The application is the first step in a two-phase commercial release strategy for the ALLY Adaptive Cataract Treatment System, and it seeks marketing clearance.
As part of this strategy, the company intends to file an additional 510(k) application later in 2022 for clearance of the integrated ALLY system's phacoemulsification characteristics.
“FDA acceptance for substantive review of the 510(k) submission for ALLY marks an important milestone for LENSAR and is the result of several years of diligent teamwork and focused effort on the part of our development team. We believe that, if ALLY is cleared by the FDA, this staged approach would allow for an expeditious and efficient path to commercialization,” said Nick Curtis, Chief Executive Officer of LENSAR.
“The vast majority of cataract surgeons performing FLACS procedures rely on aging femtosecond lasers. ALLY’s design includes a small footprint, enhanced ergonomics, superior imaging, dual-pulsed laser, and advanced astigmatism management tools which we believe, if cleared, would set the new standard of femtosecond laser cataract technology.”
Mr. Curtis added they they believe ALLY has the potential to improve surgeon efficiencies, including optimizing FLACS procedures in any operating room and enabling surgeons to deliver improved outcomes for patients. We look forward to the FDA’s review of the 510(k).
If cleared, LENSAR plans to launch ALLY in the second half of 2022. On March 3, 2022, at 8:30 a.m. ET, the company will have a conference call to discuss this significant milestone as well as its fourth quarter and full-year 2021 results.