Lutronic’s product story: ① R:GEN
Lutronic is the No. 1 company in Korea and one of the world’s top 10 companies in the field of medical devices for aesthetic treatment.
Since 2009, Lutronic has worked on producing R:GEN, a smart laser device for ophthalmic treatment, by leveraging its outstanding laser technology to expand into medical treatment devices beyond aesthetic devices.
After eight years of research, commercialization of R:GEN is right around the corner. Today, let's look at everything about R:GEN.
R:GEN is the world's first macular-treatment smart laser device.
The macula is an area very difficult to treat, as more than 50% of the cells responsible for vision are concentrated there. Behind these cells is a very thin layer, the Retinal Pigment Epithelium (RPE), which plays an essential role in supporting and maintaining the retina. Occasionally, they can be affected by disease which in turn negatively affects our sight. R:GEN selectively removes only the damaged RPE without damaging the other delicate retinal tissues, thereby helping with regeneration of the RPE and restoration of its function.
Just like improving facial wrinkles by regenerating the skin cells with a laser of a specific wavelength, the affected tissues of the eye can be regenerated with R:GEN.
The above figure shows on the left the selective rise in temperature in the RPE layer with different laser pulse widths. The longer the pulse width, the greater temperature rise can be seen in the retina with potential damage to the photoreceptor cells, but with its ultra-short microsecond pulse width, the temperature rise is limited to the RPE, selectively damaging it and leaving the photoreceptor cells unaffected. This is illustrated on the right of the figure, where a very mild temperature rise is recorded in the photoreceptors, with significant temperature rises in the RPE causing selective RPE damage.
With R:GEN, it is now possible to treat Diabetic Macular Edema (DME), one of the major complications of diabetes and the cause of blindness, and Central Serous Chorioretinopathy (CSC), a rare disease that affects 6 out of 100,000 people.
With R:GEN, safety is ensured through unique real-time feedback technology. This core technology is an automatic control system that receives feedback from the laser-irradiated tissue in real time, which is implemented by Ramp-up technology and Dosimetry technology, which work together to allow maximum laser intensity to achieve the desired effect with immediate cut back of the dose when the ideal point has been reached, as follows:
When the pigment cells in the RPE are irradiated with R:GEN laser energy, the light energy is instantaneously transformed into heat, and microbubbles are formed through vaporization of the target pigment. The Ramp-up Technique is designed to raise the incident laser energy only up to a specific point in time when the microbubble reaction occurs when RPE cells are removed. This is linked in real time with the Dosimetry technology that automatically controls the output power of the laser by detecting sound and light generated when the RPE cells are targeted and removed.
The effectiveness and safety of R:GEN has also been seen in actual clinical results.
The team led by Dr. Roh Young Jung, Professor of the Department of Ophthalmology at Yeouido St. Mary's Hospital, Catholic University of Korea, reported that the efficacy was proven in 88.2% of patients with diabetic macular edema (DME) based on up to 180 days of observation after R:GEN treatment. Of these, the best corrected visual acuity (BCVA) improved by 1-2 lines on the standard sight test chart (6-12 letters) in 41.2%, improved by more than 2 lines (12 letters) in 29.4%, and was maintained in 17.6%. In addition, throughout the whole treatment, there was no single adverse event such as scotoma formation (the appearance of dark spots in the visual field), and R:GEN treatment improved the retinal function, whereas conventional laser treatment decreased retinal sensitivity.
With this unparalleled technology and safety, Lutronic's R:GEN has obtained DME and CSC approval both in Korea and Europe, and received clearance from the US FDA last year for the treatment of Clinically Significant Macular Edema (CSME).
R:GEN, a new treatment that has not been available in the world, can safely treat macular lesions without damaging the photoreceptor cells responsible for vision and visual acuity. This now means that R: GEN will therefore be a viable and valuable alternative treatment for patients with macular diseases that can lead to blindness.