LENSAR Receives EU Certification for ALLY®

First EU ALLY Commercial Installation Expected in August 2024

ORLANDO, Fla.—LENSAR, Inc. (Nasdaq: LNSR), a global medical technology company specializing in advanced laser solutions for cataract treatment, announced that the ALLY Adaptive Cataract Treatment System has achieved certification under the European Union’s Medical Device Regulation (MDR).

"We are pleased to receive EU MDR certification for ALLY, marking a significant milestone for LENSAR," said Nick Curtis, President and CEO of LENSAR. "The availability of ALLY in the EU presents a growth opportunity, allowing us to introduce advanced next-generation laser technology to European surgeons."

The MDR certification enables LENSAR to offer European surgeons a new technology solution for cataract procedures. ALLY is designed to perform laser cataract procedures seamlessly within a single, sterile environment. Its ergonomic design, enhanced speed, and features aim to increase both patient and practice efficiencies. LENSAR plans to commercialize ALLY through its distributor network in the EU, with the first installations expected in the third quarter of 2024.

The ALLY System addresses the limitations of earlier technologies, allowing physicians to improve efficiency in the operating room. Recent time and motion studies indicate significant procedure time savings, which could result in increased revenue opportunities for surgeons and ambulatory surgery centers, as well as reduced patient throughput time.

ALLY’s compact design and enhanced ergonomics offer potential efficiency improvements in various surgical settings. The system is the first cataract laser to incorporate artificial intelligence in the iris registration and surface identification of astigmatism management. It also automatically determines cataract density, optimizes fragmentation patterns, and adjusts energy settings to minimize the energy required for the procedure, potentially leading to quicker visual recovery and improved patient outcomes.

About LENSAR

LENSAR is a commercial-stage medical device company focused on developing and marketing advanced systems for cataract treatment and astigmatism management as part of cataract procedures. The ALLY® Adaptive Cataract Treatment System is a compact, ergonomic system that uses a fast dual-pulse laser and integrates AI into its imaging and software. The system is designed to perform the entire procedure in a sterile operating room or in-office surgical suite, enhancing operational efficiencies. ALLY also includes LENSAR’s proprietary Streamline® software technology, which supports surgeons in achieving better outcomes.

For more detailed information on cataract surgery and treatment options, you can visit Your Complete Guide to Cataract Surgery in 2024