KeraMed, Inc. – Dedicated to Corneal Surgery. We are a medical device company that specializes only in surgical devices and implants for the cornea. We are located in Orange, CA, USA. KeraMed, Inc. was founded in 2005 by Yichieh Shiuey, MD a corneal specialist and former Associate Chief of Ophthalmology at Harvard Medical School.
Our products include the KeraKlear Artificial Cornea and the EndoInjector. The KeraKlear Artificial Cornea is a medical device for the treatment of cornea blindness. The KeraKlear is designed to be implanted into a partial thickness corneal pocket made by a femtosecond laser through an opening of 3.5 mm in diameter. The KeraKlear is a non-penetrating artificial cornea which requires removal of only 5% of the recipient corneal tissue for implantation.
The EndoInjector is an injector for endothelial keratoplasty that allows one handed insertion through a 3.2 mm clear corneal incision without forceps. Six month average endothelial cell loss is only 14% for the EndoInjector as compared to 34% for forceps.
KeraMed Inc. operates under the highest quality standards and is ISO-13485 certified, which allows it to design and manufacture ophthalmic medical devices for Europe and the United States. KeraMed Inc. has received three CE marks, which allow the use and sale of the KeraKlear artificial cornea, the KeraKlear artificial cornea injector and the EndoInjector (Formerly known as Endoshield) in Europe. We are currently starting the sales of the EndoInjector DSEK graft inserter throughout Europe. A U.S. 510K clearance for The EndoInjector DSEK graft injector is pending.
The EndoInjector and the KeraKlear Artificial Cornea have received European CE Mark approval.
CAUTION: The EndoInjector and the KeraKlear are investigational devices, limited by federal (U.S.) law to investigational use and are not available for sale in the United States.