L&C Bio said its human tissue-based extracellular matrix (ECM) skin booster, Re2O, is made from acellular dermal matrix (ADM) derived from donated human tissue, pushing back against controversy over regulation and ethics.
The company held a press briefing on the 29th at Conference House Dalgaebi in Jung-gu, Seoul, to explain ECM structure, Re2O’s characteristics and how human tissue is used. Re2O has recently faced claims and misunderstandings, including suggestions it involves injecting “cadaver skin,” as well as ethical questions about using donated tissue for cosmetic purposes.
Re2O is based on ECM biomaterial composed of collagen, elastin and glycosaminoglycans (GAG), the company said. By removing cells, it aims to minimize immune reactions while providing an environment needed for skin tissue regeneration.
Lee Ju-hee, L&C Bio’s vice chairman, said ADM has been used for decades in fields including dentistry, head and neck cancer and breast cancer reconstruction. Re2O, she said, applies ADM as a skin booster and is differentiated from existing products by its ability to reduce immune response while promoting tissue regeneration.
Company officials also addressed oversight, saying human tissue is not in a regulatory blind spot but is managed under a system separate from pharmaceuticals and medical devices.
Han Bang-hee, an L&C Bio vice president, said strict standards apply, including donor screening tests, sterile management and full life-cycle traceability. He said tracking is possible at the donor level, allowing causes to be identified if adverse events occur. The company said it ensures safety through nine test items in the United States and eight in South Korea.
On the ethics debate over cosmetic use, the company cited donor consent and legal standards.
Chairman Lee Hwan-cheol said the Human Tissue Act is aimed at “physical stability and restoration of physiological function,” and that restoring skin structure also falls under that purpose. He said the company submitted related materials to the Ministry of Food and Drug Safety and that on-site inspections have been completed.
Lee said the core of ethics is not emotional judgment but donor consent and the appropriateness of medical use. He said Re2O uses only tissue from donors who provided prior consent that includes cosmetic use.
* This article has been translated by AI.
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