Implandata Successfully Gains CE Mark for its EYEMATE System for an Orphan Eye Indication

Ophthalmic sensors and digital health company Implandata Ophthalmic Products GmbH (Implandata) announced today that it successfully attained CE mark for its EYEMATE system for use in patients undergoing keratoprosthesis surgery. Keratoprosthesis represents an infrequent yet important procedure for restoring vision; it is performed on patients whose donor cornea transplantation procedure has failed or shows only limited success. Increased intraocular pressure (IOP) in keratoprosthesis patients is a frequent and major post-surgical complication, resulting in failure of the procedure, secondary glaucoma and, consequently, vision loss.

Implandata’s CE-certified and now commercially-available product allows ophthalmologists to detect increased IOP and to better manage the patient’s condition, minimizing the risk of post-surgical complications and associated vision loss. This is particularly important given that keratoprosthesis patients are typically younger individuals, where preservation of vision is extremely important and costly. Implandata’s proprietary EYEMATE eye pressure sensor is implanted in such patients in conjunction with the keratoprosthesis procedure, enabling continual monitoring of the eye pressure. With EYEMATE, increased IOP can be detected early on and ophthalmologists are able to better manage challenging situations encountered in such patients.

Prof. med. Claus Cursiefen, Director of the Eye Center of University Hospital Cologne (Germany) and President of the German Association of Ophthalmologists (D.O.G) emphasizes: "Keratoprosthesis surgery is often the last option for these patients to see again. Glaucoma is a severe long-term threat to keratoprosthesis surgery success and there is a significant unmet need to precisely measure intraocular pressure in these patients. This was impossible prior to this novel technology from Implandata."  Prof. Cursiefen, together with Prof. med. Thomas Neuhann, Munich (Germany), has been the Principal Investigator of the multi-center ARGOS-KP01 clinical study, where safety and performance of the EYEMATE system have been demonstrated in keratoprosthesis patients.

"Though increasing, the number of patients undergoing keratoprosthesis procedure is still rather low, compared to other procedures performed in the eye care field," explains Implandata’s CEO, Max Ostermeier. "Implandata realized that there is a grossly underserved medical need for these patients in order to attain better post-surgical monitoring. Keratoprosthesis is a costly and complex procedure to restore vision in patients. Potentially impairing again their ability to see because of secondary glaucoma or other post-surgical complication is extremely frustrating for ophthalmologists, but especially sad for patients and their families. We are convinced that our EYEMATE system will enable eye doctors to better manage these critical patients and support their efforts to preserve vision."

With the CE mark, Implandata is now making its EYEMATE system available to clinical centers performing keratoprosthesis procedures across Europe. Implandata is currently introducing the already CE approved EYEMATE product for use in primary open angle glaucoma patients in various markets.

About Implandata
Implandata is a privately-held, ISO 13485-certified sensor and digital health company, which was founded in 2010 in Hannover, Germany. Implandata has developed the world’s first system for continual monitoring and remote management of intraocular pressure in glaucoma patients. The EYEMATE system consists of an implantable, permanent IOP pressure sensor for direct measurement and continual monitoring of eye pressure. The EYEMATE system is complemented by a patient device for automated intraocular pressure data acquisition and real time data-provision to the eye care specialists.

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