Hugel Biopharmaceuticals has obtained domestic sales license for the “Chaeum Shape 10,” an HA (hyaluronic acid)-filler penis enlargement medical device, from the Ministry of Food and Drug Safety for the first time in Korea.
Hugel said it would soon begin the full-fledged production and start the supply of the medical devices to domestic hospitals and clinics through Hugel Pharmaceuticals.
In the past, implants after incision were mainly used for enlargement of the penis, but there were concerns about side effects because of foreign body insertion.
|The “Chaeum Shape 10,” the first HA filler penis enlargement device in Korea, received marketing license from the Ministry of Food and Drug Safety, Friday.|
Hugel pins hope on reduced side effects and biocompatible procedures, with the permission of marketing of HA filler products using hyaluronic acid distributed in human tissues and neural tissues, the company said.
“Chaeum Shape 10” has been tested for safety and efficacy after clinical trials for penis enlargement since it began development in 2012. Also, the production capacity has increased from 1 ml of the conventional facial pillar to 10 ml of high-capacity injections.
"It has been meaningful since it’s the first in Korea to undergo clinical trials for the filler product that was used for the penis enlargement, and it has proved the safety and efficacy for that purpose,” said Kim Jong-ik김종익, managing director of sales and marketing at Hugel Pharma휴젤.
Hugel’s HA filler has been licensed in 11 countries and is preparing to get additional licenses in Asia and Latin America while seeking to enter the European market, too.
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