LENSAR® Laser System Receives FDA Clearance to Perform Micro Radial Incisions to Optimize Outcomes of Refractive Cataract Procedures

LENSAR® Laser System with Streamline® IV Capabilities Expands
to Include Micro Radial Incisions, Allowing Surgeons to Treat Additional
Corneal Conditions

ORLANDO, Fla.–(BUSINESS WIRE)–LENSAR, Inc., an emerging leader in next-generation femtosecond laser
technology for refractive surgery, today announced it received 510(k)
clearance from the U.S. Food and Drug Administration for the LENSAR®
Laser System with Streamline® IV, expanding the platform’s capabilities
to include the creation of micro radial incisions that allow surgeons to
treat additional corneal conditions post cataract surgery.

This indication is the latest example of LENSAR responding to the needs
and feedback from our customers, those refractive cataract surgeons
looking to deploy from a full arsenal of treatment options that support
their pursuit of best possible outcomes for patients,” said Nicholas
Curtis, CEO of LENSAR. “Our top priority is continuing to build upon our
foundation of adaptive innovation with relevant, purposeful and
continuous upgrades.”

Micro radial incisions performed with the LENSAR Laser System are guided
by the femtosecond laser platform’s powerful imaging capabilities. Fully
programmable for depth, length and position by the surgeon based upon
the patient’s biometric data, micro radial incisions are used to treat
additional corneal conditions.

The addition of the micro incisional capability to the existing suite
of enhancements for managing astigmatism, including arcuate incisions,
increases the value of the LENSAR Laser System in delivering on the
expectations of the premium cataract procedure,” said F. Beau Swann,
M.D., M.S., of Brazos Eye Surgery of Texas. “Particularly for those
patients who are not candidates for a LASIK or SMILE procedure, this
latest LENSAR innovation offers the surgeon an additional option to
improve a patient’s result and, ultimately, level of satisfaction with
their choice of a customized, advanced procedure.”

Dr. Swann is participating in the rollout incorporating micro radial
incisions into refractive cataract treatment planning with the LENSAR
Laser System. The initial data collection will be conducted at two
sites. LENSAR has applied for regulatory approval for micro radial
incisions in the EU and anticipates the in-market availability of the
new feature pending approval.

About the LENSAR Laser System with Streamline IV

The LENSAR Laser System with Streamline IV, the fourth LENSAR system
upgrade in two years, is the only femtosecond laser on the market today
developed specifically for refractive cataract surgery. The LENSAR Laser
System helps surgeons manage astigmatism with extreme treatment planning
insights featuring quick and easy patient docking, as well as superior
imaging capabilities including LENSAR’s proprietary Augmented Reality™
3-D model. This technology facilitates enhanced procedure outcomes by
allowing the physician to develop individualized treatment plans
including precise laser delivery and efficient lens fragmentation that
can reduce, and potentially eliminate, the amount of ultrasonic energy
delivered into the eye. The latest platform upgrade adds the ability to
leverage LENSAR’s powerful and adaptive femtosecond laser technology for
incisions to perform micro radial incisions and to support presbyopia
inlay procedures.

About LENSAR, Inc.

LENSAR, Inc. is a global leader in next generation femtosecond laser
technology for refractive cataract surgery. The LENSAR Laser System with
Streamline IV offers cataract surgeons automation and customization for
their astigmatism treatment planning and other essential steps of the
refractive cataract surgery procedure with the highest levels of
precision, accuracy, and efficiency. These features assist surgeons in
managing astigmatism treatment for optimal overall visual outcomes.

The LENSAR Laser System has been cleared by the U.S. Food and Drug
Administration for anterior capsulotomy, lens fragmentation, corneal
incisions including corneal pockets and flaps, and arcuate incisions.
For other indications, it is an investigational device limited by U.S.
law to investigational use only.

LENSAR, Inc., is a wholly-owned subsidiary of PDL BioPharma, Inc. For
more information, please visit www.lensar.com.


Media Contact: Lisa Spicer for LENSAR
P: 818-914-2579

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