Novità

Waltham, Massachusett, 19 gennaio 2026 – BVI, leader mondiale nel mercato dei dispositivi oftalmici, oggi annuncia la nomina di Jim Hollingshead a presidente e CEO (Chief Executive Officer). Hollingshead assume la carica precedentemente ricoperta da Shervin Korangy, che continuerà a fungere da consulente di BVI e assumerà un nuovo ruolo come consulente senior di TPG Capital.

Hollingshead apporta un’esperienza più che ventennale nella dirigenza e nella crescita di aziende attive nel settore dei dispositivi medici e delle scienze della vita; di recente ha ricoperto il ruolo di CEO di Insulet, innovativa azienda leader nella somministrazione di insulina. Durante il mandato di Hollingshead, Insulet ha rafforzato la propria leadership di mercato grazie all’ampliamento dell’offerta di prodotti, tra cui il lancio del primo sistema di somministrazione automatica di insulina con microinfusore in cerotto del settore. In precedenza, Hollingshead ha collaborato per 12 anni con ResMed, ricoprendo l’incarico di presidente per le attività di cura del sonno e delle vie respiratorie dell’azienda nell’ultimo periodo.

“Da tempo il ruolo dell’innovazione tecnologica nel migliorare l’esperienza e i risultati dei pazienti rappresenta per me una fonte di ispirazione”, ha dichiarato Hollingshead. “BVI sta trasformando la visione dell’assistenza oculistica grazie a una missione semplice ed efficace: fornire soluzioni affidabili, innovative e su misura per le esigenze specifiche di medici e pazienti. È un privilegio entrare a far parte del team di BVI, mentre sfruttiamo la forte spinta propulsiva dell’azienda e lanciamo diverse nuove piattaforme leader del settore.”

Negli ultimi anni, BVI ha proseguito in questo slancio ampliando nettamente il proprio portafoglio di soluzioni ad hoc; l’azienda ha sviluppato una delle pipeline di prodotti più solide del settore e ora offre una soluzione procedurale completa per il mercato della chirurgia della cataratta e della retina, oltre ad aver ampliato la piattaforma di lenti intraoculari (Intraocular Lenses, IOL), per rispondere alla crescente domanda globale, e ad aver lanciato nuove linee di prodotti come SERENITY e SERENITY Toric per la visione a distanza e intermedia. BVI nel 2025 ha ottenuto l’approvazione dell’Agenzia statunitense per gli alimenti e i medicinali (Food and Drug Administration, FDA) per la sua IOL trifocale FINEVISION HP e ha affermato la propria posizione di leadership globale nelle IOL di qualità superiore per i pazienti statunitensi. L’azienda ha inoltre presentato il sistema per glaucoma Leos™, approvato dalla FDA, un importante progresso nella cura del glaucoma, e ha lanciato Virtuoso®, una nuova piattaforma di faco-vitrectomia a doppia funzione per le procedure di cataratta e vitreoretina.

“La visione strategica di Jim, la sua competenza e il suo curriculum di innovazione e trasformazione nel settore dei dispositivi medici lo rendono un elemento eccellente per BVI, che continua ad aumentare la propria leadership di mercato e il proprio impatto a livello globale”, ha dichiarato Ron Labrum, presidente di BVI. “Ringraziamo Shervin per la sua attività dirigenziale mentre BVI era impegnata nello sviluppo di uno dei portafogli di prodotti più innovativi del settore, e siamo certi che il team continuerà a usufruire della sua competenza

“Desidero ringraziare tutto il team di BVI per la collaborazione nel trasformare l’azienda nell’attuale piattaforma dinamica”, ha dichiarato Korangy. “Sono orgoglioso della portata del portafoglio e della pipeline che abbiamo realizzando, sfidando lo status quo di lunga data del settore. Sono pronto a continuare a supportare l’azienda nel percorso di crescita sotto la guida di Jim”.

Informazioni su BVI
BVI® è un’azienda globale diversificata di dispositivi oftalmici con una missione: fornire soluzioni di qualità elevata e innovazione per il progresso della chirurgia oculistica e il miglioramento della visione dei pazienti. Forte di novant’anni di sviluppo prodotti e soluzioni leader, BVI collabora con i chirurghi oftalmici per migliorare la visione di milioni di pazienti in tutto il mondo. La nostra organizzazione supporta le équipe chirurgiche in più di 90 paesi in tutto il mondo, sia direttamente che tramite una rete di distributori di fiducia.

Per ulteriori informazioni su BVI e sulla sua missione, cioè far progredire il futuro della visione, visitare il sito https://www.bvimedical.com

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Contatto stampa
David Chavez
Global Communications Lead
dchavez@bvimedical.com
+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.

*** 

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 
dchavez@bvimedical.com 
+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

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Press Contact
David Chavez
Global Communications Lead
dchavez@bvimedical.com
+1 (857) 869 8706

• 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 10, 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

David Chavez

Global Communications Lead

dchavez@bvimedical.com

+1 (857) 869 8706

• Le IOL non diffrattive SERENITY e SERENITY Toric sono la seconda generazione della IOL Premium Monofocale originale e innovativa ISOPURE di BVI, lanciata nel 2019. 

• Queste IOL incorporano la tecnologia ottica brevettata ISOFOCAL per fornire sia visione da lontano che visione intermedia.¹ La piattaforma rivoluzionaria POD a doppio c-loop è progettata specificamente per fornire una correzione precisa dell’astigmatismo e un posizionamento stabile della IOL.² 

• Queste lenti sono progettate per soddisfare la crescente domanda di IOL ottimizzate per visione intermedia, per le quali si prevede un CAGR del 15%.³ 

Waltham, MA, 3 settembre 2024 – BVI ha presentato oggi le sue ultime innovazioni: le IOL Premium Monofocali SERENITY e SERENITY Toric. Queste IOL non diffrattive e asferiche sono la seconda generazione della pionieristica famiglia ISOPURE di BVI, introdotta per la prima volta nel 2019. Utilizzando la tecnologia ottica brevettata ISOFOCAL per bilanciare elegantemente la profondità di fuoco (DoF) e la qualità dell’immagine, queste lenti forniscono una visione da lontano pari a una monofocale ma con una buona visione intermedia fino a 66 cm.¹ 

Continuando l’eredità nell’ innovazione delle IOL 

Dalla presentazione di ISOPURE nel 2019, BVI si è sempre impegnata a fornire soluzioni innovative per i pazienti che cercano una gamma estesa di visione senza compromessi. La serie SERENITY mantiene la semplicità di una IOL monofocale mentre incorpora la tecnologia ISOFOCAL per offrire correzione dell’aberrazione sferica su tutto il diametro ottico e personalizzare il livello di aberrazione sferica per potere diottrico. 

Il modello SERENITY Toric beneficia in modo significativo della manovrabilità della piattaforma POD a doppio c-loop. Questa piattaforma è esclusiva di BVI e consente alla IOL di essere ruotata in senso orario o antiorario per allineare il cilindro con l’asse. Per i pazienti astigmatici, la piattaforma POD fornisce una IOL torica che rimane stabile nel sacco capsulare,² con risultati accuratamente previsti dal calcolatore torico di BVI. 

Il dottor Sheraz Daya MD FACP FACS FRCS(Ed) FRCOphth (Centre For Sight, Regno Unito), uno dei primi chirurghi a impiantare SERENITY, ha commentato: “È meraviglioso vedere questa lente con gamma di messa a fuoco aumentata (IROF) sulla stessa piattaforma della Finevision con le 4 alette a C loop. Attendo con ansia anche la versione torica, che so sarà molto stabile senza rotazione.” 

“Con il lancio della seconda generazione di IOL SERENITY e SERENITY Toric, BVI immagina queste IOL come potenzialmente rivoluzionarie quando si tratta di standard di cura per le procedure monofocali”, ha dichiarato Shervin Korangy, presidente e CEO di BVI. “Il nostro portafoglio include una vasta gamma di IOL, progettate meticolosamente, dal materiale alle alette fino all’ottica per fornire il risultato ottimale senza il peso di adattare dispositivi legacy.” 

Programma di lancio globale 

SERENITY e SERENITY Toric saranno disponibili commercialmente in tutti i mercati che accettano CE nel 2025.⁴ 

Informazioni su BVI 

BVI® è un’azienda globale diversificata di dispositivi oftalmici con la missione di fornire soluzioni di alta qualità e innovazione per avanzare nella chirurgia oculare e migliorare la visione dei pazienti. Con nove decenni di sviluppo di prodotti e soluzioni leader, BVI collabora con i chirurghi oftalmici per migliorare la vista di milioni di pazienti in tutto il mondo. La nostra organizzazione supporta i team chirurgici in oltre 90 paesi a livello globale, direttamente o tramite la nostra rete di distributori di fiducia. 

Per ulteriori informazioni o per parlare con un rappresentante di BVI, inviare un’e-mail a Andrew Dawson, capo delle comunicazioni aziendali di BVI: adawson@bvimedical.com 

Riferimenti 

1. Bernabeu-Arias G, Beckers S, RincónRosales JL, Tañá-Rivero P, Bilbao-Calabuig R. Prestazioni visive a diverse distanze dopo l’impianto di una lente intraoculare con design ottico isofocale. 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. Risultati visivi e rifrattivi dopo l’impianto bilaterale di una lente intraoculare monofocale torica asferica biconvessa con un design a loop doppio C. Clinical Ophthalmology 2023:17 2765–2776. 

3. P 188 Marketscope 2024. 

4. Non disponibile per la vendita negli Stati Uniti. 

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 Daya MD 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,” said Shervin 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: adawson@bvimedical.com 

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. P 188 Marketscope 2024 

4. Not Available for Sale in the United States 

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: adawson@bvimedical.com Market Scope

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: adawson@bvimedical.com

• 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: adawson@bvimedical.com

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

adawson@bvimedical.com

Investors

Vivian Cervantes

Gilmartin Group

IR@bvimedical.com

WALTHAM, Mass., Sept. 15, 2022 (GLOBE NEWSWIRE) — BVI, a diversified global ophthalmic device company, today announced certification for its intraocular lens (IOL) portfolio under the European Medical Device Regulation (MDR, (EU) 2017/745) from its Notified Body, the British Standards Institution (BSI)¹. The new regulatory criteria came into effect in May 2021, replacing the prior Medical Device Directive (MDD).

The MDR, representing the most significant change to European regulatory framework in decades, ensures a consistently high level of health and safety for medical devices. The new provisions focus on:

• Strict requirements with the intention to prove the safety of medical devices for both users and patients;
• Increased transparency of clinical evaluation, post market surveillance, and clinical investigation that needs to be up to date, clear, convincing, and publicly available;
• Greater emphasis on detailed requirements for technical documentation;
• Increased control and monitoring by national competent authorities and the EC;
• Reclassification of devices, wider scope of devices; and
• New Unique Device Identification system with enhanced traceability and post-market surveillance.

“Achieving and maintaining MDR certification is a major effort that requires a tremendous amount of investment, capabilities, and hard work,” said Shervin Korangy, BVI President and CEO. “This important milestone ensures continued supply of our innovative and clinically differentiated IOLS to our surgeons and patients worldwide.”

BVI Senior Vice President, Business Operations and Quality Assurance, Devang Shah, Ph.D. added, “We are proud to have obtained this certification, in partnership with our Notified Body BSI, which confirms BVI’s commitment to quality and compliance to the highest of regulatory standards. A recent MedTech report highlighted that Notified Bodies have yet to issue MDR certificates for more than 85% of the products certified under the prior directives² – so being at the forefront of this is a testament to our team’s expertise and dedication to our customers.”

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).

1. BSI Client Directory Profile: https://www.bsigroup.com/en-GB/validate-bsi-issued-certificates/client-directory-profile/PHYSIO-0047610705-000
2. https://www.medtechdive.com/news/legacy-devices-lack-mdr-certificates-medtech-europe/627439/