Chaeum Shape 10

Hugel Biopharmaceuticals has obtained domestic approval for its innovative medical device, “Chaeum Shape 10,” which is designed for penis enlargement using hyaluronic acid (HA). This approval marks a significant milestone as it is the first of its kind granted by the Ministry of Food and Drug Safety in Korea.

Hugel plans to initiate full-scale production and distribute the device to local hospitals and clinics via Hugel Pharmaceuticals. Unlike traditional enlargement methods that require implants and surgical incisions, “Chaeum Shape 10” employs an HA filler, addressing concerns about the potential side effects linked to foreign body insertions.

As the first device of its kind in Korea, “Chaeum Shape 10” has received marketing authorization from the Ministry of Food and Drug Safety. Hugel expresses confidence in the procedure’s reduced side effects and improved biocompatibility, utilizing HA filler products derived from human and neural tissues.

Since the initiation of its development in 2012, the “Chaeum Shape 10” has undergone rigorous safety and efficacy testing through clinical trials. The production capacity has also been enhanced, increasing from the standard 1 ml used for facial fillers to 10 ml for high-capacity injections.

Kim Jong-ik, Managing Director of Sales and Marketing at Hugel Pharma, highlighted the importance of being the first in Korea to carry out clinical trials for a filler product aimed specifically at penis enlargement. Hugel’s HA filler has already secured licenses in 11 countries, and the company is actively seeking additional approvals in Asia and Latin America, with plans to expand into the European market in the future.