The Company's lead product is a drainage implant device that helps effectively drain eye fluid and reduces intraocular pressure that will prevent the progression of glaucoma and vision loss. InnFocus developed the Microshunt™ (formerly known as MIDI Arrow) with the University of Miami's Bascom Palmer Eye Institute (one of the leading ophthalmology institutes in the world).
The Company's goal is to provide a safe, effective, easy to perform alternative for surgical treatment of glaucoma. Primary Open Angle Glaucoma is the first area of focus and is currently under investigation in FDA trials in the US and other studies around the world.
The drainage implant consists of an extremely small micro-tube (about twice the size of an eyelash) that shunts aqueous fluid from the anterior chamber of the eye to a sub-conjunctival/sub-Tenon flap. The shunt was designed to be thin and soft to conform to the curvature of the eye.
The InnFocus Microshunt™ is designed to maintain a low level of intraocular pressure (in the mid to low teens). Intraocular pressure below 14mmHg is presumed to be paramount to preventing the progression of vision loss in glaucoma patients.
The implantation time is estimated at 15 minutes, is easy to perform and is an alternative to tube or trabeculectomy procedures.
The Microshunt™ received CE Mark in January 2012. It also has been cleared for Phase 1 clinical study by the United States Food and Drug Administration.
43 patients in France and the Dominican Republic have the device implanted in a consistent manner, and the conclusion from the study with data out to three years post-surgery is very encouraging.
The product has been implanted alone or in combination with cataract surgery in clinical trials outside of the U.S. in patients ranging from early to late stage glaucoma.
Caution: The InnFocus Microshunt™ is an investigational device in the United States and is limited by United States law to investigational use.