CGBIO, a bio regenerative medicine company, announced on Oct. 31 that its facial tissue fixation thread Dooth has received approval from South Korea’s Ministry of Food and Drug Safety (MFDS) for a confirmatory clinical trial.
The start of the trial marks a key step toward domestic regulatory clearance and global commercialization of Dooth, which CGBIO developed jointly with its subsidiary CG MBASE (CEO Jin‑Ho Yoo). The multicenter study will be conducted at several institutions, including major tertiary hospitals, and is designed to scientifically evaluate the safety and efficacy of the product.
Facial tissue fixation threads are implanted to lift and secure skin, and some products require an auxiliary tying (Tie) procedure to enhance fixation and durability. Such tied areas can produce dimpling or lose retention over time. Dooth addresses these limitations with a proprietary design that secures firmly in tissue without a separate tying step, offering more stable retention.
By eliminating the tagging and tying process, Dooth shortens procedure time and reduces skin trauma, improving both clinician convenience and patient satisfaction. The product’s patented domestic structure enhances ease of use and durability. CGBIO also notes that Dooth may promote collagen production during biodegradation, potentially contributing to longer‑term improvements in skin elasticity.
Using clinical evidence generated from the confirmatory trial, CGBIO plans to pursue staged global regulatory approvals, including CE marking in Europe, FDA clearance in the United States, and NMPA approval in China.
“We expect Dooth, a next‑generation lifting solution that embodies CGBIO’s core technologies, to raise satisfaction for both clinicians and patients,” said Hyun‑Seung Yoo, CEO of CGBIO. “Through this confirmatory trial we will scientifically demonstrate Dooth’s safety and efficacy and accelerate global regulatory approvals and commercialization.”
