Source: Eye Future; Editor: Bai Xiaofei
Reprint Requirements: Can be reprinted 24 hours after the first publication, source must be cited.Recently, the CMDE issued a notice, and Document No. 1 of 2024 announced seven products enteringInnovation ChannelThe equipment, includingHSGDTheGlaucoma Drainage Device (MicroCOGO® Trabecular Micro-Stent Drainage System)。
In November 2022, the product entered a multi-center clinical trial across China, completed at the "China Minimally Invasive Glaucoma Surgery Research & Training Center" of the Eye, Ear, Nose, and Throat Hospital affiliated with Fudan University and the Third Medical Center of the Chinese People's Liberation Army General Hospital.FirstExample of Clinical Enrollment Surgery。
It is reported that the "MicroCOGO® Trabecular Micro-Stent Drainage System" is designed for patients with early to mid-stage open-angle glaucoma.Currently the smallest Class III ophthalmic implant in China. This entry into the innovation channel has achievedA New Generation of Minimally Invasive Glaucoma Surgery (MIGS) Produced in China（Minimally Invasive Glaucoma Surgery, MIGS）ProductBreakthrough from "0 to 1", filling the gap in China's product field.
# Overview of the MIGS Procedure MarketAccording to FMI data,The net value of the glaucoma treatment market will increase from USD 5.5 billion in 2021 to$7.6 Billion in 2032, with an average annual compound growth rate of 3%.At present, the treatment of glaucoma mainly includes medication, laser, and surgical treatments. Reducing intraocular pressure through medication or surgery helps to slow down disease progression. Medication is usually the first-line treatment, butGradually increasing the 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 may pose risks of irreversible complications and usually require long-term patient management.。
Compared to medication and surgical treatment, the reason why Micro-Invasive Glaucoma Surgery (MIGS) has gained attention in glaucoma treatment methods isMIGS technology has the advantages of being minimally invasive and safe.MIGS belongs to a new type of treatment method.Small surgical incision, faster postoperative recovery, minimal impact on quality of life, typically performed in an outpatient setting, with a micro-incision of less than 3mm.Can significantly reduce tissue damage andCanSuture-free。As a new approach for glaucoma treatment, the new generation of MIGS has been widely applied on a large scale internationally. Since the FDA approval in 2018 of a series of products represented by iStent inject®, over a million glaucoma patients worldwide have undergone MIGS procedures for intervention and treatment within four years. Among these,iStent from Glaukos in the U.S. and XEN from AbbVieAs a typical representative.▲Glaucoma MIGS Surgical Products (Data Source: Pubmed)At present, China only hasIndependently developed by Tianjin YoushiUsights Microcatheter Surgical SystemObtained NMPA marketing authorization in October 2022, becomingThe First in China to be Approved for MarketingTheChina-produced Glaucoma MIGS Surgical Products; andXEN by AbbVieMinimally Invasive Glaucoma Drainage DeviceIn 2020, it was approved for marketing in China through real-world data research in Hainan. In China, apart from HSGD, other companies such as Chaosight Technology, Mingche Bio, Longmu Medical, Huashinuowei, and Migos are also developing the next generation of MIGS products.With the development and promotion of technology,The proportion of MIGS in the overall glaucoma treatment options is expected to reach 10-15% by 2030., i.e., exceeding 2.5 million patient population, a conservative estimateOnly around MIGS pharmaceuticals, devices, and services can be formedA market exceeding 10 billion yuan。# MicroCOGO® Trabecular Micro-Stent Drainage SystemMicroCOGO® Trabecular Micro-Stent Drainage System is designed for patients with early to mid-stage open-angle glaucoma and is currentlyThe Smallest Class III Implant in Clinical Stage by a Domestic Enterprise in China. According to the company's person in charge, this systemThe diameter of the peripheral stent is less than 300 micrometers., The stent also features highly precise drainage channels, special coatings, and other designs, with the smallest drainage pore size being approximately forty to fifty micrometers.▲Image source: Company official websiteThe working principle of MicroCOGO® isImplanting stents into the trabecular meshwork through an ultra-fine needle, with its head embedded in Schlemm's canal and its tail exposed to the anterior chamber. The hollow lumen and side holes of the trabecular meshwork micro-stent create an aqueous humor channel across the trabecular meshwork, bypassing the obstructed trabecular meshwork to promote aqueous outflow, thereby reducing intraocular pressure in glaucoma patients.▲Image source: Company official websiteIn the first clinical enrollment trial, the patient was a 73-year-old male with mild to moderate open-angle glaucoma and cataracts. The convenient and user-friendly design of the MicroCOGO® Trabecular Micro-Stent Drainage System significantly reduced the difficulty of the surgical procedure.Without the need for additional large equipment，Can be completed under a conventional ophthalmic optical surgical microscope with the assistance of a gonioscope.The micro-stent implantation can be completed within 3 minutes, with a minimal incision that requires no suturing.。On the second day of postoperative follow-up, the patient's intraocular pressure decreased from 26mmHg preoperatively to 16mmHg. The expert team highly recognized the design concepts and features of the MicroCOGO® Trabecular Micro-Stent Drainage System, such as no suturing required, ergonomic design, button-triggered, and mechanical ejection implantation, and expressed satisfaction with the operational convenience of the surgery.
HSGD (Suzhou) Biomedical Technology Co., Ltd. (referred to as "HSGD") was established in September 2020, with its headquarters located in Biobay, Suzhou Industrial Park, China. It is a company focused onInnovative Minimally Invasive Surgical Solutions in the Field of GlaucomaAn innovative technology enterprise developing a full range of products. The new generation of MIGS products developed by HSGD significantly broadens the surgical applicability with excellent safety and efficacy.HSGD is committed toHigh-End Implantable Medical Devices for Blinding Ophthalmic DiseasesField,Developed minimally invasive glaucoma surgery (MIGS) instruments and delivery systemsSystem。As a leading enterprise in the field of China's new generation of MIGS, HSGD has built a complete product matrix to accelerate breakthroughs in related products for China’s new generation of MIGS. The product with the fastest progress and already in the innovation channel is the "MicroCOGO Trabecular Micro-Stent Drainage System," designed for patients in the middle to early stages of open-angle glaucoma.The company is alsoThe First in ChinaAn innovative medical device enterprise that mass-produces the next-generation MIGS products and advances them into clinical trial stages.。Another product of the company"PassCOGO® Glaucoma Drainage System" has also entered the clinical trial stage.. This product belongs to the glaucoma drainage device category, establishing a new aqueous humor drainage pathway between the anterior chamber and the subconjunctival space to achieve long-term stable control of intraocular pressure. This also positions the company asOne of the companies with the most comprehensive product pipelines for MIGS procedures globally。As of the date of publication,The company has completed 3 rounds of financing in total., the latest financing was the Series A round in September 2022,Led by Delian Capital, with investments from Rongquan Capital and Huahong Capital, and continued support from Boyuan Capital and Taifu Capital. This round of financing will mainly be used to advance the national multi-center clinical trials of the company's glaucoma minimally invasive products MicroCOGO® and PassCOGO® in China, while accelerating the research and development, clinical applications, and production of other innovative ophthalmic products in multiple pipelines.The company's financing history is as follows:
Editor-in-Chief | Zhao Qing Reviewed by | Yi He
