CGBio's Facial Tissue Fixation Suture 'Dooth' Receives Approval for Pivotal Clinical Trial Plan

CGBio, a company specializing in regenerative biomedicine, announced on October 31 that its facial tissue fixation suture, Dooth, has received approval for a "pivotal clinical trial plan" from the Ministry of Food and Drug Safety.

Dooth, a facial tissue fixation suture by CGBio. CGBio

This clinical trial marks a key step for CGBio toward domestic regulatory approval and global commercialization of Dooth, which was jointly developed with its subsidiary CGM Base. The trial will be conducted at multiple institutions, including major tertiary hospitals. Through this clinical study, the company plans to scientifically verify the safety and efficacy of Dooth.

Facial tissue fixation sutures are inserted into tissue to pull and secure the skin; however, a supplementary tying process is sometimes used to enhance fixation or retention. In such cases, dimpling may occur at the tied area, or the retention strength may diminish over time. Dooth is designed to address these limitations, allowing the suture to be firmly fixed within the body without any additional tying process, thereby ensuring stable retention strength.

In other words, since no separate tagging or tying process is required, the use time is reduced and skin damage is minimized, improving both convenience for medical professionals and satisfaction for consumers. The product applies a proprietary structure patented in Korea, enhancing both ease of use and retention strength. Additionally, Dooth induces collagen production during the biodegradation process, which can help improve long-term skin elasticity.

Based on the clinical evidence obtained from this pivotal trial, CGBio plans to pursue a phased entry into global markets by obtaining CE certification in Europe, FDA approval in the United States, and NMPA approval in China.

Hyunseung Yoo, CEO of CGBio, stated, "Dooth is a next-generation lifting solution that embodies CGBio's core technological capabilities, and we expect it will increase satisfaction for both medical professionals and consumers. Through this pivotal clinical trial, we will scientifically prove the safety and efficacy of Dooth and accelerate global regulatory approval and commercialization."

This content was produced with the assistance of AI translation services.