In a typical laser-assisted cataract surgery, the procedure is split between a laser suite and an operating room. Lensar, however, set its sights on building an all-in-one system that could allow the surgery to occur in one location—and was rewarded for that vision with an FDA clearance announced this week.
The resulting system combines Lensar’s augmented-reality imaging technology and dual-pulse femtosecond laser into one compact, mobile platform that’s designed to assist with the entire cataract replacement process, all within either an OR or in-office surgery suite.
With the FDA’s nod, Lensar said it will begin rolling out the Ally adaptive cataract treatment system in a small-scale initial launch in the third quarter of this year. After that, it’ll expand into a wider commercial launch for U.S. cataract surgeons in 2023.
The Ally system starts by using Lensar’s AR-assisted imaging technology to automatically determine the density of a cataract, location of the nucleus and layers of the lens. With that information, surgeons can plot out the best fragmentation patterns needed to break up the cataract. With the tech’s help, surgeons can save time and effort on planning the procedure and also deliver the smallest possible amount of energy to the eye.
Lensar’s femtosecond laser uses the imaging data to cut an opening into the cataract. From there, the device emits ultrasound energy to break up the affected lens into small pieces—a process called phacoemulsification—and vacuums them out before the newly removed lens is replaced by an artificial replacement.
The entire femtosecond laser-assisted cataract surgery, or FLACS procedure, can typically be completed within half an hour—and the Ally system shaves off even more time since it eliminates the transfer from laser lab to operating table partway through.
“Our mission has been to develop a platform where surgeons can seamlessly perform the entire FLACS procedure in a single setting, improve workflow efficiencies and, most importantly, help surgeons deliver better outcomes through the advanced technologies in the Ally system,” said Lensar CEO Nick Curtis, adding, “We are seeing an overwhelmingly positive response to the Ally system.”
Lensar scoped out the FDA nod as it kicked off the fiscal year on a high note. In the first quarter of 2022, the Orlando-based company saw its procedure volume soar nearly 40% compared to the same period in 2021, leading to a year-over-year revenue boost of 33%.
In total, Lensar’s revenue for the quarter clocked in at $9.3 million, though it ended the period with a net loss of $6.7 million, thanks in large part to a near doubling of its R&D expenses to continue developing and manufacturing the Ally system as it prepared for FDA submission.