EPFL spin-off Rheon Medical has developed the world’s first adjustable glaucoma drainage system, which has already been used successfully in over 250 patients in Europe. 6 million Series C funding round in December 2020 and just received the U.S. FDA’s Breakthrough Device Designation for its technology.
Glaucoma is one of the leading causes of blindness, afflicting more than 75 million people worldwide. "It’s most often due to an increase in a patient’s intraocular pressure (IOP). When this pressure gets too high, the optic nerve could get damaged and, if left untreated, result in vision loss," says Nikos Stergiopulos, founder and CEO of Rheon Medical and head of EPFL’s Laboratory of Hemodynamics and Cardiovascular Technology.
Stergiopulos’ father suffered from glaucoma, causing him to lose one eye and impairing his vision in the other. At the time, Stergiopulos was supervising a PhD candidate who was an ophthalmologist. "I asked him about the different possible treatment options, and he explained that the disease is first treated with eye drops," says Stergiopulos. "But at some point, the eye drops are no longer enough and surgery is needed to lower the patient’s IOP. That is done with glaucoma drainage devices called aqueous shunts."
The problem with these shunts is that they have a fairly high rate of post-surgical complications and often lead to surgical failures when the patient’s IOP is not sufficiently controlled. "My PhD candidate mentioned that it would be really helpful to be able to control fluid flow in the glaucoma drainage tubes. I spent a whole weekend thinking about it and eventually came up with a potential solution," says Stergiopulos. "Since my areas of expertise are fluid mechanics and medical devices, the idea I had was to insert a magnetic disc in the tubes that ophthalmologists could turn non-invasively to change fluid resistance. That was the simplest thing I could think of."
A major breakthrough
To take his idea further, Stergiopulos filed an Invention Disclosure Form with EPFL’s Technology Transfer Office, which used this information to apply for a patent. The first prototypes were developed within his lab. "We were able to make a tiny, curved device that was only 0.7 mm thick," he says. He named his device the eyeWatch.
Once an eyeWatch is implanted, ophthalmologists can easily monitor and correct the patient’s IOP by making just a few simple non-invasive adjustments during routine check-ups. "The key component of our device is its rotating magnetic plate," says Stergiopulos. "Ours is the first non-invasive pressure-adjustment system in the world for treating glaucoma."
Rheon Medical was incorporated on 24 March 2010 after pre-clinical research proved successful. The firm licensed the patent from EPFL - patents have since been granted by the European Patent Office and offices in the US, China and Japan - in order to raise funds and carry out the clinical trials needed for market approval.
Over 250 patients treated successfully
Since then, Rheon Medical has been steadily making a name for itself. It received the European Union’s CE mark in 2019 and won the Swiss Medtech Award in 2020. In December 2020, the company closed a Series C funding round in the amount of CHF 5.6 million; in May 2021, the US Food and Drug Administration (FDA) granted Breakthrough Device Designation for the eyeWatch. "This marks an important step in our strategy to bring our innovative glaucoma drainage device to the US market, which is the biggest in the world," says Stergiopulos.
Today, the eyeWatch has been used successfully in over 250 patients across Europe, and the number of centers adopting the device is rising. "Centers in Italy, Germany, Spain and the UK have recently started using our technology and have secured distribution agreements with firms in the United Arab Emirates, Turkey, Greece, Israel and Hong Kong," says Stergiopulos. "By year-end we plan to have around 15 centers worldwide using our technology, and we expect to begin US-based clinical trials in early 2022."