WALTHAM, Mass.--(BUSINESS WIRE)--Avedro, Inc. announced today that it has received CE Mark clearance for its Mosaic System. The Mosaic System has the potential for non‐surgical improvement for low myopia with a procedure called PiXL™ (Photorefractive Intrastromal Cross‐linking). The Mosaic system is now commercially available outside of the United States.
Brian Roberts, Avedro’s Chief Operating Officer, said, “The Mosaic CE Mark sets the stage for us to launch PiXL internationally. The PiXL procedure has the potential to improve the vision of millions of people with low myopia who have never considered Lasik surgery but who would consider a non‐invasive alternative for improving their vision.” Roberts continued, “The team is energized for what we expect to be an exciting 2016. Outside of the United States the Mosaic system is demonstrating great promise for non-surgically improving the vision of people with low myopia; while in the United States, the PDUFA date for the New Drug Application (NDA) for riboflavin ophthalmic solution/KXL® System is set for April 16, 2016. If approved by the FDA, we would hope to commercialize the KXL System in the US in the second half of 2016.”
Avedro also announced that following the successful completion of a recent $32 million financing, David Muller resigned as Chief Executive Officer in order to pursue other opportunities. Gil Kliman, MD, Interwest General Partner, and member of the Avedro Board of Directors said, “On behalf of the Board and all the Avedro employees, I want to thank David for his tireless efforts. Ophthalmologists around the world have David to thank for the advances in corneal cross-linking that Avedro researched, developed and commercialized around the world under his leadership.”
Brian Roberts will lead the Company while the Board conducts a search for Avedro’s next CEO.
About Avedro, Inc.
Avedro is a privately held pharmaceutical and medical device company advancing the science and technology of corneal cross-linking and refractive correction.
Avedro distributes its products in countries outside of the United States through a network of ophthalmic medical device distributors. Avedro’s products sold outside of the United States include capital equipment such as the UV-X devices, the KXL® and Mosaic™ Systems, and related proprietary pharmaceuticals such as the VibeX® and MedioCROSS® formulations. These systems and products are used in a variety of treatments including accelerated cross linking for keratoconus, Lasik Xtra and PiXL. Avedro products are not approved for sale in the United States.