BVI Medical receives 510(k) clearance FDA for laser endoscopic surgical system for glaucoma

Notably this is the only laser system that lowers intraocular pressure by addressing aqueous humor production in a minimally invasive ab interno procedure.

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The FDA has granted 510(k) clearance to BVI Medical for its glaucoma surgical system, called Leos (Laser Endoscopy Ophthalmic System).

Leos is designed to introduce a novel, intuitive Laser ECP procedure that can integrate seamlessly into the surgical workflow. Notably this is the only laser system that lowers intraocular pressure by addressing aqueous humor production in a minimally invasive ab interno procedure. The system also has unique endoscopic capabilities to provide enhanced visualization of the eye anatomy. Leos is supported by emerging data from a randomized controlled clinical trial, further validating its safety and efficacy.

In the company’s press release, Shervin Korangy, BVI President and CEO commented on this clearance, saying, "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."

Earlier this year, BVI Medical announced it had completed a $1 billion strategic capital raise in partnership with global alternative asset management firm TPG, which refinanced BVI's debt while adding equity from a mix of new investors and TPG.² Prior to this, BVI expanded its IOL manufacturing to Europe to meet global product demand, introduced Serenity and Serenity Toric premium monofocal IOLs, and engaged in a number of strategic acquisitions.³

Mikhail Boukhny, Vice President, Global R&D for BVI is also quoted in the release, saying, "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. 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 anticipates launching Leos commercially in the US in the coming months.

References

1. Laser Endoscopy Ophthalmic System: Leos™. BVI Medical. Press release. Published April 17,2025. Accessed April 17, 2025. https://www.globenewswire.com/news-release/2025/04/17/3063574/0/en/BVI-Medical-Announces-Approval-of-Breakthrough-Technology-FDA-510-k-Clearance-of-its-Laser-Endoscopy-Ophthalmic-System-Leos.html

2. Joy J. BVI Medical completes a $1 billion strategic capital raise. Optometry Times. March 14, 2025. Accessed April 17, 2025. https://www.optometrytimes.com/view/bvi-medical-completes-a-1-billion-strategic-capital-raise

3. Joy J. BVI to launch new SERENITY and SERENITY Toric monofocal IOLs. Optometry Times. September 5, 2024. Accessed April 17, 2025. https://www.optometrytimes.com/view/bvi-to-launch-new-serenity-and-serenity-toric-monofocal-iols