Source of the article: Eye Future ；Editor: SophiaReprint requirements: Can be reprinted 24 hours after the first publication, source must be credited.
As of 2024, the Center for Medical Device Evaluation of the National Medical Products Administration has agreed in total48 Innovative Medical DevicesEntering the special review channel, among whichFive of them are ophthalmology-related products., includingGlaucoma Drainage Device(HSGD),Ocular Muscle Neurostimulator(Super Eye Technology),Intraocular Lens(Aibono & Century Kanton & Saimeishi), specific information as follows:
# Glaucoma Drainage Device
HSGD (Suzhou) Biomedical Technology Co., Ltd. developed and produced“MicroCOGO®Trabecular Microstent Drainage System (Glaucoma Drainage Device)ForCurrently the world's smallest Class III implant, DesignFor reducing intraocular pressure in patients with mild to moderate open-angle glaucoma。
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.The smallest drainage pore size is approximately forty to fifty micrometers.。
▲Image source: Company official websiteMicroCOGO®The working principle isImplanting stents into the trabecular meshwork through an extremely 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 to bypass the obstructed trabecular meshwork.Promote Aqueous Outflow, achieving the goal of 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/moderate open-angle glaucoma and cataracts, due to MicroCOGO®The convenient and user-friendly design of the trabecular meshwork micro-stent drainage system significantly reduces the difficulty of surgical operation.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 does not require suturing.。Postoperative Follow-up on the Second Day,The patient's intraocular pressure decreased from 26mmHg preoperatively to 16mmHg.. The expert team on MicroCOGO®The micro-stent drainage system of HSGD, with its design concepts and features such as no suturing required, ergonomic design, button-triggered, and mechanical ejection implantation, has been highly recognized, and the convenience of the surgical operation is satisfactory.November 2022,The product enters the multi-center clinical trial in China., respectively 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 General Hospital of the People's Liberation Army.First Clinical Enrollment Surgery。Compared with traditional trabeculectomy, it has the advantages of small incision, simple surgical process, short learning curve for doctors, and fewer postoperative complications. This product breaks through the monopoly of foreign technologies, providing a new treatment option for glaucoma patients in China and filling the gap in this field domestically.HSGD (Suzhou) Biomedical Technology Co., Ltd. (referred to as "HSGD") was established in September 2020, with its headquarters located in Suzhou Industrial Park, China.An innovative technology enterprise focusing on the development of a full range of products for innovative minimally invasive surgical solutions in the glaucoma field.。The company is committed toThe Field of High-End Implantable Medical Devices for Blinding Ophthalmic Diseases, developedMinimally Invasive Glaucoma Surgery (MIGS) Instruments and Delivery Systems，AlsoThe First in ChinaAn innovative medical device company that has mass-produced the next-generation MIGS product and entered the clinical trial stage.Another product of the company "HSGD"PassCOGO®Glaucoma Drainage System"has also entered the clinical trial stage, making the company one of the enterprises with the most comprehensive product pipelines globally under the MIGS procedure."In July 2024, HSGD completed its Series A financing (amount undisclosed). This round of financing was led by Guohai Innovation Capital, with SIP Science and Technology Innovation Fund participating.Mainly used to promote the company's glaucoma intraocular pressure monitoring product, HSGD.Scalable production and commercialization.# Ocular Muscle Nerve Stimulator (i-NYS)Congenital Nystagmus (CN) develops between 3 to 6 months after birth and persists throughout the patient's life, characterized by rhythmic, involuntary oscillations or movements of the eyes. Due to continuous eye movement,Visual function in CN patients is significantly reduced, and the quality of life throughout the entire life cycle is markedly decreased.。▲Image source: Company official websiteThe implantable ocular muscle neurostimulator i-NYS is an innovative medical product used for treating congenital nystagmus, utilizingElectrical Stimulation Therapy for NystagmusA New Method,Stimulate the extraocular rectus muscles with microcurrents at a certain intensity and frequency to suppress abnormal nerve impulses., thereby treating nystagmus.i-NYS has obtained multiple patents domestically and internationally, completed 70 clinical human implants, and achieved positive therapeutic effects in the treatment of nystagmus.Wang Wensi, Chief Scientist of Super Eye Technology and Professor at the Faculty of Information Technology, Beijing University of Technology, explained: "This implantable ocular muscle neurostimulator is similar to products like cochlear implants and pacemakers. It has a well-encapsulated structure, containing...Wireless Power Supply, throughWireless Energy Transmission, there is a setChip System, used forPerform controlled neural stimulation in vivo, throughPositive and negative reverse-direction, repetitive and high-frequency neural stimulationThereby suppressing some of the original abnormal nerve impulses, such as nystagmus, and other issues related to the ocular muscle nervous system."Proven by 8 clinical trials,i-NYSCan reduce tremor frequency and amplitude by more than 50%，Increase Fixation Time by 3 Times，Improve vision from below 0.3 to above 0.5, this isThe World's First True Control of Nystagmus Symptoms, which is also a major breakthrough in medicine.▲Image source: Company's official websiteGaze Beyond Technology (Beijing) Co., Ltd. (referred to as "Gaze Beyond Technology") was established in 2018 and is a company focused onInnovative Diagnostic and Treatment Technologies in OphthalmologyThe start-up company was jointly founded by ophthalmology experts from Peking University People's Hospital and professors from Beijing University of Technology.The company has developed a rich pipeline of products under research and pre-research, including implantable ocular muscle neurostimulators, myopia treatment devices, implantable glaucoma micro-drainage devices, implantable adjustable intraocular lenses, as well as integrated strabismus diagnosis and treatment equipment. Among them,Implantable Ocular Muscle Neurostimulator isThe world's first and currently only treatment capable of curing congenital nystagmusProducts。In July 2024, GazeTech completed its Series B financing (amount undisclosed).The investors are Qing Shi Asset Management Group andChangping SME Growth Investment Fund.The "Intraocular Lens" product developed by Aibono De (Beijing) Medical Technology Co., Ltd.,It is an intraocular lens with an extended depth of focus effect.Capable of providing equivalent to common monofocal intraocular lensesDistance Vision Support, while allowing patients to obtainBenefits of Medium and Near Vision。CurrentlyChina relies entirely on imports for extended depth-of-field intraocular lens products.Under these circumstances, Aibei Medical’s innovative breakthrough, based on the innovation of its multiple core technologies and having obtained several patent authorizations, will achieve the first breakthrough for domestically produced similar products, filling the gap in the Chinese market.Aiboi Medical is a STAR Market listed company (Stock abbreviation: "Aiboi Medical", Stock code: 688050).Founded in 2010, it is a leading innovative ophthalmic medical device company in China. Starting with intraocular lenses, the company...China's First High-End Refractive Intraocular Lens Manufacturer。The company's main business is the research and development, production, sales, and related services of ophthalmic medical devices, with products coveringOphthalmic Surgery Treatment, Myopia Prevention and Control, and Vision Health CareThree major fields provide one-stop solutions for cataract surgery, refractive error correction, and optometric consumption.Core products in the surgical fieldIntraocular Lensand the field of optometryOrthokeratology Lenses, and includingDefocus lenses, color contact lenses, related surgical equipmentA series of supporting products, including those produced in China.The first half of 2024,The company achieved a total operating revenue of 686 million yuan,Increased by 68.54% year-on-year；Achieved a net profit attributable to shareholders of the listed company of 210 million yuan,Increased by 27.49% year-on-year。
In surgical treatment products, "Pronomia"SeriesIOL Revenue Up 30.20% Year-on-Year. Among myopia prevention and control products, "Punotong"Orthokeratology Lens Revenue Increased by 6.89% Year-on-Year"ProNuo Tong", "XinNuo Tong"Defocus Mirror Revenue Increased by 86.78% Year-over-Year. In vision health care products,Contact Lens Revenue Reaches 183 Million Yuan, Up 956.92% Year-on-Year, accounting for 26.76% of operating revenue.
The growth in company revenue drove the overall gross profit growth. However, this was affected by the price decline of intraocular lenses after centralized procurement, as well as the increasing share of vision care business, mainly contact lens products, in the company's revenue.Overall Gross Profit Margin of the Company Declines; In additionThe contact lens business is in a period of capacity expansion, with various costs being relatively high., the profit margin has not yet reached a steady state level, affecting the overall net profit growth rate of the company.
# EDOF Continuous Vision Intraocular LensThe intraocular lens entering the "green channel" this time isNew Generation EDOF Continuous Vision Intraocular Lens, with several core technologies that are首创 in China. Currently,In China, all extended depth of focus (EDOF) intraocular lenses are imported brands.The rise of domestically produced extended depth-of-field intraocular lenses will break foreign monopolies and fill the domestic gap.▲Source: Company official websiteAt the same time, Century Kaitai collaborates with experts in China on joint research., optimized design based on the height, living habits, and eye-use habits of Chinese people., aiming to achieve surpassing Chinese-made products.It is expected that in the second half of 2024, Century Kangtai's extended depth-of-field intraocular lens will be officially launched., which will enrich the choices of functional intraocular lenses for people in China and promote the rapid development of high-end ophthalmic medical devices in the country.
Tianjin Century Kaitai Biomedical Engineering Co., Ltd. (referred to as "Century Kaitai") was established in 2008,Located in the West District of Tianjin Development ZoneThe company relies on high-quality scientific research platforms,Guided by the strategic direction of "Innovative Ophthalmic Materials and Optical Design Platform", coveringIntraocular Lens, Optometry Field, Biomaterial CollagenAnd other fields.Has obtained more than 70 invention patents and utility model patents,8 Class III Medical Device Registration Certificates and 3 Class II Medical Device Registration Certificates`, Company`The intraocular lens product has also obtained CE certification.。The company is currently one of the few domestic ophthalmic companies in China that simultaneously mastersHydrophilic, Hydrophobic, Monofocal, Multifocal Intraocular Lens Optical Design, Processing and ProductionOne of the companies with core technologies such as "-0.1μm spherical aberration design", "Edge-enhanced zero spherical aberration", "Hollow haptics", and "625 large optical zone".Aspheric Intraocular Lens: A First in China; The collagen sponge product has also obtained the first Class III medical device registration certificate for full surgical use of collagen sponge approved by the National Medical Products Administration under the new standards since 2011.# Trifocal Intraocular LensHena Simi Vision Biotechnology Co., Ltd. ("Simi Vision"), a subsidiary of Haohai BioScienceTrifocal Intraocular Lens，Mainly used in cataract surgery or presbyopia correction surgery, aiming to restore or improve the patient's far, intermediate, and near vision.。HSGD's High-End Intraocular Lens ProductsDeveloped under the MOM technology platform,MOM Technology PlatformNew material formulation, precise optical control, and molding technology, launching stable and clear intraocular lenses.The product is made of acrylate material,Block UV and partial blue light, effectively protecting the surgical eye from light damage;Material with Low Flash and Excellent BiocompatibilityAlso allows patients to have better visual quality after surgery; strict optical design, precision manufacturing process, and no traditional polishing.Effectively reduces PCO(Posterior Capsule Opacification)And the probability of residual refractive error after surgery。Semeis Three-Focus Intraocular Lens Product Parameters■ Optimized C-loop design, high mechanical stability; The hydrophobic properties of the material ensure good adhesion of the product to the posterior capsule of the eye; plasma surface treatment technology reduces postoperative inflammatory response and provides excellent low-flash performance.■ Can block UV and harmful blue light, nano-level optical surface, no polishing required.■ Adopting Innovative Injection Molding Technology, Optical surface one-time molding, no polishing required; Control the position of the second principal optical plane to improve surgical prediction accuracy; Refractive power tolerance +/-0.20D, enhancing surgical precision.In September 2023, Aier Eye Hospital Affiliated to Wuhan UniversityProfessor Wang Yong, Vice President, starting from the clinical usage characteristics of the Semis hydrophobic intraocular lens,SemeisClinical Evaluation of Tri-focal Intraocular LensesConduct a detailed interpretation。Dean Wang: The trifocal intraocular lens is currently undergoing clinical research,Its additional diopters are 3.2 and 1.6, which are relatively close to ZEISS's 3.33 and 1.66.，The medium distance is also 40 to 80 centimeters.. This intraocular lens isCombination of Refraction and DiffractionThe trifocal intraocular lens has 16 diffraction rings in the middle and an effective optical aperture of 6.0 millimeters, which is also a very interesting design feature of the Saimeisi trifocal intraocular lens.Besides, HSGD's trifocal intraocular lens50% for distance vision, 20% for intermediate vision, 30% for near visionThe light energy distribution design can address the far, intermediate, and near vision needs of patients with or without cataracts; based on the patient's vision requirements, the light is asymmetrically distributed, allocated in a 20:30 ratio for intermediate and near focus.More Demand for Improving Near Vision; With a large aperture, its light can be distributed more towards the far focus, meeting the demand for long-distance vision under a large aperture.At the same time, the Semeis three-focus intraocular lens provides spherical aberration designs of 0μm, -0.1μm, and -0.2μm.Compensate for the positive spherical aberration generated by the crystal itself and the cornea, achieving superior visual quality. In clinical studies compared with the control group, we can seeThe functional distribution of the Semeis Three-Focus Intraocular Lens is ideal.。Henan Saimeishi Biotechnology Co., Ltd.Registered and established in Zhengzhou, China in October 2018, with a registered capital of 50 million yuan,Investment-controlled by Shanghai Haohai Pharmaceutical Development Technology Co., Ltd.Sino-US Joint Venture。Semeis Vision possessesThe core technical team is highly experienced, with both R&D and production leaders having over a decade of relevant experience in leading multinational companies in the overseas industry. They possess deep qualifications and numerous patents.The management team has more than ten years of international management experience in large multinational pharmaceutical groups overseas; core team members in R&D, production, and quality management all have at least five years of working experience in this field. The company utilizes internationally leading R&D, production, and testing equipment, and is committed to...Research and development and production of high-end intraocular lens series products and high-end ophthalmic equipment, providing high-quality product services for every ophthalmic patient.# Global Leading Ophthalmic Device and Consumables CompanyCarl Zeiss AG｜Alcon| J&J Vision | Bausch + LombBaushe & Lomb | EssilorEssilor | TopconTopcon | Nidek Nidek | CooperCompanies
# Chinese Ophthalmic Devices and Consumables Companies
# Chinese Ophthalmology Medical Service Company
# Overseas Ophthalmology Startups
AEYE Health | Samsara Vision | AcuSurgical | Balance Ophthalmics | CorneaGen | ThermOcular AI
