• BVI’s Leos™ system has been used clinically for the first time, marking a major milestone following its FDA 510(k) clearance in April 2025.
• Leos™ is the first and only FDA-cleared laser system with advanced digital endoscopic visualization for ab interno intraocular pressure reduction.

WALTHAM, Mass., July 31, 2025 – BVI, a leading global ophthalmic device company dedicated to sitting at the forefront of advancements in eye surgery, today announced the first clinical use of its FDA-cleared Leos™ Laser Endoscopy Ophthalmic System. The milestone procedure was performed by Dr. Nathan Radcliffe, a glaucoma specialist at the Ambulatory Surgery Center of Greater New York, Bronx, NY.

Leos™, which received U.S. Food and Drug Administration (FDA) 510(k) clearance in April 2025, is the first and only digital endoscopy and laser system designed to reduce intraocular pressure through an intuitive, minimally invasive ab interno approach—while providing exceptional visualization of the eye’s internal anatomy. The system represents a new evolution in endoscopic cyclophotocoagulation (ECP), integrating seamlessly into modern surgical workflows.

“This first case highlights the potential of this technology to transform glaucoma management,” said Dr. Radcliffe. “Leos brings a new level of precision and efficiency to laser ECP, with enhanced visualization that improves both control and confidence in surgery.”

Designed to meet the evolving needs of surgeons treating a broad range of glaucoma patients—including those in earlier stages of disease—Leos is supported by emerging ECP clinical data and powered by advanced endoscopic visualization capabilities. The system enables a targeted, personalized approach to provide treatment for one of the world’s leading causes of irreversible blindness.

“Seeing Leos used in a real-world surgical setting marks an important milestone for BVI and a testament to the progress we’re making across our innovation pipeline,” said Shervin Korangy, President and CEO of BVI. “It’s incredibly rewarding to see our technologies have such a beneficial impact for both the surgeons and the patients they serve.”

BVI plans to commercially launch Leos in late 2025.

About BVI

BVI® is a diversified global ophthalmic device company with a mission to deliver high-quality solutions and innovation for advancing eye surgery and improving patients’ vision. With nine decades of developing leading products and solutions, BVI partners with ophthalmic surgeons to improve the vision of millions of patients across the globe. Our organization supports surgical teams in more than 90 countries worldwide, either directly or through our network of trusted distributors.

To learn more about BVI and its mission to advance the future of vision, visit https://www.bvimedical.com

***

Press Contact

David Chavez

Global Communications Lead

[email protected]

+1 (857) 869 8706