PRESS RELEASE

PRESS RELEASE

FOR IMMEDIATE RELEASE

Norlase Receives CE Mark Approval for LION Green Laser System

First-of-its-kind, all-in-one laser and indirect ophthalmoscope allows for retina treatment anywhere, anytime

Ballerup, Denmark and Redwood City, CA, USA – January 5, 2021 – Norlase today announced that it has been granted the European CE Mark for the LION™ green laser system. LION combines the Keeler Vantage Plus diagnostic indirect with Norlase’s groundbreaking compact laser technology into one device. With LION’s untethered and portable design, physicians can move freely between treatment rooms – conveniently treating patients anywhere, anytime.

“We are excited to greet 2021 with this important milestone,” said Oliver Hvidt, Norlase President and CEO. “With CE Mark approval for LION following the recent establishment of our strategic distribution partnerships, we have expanded our reach and will arm even more ophthalmologists with innovative laser solutions to optimize practice efficiency and workflow. I am extremely proud of our team for yet another major accomplishment.”

LION Green Laser features include:
  • Green laser and LIO in one integrated device
  • No fiber tether, reducing risk of fiber breakage and costly repairs

  • Ultra-clear optics offering enhanced visualization during treatment and diagnosis

  • Portable and untethered design allows treatment anytime, anywhere

  • Rechargeable battery providing more than a full day of continuous use

  • Parameter settings operable through an intuitive user interface on a wireless tablet

  • Optional voice control providing touchless parameter adjustment during treatment

“We’re confident that LION will be the new gold standard portable laser photocoagulator now and into the future,” said Greg Fava, Norlase VP of Medical Devices. “Through research and collaboration with key ophthalmologists, we have developed a green laser that checks off all the boxes – it’s easy to use, improves practice efficiency, reduces costly repairs and it’s affordable.” Taoufiq Jellal, Norlase VP of Global Distribution adds, “Our team of distributors can now offer both LION and LEAF green laser systems to ophthalmologists in Europe and other countries, further growing our global footprint in the eyecare and laser photocoagulator market. We look forward to continued expansion into new regions around the world.”

CE Mark approval follows the October 2020 510(k) market clearance of LION by the U.S. Food and Drug Administration (FDA) and recent announcements of strategic global distribution partnerships to expand the family of Norlase Green Laser Systems into new markets.

About Norlase

Norlase develops next-generation laser solutions for the treatment of retina and glaucoma diseases. Founded in Denmark, Norlase is comprised of worldwide industry experts in ophthalmology, laser technology, medical device development, and customer care. Norlase is on a mission to improve practice efficiency, patient care, and physician convenience for ophthalmologists worldwide. Norlase devices include its flagship product LEAF, a laser photocoagulator that’s 10X smaller than existing systems and mounts directly on the slit lamp, and LION – the first fully integrated green laser and LIO.

FOR IMMEDIATE RELEASE

Norlase Receives CE Mark Approval for LION Green Laser System

First-of-its-kind, all-in-one laser and indirect ophthalmoscope allows for retina treatment anywhere, anytime

Ballerup, Denmark and Redwood City, CA, USA – January 5, 2021 – Norlase today announced that it has been granted the European CE Mark for the LION™ green laser system. LION combines the Keeler Vantage Plus diagnostic indirect with Norlase’s groundbreaking compact laser technology into one device. With LION’s untethered and portable design, physicians can move freely between treatment rooms – conveniently treating patients anywhere, anytime.

“We are excited to greet 2021 with this important milestone,” said Oliver Hvidt, Norlase President and CEO. “With CE Mark approval for LION following the recent establishment of our strategic distribution partnerships, we have expanded our reach and will arm even more ophthalmologists with innovative laser solutions to optimize practice efficiency and workflow. I am extremely proud of our team for yet another major accomplishment.”

LION Green Laser features include:

  • Green laser and LIO in one integrated device
  • No fiber tether, reduces risk of fiber breakage and costly repairs

  • Ultra-clear optics offer enhanced visualization during treatment and diagnosis

  • Portable and untethered design allows anywhere, anytime treatment

  • Rechargeable battery provides more than a full day of continuous use

  • Parameter settings operable through an intuitive user interface on a wireless tablet

  • Optional voice control provides touchless parameter adjustment during treatment

“We’re confident that LION will be the new gold standard portable laser photocoagulator now and into the future,” said Greg Fava, Norlase VP of Medical Devices. “Through research and collaboration with key ophthalmologists, we have developed a green laser that checks off all the boxes – it’s easy to use, improves practice efficiency, reduces costly repairs and it’s affordable.” Taoufiq Jellal, Norlase VP of Global Distribution adds, “Our team of distributors can now offer both LION and LEAF green laser systems to ophthalmologists in Europe and other countries, further growing our global footprint in the eyecare and laser photocoagulator market. We look forward to continued expansion into new regions around the world.”

CE Mark approval follows the October 2020 510(k) market clearance of LION by the U.S. Food and Drug Administration (FDA) and recent announcements of strategic global distribution partnerships to expand the family of Norlase Green Laser Systems into new markets.

About Norlase

Norlase develops next-generation laser solutions for the treatment of retina and glaucoma diseases. Founded in Denmark, Norlase is comprised of worldwide industry experts in ophthalmology, laser technology, medical device development, and customer care. Norlase is on a mission to improve practice efficiency, patient care, and physician convenience for ophthalmologists worldwide. Norlase devices include its flagship product LEAF, a laser photocoagulator that’s 10X smaller than existing systems and mounts directly on the slit lamp, and LION – the first fully integrated green laser and LIO.