L&C Bio, a regenerative medicine company specializing in human tissue, has established a foothold for entering the Middle East market after securing import approval in the United Arab Emirates (UAE) for its human tissue-based product Re2O. The company is expanding its overseas business following formal approvals in Thailand and Peru and a supply agreement in the United States.
On the 14th, L&C Bio announced that Re2O had received import approval from the UAE’s Emirates Drug Establishment (EDE).
The UAE serves as a link between the Middle East, Asia and Europe, with a medical tourism industry centered in Dubai. L&C Bio plans to work with local medical device companies to build a network of healthcare professionals and expand its sales base.
Re2O is a human tissue extracellular matrix (ECM) product made by processing acellular human dermal allograft (hADM), derived from donated human skin with its cellular components removed, into microparticles. The product utilizes the structural characteristics and components of the skin’s extracellular matrix, including collagen.
L&C Bio exports and sells Re2O in markets including Japan, Singapore and Mongolia. In September, Re2O and Re2O Fine received formal Class IV medical device approvals from Thailand’s Food and Drug Administration, while Re2O also secured formal approval from Peru’s health authorities. More recently, the company signed an exclusive supply agreement with a U.S. partner.
The company plans to expand its overseas sales base by pursuing regulatory approvals in individual countries while identifying local partners. It intends to use the UAE as a hub for its Middle East operations, strengthen engagement with local healthcare professionals and establish a stable supply system.
L&C Bio also plans to expand production capacity. The company aims to increase monthly production of Re2O from approximately 80,000 units to more than 150,000 units by the end of the year. Over the medium to long term, it plans to build a new factory in Dongtan to expand manufacturing capacity in response to growing overseas demand.
“Following approvals in Thailand and Peru, securing UAE import approval extends Re2O’s overseas business reach into the Middle East,” an L&C Bio representative said. “We will strengthen engagement with local partners and healthcare professionals and pursue a stronger foothold in the Middle East and broader global export growth through stable supply.”
L&C Bio, founded in 2011, specializes in regenerative medicine using human tissue. Its business includes skin graft materials and medical devices for tissue regeneration based on human tissue processing technology. The company listed on South Korea’s Kosdaq market in 2018 and has expanded its portfolio to include Megaderm, a skin graft material; Megashield, an anti-adhesion barrier; and Megacarti, a cartilage regeneration product.
