Drugs / EHSG-KF
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2 | NCT03394612 | Feb 2018 → Dec 2023 overdue | — | CUTISS AG | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03229564 | Oct 2017 → Jun 2026 overdue | — | CUTISS AG | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03227146 | Oct 2017 → Nov 2022 overdue | — | CUTISS AG | Active not recruiting | Met primary |
News releases announcing trial results or a regulatory action · 15
| Date | Issuer | Release |
|---|---|---|
| 2026-03-31 | CUTISS AG | Results New publication reports 1-year phase II results for denovoSkin™ in reconstructive surgery cutiss.swiss ↗
According to the publication, denovoSkin™ demonstrated significantly better scar quality than STSG at 3 months, with benefits maintained at 12 months. |
| 2026-03-17 | CUTISS AG | Results New publication reports U.S. compassionate use of denovoSkin™ in pediatric reconstructive surgery cutiss.swiss ↗
The publication details reconstructive procedures including contracture release and treatment of unstable scars, reporting high engraftment rates, durable healed skin, and handling characteristics comparable to full-thickness autografts. |
| 2025-12-02 | CUTISS AG | Results denovoSkin™ positive safety & efficacy 1-year readout in Phase 2 trial for adolescent and adult burn patients cutiss.swiss ↗
CUTISS is pleased to share that the 1-year results of the Phase IIb clinical trial evaluating denovoSkin™ in adolescent and adult burn patients have been published in eClinicalMedicine, part of The Lancet Discovery Science. |
| 2025-05-27 | CUTISS AG | Results Positive Phase 2 trial interim analysis on safety and efficacy for denovoSkin™ in pediatric burn patients cutiss.swiss ↗
CUTISS has completed an interim analysis in its Phase 2 clinical trial evaluating the safety and efficacy of denovoSkin™ in children with severe burns, with positive results. |
| 2025-05-20 | CUTISS AG | Results Case report: denovoSkin™ used under compassionate use in pediatric reconstructive burn surgery cutiss.swiss ↗
The denovoSkin™ grafts demonstrated an engraftment rate greater than 95%, with the resulting skin described as durable and manageable, comparable to traditional full-thickness autografts but with advantages over conventional cultured epidermal autografts (CEAs). |
| 2025-02-12 | CUTISS AG | Results Positive Phase 2 trial readout for long-term efficacy & safety of denovoSkin™ in reconstructive skin surgery and in burns cutiss.swiss ↗
CUTISS AG, a life sciences company at the forefront of tissue engineering therapy and regenerative medicine, announced positive long-term efficacy and safety readout in the Phase 2 clinical trials of denovoSkin™ in reconstructive surgery as well as in burns treatment. |
| 2024-12-03 | CUTISS AG | Regulatory EMA authorizes Phase 3 clinical trial for denovoSkin™ cutiss.swiss ↗
CUTISS has received authorization from the European Medicines Agency (EMA) to commence the Phase 3 clinical trial for our lead product denovoSkin™ in adult & adolescent severe burn patients. |
| 2024-07-09 | CUTISS AG | Results Reconstructive skin surgery: positive Phase 2 interim analysis on efficacy for denovoSkin™ in pediatric, adolescent and adult patients cutiss.swiss ↗ |
| 2024-02-14 | CUTISS AG | Results Positive one-year follow-up data from Phase 2 trial of denovoSkin™ cutiss.swiss ↗
CUTISS AG, a Swiss clinical-stage life science company focused on skin regenerative medicine and tissue engineering, has announced positive one-year follow-up data from its Phase 2 clinical trial of the lead product denovoSkin™, in adult and adolescent severe burn patients. |
| 2023-04-03 | CUTISS AG | Results CUTISS announces positive Phase 2 clinical trial results for denovoSkin™ cutiss.swiss ↗
The efficacy endpoint has been reached with high statistical significance, demonstrating efficacy of denovoSkin™ as a personalized, bio-engineered dermo-epidermal skin substitute for patients requiring a skin graft due to a major burn. |
| 2023-03-28 | CUTISS AG | Results Case report: Youngest patient ever treated with denovoSkin – a neonatal case cutiss.swiss ↗
The published paper is based on a one-year follow-up of the patient, and these results deliver further proof of concept that denovoSkin can be successfully applied in pediatric severe burns. |
| 2022-06-16 | CUTISS AG | Regulatory CUTISS granted European patent for skin tissue graft cutiss.swiss ↗
CUTISS is pleased to announce that a tissue graft patent has been granted by the European Patent Office for the personalized bioengineered human skin tissue therapy developed by CUTISS. |
| 2021-10-28 | CUTISS AG | Regulatory CUTISS’s skin tissue graft is granted US patent cutiss.swiss ↗
We are pleased to announce that a tissue graft patent has been granted by the United States Patent and Trademark Office (USPTO) for the personalized bioengineered human skin tissue therapy developed by CUTISS. |
| 2020-08-03 | CUTISS AG | Regulatory CUTISS receives Positive Opinion from the Paediatric Committee of the EMA for denovoSkin™ cutiss.swiss ↗
The PDCO’s positive opinion on CUTISS’ PIP endorsed the Company’s program for denovoSkin™ as acceptable for assessment of safety and efficacy for the use in children from birth to less than 18 years of age. |
| 2020-05-26 | CUTISS AG | Regulatory Phase II start in Italy cutiss.swiss ↗
denovoSkin™, una rivoluzionaria terapia cellulare per gli autotrapianti di pelle sviluppata da CUTISS AG, ha ottenuto da AIFA (Agenzia Italiana del Farmaco) l’approvazione per l’avvio in Italia di studi clinici di fase II. |
All press releases naming this drug 28 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | EHSG-KF | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03227146 ↗ |
| Known as | denovoSkin | “This study evaluated the safety and efficacy of denovoSkin™-a bio-engineered autologous dermo-epidermal skin graft consisting of patient-derived epidermal and dermal cells...” PMID 41890789 ↗ Mar 2026 |
| Modality | Other / unclassified | “an Autologous Bio-engineered Dermo-epidermal Skin Substitute (EHSG-KF)” NCT03227146 ↗ |