Skin-derived K-beauty injection heads to US after $60 million distribution deal

Market-leading Re2O could test whether donor-tissue cosmetics need FDA approval

By LineZotpaper

Published21 October 2026

Read Time4 min

South Korea's L&C Bio, maker of the market-leading Re2O injection, says it has signed a distribution contract worth at least $60 million over five years to introduce the treatment to the US next year. The product is made from donated human skin sourced from American tissue banks, a supply chain that Business Insider traced from US donors to Seoul clinics, and its planned entry is likely to test whether the injections can be sold without approval from federal regulators.

An investigation by Business Insider has traced the journey of donated skin from American tissue banks to clinics in Seoul, where it is processed into injectable beauty treatments. The market leader, South Korea's L&C Bio, announced last week that it has signed a distribution contract to bring its Re2O injection to the US next year, a deal worth at least $60 million over five years.

Re2O is the latest generation of what beauty enthusiasts call 'skin boosters.' Business Insider reports that tens of millions of dollars' worth of donated skin has travelled from American tissue banks to South Korean biotech companies in recent years. At least 10 South Korean biotech companies are making or planning skin-derived injections, and analysts at Yuanta Securities project the products will generate $75 million in sales in South Korea this year. L&C Bio says Re2O accounts for between 60% and 70% of the category, and it reported more than $17 million in Re2O sales in the first half of the year, swinging it to an operating profit of about $11 million. The company says it has sold 700,000 units as of September.

The supply chain starts in the US, where tens of thousands of Americans donate bodily tissue each year, often by checking a box at a motor vehicle department or through authorisation by a loved one. Cadaver skin is collected by organ procurement organisations and tissue banks, then sold to South Korean biotech firms. Under US law, donors and their families cannot be paid. L&C Bio says it spent more than $25 million on donor skin from US tissue banks between 2023 and 2025, and that a quarter of its skin supply goes into Re2O.

L&C Bio's founder and CEO, Whan Chul Lee, said in a February interview with a South Korean outlet: "In the human tissue business, access to raw materials is the lifeblood of the industry."

L&C Bio's push into the US could become a regulatory flashpoint. The company says Re2O falls into a category of products, such as skin grafts, that do not require approval from the US Food and Drug Administration. The FDA told Business Insider that some products marketed under that category do not meet the criteria, and that products derived from donor skin that have been decellularised, dried and ground into a powder for injection as a cosmetic 'skin booster' may raise significant questions and require a more complex approval process. L&C Bio said it would not comment on its discussions with regulators.

The ethics of the trade concern some observers. "People who donate tissue have no idea of how much money is changing hands in the course of all of this," said Ana Iltis, a professor at Wake Forest and former president of the American Society for Bioethics and Humanities. "With tissue donation, there's a lot of money at stake."

A 2010 survey of more than 1,000 US donor families found fewer than 30% considered it acceptable for donated tissues to be processed and distributed by for-profit companies. Jerold Mande, who helped write the National Organ Transplant Act, told Business Insider that in a system that relies on altruism, money changing hands could affect public trust. Tissue revenue, primarily from skin and bone, drove 93% of American organ procurement organisation profits between 2013 and 2017, about $107 million a year across 51 OPOs.

The competition is also heating up. Re2O's biggest South Korean rival, CellREDM, launched in late 2025 and helped push its maker, Hans Biomed, to more than $3 million in operating income in the quarter ended June 30.

Analysis

Why This Matters

Re2O's US launch would bring a cosmetic made from donated human tissue into the American market where that tissue originates.
It puts pressure on regulators to decide whether such products are skin grafts, medical products, or cosmetics, and whether FDA approval is required.
The commercial trade in donated skin raises questions about profit, consent, and public trust in the donation system.

Background

Tissue from deceased donors has been used for decades in US medicine, mainly for skin grafts and reconstructive surgery. What is new is the scale of the beauty market: South Korean companies have turned imported donor skin into injectable 'skin boosters' sold for a few hundred dollars at clinics and med spas. Re2O is the sales leader, and its maker plans to bring the product to the US next year.

Key Perspectives

L&C Bio, Re2O's maker: It argues that Re2O belongs to the tissue-graft category that does not require FDA approval. It describes access to raw material as the lifeblood of the industry and has signed a five-year US distribution deal worth at least $60 million, while exploring possible acquisitions of US tissue banks.

US Food and Drug Administration: The FDA told Business Insider that some products marketed under the claimed category do not meet the criteria. It said decellularised, dried and powdered donor skin injected as a cosmetic may raise significant questions and could need a more complex approval pathway.

Donor families and ethicists: Bioethicist Ana Iltis says donors have no idea how much money changes hands. A survey of donor families found fewer than 30% accepted for-profit processing and distribution, and Jerold Mande, who helped write the National Organ Transplant Act, warned that money changing hands could affect public trust.

What to Watch

Any public FDA position on Re2O or similar skin-derived injections as the planned US launch approaches.
Whether L&C Bio or its distribution partner moves to acquire US tissue banks, which would deepen the commercial supply chain.
How the category performs in South Korea, including the early success of competitor CellREDM, as a signal for US demand.

Sources

The latest K-beauty craze is made from dead Americans' skin. Now it's aiming for the US. · All Content from Business Insider

Checked

8 claims in this story checked against 1 source: 1 supported.

Show each claim

Partly supportedThe distribution deal is worth $60 million.All Content from Business Insider: “Last week, L&C Bio said that it has signed a contract to deliver at least $60 million of Re2O to the US over the next five years.”
Partly supportedRe2O’s US entry could test whether donor-tissue cosmetics need FDA approval.All Content from Business Insider: “It isn't clear whether the product can be sold in the US without approval from federal regulators.”
Partly supportedRe2O’s planned US entry is likely to test whether the injections can be sold without federal approval.All Content from Business Insider: “L&C Bio's plan to introduce Re2O to the US could spark a regulatory showdown.”
Partly supportedThe FDA said the products may raise significant questions and require a more complex approval process.All Content from Business Insider: ““Products derived from donor skin that have been decellularized, dried, and ground into a powder for injection as a cosmetic 'skin booster' may raise significant questions” and may have to go through a more complex regulatory approval process, the agency said.”
Partly supportedTens of thousands of Americans donate bodily tissue each year.All Content from Business Insider: “Each year, tens of thousands of Americans donate bodily tissue upon their deaths, generally by checking a box at a motor vehicle department or through an authorization made by a loved one.”
Partly supportedRe2O accounts for between 60% and 70% of the category.All Content from Business Insider: “It accounts for between 60% and 70% of sales in the category, according to L&C Bio, its manufacturer.”
Partly supportedTissue revenue drove 93% of American OPO profits from 2013 to 2017, or about $107 million a year across 51 OPOs.All Content from Business Insider: “Revenue from tissue, primarily skin and bone, drove 93% of American OPO profits between 2013 and 2017, or a total of about $107 million per year in profit at 51 OPOs, according to a study in the medical journal Transplantation.”
SupportedWhan Chul Lee said, “In the human tissue business, access to raw materials is the lifeblood of the industry.”All Content from Business Insider: ““In the human tissue business, access to raw materials is the lifeblood of the industry,” L&C Bio's founder and CEO, Whan Chul Lee, said in Korean in a February interview with a South Korean news outlet.”