17.5.2021 – Rheon Medical announces today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the eyeWatch, the world’s first adjustable glaucoma shunt for the treatment of glaucoma.
Rheon Medical SA, a Swiss medical device company active in the surgical treatment of glaucoma and based at EPFL Innovation Park, announces that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to the eyeWatch technology, the world’s first adjustable glaucoma shunt for the treatment of refractory glaucoma. The eyeWatch technology has already received the CE-mark in 2019 and is currently marketed in European and Asian markets. The Company expects to initiate US-based clinical trials evaluating the therapy early 2022.
Breakthrough Device Designation is granted by the FDA to specific medical devices that have the potential to provide a more effective treatment for life-threatening or irreversibly debilitating diseases. The goal of the Breakthrough Devices Program is to provide patients and health care providers with timely access to these medical devices by speeding up their development, assessment, and review while preserving the statutory standards for marketing authorization.
“This marks an important step in our strategy to bring our most innovative glaucoma drainage device to American people suffering from refractory glaucoma“, says Nikos Stergiopulos, CEO and founder of Rheon Medical. “We thank the FDA for the thorough review and the great recognition of the potential of the eyeWatch technology to provide a more effective treatment to such a debilitating disease.“
About the eyeWatch technology
While current glaucoma shunts have been used effectively to lower intraocular pressure they still suffer from high rates of failure and post-operative complications, many of which are attributed to poor aqueous humour flow control. Based on a unique proprietary patented technology, the eyeWatch device is designed to offer non-invasive, patient-specific flow and pressure control, providing the means to avoid hypotony-related complications. For details on the design and features of the eyeWatch technology as well as its clinical benefits, please visit www.rheonmedical.com.
About Rheon Medical SA
Rheon Medical SA is focusing on providing glaucoma surgeons the best possible solutions for the surgical treatment of glaucoma. The Company’s current and future product pipeline is designed to deliver personalized therapy and maximize success rates while reducing substantially post-operative complications. Rheon Medical is the winner of the 2020 Swiss Medtech award. The Company is financed by private and institutional investors. For more information, please visit www.rheonmedical.com.
Source: Press release