[April 23, 2014] |
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Avedro Announces Canadian Approval for its KXL II ™ Advanced Cross-Linking System
WALTHAM, Mass. --(Business Wire)--
Avedro Inc., a Boston-based ophthalmic medical device and pharmaceutical
company announces today the Canadian approval for the company's KXL II
System. The KXL II System performs a procedure called PiXL™
(Photorefractive Intrastromal Cross-Linking) which has the potential to
deliver non-surgical correction of myopia, and improve cataract surgery
outcomes.
The KXL II device is designed to deliver specific light patterns to the
cornea based on the patient's own topographic data which is collected
during routine pre-operative screening. This allows cross-linking to be
customized to a patient's specific refractive needs.
Avedro has already begun installing its new KXL II device in multiple
sites around the world. Early clinical results, with follow-up
approaching one year, will be discussed at the upcoming '3rd
International Congress on Advanced Corneal Cross-Linking' being held in
conjunction with the AECOS European Meeting on June 28th,
2014.
David Muller, PhD, CEO of Avedro states, "With this approval of the KXL
II, Canada joins the 28 members of the European Union that have received
the CE mark and approval to use this advanced technology. This
revolutionary procedure for treating myopia and astigmatism 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. In addition, it has the potential to improve
the outcomes of routine cataract procedures by non-surgically reducing
post-operative astigmatism."
Currently, Avedro's approved KXL® system is being used in Canada to
perform Lasik Xtra® and Accelerated Cross-Linking for keratoconus and
post-LASIK ectasia.
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. The KXL System's cross-linking, in
combination with its pharmaceuticals, is used to treat keratoconus and
corneal ectasia outside the United States. Those products are also used
in a procedure known as Lasik Xtra. Over 100,000 treatments have been
successfully performed outside the US using Avedro's KXL System.
Avedro distributes its products in 62 countries through 33 ophthalmic
distributors with 115 sales and service representatives. Avedro products
that have received CE Mark include: the KXL System for performing Lasik
Xtra and Accelerated Cross-Linking, the KXL II System for performing
PiXL, and the Avedro family of proprietary single dose pharmaceutical
formulations.
Avedro's KXL System and single dose pharmaceutical products are
currently being used in three Phase III US clinical trials involving
over 100 US clinical sites. Avedro products are not for sale in the US.
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