"Re2O (Elravie Re2O) has had no reports of serious side effects since its launch."
Lee Hwan-cheol, chair (CEO) of L&C BIO, said this at a press briefing on Re2O held in Jung District, Seoul, on the 29th.
Re2O is a type of cosmetic injection that helps improve skin. Recently, it became known that Re2O was made from cadaver skin and did not undergo clinical trials, sparking safety and ethics controversies.
Re2O is a skin booster containing collagen and elastin, among other components. A skin booster is an injection that delivers active ingredients directly into the skin. Re2O is made by extracting extracellular matrix (ECM) from skin tissue donated by deceased individuals overseas, processing it into powder, and then diluting it with saline for injection into the skin. Each procedure reportedly costs several hundred thousand won.
Lee said, "There is a question of whether this is injecting cadaver skin into the face, but we do not use that expression," adding, "It is 'human-derived acellular allogeneic dermis' from which immune rejection in the skin has been eliminated." The point, Lee said, is that cells that cause immune responses in human skin tissue are thoroughly removed, and the remaining components are used.
Lee said, "There is criticism about whether it is acceptable to use tissue donated to save lives for cosmetic purposes," adding, "We produce Re2O by selecting donors overseas who consented to cosmetic use." Lee also said, "From product development to manufacturing and distribution, we rigorously manage every step, and we are building a system in line with Ministery of Food and Drug Safety guidelines that allows traceability even if side effects occur."
Under the Pharmaceutical Affairs Act, products injected into the skin dermis are classified as drugs, medical devices, or human tissue. Because Re2O falls under human tissue, it did not undergo separate clinical trials, drawing controversy over a regulatory blind spot.
Han Bang-hee, executive vice president of L&C BIO, explained, "Human tissue has been used in medical settings for decades, and because it is derived from the human body, the basic premise is that it is safe for our bodies." Han added, "Human tissue is also supervised and overseen by the Ministery of Food and Drug Safety."
Lee Ju-hee, vice chair of L&C BIO (a dermatology professor at Severance Hospital of Yonsei University), said, "After selecting donors overseas, we reduce the risk of infection to zero (0) during the manufacturing process," emphasizing, "There are no risk factors because we sterilize through the final step."