Medytox获哥伦比亚INVIMA批准三款透明质酸填充剂Atière上市

Medytox is accelerating its push into Latin America's aesthetics market after winning Colombian marketing approval for its hyaluronic acid filler Atière. The company plans to use Colombia as a base for regional expansion, leading with a product lineup that spans both botulinum toxin and fillers.
Medytox (086900.KS) said on the 2nd that it had obtained approval from Colombia's food and drug agency INVIMA for three hyaluronic acid fillers: Atière Classic, Atière Intensive and Atière Volume.
The approval marks Atière's second entry into Latin America, following the Dominican Republic.
Colombia is considered the third-largest medical device market in Latin America after Brazil and Mexico. Because the country imports about 89% of its medical devices, it is viewed as offering substantial opportunity for foreign device makers. It is also one of the main markets in a region where demand for cosmetic procedures runs high.
With the approval, Medytox now has an aesthetics lineup in Colombia that allows it to sell the hyaluronic acid fillers Neuramis and Atière alongside its botulinum toxin product Meditoxin.
Hyaluronic acid is a substance naturally present in the skin that attracts moisture, and it is used to add volume or reduce wrinkles. A hyaluronic acid filler is a medical device made by turning the substance into a gel that is injected into hollow areas of the face. Botulinum toxin works differently, temporarily blocking signals between nerves and muscles to limit muscle movement and smooth wrinkles.
By offering both fillers and botulinum toxin, which improve wrinkles and facial contours through different mechanisms, Medytox expects to meet a wider range of procedure needs among local physicians.
The company plans in particular to use Colombia as a base for expanding into neighboring countries. It will seek additional overseas approvals while strengthening locally tailored sales and marketing to broaden Atière's global distribution network.
Atière is a hyaluronic acid filler made using Medytox's proprietary H.E.A.R.T. process, which stands for High, Elastic, Advanced, Rheological and Throughput. Viscoelasticity refers to how much a filler deforms under external force and how well it returns to its original shape. It affects how the filler feels in use and how suitable it is for different treatment areas.
Atière is manufactured without animal-derived culture media or enzymes. Culture media supply the nutrients needed to grow cells, and the company said excluding animal-derived ingredients was intended to lower the risk of viral contamination.
The filler also uses hyaluronic acid raw material registered with the U.S. Food and Drug Administration's Drug Master File system and certified by the European Directorate for the Quality of Medicines. It contains lidocaine to reduce pain during procedures.
"This Colombian approval is significant in that it secures a strategic base for expanding in Latin America," a Medytox official said. "We plan to expand overseas approvals and strengthen locally tailored sales and marketing to build Atière, together with Neuramis, into a leading global hyaluronic acid filler brand."