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LENSAR Announces Application for Certification of the ALLY™ Adaptive Cataract Treatment System in the EU
ORLANDO, Fla.--(BUSINESS WIRE)-- LENSAR, Inc. (Nasdaq: LNSR) (“LENSAR” or “the Company”), a global medical technology company focused on advanced femtosecond
About this update from Lensar, Inc.
[{"type":"text","content":" ORLANDO, Fla.--(BUSINESS WIRE)--\nLENSAR, Inc. (Nasdaq: LNSR) (“LENSAR” or “the Company”), a global medical technology company focused on advanced femtosecond laser surgical solutions for the treatment of cataracts, today announced the application for certification of the ALLY™ Adaptive Cataract Treatment System (“ALLY” or the “ALLY System”) in the European Union.\n\n“Following the FDA clearance of ALLY in June 2022 and recent U.S. commercial launch, this is another important step in our effort to bring ALLY to cataract surgeons in key global markets. Our mission has always been to create a platform that optimizes the way premium cataract surgeries are performed, and we believe that ALLY addresses all limitations of current competitive technologies.” said Nick Curtis, Chief Executive Officer of LENSAR. “Following successful completion of the certification process, we are prepared to launch ALLY in the EU. This application marks yet another major milestone met for LENSAR in 2022.”\n\nALLY enables surgeons to complete a femtosecond-laser-assisted cataract surgery (“FLACS”) procedure seamlessly in a single, sterile environment and provide Adaptive Intelligence™ to automatically determine cataract density, optimize fragmentation patterns, and energy settings. The CE Mark, if affixed following successful completion of the certification process, allows for commercialization of ALLY in the European Union. The application for certification in the European Union follows U.S. FDA clearance of ALLY in June 2022. If ALLY is certified and CE marked, LENSAR plans to make the system commercially available to European surgeons through a distributor network, similar to the approach taken for its first-generation LENSAR Laser System.\n\nAbout LENSAR\n\nLENSAR is a commercial-stage medical device company focused on designing, developing, and marketing advanced systems for the treatment of cataracts and the management of visually significant astigmatism as an integral aspect of the cataract procedure. LENSAR has developed its next-generation ALLY™ Adaptive Cataract Treatment System, its first platform to integrate its proprietary imaging with an optimized femtosecond laser in a compact system. ALLY is designed to transform cataract surgery by utilizing LENSAR’s advanced technologies with the ability to perform the entire procedure in an operating ...