Healthcare Industry News:  cataract 

Devices Ophthalmology Regulatory

 News Release - November 5, 2013

Avedro Announces CE Mark Clearance for its KXL II (TM) Advanced Cross-linking System

Offering the Potential for a Non-surgical Alternative to Lasik and for Improving cataract Surgery Outcomes

WALTHAM, Mass.--(Healthcare Sales & Marketing Network)--Avedro Inc., a Boston-based ophthalmic medical device and pharmaceutical company, announces CE Mark clearance for its KXL II System. The KXL II System has the potential for non-surgical correction of myopia, as well as improving cataract surgery outcomes, with a procedure called PiXL™ (Photorefractive Intrastromal Cross-linking).

“As one of the first KXL II clinical sites, we experienced the amazing capabilities of customized accelerated cross-linking to achieve specific, reproducible and interim-stable refractive changes on the cornea,” said A. John Kanellopoulos, MD, NYU Medical School and Member of Avedro’s Medical Advisory Board. “It seems to me that every surgeon who has performed cross-linking has experienced refractive corneal changes. We now have a way to design and customize these refractive changes. If these initial clinical results continue to be repeated, as I believe they will, the potential seems unlimited.”

David Muller, PhD, CEO of Avedro states, “The KXL II and PiXL procedure continue our mission to make refractive correction truly non-surgical. Treating myopia and other refractive disorders with PiXL has the potential to open up refractive correction to millions of people who have never considered Lasik surgery before, but would consider a non-surgical alternative.”

Avedro products that have received CE Mark include: the KXL II System for performing PiXL, the KXL® System for performing Lasik Xtra® and Accelerated Cross-linking, and the Avedro family of proprietary single dose riboflavin formulations.

About Avedro, Inc.

Avedro is a privately held medical device and pharmaceutical company advancing the science and technology of corneal cross-linking and refractive correction. Avedro’s products include capital equipment and related single dose pharmaceuticals. Those products are currently used to enhance Lasik outcomes in a procedure known as Lasik Xtra. Over 75,000 surgeries have been successfully performed outside the US using Avedro’s KXL System. The KXL System’s accelerated cross-linking, in combination with its pharmaceuticals, is also used to treat several important and debilitating ophthalmic pathologies.

Avedro’s KXL and pharmaceutical products are currently being used in three Phase III US clinical trials involving over 100 clinical sites.

Avedro distributes its products in 62 countries through 33 ophthalmic distributors with 115 representatives. Avedro products are not for sale in the US.

Source: Avedro

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