FDA Breakthrough Status Granted for Implandata’s EYEMATE System

Implandata Ophthalmic Products, a digital health company with offices in Germany and San Diego, Calif., has announced that its EYEMATE system for digitally enabled remote patient monitoring and management of glaucoma has obtained Breakthrough Device Designation (BDD) from the U.S. Food and Drug Administration (FDA). A BDD is only assigned for breakthrough technologies that have the potential to provide more effective treatment of life-threatening or irreversibly debilitating diseases in order to provide patients and physicians more timely access to such technologies without compromising safety.
 
The patented EYEMATE system is the world’s only clinically-validated product used for comprehensive remote glaucoma monitoring. It empowers patients with the ability to measure their intraocular pressures from anywhere and anytime, and then automatically send that information in real-time to their doctor. This information empowers doctors to adjust glaucoma therapy based on a patient’s current condition rather than make therapeutic adjustments only during an office visit.
 
Max G. Ostermeier, CEO and founder of Implandata, stated: “We are extremely pleased to move forward under the FDA BDD program, as we will benefit from additional FDA input during the premarket development as well during the submission process and through an expedited review once the submission is filed. With FDA market authorization, the EYEMATE system will now be entitled to Medicare Coverage of Innovative Technology for at least four years, offering beneficiaries predictable access to the breakthrough EYEMATE system, helping to improve their health outcomes.”

Eighty million people with age-related chronic eye disease glaucoma suffer the risk of permanently losing vision, eventually going blind. Current practice (typically two to four office visits/year) is insufficient to prevent vision loss for many patients. Glaucoma status between visits is unknown. Though doctors have a plethora of treatment options, delayed detection of disease progression delays therapy adjustment and results in further loss of eyesight.
 
Robert N. Weinreb, M.D., chair and distinguished professor of Ophthalmology at University of California, San Diego and Implandata medical advisor, said: “The BDD for the EYEMATE system is exciting news. It is an important step towards developing a digital platform for using intraocular pressure and other diagnostic data to enhance management of glaucoma patients.”
 
EYEMATE is the only CE-marked and clinically-validated system for continual, remote monitoring and management of glaucoma patients. Implandata’s proprietary biosensors and cloud-based, artificial intelligence system alert patients and their eye doctor in real-time of uncontrolled glaucoma, enabling real-time therapy adjustment to prevent vision loss.

“Our clinical experience with the EYEMATE system in Europe has been very positive as evidenced by over a 100.000 pressure readings that have been taken by patients who have had the EYEMATE sensor implanted. The real-life information provided by the EYEMATE system enables eye care specialists to better understand a patients’ disease and to apply more effective treatments in a timely fashion. And patients are empowered via self-monitoring, resulting in improved therapy adherence,” said Kaweh Mansouri, M.D., M.P.H, consultant ophthalmologist at Clinique de Montchoisi Lausanne/Switzerland, adjoint professor at the Department of Ophthalmology, University of Colorado, Denver, and Implandata’s chief medical officer.
 
Implandata is a digital health company dedicated to improving the life of millions of glaucoma patients. Breakthroughs in biosensing, telemetry and data analytics led to the EYEMATE system. The CE-marked EYEMATE system is in use at leading eye centers in Europe.