Beijing-Based Startups Secure Approvals for Two Groundbreaking Medical Devices, File IPO Prospectus

Recently, there has been a series of positive developments in Beijing's medical device innovation sector.Two pioneering medical devices have successively received market approval from the National Medical Products Administration (NMPA):These are the world's first treatment device for congenital nystagmus developed by Super Vision —— i-NYS implantable ocular muscle nerve stimulator, and the first domestic Class III carbon dioxide contrast pressure injection set independently developed by Amet Medical. The successive landing of these two innovative achievements highlights the core strength of the capital in high-end medical device R&D and clinical transformation.

As the world's first Class III active implantable medical device for the treatment of congenital nystagmus, i-NYS has filled the treatment gap for this "incurable" eye condition. Congenital nystagmus is a hereditary eye disease that occurs at birth or within the first six months of life, typically lasting a lifetime. The condition is characterized by involuntary rhythmic oscillations or movements of the eyeballs, often leading to decreased vision, binocular visual dysfunction, and abnormal head posture. In China, the number of patients with this condition is approximately 1.3 million.

The i-NYS approved this time installs a "precise electrical stimulation regulator" on the eye muscles and associated nerves. By setting specific current parameters, it performs individualized mild electrical stimulation intervention on the eye muscles, restoring uncontrolled twitching or swaying eyeballs to stability.This product is the result of over two decades of dedicated research by Professor Wang Lejin's team from Peking University People's Hospital. It is the first to apply neuroelectrical stimulation technology in the field of congenital nystagmus treatment and has led to the establishment of Super Vision Technology, Inc. to commercialize this scientific achievement.Clinical trials showed that, among the 71 enrolled subjects, the fixation time of the macular center improved by 587% post-surgery, while the amplitude and frequency of nystagmus decreased by 84.1% and 79.4%, respectively, with no surgery-related adverse events reported. This product has not only been selected by the National Medical Products Administration...Innovative HealthcareInstrument "Green Channel" Also Receives Humanitarian Use Device Designation from the U.S. Food and Drug Administration (FDA).

The self-developed carbon dioxide contrast pressure injection kit by Amet Medical has been approved for marketing, achieving a key technological breakthrough in the field of peripheral interventions in China.This innovative medical device replaces the traditional iodine-containing liquid "contrast agent" used in angiography with carbon dioxide gas and is paired with a dedicated automated injection device, thereby solving the imaging diagnosis challenges for populations with iodine allergies, renal insufficiency, and hyperthyroidism.Multi-center clinical studies in China show that the incidence of contrast-induced nephropathy and severe adverse events in the applicable population is 0%, significantly enhancing the safety of angiography. This product has already completed its global layout ahead of schedule, successively obtaining EU CE-MDR certification and U.S. FDA market registration.It has been approved for sale in more than 20 countries and regions worldwide, officially ushering in a new "iodine-free" era for global angiography.。

The successful implementation of two pioneering medical devices is a vivid example of the continuous optimization of Beijing's medical device industry innovation ecosystem.Relying on core industry highlands such as the Future Science City's Life Valley and Daxing Biomedical Industry Base, Beijing has established a full-chain innovation service platform covering research and development, clinical transformation, and overseas expansion. With additional policy support like the "green channel" for innovative medical devices, this ensures a supportive environment for enterprise innovation.Currently, Beijing has cumulatively approved 84 national innovative medical devices and surgicalRobot43 AI medical devices, totaling 60, both rank first in China.

Source: Beijing Daily Client