BVI Medical announced that it received FDA 510(k) clearance for its Leos (laser endoscopy ophthalmic system) for treating glaucoma.
Waltham, Massachusetts–based BVI designed Leos for a more intuitive laser endoscopic cyclophotocoagulation (ECP) procedure. It aims to integrate seamlessly into the surgical workflow while treating glaucoma.
The company says Leos is the only laser system that lowers intraocular pressure by addressing aqueous humor production in a minimally invasive ab interno procedure. It incorporates unique endoscopic capabilities to provide superior visualization of the eye anatomy. According to a news release, this level of visualization hasn’t been seen in the past or with the latest imaging technology.
BVI Medical VP of Global R&D, Mikhail Boukhny, said the company sought to create a system that enhances the surgical experience. Boukhny said the company wanted to deliver a novel, effective treatment with intuitiveness, precision and ease of use.
The company plans to launch Leos commercially in the U.S. in the coming months.
“This momentous milestone underscores our commitment to innovation. We have been building a strong pipeline that is starting to play out in numerous geographies across the world, including Leos in the US market,” said Shervin Korangy, BVI president and CEO. The momentum for BVI continues to build behind a recent $1 billion capital raise and several very high-profile product approvals in the EU and Asian markets.
This marks the latest milestone for BVI Medical, which just this week announced the appointment of a new CCO. That appointment came on the heels of last month’s $1 billion financing. Prior to that, BVI also expanded its intraocular lens (IOL) manufacturing in Europe to meet growing demands. It also launched its Serenity and Serenity Toric premium monofocal IOLs and made strategic acquisitions.
