Help the blind recover their eyesight and realize their dreams today
On December 7, Beijing Mihe medical device Co., Ltd. (hereinafter referred to as "Mihe medical") officially obtained the class III medical device registration certificate issued by the State Drug Administration, and the product name is artificial cornea. The acquisition of the registration certificate has opened the "last kilometer" for the listing of Michaelis artificial cornea.
24-year journey, return home with reputation
The achievement of any career is by no means overnight. There are smooth roads, dangers, peaks and difficulties. The 24-year development of MIH medical has well confirmed this.
In 1997, MIH medical was established and began to develop artificial cornea. Two years later, the company officially conducted a human trial of artificial cornea. In 2010, Mihe medical began to establish an artificial cornea production base; In 2012, MIH medical obtained the production license and officially declared MIH artificial cornea products. In 2014, the company signed agreements with Beijing Tongren Hospital and PLA General Hospital to conduct clinical trials in the two hospitals. In 2018, it obtained the special approval of green channel innovative medical devices, and the approval was accelerated. In 2020, Mihe medical started registration declaration and system verification. A year later today, MIH artificial cornea officially obtained the "legal ID card".
What many people don't know is that artificial cornea belongs to three types of medical devices. Before mass production, it needs to go through a series of steps, such as technology research and development, process confirmation, physical and chemical performance testing, registration and inspection of national authorities, animal experiments, clinical trials and so on, in order to obtain the medical device registration certificate issued by the State Food and drug administration. This is a long process. Two generations of Mihe medical have gone for 24 years, and the hardships are very understandable. But they never thought of giving up, helping the blind recover their eyesight and making domestic artificial cornea go to the world, which is their lifelong pursuit.
Don't forget your original heart and set out bright
For patients with corneal blindness, corneal transplantation is the only effective treatment. However, due to the shortage of donor cornea, there are less than 5000 corneal transplantation operations in China every year. Therefore, some patients with corneal blindness can only rely on artificial cornea if they want to see light again. That is, artificial transparent materials are implanted into the eyes to replace the turbid cornea and play its role.
Michaelis medical has been devoted to research for many years, made continuous technological innovation, created a precedent of "no need for living cornea", and solved the problems of lack of corneal donors and rejection of corneal transplantation. At the same time, Michaelis artificial cornea has a wide range of indications. According to official documents, mikh artificial cornea is suitable for patients with bilateral corneal blindness who are difficult to succeed in corneal transplantation, including corneal transplantation failure, severe keratoconjunctival scar vascularization caused by chemical injury, thermal burn and explosion injury, eyelid atresia, and serious autoimmune diseases (such as Steven Johnson syndrome and cicatricial pemphigoid), Corneal blindness caused by end-stage dry eye.
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 registration certificate is obviously not a full stop, but a comma for accelerating the development of artificial cornea; Not the end, but a new beginning. Next, Mihe medical will move forward with everyone's trust and trust, constantly improve product technology and service level, and go all out to help the blind recover their eyesight and fight for the light!