On December 16, Beijing Mihe Medical Devices Co., Ltd. (hereinafter referred to as "Mihe medical") obtained the medical device production license issued by Beijing Municipal Drug Administration. After the license is obtained, Mihe artificial cornea will be officially put into production.
On December 7, the State Drug Administration approved the registration of Mihe medical innovative product "artificial cornea", which was reported by various media. Nine days later, Mihe medical obtained the medical device production license. Since then, Mihe medical has pressed the "fast forward" button for the cause of blind rehabilitation.
According to the World Health Organization's global data report on visual disability, there are more than 8 million blind people in China. Corneal disease is the second major blindness after cataract. At present, there are about 4 million patients in China, increasing at the rate of 100000 per year, of which 10% are severe corneal blindness. These severe patients often suffer from severe corneal chemical injury or thermal burn, resulting in complete corneal destruction, multiple donor corneal transplantation failures, corneal coverage by a large number of neovascularization and so on. If the traditional corneal transplantation is carried out, the rejection reaction is easy to occur after the operation, resulting in the failure of the operation. The implantation of artificial cornea is their only choice.
Michaelis artificial cornea is a product completely made of artificial materials, which does not need donor cornea, which is helpful to alleviate the current situation of donor cornea shortage in China. The product is suitable for patients with bilateral corneal blindness who are difficult to succeed in corneal transplantation, including severe keratoconjunctival scar vascularization and eyelid atresia caused by corneal transplantation failure, chemical injury, thermal burn, explosion injury, etc, Severe autoimmune diseases (such as Stevens Johnson syndrome and cicatricial pemphigoid) and corneal blindness caused by end-stage dry eye provide a new way for the clinical treatment of patients with contraindications to traditional corneal transplantation.
In other words, patients who cannot recover their eyesight through traditional corneal transplantation will have "medicine" to save. At the same time, it also marks that the domestic artificial cornea technology with completely independent intellectual property rights has reached the world advanced level and filled the gap in ophthalmology.
The acquisition of the production license indicates that the production line of MIH medical has met the requirements of commercial production of artificial cornea, which undoubtedly paved the way for MIH medical to enter the international market and won the first opportunity to develop the artificial cornea industry. In the future, Mihe medical will continue to improve the company's product R & D, innovation ability and service level, and go all out to help the blind recover their eyesight and fight for the light!