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09 Mar 2022
US firm's dual-pulsed femtosecond laser now under FDA review, with plans to launch later this year.
The CEO of Florida-based Lensar, which has developed a new ultrafast laser system for cataract surgery, says he is hopeful of launching the technology later this year.
Speaking during an investor conference call, Nick Curtis described the dual-laser “ALLY” system as “revolutionary”, and capable of cutting procedure times by two-thirds.
The company, which listed on the Nasdaq in October 2020 after being spun-off by PDL Biopharma, has just submitted the system for review by the US Food & Drug Administration (FDA). Lensar says it is confident that many physicians who are yet to use femtosecond lasers for cataract treatment will adopt the technology following FDA approval.
We are pleased to announce that the FDA accepted our 510(k) application. In-person demos of the #ALLY™ System at #ASCRS22. If cleared, #FemtoPhaco will be the future of #cataractsurgery. Request a demo https://t.co/tgBPgl9e0t #LENSAR #Ophthalmology #eyesurgeon #cataracts #eyes pic.twitter.com/kmhOVyviO4
— LENSAR, Inc. (@LENSAR) March 4, 2022
Ageing systems
Using techniques first developed for “LASIK” vision correction, femtosecond laser-assisted cataract surgery (FLACS) uses ultrafast bursts of photons to fragment the clouded lens characteristic of a cataract patient.
This allows physicians to then remove and replace the lens without heating up any surrounding tissue, and reduces the need for ultrasound to aid lens removal. In turn, that places less stress on tissues within the eye, and reduces the likelihood of an inflammatory response.
However, Lensar says that many physicians are still using femtosecond laser systems now a decade old, and that its ALLY system will provide a number of technological upgrades and - it is hoped - better patient outcomes.
“The vast majority of cataract surgeons performing FLACS procedures rely on ageing femtosecond lasers,” Curtis said. “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.
“We believe ALLY has the potential to improve surgeon efficiencies, including optimizing FLACS procedures in any operating room, and to enable surgeons to deliver improved outcomes for patients. We look forward to the FDA’s review of the 510(k).”
The CEO told investors discussing the firm’s latest financial results that Lensar was “on track” to launch the new system in the second half of this year, assuming it is given the green light by the FDA.
Two-stage FDA submission
The current submission represents the first of a two-stage approval process being pursued by the firm, with Curtis saying that ALLY will be launched as “the next-generation femtosecond laser cataract system”.
“Existing femtosecond lasers are clearly vulnerable to replacement,” Curtis told investors, pointing out that many had now been in operation for close to a decade.
“The first femtosecond lasers for cataracts were deployed in 2010, and haven’t evolved much since then,” he added. In contrast, Curtis says that Lensar has provided six evolutionary upgrades to its systems, offering better efficiencies and outcomes.
“ALLY is revolutionary,” the CEO stressed, pointing to much faster laser speeds in both corneal and lens tissue, thanks to the dual laser setup. “The dual-pulse laser cuts procedure time by up to two-thirds,” he noted.
The new system is also said to be much smaller than existing systems, which will give physicians much greater ergonomic flexibility, and features automatic data transfer.
Reviewing the firm’s financial results for 2021, Curtis reported a 35 per cent increase in procedures with Lensar’s existing equipment, compared with the Covid-hit figure for 2020.
That translated to a 31 per cent rise in annual revenues, although Lensar still posted an operating loss of close to $20 million on sales of $34.5 million for 2021 overall.
As of December 31, the company’s balance sheet showed cash and equivalent liquid assets totalling $31.6 million.
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