South Korean biotechnology company L&C Bio is preparing to expand its human-tissue-based beauty treatment into the United States after signing a distribution agreement worth at least $60 million over five years. The product, Re2O, is made using donated human skin sourced from the United States and processed into an injectable treatment marketed to improve skin texture and reduce visible signs of ageing.
The planned expansion comes as South Korea’s skin-booster market grows, driven by demand for cosmetic procedures promising smoother, firmer and more hydrated skin. Unlike conventional skincare products applied to the surface, injectable skin boosters are administered beneath the skin by practitioners at medical aesthetic clinics.
Re2O has become a leading product in this emerging category. L&C Bio estimates that the treatment accounts for between 60% and 70% of South Korea’s skin-derived injection market, which analysts at Yuanta Securities project will generate approximately $75 million in sales in 2026.
The company reported more than $17 million in Re2O sales during the first half of 2026, helping it return to operating profitability. It has also expanded the product range with Re2O Fine, designed for more delicate skin, and is planning a human-fat-derived filler for a future launch.
The treatment relies on a supply chain that begins with deceased American donors. Tissue recovery organisations and tissue banks collect and distribute donated skin, which can be used for medical applications such as treating burn injuries and reconstructive surgery. Some of the tissue is also supplied to South Korean biotechnology companies for aesthetic products.
L&C Bio confirmed that Florida-based Regenerative Biologics supplies the skin used in Re2O. The manufacturer said it spent more than $25 million purchasing donor skin from US tissue banks between 2023 and 2025, as well as $3.8 million in the first half of 2026. Approximately one-quarter of its skin supply is used to manufacture Re2O.
The commercial use of donated human tissue has raised questions about informed consent, transparency and the financial interests of companies involved in the supply chain. US law prohibits paying donors or their families for organ and tissue donations, although tissue recovery organisations and banks may receive payments covering processing costs and other operational expenses.
Some tissue organisations say donors or their families can decline cosmetic or international use. However, bioethics experts have questioned whether families fully understand how donated tissue may be commercially processed and distributed. The debate has implications for public trust in donation programmes that also supply tissue for life-saving medical procedures.
Regulatory approval is another major obstacle to the US launch. L&C Bio has argued that Re2O may fall within a category of human-tissue products that does not require approval from the US Food and Drug Administration (FDA). The agency, however, has warned that donor skin that is processed, dried, ground into powder and injected for cosmetic purposes may require a more extensive regulatory review.
The company has not publicly resolved those questions with the regulator, leaving uncertainty over the conditions under which the product could be sold in the US. The distribution agreement establishes a commercial plan, but does not itself confirm regulatory clearance.
Concerns have also emerged in other markets. Hong Kong authorities have investigated the sale of Re2O, with officials raising questions about registration requirements and potential health risks. Medical experts have questioned whether available evidence is sufficient to establish the treatment’s safety and effectiveness, particularly over the long term.
For L&C Bio, entry into the US would open access to a large market for cosmetic procedures and potentially strengthen its international distribution business. Its success will depend not only on consumer demand but also on regulatory decisions, clinical evidence and public confidence in how donated human tissue is sourced and used.
