- This clearance marks a significant advancement in glaucoma care, especially for earlier stages of the disease and across a wide spectrum of glaucoma types.
- This novel, proprietary laser-based system features a unique mechanism of action.
- Designed to deliver vibrant, high-quality visualization of eye anatomy.
- Broad commercialization is planned for 2025.
WALTHAM, Mass., April 17, 2025 (GLOBE NEWSWIRE) -- BVI Medical, a leading global ophthalmic device company dedicated to sitting at the forefront of advancements in eye surgery, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its innovative glaucoma surgical system, Leos™ (Laser Endoscopy Ophthalmic System)
Leos™ introduces a novel, more intuitive Laser ECP procedure that integrates seamlessly into the surgical workflow. It 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 in a way not seen in the past, or with the latest in imaging systems.
"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 $1bn capital raise and several very high-profile product approvals in the EU and Asian markets.
This clearance marks a significant advancement in glaucoma care, especially for earlier stages of the disease and across a wide spectrum of glaucoma types affecting more than 76 million people globally, with projections reaching 111.8 million by 20401. Leos is supported by emerging data from a randomized controlled clinical trial, further validating its safety and efficacy.
"The development of Leos was driven by a deep understanding of the challenges clinicians face in managing glaucoma, such as visualization and access to target tissue," said Mikhail Boukhny, Vice President, Global R&D. Our goal was to create a system that not only offers a novel and effective treatment approach but also enhances the surgical experience through improved intuitiveness, precision, and ease of use. This 510(k) clearance is a testament to years of effort, and we are excited to bring this groundbreaking technology to physicians and their patients."
BVI Medical is committed to delivering innovations, support, and solutions to the ophthalmic community. The company anticipates launching Leos commercially in the U.S. in the coming months.
About BVI Medical
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 Medical and its mission to advance the future of vision, visit https://www.bvimedical.com
Press Contact
David Chavez
Global Communications Lead
dchavez@bvimedical.com
+1 (857) 869 8706
1 Tham YC, Li X, Wong TY, Quigley HA, Aung T, Cheng CY. Global prevalence of glaucoma and projections of glaucoma burden through 2040: a systematic review and meta-analysis. Ophthalmology. 2014 Nov;121(11):2081-90. doi: 10.1016/j.ophtha.2014.05.013. Epub 2014 Jun 26. PMID: 24974815.
