Developed by domestic biotech firm NGene Preventing blood backflow with a bio-adhesive
As the number of modern people spending long hours sitting increases, the number of patients with varicose veins in the lower extremities has also been steadily rising. Against this backdrop, a domestic bio company has developed a medical device for treating varicose veins and has begun full-scale sales.
On the 5th, domestic bio company Engain announced that it recently received marketing authorization from the Ministry of Food and Drug Safety for its medical device for varicose vein treatment, “Nuvena” (photo). Varicose veins in the lower extremities refer to a disease in which the valves inside the veins that send blood from the legs to the heart become weakened, preventing blood from reaching the heart and causing it to pool in the legs. In severe cases, the blood vessels thicken and protrude like lumps. While this often occurs as the valve function weakens with age, it can also develop in people who remain in the same posture for long periods of time.
Surgery or laser therapy is used to treat severe varicose veins, but these methods have been considered limited because surrounding tissues can be damaged together. Accordingly, medical devices that use a bio-adhesive (medical glue) to block the refluxing vein while maintaining blood flow through healthy veins—thereby preventing blood from pooling in the legs—have been attracting attention.
In the case of Nuvena, developed by Engain, the bio-adhesive uses “N-butyl cyanoacrylate (NBCA)” as its active component. Before Nuvena was developed, “VenaSeal,” created by global medical device company Medtronic, was mainly used. Engain explained that it optimized the NBCA component and the device to improve safety and increase treatment speed. Ko Young-kuk, CEO of Engain, said, “Nuvena hardens in about one minute when it comes into contact with blood, effectively blocking reflux in the leg.”
Through confirmatory clinical trials for marketing authorization, Engain obtained results in terms of efficacy and safety that were at a similar level to Medtronic’s VenaSeal. CEO Ko said, “We verified the safety and effectiveness of the product through preclinical and confirmatory clinical trials,” adding, “By localizing all components of the treatment device, we have also achieved a competitive price.”
Choi Ji-won
AI-translated with ChatGPT. Provided as is; original Korean text prevails.
ⓒ dongA.com. All rights reserved. Reproduction, redistribution, or use for AI training prohibited.
