• BVI announces Virtuoso®, its first dual-function phaco-vitrectomy system designed to deliver advanced control, efficiency, and versatility for both cataract and vitreoretinal surgery.
• European debut planned for 2025 Global ophthalmic congresses in Europe (Euretina and ESCRS).  

Waltham, Mass., September 3, 2025 – BVI, a leading global ophthalmic device company dedicated to sitting at the forefront of advancements in eye surgery, today announced the European market unveiling of its innovative phaco-vitrectomy surgical platform, Virtuoso®, a dual-function system designed for both cataract and vitreoretinal procedures.

Virtuoso® is engineered to redefine control and accuracy in ophthalmic surgery by combining advanced technologies across fluidics control, vitreoretinal applications, ultrasound delivery, and usability into a single, high-performance platform with a thoughtful footprint design to optimize space in the operating room. Its introduction in the ophthalmic community marks a significant milestone in BVI’s mission to reshape the future of ophthalmic care with best-in-class solutions.

“Virtuoso® represents a significant leap in surgical technology, bringing efficiency and control to both anterior and posterior segment procedures,” said Shervin Korangy, President and CEO of BVI. “With Virtuoso®, we are expanding our presence in the equipment segment of ophthalmology and look forward to watching millions of patients benefit from this technology. The excitement from the ophthalmic community for this much anticipated introduction is palpable.”

Built for the Future of Eye Surgery
Virtuoso® is designed to deliver market-leading applications across cataract, vitrectomy, and combined procedures, built into One Platform — providing versatility in multi-specialty centers and high-efficiency surgical environments.

Virtuoso® is positioned at the top tier of ophthalmic surgical systems, addressing the needs of a growing number of ambulatory surgical centers and hospitals seeking flexible, cost-effective platforms. The system also strengthens BVI’s value proposition by coupling with its extensive portfolio of consumables and IOLs.

Leading surgeons have already highlighted the system’s breakthrough features, coming from their testing. Dr. Tommaso Rossi (Italy) noted: “Virtuoso has a very novel fluidics concept maintaining target IOP throughout ALL procedure steps, from phaco to I/A, uniquely fusing the control of a flow pump with the efficiency of a pressure pump. Also, the featured Load Sensing Phaco maintains the programmed U/S energy regardless of lens resistance—this may translate into enhanced energy delivery.”

In the field of vitreoretinal surgery, Dr. David Steel (UK) emphasized the platform’s advanced capabilities: “The new Virtuoso platform shows very promising capabilities for vitreoretinal surgery: an enhanced aspiration performance matched with infusion under a variety of challenging scenarios, paired with high-speed and dual-action cutting performance, even under load with a bent shaft.”

BVI is planning to introduce the Virtuoso® phaco-vitrectomy system at the upcoming 2025 Global surgical ophthalmic congresses in Europe (ESCRS, Euretina) through targeted promotional activities. These congresses will also feature the first-ever Virtuoso® abstracts included in the Scientific Program: these will cover data about post-occlusion break surge, energy delivery consistency, vitrectomy probe stiffness and aspiration efficiency.

As evidence of a strong responsibility towards the ophthalmic community, BVI has committed to a prospective, single-center, clinical investigation at LMU Klinikum, Munich, Germany, under the lead of Prof. Priglinger, with the aim of confirming the safety and effectiveness of Virtuoso® phaco-vitrectomy system.

Commercial availability will begin in selected European markets, with a global rollout according to appropriate market approvals.

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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

• Vitreoretinal surgeons can now benefit from access to BVI’s high-quality ISPAN^TM ophthalmic gases, supporting the critical needs of advanced retinal procedures.
• This latest development leverages BVI’s U.S. distribution network to ensure faster, more efficient delivery to surgeons and clinics.

WALTHAM, Mass., August 11, 2025 – BVI Medical, a leading global ophthalmic device company at the forefront of advancements in eye surgery, today announced its official launch of ISPAN^TM ophthalmic gases.  This is the first ever introduction by BVI of retinal gases for the US market.

This marks another major milestone during a period of accelerating momentum for BVI. Recently, BVI received US FDA approval of the innovative laser and endoscopy glaucoma surgical system, Leos™. With its initial roots in the cataract segment of ophthalmology, these recent developments are building BVI’s presence in the glaucoma and retina markets as well.

The high-quality ISPAN^TM ophthalmic gases, such as sulfur hexafluoride (SF₆) and perfluoropropane (C₃F₈), used in retinal tamponade procedures, will be more readily available for vitreoretinal surgeons, clinics, and hospitals via BVI’s network throughout the United States.

“Ophthalmic gases are essential tools in vitreoretinal surgery,” said Shervin Korangy, President & CEO of BVI. “We are excited to expand our offering in retinal care. This is another step in our global expansion and ISPAN compliments our existing broad range of single-use instruments for the US retina market.”

Ophthalmic gases are primarily used by vitreoretinal surgeons to provide a temporary tamponade following procedures for conditions such as retinal detachment repair. These gases play a crucial role in maintaining retinal positioning during healing, directly impacting surgical outcomes and patient recovery.

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

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Press Contact

David Chavez

Global Communications Lead

[email protected]

• 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

• 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 2040[1]. 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

[email protected]

+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.

WALTHAM, Mass. — July 18^th, 2023 (GLOBE NEWSWIRE) — BVI, one of the fastest growing surgical ophthalmic businesses in the world, is proud to announce the opening of its new, state of the art facility in Liège, Belgium.  This results in a sizeable increase in BVI’s intraocular lens (IOL) business capacity, unlocking new growth opportunities and reinforcing the company’s environmental, social, and governance (ESG) leadership.

In line with the company’s commitment to efficiency, sustainability, and compliance, the new facility was designed to optimize delivery and involved a comprehensive process review aimed at increasing yield and efficiency.  BVI also prioritized environmental considerations and implemented various measures to minimize carbon footprint.

Affirming BVI’s commitment to innovation, the facility further enlarged BVI’s integrated IOL research and development (R&D) and manufacturing capabilities.  With a clear focus on delivering pioneering, quality products to patients, the integrated R&D and manufacturing installation promotes seamless collaboration, efficient product development and production, and accelerated time to market.

This strategic investment exemplifies BVI’s commitment to economic growth, technological advancement, and dedication to maintaining industry leadership. As BVI embarks on this exciting journey, the company anticipates significant positive contributions to its financial success and overall economic landscape.

Frederic Jodogne, Head of Operations said: “I see in this newly built state of the art facility a sign of trust in BVI that confirms Liège as a key pillar in IOL R&D and production.  Amazing products, amazing staff, and amazing potential! Each employee can be proud of the journey already accomplished and can see clearly now the path toward a successful future.”

Shervin Korangy, BVI President and CEO said: “I commend our team who drove this significant capital expansion project. Their unwavering commitment to excellence has been instrumental in tripling our IOL production capacity whilst in parallel deploying cutting-edge, proprietary precision molded optics to the highest quality standards.  The combination of our patented, novel optical designs alongside our world-class manufacturing technology creates an elegant and unrivaled outcome. Our IOL expertise has consistently surpassed even my lofty expectations.”

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 the vision of patients. 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. Our trusted brands include Beaver® (Knives and Blades), Visitec® (Cannulas), Malosa® (Single-Use Instruments), Vitreq® (Vitreoretinal Surgical Products) and PhysIOL® (Premium IOLs).

For further enquiries or to speak to a BVI representative, please email Andrew Dawson, Head of BVI Corporate Communications: [email protected]

• FINEVISION HP is the first patented diffractive trifocal IOL and is one of the flagship products in BVI’s IOL portfolio; FINE Trifocal technology is utilized across the company’s entire range of presbyopia-correcting IOLs.
• The Japan launch follows two key FINEVISION HP 2023 milestones: One million FINEVISION IOL implants sold worldwide and the recent completion of the FINEVISION HP IDE clinical study patient enrollment in the US.
• BVI expects to introduce several IOL models over the next few years in Japan, demonstrating BVI’s commitment to ophthalmic surgeons and their patients in Japan.

WALTHAM, Mass., June 19^th, 2023 (GLOBE NEWSWIRE) BVI, one of the fastest growing surgical ophthalmic businesses in the world, is thrilled to announce the official launch of FINEVISION HP in Japan. The FINEVISION HP hydrophobic and glistening free trifocal IOL represents a significant breakthrough in trifocal technology as the first trifocal platform to offer cataract patients high quality vision across all distances. 

Given substantial excitement and interest in the product, BVI Japan has already received orders for FINEVISION HP and will host the official launch event at the upcoming Japanese Society of Cataract and Refractive Surgeons (JSCRS) annual meeting in Sapporo, Japan on June 22 through June 24.  Dr. Kazunori Miyata (Miyata Eye Hospital), Dr. Hisaharu Suzuki (Zengyo Suzuki Eye Clinic), and Dr. Yousai Mori (Miyata Eye Hospital) will be presenting the results of the clinical trial conducted in Japan.  

As part of BVI’s commitment to continuously improve product performance to meet patients’ and surgeons’ needs, the FINEVISION HP IOL is now in its third generation since the initial FINE optical technology platform was launched in 2010. BVI has developed this unique IOL with numerous novel designs, including proprietary, patented hydrophobic material, a one-of-a-kind double C loop haptic design, and patented CoPODize™ optical surface technologies which enables Convolution and Apodization across the entire optic zone.  As the trifocal market leader in Europe, BVI has proven this technology with over 10 years of success and one million FINEVISION implants sold across the world.    

Dr. Kazuo Ichikawa of Chukyo Eye Clinic, Nagoya said: “It is great to see a new option of Multifocal IOL lens for our patients in Japan. Not only was FINEVISION the original trifocal, but the new generation FINEVISION HP provides 20/20 vision from -3D to +.5D of defocus as well as controlling dysphotopsia.

Shervin Korangy, BVI President and CEO said: ‘‘I could not be more pleased with the feedback we are receiving from surgeons about their experience partnering with BVI. The FINEVISION launch in Japan continues to execute on our strategic vision of expanding into key markets globally. Our commitment to bring BVI’s world-class products to surgeons and patients across the world is unwavering and continues at an accelerated pace. I look forward to watching our team’s success with this and subsequent product launches in the Japanese market”.

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 the vision of patients. 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. Our trusted brands include Beaver® (Knives and Blades), Visitec® (Cannulas), Malosa® (Single-Use Instruments), Vitreq® (Vitreoretinal Surgical Products) and PhysIOL® (Premium IOLs).

For further enquiries or to speak to a BVI representative, please email Andrew Dawson, Head of BVI Corporate Communications: [email protected]

WALTHAM, MA – May 1, 2023 (GLOBE NEWSWIRE) — BVI, a diversified global ophthalmic device company, today announced it has completed enrollment of its U.S. Investigational Device Exemption (IDE) clinical study for its latest hydrophobic trifocal intraocular lens, FINEVISION® HP. 

The milestone marks the final implantation of the 539^th patient enrolled in the prospective, multicenter, randomized, masked, controlled IDE clinical study.  Patients will now be followed to evaluate the safety and performance of the FINEVISION HP intraocular lens, with the results to form the basis for a regulatory submission to obtain marketing approval in the United States.

BVI has one of the most comprehensive ophthalmic surgery portfolios in the industry and is committed to expanding its availability globally.

“With the IDE clinical study completing both the enrollment and implantation phase in less than 12 months, we are pleased with our momentum and acknowledge the patients and clinical investigators for their commitment to the trial,” said Devang Shah, Ph.D., BVI Senior Vice President, Business Operations.

Shervin Korangy, BVI President and CEO, added, “Achieving this milestone represents an exciting and significant step towards bringing our IOL technology to US patients and surgeons.  This trial is the first of a series of studies on innovative ophthalmic devices that BVI will be undertaking in the U.S. in the coming years.”

FINEVISION® HP is a hydrophobic trifocal IOL and the third generation in the FINEVISION® family, featuring BVI’s proprietary hydrophobic material and two novel patented CoPODize™ technologies enabling Convolution and Apodization concepts on the entire optic surface.

CAUTION  FINEVISION® is CE Marked since 2010.  FINEVISION® HP is an Investigational device in the United States. Limited by Federal Law to investigational use; Pending PMA, not available for sale within the United States. 

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 the vision of patients. 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. BVI supports surgical teams in more than 90 countries worldwide, either directly or through its network of trusted distributors. BVI trusted brands include: Beaver® (Knives and Blades), Visitec® (Cannulas), Malosa® (Single-Use Instruments), Vitreq® (Vitreoretinal Surgical Products) and PhysIOL® (Premium IOLs).

Contacts

BVI

Andrew Dawson

Corporate Communications

[email protected]

Investors

Vivian Cervantes

Gilmartin Group

[email protected]