. This persistence in “manual emergency intervention” thus carried profound significance and reinforced the team’s original commitment to developing standardized, precision-engineered implants.

Breaking the Therapeutic Dilemma of Macular Hole Retinal Detachment in High Myopia: The Core Is to Overcome"Staphyloma"this fundamental crux. Drawing on clinical surgical experience from over a thousand cases, the team has identified three core requirements that innovative implants must meet:

1. Morphological Adaptability:The protruding morphology of staphylomas varies among individuals, and the ocular surface is not a regular curved surface. Therefore, implants must be capable of flexibly conforming to the varying scleral curvatures of different patients to achieve “precise indentation,” thereby avoiding the poor fit associated with the “one-size-fits-all” approach of traditional implants.

Second, stable safety:The implant must be securely fixed to the scleral surface for the long term, preventing postoperative displacement or loosening, while avoiding compression of ocular tissues due to excessive material stiffness, as well as complications such as inflammation and rejection; its biocompatibility must be clinically validated.

3. Ease of Operation:The surgery must be performed within the confined space of the orbit; the implant should facilitate intraoperative localization and suture fixation, without increasing surgical complexity, while reducing reliance on high-end equipment to ensure the technique’s feasibility for widespread adoption.

These three requirements are essentially aimed at addressing“How to ensure that implants precisely ‘fit’ staphylomas, firmly ‘adhere’ to the eyeball, and safely ‘serve’ patients”core proposition.

With this clear goal in mind, the team embarked onMaterial Screening and Engineering Designpath of exploration. In this process, they underwent arduous trials, evolving from single-material use to composite combinations:

Initially, the team experimented with pure silicone materials. While their softness met the requirements for shaping, they lacked sufficient support, leading to postoperative displacement due to eye movement. Subsequently, pure metal materials were tested. Although these offered strong support, their rigid nature prevented them from conforming to the irregular curvature of the eyeball. Furthermore, they tended to compress the sclera, were prone to postoperative displacement, and their biocompatibility failed to meet the requirements for long-term implantation.

A single material has always been unable to balance the three major demands of “shaping, stability, and safety,” becoming the first hurdle in technological breakthroughs. Through countless clinical feedback sessions and material tests, the team discovered"Silicone + Medical-Grade Titanium Plate"The golden combination logic.

Silicone is a well-established material that has been used in orbital surgery for many years, with its biocompatibility validated over the long term. Medical-grade titanium plates, on the other hand, offer the characteristics of being “thin, lightweight, yet strong,” providing ample support without bulkiness. They effectively prevent implant displacement while avoiding compressive damage to the eyeball caused by rigid materials. Both materials are used in minimal quantities (each product weighs only a few grams), ensuring controllable costs. This approach retains the advantages of each individual material while compensating for their respective limitations, precisely addressing core clinical needs.

From material combination determination to the implementation of standardized products, the team used3-4 YearsOver time, four generations of products have been iterated, with each generation precisely optimized based on clinical feedback, addressing existing issues while continuously tackling new challenges:

Fourth-Generation Silicone + Titanium Plate Combination Implant,This mature product integrates the iterative experience of the previous three generations, thoroughly addressing the triple demands of “stability, shaping, and biocompatibility.” Featuring an integrated design, it utilizes a silicone layer for conformal shaping and a medical-grade titanium layer for support and fixation, eliminating the need for additional connecting structures and simplifying procedural workflow. Intraoperatively, the shaping can be adjusted in real time to match the curvature of the eyeball, allowing precise indentation of the staphyloma region and facilitating rapid retinal reattachment. Furthermore, the optimized ratio between these two components prevents all historical issues such as displacement, excessive compression, and complications, while also removing the dependency on expensive vitrectomy machines, thereby significantly lowering the surgical threshold.

As the fourth-generation product undergoes continuous refinement to closely align with the core essence of clinical needs, the team is simultaneously advancing team building, establishing a standardized system, and pursuing regulatory compliance submissions. Driven by the dual engines of “technological breakthroughs” and “regulatory implementation,” this approach ensures that innovative achievements are truly positioned to enter the market and serve patients, thereby achievingFrom “Laboratory Prototype” to “Clinically Viable Product”key leap.

Product iteration provides core support for the implementation of standards, while the establishment of a standard framework, in turn, guides technological optimization. Therefore, to achieve parallel advancement of technology and standards, a team with a rational structure and complementary expertise is key.

The team, starting with just over 10 members, deliberately built“Clinical + Engineering + Compliance + Market” Full-Chain Architecture, ensuring that every task is backed by professional expertise.

Core TeamProf. Lin Lü, Prof. Bingqian Liuled by clinical experts.

Professor Lin LüAs the team founder and chief scientist, he is a leading expert and discipline leader in vitreoretinal surgery, serving as the Director of the Department of Vitreoretinal Surgery at the Zhongshan Ophthalmic Center, Sun Yat-sen University. He invented“New Surgical Technique of Releasable Scleral Buckling for the Treatment of Rhegmatogenous Retinal Detachment”Published in the premier ophthalmology journal Ophthalmology, it was commented on by U.S. expert Professor Klufas MA in an editorial in Ophthalmology as“Significant Advances in Retinal Surgical Materials and Techniques over the Past Two Decades” and “Pathogenesis and Clinical Series Research on Refractory Fundus Diseases” were awarded the First Prize of the 2018 Chinese Medical Science and Technology Award.

Professor Liu BingqianAs the team founder and Director of Research and Development, he serves at the Zhongshan Ophthalmic Center of Sun Yat-sen University, where he is also the Chief Physician of the Fundus Surgery Department. He has served as a visiting scholar at the University of California and Moorfields Eye Hospital in the UK. In recent years, he has undertaken multiple research projects, including those funded by the National Natural Science Foundation of China and the Guangdong Provincial Natural Science Foundation. He served as the editorial secretary for the eight-year program textbooks "Ophthalmology" and "Ophthalmic Surgery," and has published SCI-indexed papers.Over 80 articles.

R&D ConsultantDr. Chen ShidaTo date, he has published more than 80 articles in authoritative ophthalmology journals both domestically and internationally (including over 40 SCI-indexed articles as first or corresponding author), and contributed to the writing of several ophthalmology monographs such as Clinical Glaucoma (Third Edition), Frontiers in Basic Ophthalmology, and Chinese Clinical Diagnosis and Treatment Manual for Glaucoma.

General Manager Lan possesses extensive experience in market management and new technologies, having previously held positions at multinational corporations such as Abbott Medical Optics, Bausch + Lomb, and Topcon. The new technologies he introduced achieved a significant market share within a short period.Top Three。

Deputy General Manager Li has experience in the registration of polymer-based medical devices and implantable medical devices.Over 20 Yearsof medical device registration compliance experience, enabling the synchronized advancement of regulatory submission work.

Team StructureIt has broken down the fragmented model in which “doctors only submit requirements, engineers only build products, and compliance personnel only handle regulatory submissions.”, establishing an efficient and collaborative working mechanism.

Clinical experts participate in discussions on product mold design to ensure surgical ease of use; engineers observe surgeries in the operating room to understand the clinical rationale behind staphyloma indentation; and compliance personnel regularly communicate with the R&D team to integrate regulatory requirements into product optimization details. It is this comprehensive collaboration that enables the efficient advancement of technological iteration and regulatory framework development.

Zhongshan Ophthalmic CenterAs a “benchmark” for ophthalmic diagnosis and treatment in China, it sees a large number of patients with fundus diseases associated with high myopia every year, accumulating abundant clinical case resources—this has become the most valuable “database” and “testing ground” for the research and development of products related to complex eye diseases.

During the product iteration process, the team has only implemented macular buckling for tractional maculopathy associated with high myopia.Over 2,000 cases, having accumulated extensive experience in surgical procedures, and based on this, established a computational model for personalized positioning parameters, providing robust data support for the precise design and optimization of implants.

In 2021, the product was successfully accepted into the Special Review Channel for Innovative Medical Devices.

Based on clinical data comparison and cost accounting, the overall treatment regimen (including surgery) is controlled withinUnder RMB 30,000, which is significantly lower than the cost of traditional vitrectomy, which exceeds RMB 20,000 for a primary procedure and ranges from RMB 40,000 to 50,000 for revision surgery. Meanwhile, with future inclusion of the product in the Diagnosis-Intervention Packet (DIP) payment model, the overall surgical procedure will be priced as a bundled package, ensuring that consumables do not count toward hospital costs. This approach not only alleviates the financial burden on patients but also enhances hospitals’ enthusiasm for promotion, thereby laying the foundation for widespread clinical adoption of the product.

The company has launched a new round of financing worth 30 million yuan, with the aim of continuing to advance clinical trials and regulatory submissions for its products with the support of these funds.

They aim to further expand prospective clinical studies to validate the product’s safety and efficacy, complete patient enrollment for registration-related clinical trials as scheduled, and initiate preparatory work for market commercialization.

Meanwhile, in addition to submitting qualification applications to the NMPA, they plan to pursue overseas product certifications and initiate market research in various international regions to pave the way for global expansion. Market access and registration strategies for different regions are also being planned and advanced.

In terms of products, in addition to the existing implant for macular hole retinal detachment, they aim to continue investing in research and development, strategizing next-generation products to maintain their technological leadership.

It is reported that the team has engaged in exchanges with numerous international ophthalmology experts, many of whom have expressed interest in collaborating on multicenter studies. The team looks forward to promoting this China-originated surgical technique globally, bringing benefits to patients in more countries and regions.

For Ruiqina, early clinical validation is merely the starting point. To ensure the widespread adoption of its proprietary “Precise Applanation” surgical technique, it is essential to establish a critical pathway encompassing “technical training, physician empowerment, and channel expansion.” Only by enabling ophthalmologists at more hospitals to master and effectively utilize the technology can the product achieve market scale and the company realize sustainable development.

From initial manual polishing to the iteration of four generations of products, from repeated laboratory testing to extensive clinical validation, every step forward by the Ruiqina team has stemmed from a simple original aspiration:Minimizing Suffering and Costs, Preserving Vision for Patients with Retinal Detachment Due to Macular Holes in High Myopia

Meanwhile, the team also looks forward to collaborating with more industry peers to advance the improvement of China’s medical innovation ecosystem, enabling more original medical technologies to transition from laboratories to clinical practice and achieve breakthroughs in import substitution. By making healthcare products intelligently manufactured in China accessible to patients worldwide, we aim to write a compelling chapter of Chinese innovation in the global healthcare landscape.

Expert Commentary:

Chen Yiqun, General Manager of Shangjun Investment