Notícias

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.      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: [email protected] 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: [email protected]

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

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

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

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

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

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

About BVI

BVI® is a diversified global ophthalmic device company with a mission to deliver high quality solutions and innovation for advancing eye surgery and improving the vision of patients. With nine decades of developing leading products and solutions, BVI partners with ophthalmic surgeons to improve the vision of millions of patients across the globe. Our organization supports surgical teams in more than 90 countries worldwide, either directly or through our network of trusted distributors. Our trusted brands include Beaver® (Knives and Blades), Visitec® (Cannulas), Malosa® (Single-Use Instruments), Vitreq® (Vitreoretinal Surgical Products) and PhysIOL® (Premium IOLs).

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

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

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

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

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

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

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

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

About BVI

BVI® is a diversified global ophthalmic device company with a mission to deliver high quality solutions and innovation for advancing eye surgery and improving the vision of patients. With nine decades of developing leading products and solutions, BVI partners with ophthalmic surgeons to improve the vision of millions of patients across the globe. BVI supports surgical teams in more than 90 countries worldwide, either directly or through its network of trusted distributors. BVI trusted brands include: Beaver® (Knives and Blades), Visitec® (Cannulas), Malosa® (Single-Use Instruments), Vitreq® (Vitreoretinal Surgical Products) and PhysIOL® (Premium IOLs).

Contacts

BVI

Andrew Dawson

Corporate Communications

[email protected]

Investors

Vivian Cervantes

Gilmartin Group

[email protected]

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/