The company prepares for immediate commercial launch throughout Europe and Asia
WALTHAM, Mass.--(BUSINESS WIRE)--Avedro, Inc. today announced its Vedera™ System for performing the Keraflex® procedure has received the European Union’s CE Mark. The CE Mark certifies the Vedera has met the EU’s health and safety standards and opens the door to commercialization across the European Economic Community and in other countries recognizing the CE Mark.
“I am pleased by how quickly Avedro has been able to transform its Thermo-biomechanics platform technology into a commercially available ophthalmic device. Avedro has been conducting clinical trials to treat myopia and keratoconus with the Keraflex procedure and is extremely pleased with the results. CE Mark certification is an important milestone for the company, and also represents a vital new offering to ophthalmic patients and their physicians,” said David Muller, PhD, President and CEO of Avedro.
The Keraflex procedure is a non-invasive, incision-less ophthalmic procedure for flattening the cornea. Because Keraflex thermally remodels the cornea without the removal of any tissue, the procedure offers the unique ability to induce refractive change without weakening the cornea’s biomechanical integrity, as happens with LASIK and other refractive correction procedures.
Keraflex KXL, Corneal Flattening and Corneal Stabilization
In its European clinical trials for the correction of myopia and the treatment of keratoconus, a progressive disease of the cornea, Avedro has investigated a two-step procedure whereby Keraflex provides corneal flattening to achieve refractive correction and concomitant collagen crosslinking stabilizes the cornea.
“The Keraflex procedure, by thermally altering the tension of collagen fibers, induces a corneal flattening and achieves a more prolate cornea. This confers refractive correction, and, for the keratoconic cornea, smoothing of the irregular cornea, thereby improving visual acuity. The synergistic use of corneal collagen crosslinking improves the stability of the induced refractive effect while also working to halt disease progression,” explains Prof. John Marshall, PhD, Institute of Ophthalmology, University College, London.
The company plans to immediately begin commercialization of the Keraflex procedure throughout Europe and Asia, and looks forward to training and collaborating with its ophthalmic surgeon partners.
About Avedro, Inc.
Avedro, a privately held medical device company based in Waltham, MA, is developing the science of Thermo-biomechanics for therapeutic medical applications. Keraflex® KXL is the first technology Avedro has developed from its Thermo-biomechanics platform. Avedro recently announced it has signed a definitive agreement with Peschke Meditrade GmbH to acquire the rights to its US-based Phase III studies of corneal collagen crosslinking for the treatment of progressive keratoconus and post LASIK ectasia. The company looks forward to closing the follow-up phase of the studies and completing the necessary steps to introduce crosslinking to the US market.
For more information, visit www.avedro.com.
Heather Erskine, 781-768-3400