We are pleased to announce that LTU-904, an innovative low level laser treatment of SciGen, the member of Yifan International Group dedicating to commercialize innovative therapies worldwide, will be launched to Korean market.
LTU-904, developed by RianCorp, an Australian medical device company dedicating to the development & production of medical laser products for photochemical applications in the field of Low-Level Laser Therapy (LLLT). In June 2021, SciGen entered into the distribution agreement with RianCorp of the novel therapy in Korea. According to the agreement, SciGen is responsible for the registration of LTU-904 in Korea and Post-Approval Marketing Activities. The product is approved by the Ministry of Food and Drug Safety (MFDS) in December 2022.
Lymphoedema, a potential side effect of postmastectomy or post radiation therapy, happens to 20% of breast cancer patients. The condition can present whilst undergoing treatment or within the years following treatment. LTU-904 is a novel Low Level Laser Therapy (LLLT) approved by the US FDA as Class I laser device to treat patients with lymphedema. According to the results of a randomized, double blind, placebo controlled, clinical trial for LTU-904 Laser Therapy’s Treating Post-Mastectomy Lymphoedema, the LTU-904 decreases affected limb volume and whole upper body fluid, as well as improves tonometry of upper arm and posterior torso in post mastectomy lymphoedema patients one to three months after treatment, of which has been approved its safety and efficacy to treat patients with Lymphoedema.
During the recent annual conference of Korean Society of Lymphedema (KSL), the representative organization for Lymphedema research and clinical practice in Korea, a presentation of “Low-level Laser Therapy in Secondary Lymphedema after Breast Cancer” was delivered.
“A study (Kilmartin et al, 2020) reported in the area of efficacy, reduction of edema (circumference/volume reduction) was confirmed as the primary indicator, and the secondary indicator was pain reduction (VAS etc.), functional improvement (change in grip strength, shoulder range of motion), and quality of life were reported to have improved as a result of evaluating the indicators.”, stated by Eunju Yang, Academic Director of Korean Society of Lymphedema (KSL), also known as Researcher of the Institute of Convergence Science, Yonsei University.
“We are pleased to officially launch the LTU-904 in Seoul here today at the annual conference of KSL”, said by Mr. Henry Pyun, Head of Direct Market at SciGen. “At SciGen, we aim to provide innovative and affordable treatment to patients. This hand-held battery-powered device significantly benefits patients with lymphedema in a treatment that takes less time, requires fewer consultations, and has a lower overall cost. It provides therapists with a valuable new treatment option for patients with lymphedema.”
In addition to the Korean MFDS approval, the LTU-904 is approved by U.S. FDA in 2006 and by Australian TGA in 2009.