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LENSAR Provides Update on LENSAR Laser System™ Highlighting Recent Regulatory and Commercialization Milestones
By: Business Wire
Nov. 20, 2012 07:30 AM
LENSAR Inc., developer of the LENSAR Laser System™ for cataract surgery, today provided an update on the company’s recent regulatory and commercialization efforts for its novel laser cataract surgery system. The LENSAR Laser System represents the latest scientific breakthrough in cataract surgery, combining the most advanced laser technology with unique product features specifically intended to meet the advancing needs of refractive cataract surgeons to enhance their patients’ outcomes. Recent developments include:
In recent months, LENSAR has received 510(k) clearance from the United States Food and Drug Administration and CE Mark approval from European regulators for the LENSAR Laser System. Both regulatory actions, which cover the use of the novel platform in capsulotomy with and without laser phacofragmentation during cataract surgery, have opened the door for strategic and aggressive commercialization efforts in these markets.
Following recent regulatory approvals secured in multiple regions throughout the world, LENSAR has already shipped over 20 LENSAR Laser Systems to cataract surgeons in 11 countries. In the U.S., the company announced in July that the first laser cataract surgeries using the platform were successfully completed by two of the country’s leading cataract surgeons. Interest in the system continues to grow rapidly among cataract surgeons across the country and multiple additional system placements confirm the high performance and ease of use. In Europe, the company has generated significant demand for the LENSAR Laser System and has shipped several of its systems to cataract surgeons in various European countries. LENSAR continues to work with Topcon Europe Medical BV, its distribution and marketing partner in Europe, to generate and service the growing demand for its platform.
As part of its broad commercialization efforts, LENSAR showcased the LENSAR Laser Systems’ next generation differentiating Augmented Reality imaging technology to attendees at the recent annual meeting of the American Academy of Ophthalmology (AAO). This breakthrough platform consists of proprietary high-resolution 3D-imaging measurement technology, allowing imaging and precise biometric measurements of the anterior segment eye anatomy regardless of cataract density. Unlike traditional imaging systems, LENSAR’s Augmented Reality platform provides clean, low noise images that are both high contrast and high resolution from the anterior surface of the cornea to the posterior capsule of the crystalline lens, while automating the ability to correct for lens tilt or centration during the customized treatment to accommodate each patient’s individual anatomy. In addition, this technology allows the creation of the precise capsulotomy incision size, shape, and location, enhancing effective IOL lens positioning and fitting for each individual patient, leading to optimized patient outcomes.
Importantly, the system’s sophisticated phacofragmentation techniques allow for easier and more efficient removal of all grades of cataracts and a major reduction in, or in a large number of procedures complete elimination of the use of the ultrasound energy required in conventional cataract surgery. Furthermore, the entire procedure can take place in a single procedure room and the mobile LENSAR Laser System is easily adaptable to existing surgical facilities, allowing surgeons a never before available level of precision, efficiency, patient comfort, and safety.
“Our deliberate regulatory and commercialization strategy for the LENSAR Laser System has successfully generated tremendous interest from refractive cataract surgeons in the U.S., Europe and other international markets,” said Nick Curtis, LENSAR’s Chief Executive Officer. “We are pleased by the significant worldwide demand for our system as it demonstrates that physicians are recognizing the value of the platform’s important competitive advantages in the area of its superior imaging and measurement technology, treatment efficiency, reduced ultrasound requirements and ergonomics. These features combine to facilitate surgeons being able to achieve their ultimate goal for each of their patients.”
“Following a strategic introduction of the LENSAR system in the U.S., including the successful installations in several high volume cataract practices, we are excited by the momentum also being generated for this breakthrough product in the broader international cataract surgeon community,” said Steve Elms, Managing Partner at Aisling Capital and Chairman of the Board of LENSAR. “It is gratifying to be able to support a company such as LENSAR that is able to conceive, develop, commercialize and then successfully launch a novel technology that possesses the ability to dramatically impact the lives of so many patients.”
About LENSAR, Inc.
LENSAR, Inc. is a leader in the development and commercialization of a next generation laser and advanced 3D imaging technology for refractive cataract surgery. For more information please visit www.lensar.com
LENSAR™ Laser System has been cleared by FDA for anterior capsulotomy and lens fragmentation. For other indications it is an investigational device limited by US law to investigational use only. The system has been used in about 2000 eyes in and outside the US to date.
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