News & Events

• BVI announced the first successful U.S. implantations of its FDA-approved FINEVISION® HP trifocal IOL, marking the transition from regulatory clearance to real-world surgical use.
• Five leading cataract and refractive surgeons performed the initial procedures, advancing BVI’s disciplined, surgeon-led rollout of a category-defining trifocal platform with more than 15 years of global clinical use and proven patient outcomes.

WALTHAM, Mass., February 10, 2026 — BVI, a global leader in ophthalmic device innovation, announced the first successful U.S. implantations of its FDA-approved FINEVISION HP hydrophobic trifocal intraocular lens (IOL), marking the long-anticipated arrival of one of the most established trifocal platforms in global cataract surgery and a major milestone following the product’s U.S. regulatory clearance in October 2025.

Five leading cataract and refractive surgeons, all members of BVI’s U.S. Surgical Leadership Council, performed the initial procedures at multiple surgical centers across the country:

These first clinical cases represent the transition of FINEVISION HP from regulatory approval to real-world U.S. surgical practice, advancing BVI’s strategy to expand its premium refractive portfolio in the world’s largest ophthalmic market.

FINEVISION HP received FDA approval in October 2025, bringing the original, clinically proven trifocal IOL to the U.S. market. Developed through the collaboration of BVI R&D Director Christophe Pagnoulle and ophthalmologist Damien Gatinel, MD, PhD, FINEVISION HP builds on more than 15 years of global clinical and real-world experience, with widespread use outside the United States.

“The recent entry of BVI into the U.S. presbyopia-correcting IOL market with FINEVISION HP is well timed and very exciting. As a global leader in surgical eye care, BVI’s vision and passion for excellence have the potential to meaningfully advance presbyopia correction for surgeons and patients alike.” said George O. Waring IV, MD one of the first U.S. surgeons to implant the lens.

The third-generation FINEVISION HP incorporates BVI’s proprietary POD™ platform and CoPODize™ technology, an advanced diffractive optical design refined over time while remaining true to its original optical principles to balance and harmonize light distribution across distance, intermediate, and near focal points while minimizing visual disturbances. Its unique double C-loop haptic design — provides four points of in-bag contact and a 120° contact angle, compared with conventional C-loop configurations.

U.S. clinical evaluation and global evidence have demonstrated strong contrast sensitivity, stable visual performance across all lighting conditions, including enhanced near vision in dim light, and a smooth, continuous range of vision from far to near.

“As a third-generation design, FINEVISION® HP reflects the latest advances in presbyopia-correcting IOL technology, incorporating an optical platform refined over time to meet the evolving expectations of today’s premium cataract surgeons,” said Andy Chang, Chief Commercial Officer of BVI. “This milestone marks the moment when a category-defining trifocal platform, backed by more than 15 years of global clinical use and demonstrated outcomes in delivering consistent, balanced, high-quality vision for patients, officially enters U.S. surgical practice. We are deeply grateful to the pioneering surgeons who performed these first U.S. implantations, as well as to the BVI teams whose expertise and commitment have supported this disciplined, surgeon-led rollout. Together, we are proud to expand access to this proven technology across the United States throughout 2026.”

Building on its FDA approval and global foundation, BVI is methodically rolling out FINEVISION HP across select U.S. centers, prioritizing surgeon training, phased availability, and real-world performance validation. Broader access is expected to expand throughout the country during 2026 as manufacturing capacity increases and surgeon onboarding progresses.

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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

Waltham, MA., January 19th, 2026 – BVI, a global leader in the ophthalmic device market, announced today the appointment of Jim Hollingshead as President & Chief Executive Officer. Hollingshead succeeds Shervin Korangy, who will continue to serve as an advisor to BVI and begin a new role as senior advisor to TPG Capital. 

Hollingshead brings more than 20 years of experience leading and growing medical device and life sciences companies. He most recently served as the CEO of Insulet, an innovative leader in insulin delivery. During Hollingshead’s tenure, Insulet furthered its market leadership through expanded product offerings, including the launch of the industry’s first patch pump automated insulin delivery system. Previously, Hollingshead spent 12 years at ResMed, where he last served as President for the company’s sleep and respiratory care business.

“I have long been inspired by the role that technology innovation can play in improving patient experience and outcomes,” said Hollingshead. “BVI is transforming vision care through a simple and effective mission to deliver trusted, innovative solutions tailored to the unique needs of physicians and their patients. It’s a privilege to join the BVI team as we build on the company’s already strong momentum and launch multiple new, industry-leading platforms.”

Over the past several years, BVI has continued its momentum and meaningfully expanded its purpose-built portfolio. The company has developed one of the most robust product pipelines in the industry and now delivers a full procedural solution for the cataract and retina surgical market. The company expanded its intraocular lens (IOL) platform to meet growing global demand and introduced new product lines such as SERENITY and SERENITY Toric, which deliver far and intermediate range vision. In 2025, BVI received FDA approval for its FINEVISION HP trifocal IOL, bringing its global leadership position in premium IOLs to U.S. patients. The company also debuted its FDA-cleared Leos™ glaucoma system, marking a significant advancement in glaucoma care, and unveiled Virtuoso®, a novel dual-function phaco-vitrectomy platform for cataract and vitreoretinal procedures.

“Jim’s strategic vision, insight, and track record of innovation and transformation in the medical device industry make him an excellent fit for BVI as the company continues to advance its market leadership and scale its impact globally,” said Ron Labrum, Chairman of BVI. “We want to recognize Shervin for his leadership as BVI developed one of the most innovative product portfolios in the industry and know the team will continue to benefit from his expertise.”

“I want to thank the entire BVI team for their partnership in transforming the company into the dynamic platform it is today,” said Korangy. “I am proud of the breadth of portfolio and pipeline we have built, creating a challenger to the long-standing status quo in the industry. I look forward to continuing to support the company as it builds on its strong roadmap under Jim’s leadership.”

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

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• Milestone strengthens the company’s leadership in advanced IOL innovation
• FINEVISION HP, with millions of implantations worldwide, will now be available to U.S. patients
• Proprietary design features anchor the launch of BVI’s expanded U.S. IOL portfolio

WALTHAM, Mass., Oct. 14, 2025 — BVI, a global leader in ophthalmic device innovation, today announced that the U.S. Food and Drug Administration (FDA) has approved its FINEVISION HP trifocal intraocular lens (IOL). This milestone reinforces BVI’s leadership in premium IOLs and expands advanced vision solutions for U.S. patients.

The pioneering work of Christophe Pagnoulle, BVI R&D director, and ophthalmologist Damien Gatinel, M.D., Ph.D., brought the FINEVISION HP to market and heralded a new era of premium IOLs. FINEVISION HP stands as the world’s first trifocal IOL and remains the global benchmark in trifocal innovation with a legacy of more than 15 years of clinical success and millions of implantations worldwide. U.S. surgeons and patients now gain access to this transformative lens, recognized globally for its patented diffractive optic design delivering balanced vision at far, intermediate and near distances.

“FINEVISION HP redefined premium cataract surgery and continues to set the gold standard in premium IOL innovation,” said Shervin Korangy, president and CEO of BVI. “This FDA approval marks a pivotal step in expanding our IOL portfolio in the United States, supporting our mission to deliver best-in-class visual outcomes for patients globally.”

The third-generation FINEVISION HP incorporates BVI’s proprietary POD platform and CoPODize™ technology, harmonizing light distribution and minimizing visual disturbances. Its unique double C-loop, four-point haptic design supports long-term stability and precise centration in the capsular bag.

“The development of FINEVISION HP was a pivotal moment for ophthalmology, reshaping expectations for vision correction after cataract surgery,” said Dr. Damien Gatinel, developer and ophthalmologist. “FDA approval in the U.S. means even more patients will benefit from this breakthrough technology.”

Clinical and Market Significance

• Created the category. FINEVISION HP was a breakthrough diffractive design creating the world’s first trifocal IOL, establishing an entirely new standard in cataract surgery.
• Exceptional reliability. With more than a decade of real-world clinical results, millions of successful implantations and strong surgeon preference, FINEVISION HP remains the most trusted trifocal lens.
• Unique design. Featuring BVI’s proprietary POD platform, FINEVISION HP utilizes CoPODize™ technology to harmonize light distribution and minimize visual disturbances, while its double C-loop haptic system ensures lasting stability and precise centration.

Building on this global foundation of success, the U.S. clinical study has further demonstrated the lens’s potential impact for U.S. patients. “The FINEVISION HP trifocal IOL reflects innovation in optic design, and I’m pleased to have been part of the U.S. study evaluating its performance. This lens represents an important step forward in expanding advanced IOL choices for surgeons and their patients,” said Vance Thompson, M.D., ophthalmologist and study investigator.

Given early indications, demand for this groundbreaking IOL is expected to exceed supply, and BVI has been investing in significant capacity expansion efforts to meet market demand. BVI will methodically roll out availability over the coming year. FINEVISION HP will be showcased at the AAO Annual Meeting (Orlando, Oct. 18–20, Booth No. 3521).

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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

• 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]

• The Council will serve as an advisory group, guiding BVI on corporate strategy, unmet clinical needs, product development, and surgical best practices.
• This initiative marks a key step in BVI’s global expansion, with plans underway for a European Surgical Advisory Board to further strengthen international partnerships

WALTHAM, Mass., August 6th, 2025 – BVI, a leading global ophthalmic device company dedicated to sitting at the forefront of advancements in eye surgery, today announced the formation of its first U.S. Surgical Leadership Council. This distinguished group of seven leaders spans the fields of cataract, retina, and glaucoma surgery—each dedicated to shaping the future of ophthalmology through collaboration and insight-driven innovation.

The U.S. Surgical Leadership Council reflects BVI’s drive to work hand-in-hand with surgeons to co-develop meaningful solutions across the full spectrum of eye care. These members have been instrumental in guiding industry over the years and will now collaborate closer with BVI to help chart the course for the company’s next phase of growth.

“We are thrilled to partner with BVI as inaugural members of its U.S Surgical Council.  BVI has a longstanding commitment to excellence through innovation in surgical vision, and we look forward to helping introduce more of these innovations to the United States,” said George O. Waring IV, MD.

The inaugural council members include:

• Nicole Fram, MD
• Sumit (Sam) Garg, MD
• Nathan Radcliffe, MD
• Firas Rahhal, MD
• Vance Thompson, MD
• George O Waring IV, MD
• Robert J. Weinstock, MD

“The Council will serve as a strategic advisory council, enabling BVI to gather critical insights from frontline surgeons. In doing so, BVI aims to accelerate its efforts in delivering a differentiated, end-to-end portfolio of surgical solutions that truly reflect the voice of the customer,” said Andy Chang, Chief Commercial Officer.

This initiative marks a major milestone in BVI’s commitment to co-creating solutions with the ophthalmic community.

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

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Press Contact
David Chavez
Global Communications Lead
[email protected]
+1 (857) 869 8706

• 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

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Press Contact

David Chavez

Global Communications Lead

[email protected]

+1 (857) 869 8706

• BVI received four awards in the 2025 Medical Device Network Excellence Awards—for Innovation, Product Launches, R&D, and Investments—recognizing its leadership in advancing ophthalmic technology and global growth.
• Key achievements include the launch of SERENITY IOLs with ISOFOCAL technology, FDA clearance of the Leos™ glaucoma system, and a $1 billion capital raise supporting strategic expansion and continued innovation.

WALTHAM, Mass., July 9th, 2025 – BVI, a leading global ophthalmic device company dedicated to sitting at the forefront of advancements in eye surgery, has been recognized with four prestigious accolades in the 2025 Medical Device Network Excellence Awards. The company earned top honors in Innovation, Research and Development, Investments, and Product Launches, underscoring its leadership in advancing eye care technology, strategic growth, and breakthrough product development.

The Excellence Awards celebrate the most impactful achievements and innovations across the medical device industry. Powered by Global Data’s proprietary business intelligence, the program highlights the companies and individuals driving meaningful changes across twelve key categories including Innovation, Product Launches, R&D, Safety, and Marketing.

“Being recognized across four distinct categories is an extraordinary honor and a reflection of the energy and purpose that drive our teams every day,” said Shervin Korangy, President & Chief Executive Officer at BVI. “These awards validate our vision to lead the ophthalmic industry not only through cutting-edge technologies, but also through bold financial strategy and meaningful global expansion. We’re excited by the impact we’re making — and even more inspired by what’s ahead.”

BVI was recognized in the following categories:

• Breakthrough Innovation in Ophthalmic Implants: For its patented ISOFOCAL technology, featured in the newly launched SERENITY and SERENITY Toric premium monofocal IOLs.
• Award-Winning Product Launch: SERENITY IOL Portfolio: For introducing the SERENITY IOL series, representing the second generation of BVI’s ISOPURE family.
• R&D Leadership in Minimally Invasive Glaucoma Technology: For the Leos™ Laser Endoscopy Ophthalmic System, a groundbreaking platform that combines laser treatment with endoscopic visualization. Leos has received FDA 510(k) clearance and is planned for commercial launch in late 2025.
• Strategic Capital Investment and Global Expansion: Following the successful $1 billion capital raise in partnership with TPG, enabling manufacturing expansion, global footprint growth, and accelerated product innovation.

“Winning in both the Innovation and Product Launch categories is a powerful acknowledgment of the incredible work our teams have done to bring the SERENITY IOL portfolio to market,” said Andrew Chang, Chief Commercial Officer at BVI. “We’re proud to set a new standard in monofocal IOLs and excited for what lies ahead. With upcoming launches on the horizon, we remain deeply committed to shaping the future of ophthalmology.”

These four awards reflect the strength of BVI’s strategy, the depth of its innovation, and the dedication of its global teams. As the company continues to expand its portfolio, invest in next-generation technologies, and scale global operations, BVI is well-positioned to shape the future of ophthalmology and deliver lasting value to patients, surgeons, and partners around the world.

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

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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.

• Positions company for several new product launches and scaling of operations to meet rising demand globally

• $1 billion of new capital raised to refinance debt and fund accelerated growth

Waltham, MA, March 10th, 2025 – BVI Medical, a leading global ophthalmic device company dedicated to sitting at the forefront of advancements in eye surgery, today announced the completion of a $1 billion strategic capital raise in partnership with TPG, a leading global alternative asset management firm. This investment, which fully refinances BVI’s existing debt and adds new equity from both TPG and new investors, strengthens the company’s financial position as it looks to accelerate product innovation and expand its global footprint.

This financing follows a period of accelerated momentum for BVI, during which the company has significantly grown its portfolio of product offerings and built one of the most robust product pipelines in the industry. Most recently, BVI expanded its IOL manufacturing in Europe to meet growing global demand, introduced new product lines such as SERENITY and SERENITY Toric premium monofocal IOLs, and strengthened its market position through strategic acquisitions.

“This investment marks a pivotal moment for BVI as we scale our capabilities to meet the rising demand for advanced ophthalmic solutions,” said Shervin Korangy, President and CEO. “We are redefining the future of eye surgery and changing the competitive landscape by driving the launch of breakthrough technologies that will empower surgeons worldwide.”

“TPG is proud to continue our partnership with BVI as it works to scale its global impact in ophthalmic care,” said Kendall Garrison, Partner at TPG. “The company has strengthened its market position while advancing patient care worldwide and this investment will further drive innovation and expansion. We look forward to supporting BVI’s continued success,” added John Schilling, MD, Co-Managing Partner at TPG Capital.

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

• EyeXchange Solutions connects experienced and emerging surgeons across cataract, glaucoma, and retina specialties to share insights, refine techniques, and address complex cases.

• BVI Medical aims to facilitate a collaborative forum fostering learning in ophthalmology through video series, engaging email discussions, and interactive quizzes.

Waltham, MA, January 31st, 2024 – BVI Medical, a diversified global ophthalmic device company committed to advancing eye surgery and improving patients’ vision, is excited to introduce EyeXchange Solutions. This new platform is designed to advance vision care through a comprehensive program of educational resources and clinical support, empowering surgical decisions, enhancing provider experiences, reducing the economic burden on healthcare systems, and optimizing patient care in cataract, glaucoma, and retina specialties.

In an ever-evolving field, EyeXchange Solutions facilitates insights to surgeons to navigate complex cases, refine techniques, and engage in meaningful discussions about the future of ophthalmology. By connecting experienced professionals with younger generations of surgeons, the platform fosters a continuous exchange of perspectives and practical skills.

Platform’s Core Tenets

• Education & Support: Dedicated to continuous learning through peer-to-peer education (in person or on demand), case studies, interactive surveys, and both didactic and hands-on clinical experiences.

• Patient-Centricity: Focused on improving patient outcomes by addressing the challenges and complexities inherent in vision care.

• Knowledge Sharing: Promotes collaboration, through a central intelligence hub.

“EyeXchange Solutions is about creating conversations that matter—bringing people together to share insights and learn from one another’s experiences. At BVI Medical, we are committed to being a trusted thought partner in addressing the complexities of modern ophthalmic care,” said Aimee Shimamoto, Vice President, Co-Head Global Marketing at BVI Medical.

Key Features

• EyeXchange Talks: Video series hosted on EyeXchange Solutions’ official website or presented live at major events, moderated by respected leaders in the field.

• Physician Perspectives: Thought-provoking questions sent via email each month to encourage discussion and share insights.

• Interactive Quiz: Engaging quizzes offering participants the opportunity to expand their knowledge and apply new concepts in their practice.

Through this new platform, BVI Medical reaffirms its dedication to fostering meaningful dialogue within the ophthalmology community. EyeXchange Solutions aligns with the company’s mission to support professionals navigating complex cases while providing valuable insights into perioperative, procedural, and business practices.

To learn more and join the conversation, visit https://eyexchange.bvimedical.com/

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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.

Press Contact

David Chavez, Global Communications Lead

[email protected] 

+1 (857) 869 8706

• BVI continues to grow and build a strong company culture based on simplicity, transparency and an entrepreneurial mindset.
• BVI opens an office in Krakow (Poland), welcoming over 50 employees

Waltham, MA, September 16th, 2024 – BVI, one of the fastest-growing, diversified companies in ophthalmology, is proud to announce the creation of its new BVI Poland entity, opening a new office in Krakow. This September, BVI celebrated the grand opening for local employees, their leaders, and members of the Leadership Team.

Driving efficiency and scalability

BVI consistently looks for ways to drive efficiency and scalability through process improvement, system enhancement, and workload consolidation. This approach has led the company to build new capabilities and scale that the organization didn’t have previously.

Krakow will be a new hub for a Centre of Excellence and is a great location for talent. This modern office welcomes over 50 employees from several departments: Finance, Customer Operations, Regulatory Affairs, Quality Assurance, HR, and Talent Acquisition. Teams of experts with strong language capabilities will take on business operations/back office duties, emphasising simplicity and speed in action for the company.

The BVI entity in Poland will further strengthen BVI’s footprint in Europe.

Andy Dawson, CPO said: “It is incredibly exciting to see BVI continue to grow and to see the excitement that the team continues to bring. The talent we’ve been able to attract is outstanding and will make an immediate impact as part of our global organization.”

Todd Patriacca, CFO said: “”I’m incredibly excited about opening our Poland location and establishing a base for collaboration. The fresh perspectives and expertise our team brings will drive impactful process improvements, setting us on a path to greater efficiency and success.”

Devang Shah, SVP Business Operations, RA and QA said: ““The opening of our Krakow office represents a key milestone in BVI’s journey towards greater operational excellence. This site will not only enhance our operational capabilities but also embody our commitment to a seamless customer experience. The talented team we’ve assembled here will be instrumental in driving forward our strategic goals and reinforcing our presence globally.”

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.

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

BVI to Launch New SERENITY and SERENITY Toric Premium Monofocal IOLs, Delivering an Extended Range of Vision to More Patients, at the 2024 ESCRS

• Non-diffractive IOLs SERENITY and SERENITY Toric are the second generation of BVI’s original, innovative ISOPURE premium monofocal IOL launched in 2019.
• These IOLs incorporate patented ISOFOCAL optic technology to provide both distance vision and intermediate vision.¹ The ground-breaking double c-loop POD platform is specifically engineered to deliver precise astigmatism correction and stable IOL positioning.²
• These lenses are designed to meet the growing demand for intermediate-optimized IOLs, which are projected to see a 15% CAGR. ³

Waltham, MA, September 3, 2024 – BVI today unveiled its latest innovations: SERENITY and SERENITY Toric premium monofocal IOLs. These non-diffractive, aspheric IOLs are the second generation of BVI’s pioneering ISOPURE family, first introduced in 2019. Utilizing patented ISOFOCAL optic technology to elegantly balance Depth of Focus (DoF) and image quality, these lenses provide far vision equal to a monofocal but with good intermediate vision up to 66 cm.¹

Continuing the IOL Innovation Legacy

Since the launch of ISOPURE in 2019, BVI has remained committed to providing innovative solutions for patients seeking an uncompromised, extended range of vision. The SERENITY series maintains the simplicity of a monofocal IOL while incorporating ISOFOCAL technology to deliver spherical aberration correction across the entire optic diameter and customize the level of spherical aberration per dioptric power.

The SERENITY Toric model benefits significantly from the maneuverability of the double C-loop POD platform. This platform is exclusive to BVI and allows the IOL to be rotated clockwise or counterclockwise to align the cylinder with the axis. For astigmatic patients, the POD platform delivers a toric IOL that remains stable in the capsular bag,² with outcomes accurately predicted by BVI’s toric calculator.

Mr. Sheraz DayaMD FACP FACS FRCS(Ed) FRCOphth (Centre For Sight, UK), one of the first surgeons to implant SERENITY, commented, “It is wonderful to see this Increased range of focus lens (IROF) on the same platform as the Finevision with 4 C loop haptics. I look forward to the Toric version as well which I know will be very stable with no rotation.”

“As we launch the second-generation SERENITY and SERENITY Toric IOLs, BVI views this IOL as potentially a game-changer when it comes to standard of care for monofocal procedures,” saidShervin Korangy, President and CEO of BVI. “Our portfolio includes a wide range of IOLs, meticulously designed from material to haptics to optics to provide the optimal outcome without the burden of retro-fitting legacy predicate devices.”

Global Launch Schedule

SERENITY and SERENITY Toric will have full commercial availability in CE-accepting markets in 2025⁴.

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.

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

References

1. Bernabeu-Arias G, Beckers S, RincónRosales JL, Tañá-Rivero P, Bilbao-Calabuig R. Visual Performance at Different Distances After Implantation of an Isofocal Optic Design Intraocular Lens. J Refract Surg. 2023 Mar;39(3):150-157.
2. Robert Edward T Ang, Pedro Tañá-Rivero, Francisco Pastor-Pascual, Pavel Stodulka, Manfred Tetz, Isaak Fischinger. Visual and Refractive Outcomes After Bilateral Implantation of a Biconvex Aspheric Toric Monofocal Intraocular with a Double C-Loop Haptic Design. Clinical Ophthalmology 2023:17 2765–2776.
3. 2024 IOL Market Report, Market Scope, P. 188
4. Not Available for Sale in the United States

It’s 4 for 4 in 2024!

• BVI continues to grow and build a strong company culture based on simplicity, transparency and an entrepreneurial mindset.
• BVI has re-certified Great Place to Work in the US, France, and the Netherlands for several years in a row, and certified first time around in Mexico

WALTHAM, Mass., August 14, 2024 — BVI Medical (BVI), one of the fastest-growing, diversified company in ophthalmology, is proud to have been Certified™ Great Place to Work® Certified™ for the past four years in the U.S., and also in France and the Netherlands. For the first time, BVI was also recognized in Mexico.

The prestigious award is based on what current employees say about their experience working at BVI. With 78% participation on average across all four locations this year, 83% of employees said BVI is a great place to work.

BVI attributes this accolade to the company’s focus on building a strong company culture based on simplicity, transparency, and an entrepreneurial mindset.

We are thrilled to become Great Place to Work-Certified™ as we consider employee experience a top priority every day,” said Shervin Korangy, President and CEO of BVI. “The questionnaire has highlighted what makes BVI unique and our leadership teams are proud to see that the aspects they’ve worked on have improved and our people have seen the positive impact of their actions.”

This past June, BVI celebrated the certification at its four office locations across the U.S., France, the Netherlands, and Mexico, with onsite activities, and online events.

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 Knives and Blades, Cannulas, Single-Use Instruments, Vitreoretinal Surgical Products and Premium IOLs.

At BVI, we seek engaged, innovative, and talented professionals, interested in growing their careers within the ophthalmic industry. We want to work with individuals who are looking to constantly learn, collaborate and advance eye health across the globe. 

For further enquiries, visit our career page or email Andrew Dawson, Chief People Officer: [email protected]

About Great Place to Work®
Great Place to Work® is the global authority on workplace culture. Since 1992, they have surveyed more than 100 million employees worldwide and used those deep insights to define what makes a great workplace: trust. Their employee survey platform empowers leaders with the feedback, real-time reporting and insights they need to make data-driven people decisions. Everything they do is driven by the mission to build a better world by helping every organization become a great place to work For All™.

About Great Place to Work Certification™
Great Place to Work® Certification™ is the most definitive “employer-of-choice” recognition that companies aspire to achieve. It is the only recognition based entirely on what employees report about their workplace experience – specifically, how consistently they experience a high-trust workplace. Great Place to Work Certification is recognized worldwide by employees and employers alike and is the global benchmark for identifying and recognizing outstanding employee experience. Every year, more than 10,000 companies across 60 countries apply to get Great Place to Work-Certified.

About the survey

Great Place to Work® is the global authority on workplace culture, employee experience, and the leadership behaviors proven to deliver market-leading revenue, employee retention and increased innovation.The survey measures employees’ perception by asking 60 questions, structured out of 5 dimensions around Trust: Credibility, Respect, Fairness, Pride, and Camaraderie.

Second BVI Market Debut in Less Than Twelve Months

• BVI continues to execute its roadmap of IOL launches in Japan, the world’s third-largest IOL-valued market¹
• The PODEYE hydrophobic monofocal is perfectly suited to the Japanese market, where hydrophobic IOLs constitute almost 96% of the total monofocal IOL units in Japan¹
• Following the 2023 launch of FINEVISION HP Hydrophobic Trifocal IOL, PODEYE becomes the second BVI IOL to be available in Japan

WALTHAM, Mass., April 18, 2024 (GLOBE NEWSWIRE) BVI, the most dynamic, diversified company in ophthalmology, announced today the official launch of the PODEYE hydrophobic monofocal IOL in Japan following approval by the Japanese Pharmaceuticals and Medical Devices Agency (PMDA). The achievement represents another significant step in BVI’s plan to launch its range of IOLs in Japan over the near-term.

Being unveiled at the Japanese Ophthalmic Society (JOS) annual meeting in Tokyo, PODEYE is now available for commercial use and available to surgeons across the country.

“Our commitment to the Japanese ophthalmic market is a clear priority for BVI. The PODEYE launch continues to execute on our strategic vision and global expansion. We are set to equip surgeons with more solutions to enhance patient care. Anticipate more groundbreaking product launches from us in Japan and many other major markets globally.” said Shervin Korangy, President and CEO of BVI.

Stability Made Simple.
With a focus on IOL stability, the now proven double C-loop haptic design, known as ‘POD’ which is unique only to BVI lenses, was first introduced to the market with the launch of the PODEYE hydrophobic IOL in Europe in 2012. BVI has demonstrated the success of its POD technology with over 10 years of accomplished sales worldwide. Renowned for its novel, one-of-a-kind (double C-loop) haptic design, ensuring reliable IOL centration and rotational stability, the POD platform has gained substantial popularity and serves as the foundation for all future BVI IOLs.

Focus on Safety
Given that Japan is primarily a hydrophobic market, surgeons in Japan, like their counterparts worldwide, will appreciate the proprietary, hydrophobic ‘GFY^®’ material from which BVI IOLS are made providing 100% glistening-free material.

Moreover, the company has also demonstrated market-wide expertise in IOL material development.  Alongside its patented GFY material featured exclusively in BVI lenses, BVI also develops and supplies approximately 20% of IOL material for competing IOL companies globally from its facility in Florida, US.

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]

¹Market Scope Data