What We Check When You Are Looking Into Re2O (hADM) in Daegu

The conclusion, first

The first thing to say about Re2O (human-derived acellular dermal matrix, hADM) is that this material is classified not as a medical device but as human tissue. For that reason a product-level approval number does not exist within the system — import approval for human tissue in Korea is granted per “tissue bank × type of tissue (bone, skin and so on)”, and there is no product-name field at all (MFDS open dataset of human tissue import approvals, 283 records in total). The way of verifying it is therefore different from materials such as Rejuran or Juvelook, where a medical device approval number can be looked up. And the published human trial is a single one, 20 people, 20 weeks (Lee YI et al., International Journal of Molecular Sciences 2026;27(5):2193; randomised · split-face · double-blind, control hyaluronic acid). We could not find human data supporting the “lasts 6–12 months” that circulates in the market — because the longest follow-up in that trial is 20 weeks. The thinner the data and the more the route of verification differs, the more the result turns, before any question of technique, on what is checked and what you are told.

The order we actually work through in consultation

1. We begin by saying what this material is classified as

Re2O is dermis donated from a human being, decellularised and made into particles, and in Korea it is handled as human tissue under the Act on the Safety and Management of Human Tissue. Because it is not a medical device, there was no legal obligation to submit clinical trial data before it went on sale — an MFDS official also explained to the press that “unlike a medical device, a separate clinical trial is not required.” This does not mean the quality is better or worse. It means that the procedure standing behind the same phrase “clinically verified” is different from that of a medical device, and we say so before the decision to treat. That the material comes from donated tissue we also state as it is.

2. We say exactly which numbers can be checked

With a medical device you can look up the approval number and check the class, the intended use and the date of approval. For human tissue that route does not exist. What exists is the licensing of the tissue bank and import approval, and the unit of approval is the tissue bank and the type of tissue, not the product. The date on which the manufacturer, L&C BioES, obtained its tissue bank establishment licence was reported as 23 November 2023. We could not reach the original documents giving Re2O’s tissue bank licence number and import approval number — this does not mean the numbers do not exist; it means we could not verify them.

3. We state in numbers how far it has been measured in people

Some people decide against the treatment after seeing this table. We regard that as a legitimate conclusion too. The map of the evidence for the class as a whole is in how far hADM has been established, and how it differs from Rejuran is in CellREDM · Re2O and Rejuran.

4. We say where the number of sessions came from

“Three or more sessions at 3–4 week intervals” circulates widely, but the only primary source we could verify is the protocol of that one 20-person trial — the clinical trial registry records “three intradermal injections at one-month intervals.” That is, the protocol of a single 20-person trial has carried across into the market as though it were a standard, and no study comparing different numbers of sessions and intervals exists. And the volume injected per session we could not find anywhere — not in the paper, not in the registry, not in the manufacturer’s material. We say this as it is, and decide on anything further from the condition rather than from the calendar.

5. We say what the product can be identified by

The body of the paper for this trial does not name the product and writes only “phADM.” By contrast, the clinical trial registry records the test and control arms under their real product names. So if you have been told this is “a product with a published paper,” asking for the clinical trial registration number is better for verification than asking for the paper itself.

6. We say that the regulation is changing right now

An amendment to the Rules on the Safety of Human Tissue was put out for public comment as MFDS Notice No. 2026-340 (notified 16 July 2026, comment period closing 25 August). The main points set out in the notice are shortening the adverse-event reporting cycle from once a year to once every six months, clarifying the basis on which patients may report, and adding “purpose of transplantation” and “whether the patient was informed” to the record of tissue transplantation results. As of September 2026 it has not been promulgated and no date of entry into force has been set — the most recent promulgation of these Rules that we verified is Ordinance of the Prime Minister No. 2079 (30 December 2025). Parts of the press reported that a restriction on advertising for cosmetic purposes is included in this amendment, but that item is not among the main points of the MFDS notice, so we could not confirm by comparison against the originals which of the two is right. We do not present it as settled.

7. We check what is already in there

If irreversible material (PCL · PLLA · CaHA) is already present in the same area, it becomes impossible to tell what caused a problem later. So we go through the treatment history area by area. hADM is not hyaluronic acid, so the notion of dissolving it with hyaluronidase does not apply — though, because it is a material that breaks down, neither does that mean it is “permanent.”

What we do not do

• We do not present reviews or before-and-after photographs as evidence of effect. This is prohibited in medical advertising, but before that it is because they do not hold up as evidence.
• We do not use expressions such as “side-effect-free,” “the best,” or “the only.”
• We do not speak of durations that have not been measured, such as “lasts 6–12 months.” What has been measured runs to 20 weeks.
• We do not explain the material while leaving out that it comes from donated tissue. In a 2026 survey of 1,034 adults, 69.8% said they would refuse the use of cadaver-derived tissue in cosmetic treatment. Choosing while knowing and choosing without knowing are not the same thing.
• We do not speak of things for which there is no data as though data existed. We distinguish between “we could not find any,” “there is none,” and “0%.”
• We do not disparage other clinics’ treatments. Comparison is made on products and data.

Five questions you can ask at any clinic

1. “Is this a medical device or human tissue?” The accurate answer is human tissue. If that answer does not come straight back, there is room to check the understanding of the product.
2. “How many people is the human data based on, and out to how many weeks?” The published human trial is 20 people · 20 weeks. If the only answer is “it is a product that has completed clinical trials,” you may also ask for the clinical trial registration number.
3. “Why this number of sessions?” If the answer is “three,” ask on what basis. The only primary source we could verify is the protocol of the 20-person trial.
4. “Were you told that the material comes from donated tissue?” Whether that explanation came up in the consultation at all is itself material for a judgement.
5. “How long does it last, and where does that number come from?” The longest period measured is 20 weeks. If an answer longer than that comes back, you may ask for the source.

In summary — what is confirmed, what is inferred, what we could not confirm

Where this article was written

• Miso Clinic, Daegu · 4F Bombom Building, 125 Dongdeok-ro, Jung-gu, Daegu, Republic of Korea (near Kyungpook National University Hospital station)
• Director Lee Chi-Hak · Tel. 053-428-2700
• This column was written by the director and reviewed in September 2026.

This article was written not to recommend a particular treatment but to set out the extent of the data needed for a decision. Judgement about an individual condition requires examination, and this article does not substitute for medical care. An account of the product itself is in the Re2O reference, and where it forks from the other boosters is in skin boosters: what has to be settled before the product name.

Frequently asked questions

Who wrote this

References

1. Re2O human trial — Lee YI et al., International Journal of Molecular Sciences 2026;27(5):2193. Randomised · split-face · double-blind, 20 people, 20-week follow-up, hyaluronic acid control. The body of the paper records the product only as “phADM.”
2. Registration record for the same trial — clinical trial registration number NCT07155278. Three intradermal injections at one-month intervals, six co-primary endpoints, started November 2024 · completed May 2025, sponsor Yonsei University. No results have been posted to the registry. The test and control arms are recorded in the registry under their real product names.
3. Absence of a product-level approval number — MFDS open dataset of human tissue import approvals (283 records in total). The fields provided are the name of the importing tissue bank · approval number · type of tissue approved · manufacturer · country, and there is no product-name field. The date on which the tissue bank establishment licence was obtained (23 November 2023) is on the basis of press reporting.
4. Status of the regulatory amendment — draft partial amendment to the Rules on the Safety of Human Tissue, put out for public comment as MFDS Notice No. 2026-340 (notified 16 July 2026, comments closing 25 August 2026). The main points are shortening the adverse-event reporting cycle to once every six months · clarifying the basis on which patients may report · adding the purpose of transplantation and whether the patient was informed to the record of results. As of September 2026 it has not been promulgated (the most recent promulgation is Ordinance of the Prime Minister No. 2079, 30 December 2025). A restriction on advertising for cosmetic purposes was reported by parts of the press but is not among the main points of the notice, so we could not confirm it by comparison against the originals.
5. Pointing the other way — international academic dissent — a Comment (Horch RE, 17 August 2026) and a Response (Heo CY, 18 August 2026) on the original paper on injectable ADM (ACS Applied Bio Materials 2025;8(12):10827–10838) have been formally published in the same journal. We could not verify the argument of either piece from its full text.
6. Pointing the other way — another paper by researchers at the manufacturer — Lee JK et al., Frontiers in Bioengineering and Biotechnology 2026;14:1745558. In a rat Achilles tendon model, with hADM placed as the control arm, injectable decellularised human tendon was reported to be significantly superior. This is not a facial aesthetic indication, and it is an animal study.
7. Material pointing the other way on regulation — under the amendment to the Regulations on Tissue Bank Licensing and the Safety Management of Human Tissue, in force from 23 October 2025, the obligation to submit the source tissue bank’s certificate on import was removed (on the basis of press reporting).
8. Consumer survey — 2026 survey of 1,034 adults. 66.8% consented to donation for therapeutic purposes only, 69.8% refused the use of cadaver-derived tissue in cosmetic treatment, and 72.9% called for mandatory labelling of human-derived components. This was a survey presented at a National Assembly forum, and we could not reach the raw data.
9. Adverse events — we could not find a published tally of adverse events for hADM boosters in Korea. Ten complaints relating to Re2O received by the MFDS were reported, but a complaint is not the same as an adverse event report.
10. The regulatory content of this article is as of 6 September 2026, and because the relevant rules are under discussion for amendment it may differ depending on the point in time.