Lutronic Vision’s R:GEN™ Treats First CSC Patient at Seoul National University Hospital

Monday, 17. June 2019 23:00

BILLERICA, Mass., June 17, 2019 (GLOBE NEWSWIRE) -- Lutronic Vision (“Lutronic” or the “Company”), a wholly-owned subsidiary of Lutronic Corporation, today announced that its R:GEN™ retina treatment laser, which uses Selective Retina Therapy, has treated its first Central Serous Chorioretinopathy (CSC) patient at Seoul National University Hospital (SNUH).

In July 2018, Korea’s Ministry of Health and Welfare granted R:GEN™ Conditional new Health Technology Assessment (nHTA) Approval and designated SNUH as a participating medical institution. The Conditional nHTA Approval allows for out-of-pocket medical treatment and collection of clinical data to support final nHTA Approval, which would determine R:GEN™'s reimbursement coverage.

“In a significant milestone for Lutronic, we are excited to introduce Korea’s first retina treatment laser through the Ministry’s Conditional nHTA program,” said Jhung Vojir, PhD, President and COO of Lutronic Vision. “The conditional approval is mutually beneficial: patients are able to access treatment for CSC with R:GEN™, while Lutronic collects data from treated patients to support the device’s nHTA Approval. We are looking forward to working with SNUH as it treats CSC patients, while we continue to prepare to initiate clinical trials of R:GEN™ in another ophthalmic indication later this year.”

R:GEN™ is a laser that targets retinal pigment epithelium (RPE) cells. In CSC, the RPE becomes susceptible to leaks, causing the accumulation of fluid in the subretinal space that can cause visual impairment and retinal detachment. Using proprietary Real Time Feedback Technology, R:GEN™ transfers energy to the established retinal treatment area to repair the leaks in the RPE, optimizing laser energy for maximum therapeutic benefit while minimizing thermal damage.

R:GEN™ is Korea’s first retina treatment laser, and has received Korea’s Ministry of Food and Drug Safety approval for CSC and diabetic macular edema (DME); U.S. Food and Drug Administration approval for clinically significant macular edema; and CE Mark for the treatment of CSC, DME and the dry form of Age-related Macular Degeneration (AMD).

In addition to CSC, Lutronic is developing R:GEN™ for the treatment of early-stage AMD, for which there are currently no approved therapies. The Company plans to initiate clinical trials of R:GEN™ for the treatment of AMD in Australia by the end of 2019.

ABOUT LUTRONIC VISION

Lutronic Vision is bringing to market the world’s first laser for Selective Retina Therapy™ with Real Time Feedback (RTF) Technology. Our system, named R:GEN™, is a fully integrated laser platform that safely and precisely targets the Retina Pigmented Epithelium to re-generate and re-store its function. Whereas older retinal photocoagulator lasers destroyed retinal tissue in an effort to preserve vision, R:GEN™ aims to revitalize retinal tissue by stimulating repair. Through this pioneering mechanism, we aim to introduce a new concept in ophthalmic retinal lasers that will ultimately lead to better vision and an improved quality of life for patients around the world.

ABOUT LUTRONIC CORPORATION

Lutronic Corporation, a leading innovator of Aesthetic, Vision, and Surgical lasers and related technology, was established in 1997 to bring intuitive, robust, versatile devices which are affordable and efficacious to the worldwide medical community. Committed to improving medicine, Lutronic Corporation partners with key opinion leaders to advance science and ensure efficacy of its systems.

With a focus on physician needs and patient outcomes, Lutronic Corporation dedicates time and funding toward the development of devices that offer features and improvements not found in today’s market. Devoting more than 15% of revenue to R&D, Lutronic holds more than 137 current and pending patents. With more than 430 employees worldwide, Lutronic has offices in the US, Korea, China, Japan, and Europe, distributors world-wide, focused R&D centers in both the US and Korea, and is ever expanding.

CONTACT INFORMATION

Jhung Won Vojir, PhD
President and COO
Lutronic Vision, Inc.
jvojir@lutronic.com
1.215.205.2219

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