Source of the article: Eye Future; Editor: SophiaReprint requirements: Can be reprinted 24 hours after the first publication, source must be credited.Recently, NMPA announced the review results of the special review application for innovative medical devices (No. 1, 2025), with 9 products entering the innovation channel, includingSuzhou Purevision Medical Technology Co., LTD.AppliedGlaucoma Drainage Device。
Purevision MedicalChina Original with Independent Research and DevelopmentGlaucoma Treatment Stent Product AqueFish®Is one of the few in the international arenaApplicable to both angle-closure glaucoma and open-angle glaucoma simultaneouslyThe stent product brings more possibilities for glaucoma treatment.
Simply put, the internal drainage principle of the AqueFish® glaucoma stent is similar to the well-known cardiac stent, but its size is smaller, with characteristic structural dimensions reaching the hundred-micron level, comparable to a hair's breadth.AqueFish® acts on the original physiological circulation channel of aqueous humor., by "propping open" the originally collapsed passage, the circulation pathway of the aqueous humor is restored, thereby achieving the purpose of lowering intraocular pressure.
AqueFish® can be applied to the vast majority of glaucoma types, including secondary glaucoma, primary angle-closure glaucoma, and primary open-angle glaucoma, and is aMore Suitable for Asian Glaucoma PatientsInnovative solutions.
According to FMI data,The net value of the glaucoma treatment market will increase from USD 5.5 billion in 2021 to USD 7.6 billion in 2032, with a compound annual growth rate (CAGR) of 3%.At present, the treatment of glaucoma mainly involves medication, laser, and surgical treatments. Reducing intraocular pressure through medication or surgery helps to slow down the progression of the disease.Medication is usually the first-line treatment, but the increasing use of eye drops may bring side effects to patients, while daily medication also poses challenges in terms of compliance and cost burden. Invasive surgeries can carry the risk of irreversible complications and often require long-term patient management. Compared with medication and surgical treatments, minimally invasive glaucoma surgery (MIGS) represents a new therapeutic approach.Small surgical incision, faster postoperative recovery, minimal impact on quality of life, usually performed as an outpatient procedure.A tiny incision smaller than 3mm can significantly reduce tissue damage and eliminate the need for suturing.With the development and promotion of technology, MIGS is expected to account for 10-15% of overall glaucoma treatment solutions by 2030, representing a patient population of over 2.5 million, conservatively estimated.The market surrounding MIGS pharmaceuticals, devices, and services can exceed 10 billion yuan.。As an emerging treatment for glaucoma, the new generation of MIGS has been widely applied on a large scale internationally. Currently, high-end ophthalmic medical devices in China are still dominated by overseas companies. Moreover, the pathogenic factors of glaucoma are complex, with numerous types of the disease and varied symptoms. Existing treatment methods cannot adequately meet the clinical needs of all glaucoma patients.General Manager of the CompanyIntroduction of Dr. Kan Min:"Although modern trabeculectomy is an external drainage filtering surgery, when the inventor Cairns first proposed trabeculectomy in 1968,The original idea was to hope that the aqueous humor could flow into the Schlemm's canal through the trabeculectomy end.Achieve the purpose of reducing intraocular pressure through internal drainage., but this idea was not realized at that time.”
"At present, the mainstream products on the European and American markets are often limited to indications for early- to mid-stage open-angle glaucoma. However, based on the characteristics of ocular anatomy in Asian populations as well as national conditions and other factors,Currently, Chinese glaucoma patients generally undergo surgical treatment at moderate to advanced stages, and most of these patients have angle-closure glaucoma."This reality of China's national conditions may lead to the problem of 'inappropriate medication' in the clinical application of imported products," said Dr. Kan Min.
Therefore, through the combination of medical and engineering,Purevision Medical Team Collaborates with Professor Liang Yuanbo's Team to Develop the AqueFish® Glaucoma Schlemm's Canal Drainage StentBy adopting physiological internal drainage, it not only reduces the damage to the endothelial cells and structure of Schlemm's canal, preserving the integrity of Schlemm's canal and trabecular meshwork to the greatest extent, but also ensures the physiological circulation of aqueous humor through a non-filtering bleb-dependent approach, reducing the incidence of related complications.
# Glaucoma Treatment Stent AqueFishSince 2015, Professor Liang Yuanbo, Vice President of the Eye Hospital of Wenzhou Medical University and Director of the Glaucoma Institute of Wenzhou Medical University, has creatively proposed penetrating Schlemm's canaloplasty, which has been clinically practiced in over 1,000 cases across more than 100 centers.Prove that the drainage pathway of aqueous humor through the trabeculectomy opening and then through the Schlemm's canal end opening is feasible and has a high success rate.。On this basis, the Purevision Medical team collaborated with Professor Liang Yuanbo's team to develop the AqueFish® Glaucoma Schlemm Canal Drainage Stent and further proposed "Stent-Assisted Internal Trabecular Drainage Surgery (SLITs)”。The core technology of this product has been granted patent authorization in China, the United Kingdom, and the United States.“AqueFish®"Stent-assisted internal trabecular bypass surgery" can maximize the preservation of the integrity of Schlemm's canal and the trabecular meshwork, reduce damage to the endothelial cells and structure of Schlemm's canal, features minimal surgical trauma and short operation time, and can be applied to patients with open-angle or closed-angle glaucoma who require surgical reduction of intraocular pressure; due to itsThe Essence of Physiological Internal Drainage, Non-Filtering Bleb Dependent, its long-term success rate may be better than traditional trabeculectomy and other methods, with a lower complication rate.August 2023, AqueFish®The world's first patient enrolled in the glaucoma stent implant surgery is 41 years old, diagnosed with advanced bilateral primary open-angle glaucoma in July 2022, with a preoperative intraocular pressure of 35.7mmHg.The surgery was performed by Professor Liang Yuanbo's team, and the entire procedure went very smoothly, with the AqueFish® stent...The implantation process takes only 2 minutes., the implantation process is convenient and fast, with a small surgical incision. The patient's vision improved on the second day after the surgery.4.9, Intraocular Pressure18mmHg, One week after the surgery, the intraocular pressure was rechecked and decreased to13mmHg。
It is reported that the exploration project is expected to enroll patients with primary open-angle glaucoma and primary angle-closure glaucoma, with a follow-up period of more than 12 months. The first patient with primary angle-closure glaucoma has also completed clinical enrollment.It is reported that the multi-center clinical randomized controlled trial of AqueFish® Glaucoma Stent, developed by Purevision Medical, is currently being conducted at 10 institutions across China, including Peking University Third Hospital and Beijing Tongren Hospital affiliated to Capital Medical University.One-third of the clinical enrollment goal has been completed within three months., further demonstrating the high compatibility of the product indications with Chinese glaucoma patients.
In December 2024, Purevision Medical attended the 2024 Academic Annual Meeting of the Glaucoma Sub-center of the National Clinical Research Center for Ocular Diseases and the 6th Academic Symposium on Glaucoma 2030. The company's team engaged with top domestic and international ophthalmology experts and researchers around...Hot topics in glaucoma basic research, clinical diagnosis and treatment, drug therapy, and minimally invasive surgical instrumentsConducted in-depth exchanges and discussions, and showcased the company's latest R&D achievements in the field of minimally invasive glaucoma treatment devices.Source: Huizhongtong Academic Conference PlatformDuring the seminar, Dr. Wenqing Ye from the Eye Hospital of Wenzhou Medical University presentedAqueFish®Summary of the Preliminary Clinical Research Results of SLITS Surgery (Stent-Assisted Trabecular Internal Drainage Surgery).Clinical results preliminarily show that the micro-stent productIt is feasible in primary open-angle glaucoma, primary angle-closure glaucoma, and some secondary glaucomas.Effectively reduce intraocular pressure levels and the usage of IOP-lowering medications in glaucoma patients., with good safety and controllable postoperative complications., looking forward to more large-sample, long-term follow-up observation data to further prove the safety and effectiveness of this product.
# AqueEel® Ophthalmic Radiofrequency Energy Platform
In addition to the AqueFish® glaucoma stent, Purevision Medical has also focused on the ophthalmic surgical energy device sector to further promote the early detection, early diagnosis, and early treatment of glaucoma and other eye diseases, and has developedFirst ProductAn innovative device that uses radiofrequency technology to control aqueous humor production in the ciliary body to achieve the goal of lowering intraocular pressure——AqueEel® Ophthalmic Radiofrequency Energy Platform。According to the introduction, although AqueEel® is similar in principle to traditional cyclophotocoagulation, AqueEel® offers higher and more precise controllability of radiofrequency energy, lower surgical operation difficulty, and consequently, milder postoperative complications.The entire surgery can be controlled within 5-10 minutes., with higher promotional and popularization value,Expected to broaden the indications to the treatment of early, middle, and late-stage glaucoma of various types.。Currently, AqueEel® has entered the type inspection stage and has preliminarily verified its safety and effectiveness in animal experiments. The initiation of human trials is also in the planning.
Suzhou Purevision Medical Technology Co., LTD. was founded in 2020 as a technology-driven startup focusing on innovative ophthalmic medical devices. It is committed to building the world's leading platform for minimally invasive ophthalmic treatment with original innovations and is currently one of the few enterprises in China that truly owns original technology in the field of minimally invasive glaucoma treatment. The company has successively been awarded honors such as "Innovative Small and Medium-sized Enterprise of Jiangsu Province," "Potential Unicorn Enterprise of Jiangsu Province," and "National High-tech Enterprise."IfBooth/White Paper/Speech SharingIf you are interested in the above content, please feel free to contact us.Contact information is as follows:You can also contact the editor-in-chief Zhao Qing, Alice, Jacky, Ziana and other staff members of the Siyu team directly.Ophthalmology Solutions Case
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