BVI Medical has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its innovative Laser Endoscopy Ophthalmic System (Leos™), marking a significant advancement in glaucoma treatment technology.
The novel laser-based system introduces a more intuitive Laser ECP (Endoscopic Cyclophotocoagulation) procedure that integrates seamlessly into surgical workflows. Leos™ is the only laser system that lowers intraocular pressure by addressing aqueous humor production through a minimally invasive ab interno procedure.
"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.
Addressing Critical Unmet Needs in Glaucoma Care
Glaucoma affects more than 76 million people globally, with projections reaching 111.8 million by 2040 according to epidemiological studies. The condition remains a leading cause of irreversible blindness worldwide, with treatment options often limited by visualization challenges and access to target tissue.
Mikhail Boukhny, Vice President of Global R&D at BVI Medical, explained the development rationale: "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. 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."
Technical Innovations and Clinical Advantages
The Leos™ system incorporates several key technological advancements:
- Unique endoscopic capabilities providing superior visualization of eye anatomy
- Proprietary laser technology with a novel mechanism of action
- Minimally invasive approach that can be used for earlier stages of glaucoma
- Effectiveness across a wide spectrum of glaucoma types
The system's safety and efficacy are supported by emerging data from a randomized controlled clinical trial, though specific outcomes data has not yet been publicly released.
Commercial Timeline and Company Growth
BVI Medical plans to launch Leos™ commercially in the United States in the coming months, with broader commercialization planned for 2025. The company's expansion follows a recent $1 billion capital raise and several high-profile product approvals in European and Asian markets.
"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," added Boukhny.
About BVI Medical
BVI Medical is a diversified global ophthalmic device company with nine decades of experience developing solutions for eye surgery. The organization supports surgical teams in more than 90 countries worldwide, either directly or through a network of distributors.
The company's mission centers on delivering high-quality solutions and innovations for advancing eye surgery and improving patients' vision. The Leos™ system represents the latest advancement in their commitment to addressing significant challenges in ophthalmic care.
