Cataract Treatment Gets More Precise with FDA Approval of Softec HD™ Lens

New Intraocular Lens (IOL) Implant from Lenstec Enables Surgeons to Achieve Unmatched Precision and Predictability

St. Petersburg, Florida – April 6, 2010 — Lenstec, Inc. — a manufacturer of technologically-advanced implantable lenses – today announced that the U.S. Food and Drug Administration has approved the company’s Softec HD™ Intraocular Lens Implant (IOL) for treating patients with cataracts.

The newly approved Softec HD is part of Lenstec’s “Precision Series” of implantable IOLs that enable ophthalmologists to achieve previously unattainable predictability and precision in vision surgery.

Targeting a Growing Problem Worldwide

Cataract formation is among the leading causes of blindness. While not generally amenable to prevention, cataracts can usually be treated with surgery in which an IOL is used to replace the damaged natural crystalline lens. According to the World Health Organization, the number of cataract operations internationally will grow to 20 million this year, up from seven million in 2000.

The Softec HD is already in widespread use throughout the European Union, Australia, Canada, China and other international markets. More than one million Softec IOLs have been implanted worldwide since 2005.

With today’s approval announcement, cataract patients in the U.S. can now benefit from Softec HD’s advanced technology, which will be on display April 9-14 at the ASCRS (American Society of Cataract and Refractive Surgeons) Symposium & Congress in Boston (Booth # 2272).

Unrivaled Predictability

Based on Lenstec’s proprietary lens manufacturing technology, the Softec HD is designed to make cataract surgery more predictable by reducing the variability inherent in any manufactured lens. When it comes to lenses used for vision correction, variability is defined as the tolerance or margin of error measured by the difference between a lens’ labeled prescription and its actual power.The Softec HD is manufactured with a tolerance of just 0.125D (diopters), which is up to three times more precise than cataract replacement lenses manufactured under less stringent ISO standards.

“Lens variability is one of the leading causes of refractive error for patients who undergo cataract surgery,” said Lenstec Vice President Jim Simms. “Our ‘Precision Series’ technology reduces such variability and enables surgeons to better target each patient’s prescription.”

William F. Maloney, M.D., associate clinical professor of ophthalmology at the University of California, Irvine, has cautioned surgeons for years about the problems associated with lens variability.

“The accuracy of the IOL prescription label is now likely to be the greatest source of refractive error in your surgery,” Dr. Maloney warned in the September 2005 issue of Ocular Surgery News. “When it comes to power, what you see is definitely not what you get. The tolerance for error in most IOL labeling is now obsolete, and it too fails today’s refractive accuracy test. Until that changes, your efforts at refractive recalibration will be hostage to this outdated industry standard.”

Simms added, “The only way to reduce such variability is to manufacture a more precise lens. While this requires more effort, we have been able to make the process scalable in a way that larger implantable lens manufacturers with legacy systems simply can’t match.”

Unrivaled Precision

In addition to reducing variability, Lenstec’s high-precision manufacturing process makes it possible to produce Softec HD lenses in 0.25D increments for prescriptions from +18D to +25D. In contrast, standard IOLs from other manufacturers are available only in 0.5D increments, which means they can be up to 0.25D out of step with a patient’s lens prescription.

“Today’s announced approval of the Softec HD means that U.S. surgeons now have the technology to address concerns about lens variability head-on and provide cataract patients with a new, vastly superior level of predictability and precision,” Simms concluded.

Cataract formation is a vision disorder characterized by cloudy or opaque areas in the eye’s natural lens that usually develop gradually with advancing age (environmental factors, metabolic diseases and certain medications can also accelerate cataract formation).

About Lenstec Lenstec is a leading designer and manufacturer of intraocular lenses (IOLs) to treat patients with a range of vision disorders. The company’s “Precision Series” includes the Softec HD™ mono-focal Bi-Aspheric lens and the Tetraflex™ presbyopic accommodating lens, which is designed to provide cataract and presbyopia patients with clear near, intermediate and far vision. Founded in 1992, Lenstec is dedicated to advancing possibilities for ophthalmic surgeons and their patients worldwide.

Lenstec Gains FDA Approval for Softec HD™ IOL to Treat Cataracts

New Intraocular Lens Implant Enables Surgeons to Achieve Unmatched Precision and Predictability

St. Petersburg, Florida – April 5, 2010 — Lenstec, Inc. — a provider of technologically- advanced implantable lenses – today announced that the U.S. Food and Drug Administration has approved the company’s Softec HD™ Intraocular Lens Implant (IOL) for treating patients with cataracts.

The newly approved Softec HD is part of Lenstec’s “Precision Series” of implantable monofocal and accommodating IOLs that enable ophthalmologists to achieve previously unattainable precision and predictability in vision surgery.

Already approved and in use throughout the European Union, Australia, Canada, China and other international markets, the Softec HD is an aberration controlled bi-aspheric IOL designed to replace the natural crystalline lens following cataract removal in patients 21 years of age and older.

More than one million Softec IOLs have been implanted worldwide since 2005. With today’s approval announcement, cataract patients in the U.S. can now benefit from Softec HD’s advanced technology, which will be on display at the ASCRS (American Society of Cataract and Refractive Surgeons) Symposium & Congress in Boston April 9-14 (Booth # 2272).

Unrivaled Predictability

The Softec HD benefits from Lenstec’s proprietary lens manufacturing technology, which is designed to make cataract surgery more predictable by reducing the variability inherent in any manufactured lens.

When it comes to lenses used for vision correction, variability is defined as the tolerance or margin of error measured as the difference between a lens’ labeled prescription and its actual power.

With a tolerance of just 0.125D, the Softec HD reduces variability and is up to three times more precise than cataract replacement lenses manufactured under less stringent ISO standards.

“The only way to reduce lens variability is to manufacture a lens that is more precise,” said Lenstec Vice President Jim Simms. “While this requires more effort, we have been able to make the process scalable in a way that larger implantable lens manufacturers with legacy systems simply can’t match.”

Unrivaled Precision

In addition to improving predictability, Lenstec’s high-precision manufacturing process makes it possible to produce Softec HD lenses in 0.25D increments for prescriptions from +18.0D to +25D. In contrast, standard IOLs from other manufacturers are available only in 0.5D increments, which means they can be up to 0.25D out of step with a patient’s lens prescription.

“Lens variability is one of the leading causes of refractive error for patients who undergo cataract surgery,” Simms added. “Our ‘Precision Series’ technology reduces such variability and enables surgeons to more precisely target each patient’s prescription.”

William F. Maloney, M.D., associate clinical professor of ophthalmology at the University of California, Irvine, has cautioned surgeons for years about the problems associated with lens variability.

“The accuracy of the IOL prescription label is now likely to be the greatest source of refractive error in your surgery,” Dr. Maloney warned in the September 2005 issue of Ocular Surgery News. “When it comes to power, what you see is definitely not what you get. The tolerance for error in most IOL labeling is now obsolete, and it too fails today’s refractive accuracy test. Until that changes, your efforts at refractive recalibration will be hostage to this outdated industry standard.”

Simms added, “Today’s announced approval of the Softec HD means that surgeons now have the technology to address such concerns head-on and provide cataract patients with a new, vastly superior level of predictability and precision.”

Intraocular lens implants (IOLs) are used to treat cataracts – a vision disorder characterized by cloudy or opaque areas in the eye’s natural lens that usually develop gradually with advancing age (environmental factors, metabolic diseases and certain medications can also accelerate cataract formation). An estimated 2.5 million people annually in the U.S. undergo cataract surgery with an IOL implant, and an estimated 10-15 million IOLs are implanted worldwide each year.

About Lenstec Lenstec is a leading designer and manufacturer of intraocular lenses (IOLs) to treat patients with a range of vision disorders. The company’s “Precision Series” includes the Softec HD™ mono-focal Bi-Aspheric lens and the Tetraflex™ presbyopic accommodating lens, which is designed to provide cataract and presbyopia patients with clear near, intermediate and far vision. Founded in 1992, Lenstec is dedicated to advancing possibilities for ophthalmic surgeons and their patients worldwide.

Lenstec Introduces Precision Series™ Intraocular Lens Implants

New Mono-Focal and Accommodating IOLs are Designed to Help Surgeons Treat Cataracts with Enhanced Precision and Predictability

St. Petersburg, Florida – April 20, 2006 – Lenstec, Inc, — a provider of technologically- advanced lenses for treating vision disorders – today announced the introduction of its Precision Series™ intraocular lens implants (IOLs) for treating patients with cataracts.

Based on the company’s proprietary lens manufacturing technology, these premium lenses are designed to improve predictability in cataract surgery by reducing the variability (i.e., tolerance or margin of error) inherent in any manufactured lens. They reduce variability, measured as the difference between a lens’ labeled prescription and its actual power, up to 300 percent compared to other cataract replacement lenses manufactured in accordance with less stringent ISO standards.

In addition, Lenstec’s high precision manufacturing process makes it possible to produce lenses in 0.2D to 0.25D increments, compared to the standard 0.5D increments offered by other IOL manufacturers. As a result, surgeons are afforded a greater choice of lenses, which helps them tailor treatment more precisely for each patient.

“Our new Precision Series greatly reduces lens variability, which is one of the leading causes of refractive error when it comes to treating cataract patients,” said Lenstec Vice President Jim Simms.

William F. Maloney, M.D., associate clinical professor at UC Irvine, recently warned surgeons about the problems associated with such lens variability. “The IOL label itself is now likely to be the greatest source of refractive error in your surgery. When it comes to power, what you see is definitely not what you get. The tolerance for error in most IOL labeling is now obsolete, and it too fails today’s refractive accuracy test. Until that changes, your efforts at refractive recalibration will be hostage to this outdated industry standard” (Maloney W., Ocular Surgery News, Sept. 2005).Lenstec’s Precision Series includes the Softec PS™ mono-focal lens and the Tetraflex™ presbyopic accommodating lens, which is designed to provide cataract and presbyopia patients with seamless clear near, intermediate and far vision. The Softec PS is available in 0.25D steps, with a tolerance of 0.125D. The Tetraflex is available in 0.2D steps, with a tolerance of 0.10D. The Tetraflex lens is currently in clinical trials in the U.S., while the Softec lens is awaiting IDE status.

Intraocular lens implants (IOLs) are used to treat cataracts – a vision disorder characterized by cloudy or opaque areas in the eye’s natural lens that usually develop gradually with advancing age (environmental factors, metabolic diseases and certain medications can also accelerate cataract formation). Cataract surgery involves replacing the eye’s damaged lens with an implantable IOL. Accommodating IOLs such as Lenstec’s Tetraflex are designed to treat both cataracts and presbyopia, which is the progressive, age-related loss of the eye’s ability to focus for reading and other close tasks.

An estimated 2.5 million people annually in the U.S. undergo cataract surgery with an IOL implant, and an estimated 10-15 million IOLs are implanted worldwide each year.

About Lenstec

Lenstec, Inc. is a leading provider of medical devices used by ophthalmic surgeons to treat vision disorders. The company designs, manufacturers and distributes a wide range of intraocular lens (IOL) implants and lens injection systems, including the industry-leading SoftecHD IOL, Tetraflex presbyopic IOL and Precision Series™ IOLs. Proprietary lens manufacturing technology enables the company to produce premium lenses with reduced variability and improved surgical predictability. Founded in 1992, Lenstec is dedicated to advancing possibilities for ophthalmic surgeons and their patients worldwide.