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

WALTHAM, Mass., Sept. 06, 2023 (GLOBE NEWSWIRE) — BVI, one of the fastest-growing, diversified surgical ophthalmic businesses in the world, announced the acquisition of Medical Mix, a company specializing in the supply of medical devices for ophthalmic surgery across Spain and Portugal.

This strategic move builds on a period of significant momentum for BVI. The company has transformed into a broad manufacturer and supplier of market-leading, innovative solutions that provide an end-to-end range of products for cataract, retinal, and glaucoma diseases. This acquisition is another pivotal step in BVI’s growth trajectory, which began to take form and accelerate since 2018. BVI’s European footprint with direct sales representatives and infrastructure now spans all major western European markets, increasing from only three markets a short 5 years ago.

Shervin Korangy, BVI President and CEO said: “It is an honor and a pleasure to welcome Medical Mix to the BVI team. When Vicente and I began discussions, it was immediately evident that our strategic vision for our industry was incredibly consistent. This shared vision of the future will serve as a rock-solid foundation for our continued success in the market.”

Founded in 1982 and headquartered in Barcelona, Medical Mix is one of the largest providers of surgical ophthalmic products in Spain and Portugal. The robust portfolio is composed mainly of BVI products alongside other prestigious international brands. The company has been built to consistently deliver the highest quality of service alongside its breadth of products which allow it to serve as a trusted partner to surgeons and patients across both countries.

Medical Mix, a longstanding distributor of BVI’s Intraocular Lenses (IOLs) since 2008, consumables since 2012, and equipment since 2019, has been a key partner with BVI products. This acquisition solidifies the enduring partnership, allowing both companies to provide comprehensive ophthalmic solutions to their customers.

Vicente Durán, Medical Mix Founder and President said: “The partnership with BVI is a very exciting next step for us and the market in Spain and Portugal. The business philosophy and approach of BVI makes our combined future very bright, offering the market the best portfolio of innovative products together with the best service tailored to customers’ needs ”

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]

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/