Source of the article: Eye Future ；Editor: Bai XiaofeiReprint Requirements: Can be reprinted 24 hours after the first publication, source must be credited.
Recently, the National Medical Products Administration released the "Public Notice of the Review Results for Special Review Applications for Innovative Medical Devices (No. 1, 2024)", announcing that a total of seven devices are proposed to enter the special review process for innovative devices, includingSuper VisionTheOcular Muscle Neurostimulator (i-NYS)。i-NYS is an innovative product with independent intellectual property rights, developed over 19 years by Professor Wang Lejin's team at Peking University People's Hospital.The World's FirstDedicated toTreatment of Congenital NystagmusNew Technology。
Professor Wang Lejin founded Super Vision Technology, Inc.Clinical Medical Technology for Product Transformation, developed throughNeuromodulation TechnologyControl of Congenital Nystagmusi-NYS Implantable Ocular Muscle Neurostimulator, isThe World's First and OnlyUsed forTreatment of Congenital NystagmusThe third class of active implantable medical devices is expected to completely solve the treatment challenges of nystagmus.
As of October 26, 2023, the safety and efficacy clinical trial of i-NYS for the treatment of congenital nystagmus conducted in ChinaAll subjects have been enrolled.。
Congenital Nystagmus(Congenital Nystagmus, CN) is called"Incurable Diseases" in the Field of Ophthalmology，It is caused by abnormal neural discharges in the brain, leading to eye oscillation or twitching. It is often induced by genetic mutations, with onset occurring between 3-6 months of age and persisting throughout life.. The incidence rate of nystagmus in the newborn population is one in a thousand.85% of patients suffer from amblyopia, affecting their quality of life., severe cases cannot study or work normally, and their lives are severely restricted,Brings a huge burden to families and society.Currently, there are approximately 1.3 million patients with nystagmus in China.Approximately 20,000 new patients are added each year.; There are approximately 7 million patients worldwide,100,000 new cases each year. Current treatment methodsStill mainly rely on surgical treatment, with non-surgical treatment as an auxiliary method, focusing on reducing nystagmus and correcting head position, but these methods are merelyAlleviate symptoms but cannot cure the root cause.。Ocular Muscle NeurostimulatorCan achieve the effect of controlling nystagmus by stimulating the patient, which is different from traditional surgical treatment.The effect is more stable, and the long-term prognosis is good.。In 2004, Professor Wang Lejin proposed based on the experimental results of Liberson Functional Electrical Stimulation (FES) technology.Combining Functional Electrical Stimulation (FES) Technology with Extraocular Muscles, creating products that can eliminate nystagmus and improve vision.
Since then, the project has been persisting in experimentation. Around 2008, expert论证 began, and in 2012, the project started to develop equipment. In 2014, the project received the National Major Instrument Project from the National Natural Science Foundation of China. In 2015, it received 7.1 million yuan in support from the National Natural Science Foundation's Major Instrument Project.In the same year, the project conducted microelectrode stimulation experiments on the eye muscles of clinical patients. The results showed that the microcurrent overlapped and neutralized abnormal nerve discharges, effectively suppressing abnormal nerve impulses with significant outcomes.Professor Wang Lejin introduced that this intelligent nystagmus neuromuscular electrical stimulator product is expected to fill the gap in the treatment of nystagmus.The market space in China is expected to reach 20-40 billion yuan., andThe global market size will exceed 10 billion.。▲Image source: Company official websiteImplantable Ocular Muscle Neurostimulator (i-NYS) isWorld's FirstUsed forTreatment of Congenital NystagmusTheImplantable Neurostimulation DeviceThe i-NYS implant and its unique electrode suppress abnormal nerve impulses of congenital nystagmus by microcurrent stimulation of the ocular muscles, achieving the goal of inhibiting nystagmus. The i-NYS has obtained multiple patents domestically and internationally, completed 70 clinical human implants, and achieved good therapeutic effects in the treatment of nystagmus.Wang Wensi, Chief Scientist of Super Vision and Professor at the Faculty of Information Technology of Beijing University of Technology, explained:"This implantable eye muscle neurostimulator is a product similar to cochlear implants and pacemakers. It has highly advanced encapsulation, 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 stimulation, thereby 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 isWorld's First True Control of Nystagmus Symptoms, which is also a major breakthrough in medicine.▲Image source: Company's official websiteSuper Vision Technology, Inc. (referred to as "Super Vision") 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.Super Vision 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, and strabismus diagnosis and treatment integrated machines. Among them,The implantable ocular muscle neurostimulator is the world's first and currently the only product capable of curing congenital nystagmus.。Super Vision's Congenital Nystagmus (CN) Neuromodulation System and Therapy represent a groundbreaking treatment approach for nystagmus, bringing revolutionary changes to CN treatment; Corneal/Scleral Cross-Linking Technology explores possibilities in corneal refractive correction and scleral reinforcement surgery. Additionally, the strabismus diagnosis and surgical planning system enhances the accuracy of strabismus diagnosis while optimizing the design of strabismus surgery.Since Super Vision Technology, Inc. settled in the Zhongguancun Dongsheng International Science Park in 2020,The company has developed rapidly and has currently accumulated financing of over 100 million yuan.In 2020, the prototype of Super Vision's implantable ocular muscle neurostimulator was launched, representing that Chinese companies have mastered the key core technologies in the field of Class III active implantable medical devices, breaking the international technology monopoly; In 2021, a GMP factory was established, allowing the company to independently register products and manufacture. In 2022, Super Vision Technology, Inc. initiated type inspection; In early 2023, pre-clinical screening and surgical preparation began, led by Professor Tao Yong from Beijing Chaoyang Hospital.Successfully Completed the World's First Subject Implant Surgery。As of the date of publication,The company has received a total of 5 rounds of financing., the latest round was in December 2022Nearly 100 Million Yuan in A+ Round Financing. This round of financing was led by Fosun Health Capital's Xing Future Venture Capital Fund, with participation from Ming Heng Industry Investment and Zhongzhi United.The funds will be used for the clinical trials of the world's first nystagmus electrical modulation product and the research and development of a new generation of implantable medical chips, while also accelerating the advancement of new product development for myopia correction.。The company's financing history is as follows:
