L&C BIO(290650) said on the 14th that its human skin tissue–based extracellular matrix (ECM) product "Re2O" received official approval from Peru's regulator.
With this approval, the company can enter the South American market in addition to existing markets such as Japan and Singapore.
DIGEMID, the drug and medical device regulator under the Ministry of Health of Peru, approved local sales of Re2O on the 11th (local time). It is an official approval granted through local regulatory procedures, not a simple export or exceptional import.
Re2O is a human skin tissue ECM product made based on acellular dermal matrix (hADM) from donated human skin with the cells removed. It uses not only collagen but also various extracellular matrix components and structures that make up the skin. L&C BIO said Re2O is the first human skin tissue–based injectable to receive official approval in Peru.
Peru is a market in Latin America where demand is growing for non-surgical cosmetic procedures. L&C BIO plans to use Peru as a base to expand into major Latin American markets, including Brazil and Colombia, as well as Argentina and Chile. The strategy is to review each country's marketability and regulatory environment to sequentially secure approvals and distribution networks. The company is also preparing a Re2O launch symposium inviting medical professionals from neighboring countries.
While expanding its business in Japan and Singapore, Re2O is also broadening its sales base in Mongolia and Myanmar. Approval procedures are underway in Hong Kong, Thailand, the Philippines, and the Middle East. The company is also pushing to enter the U.S. human tissue market.
Following Re2O, the company plans to expand its overseas business with acellular dermal matrix "MegaDerm" and nerve human tissue "MegaNerve." The goal is to build a global business foundation that encompasses a wide range of human tissue products beyond skin, including bone, cartilage, nerves, and tendons.
A L&C BIO official said, "We will broaden our reach into major South American markets such as Brazil and Colombia with Peru as a base and also ramp up our entry into the U.S. market," adding, "Starting with Re2O, we will expand global exports of various human tissue products."