External analyst notes, journalism, and industry commentary cited with attribution.
Past catalysts on this ticker, reconciled against the announcement parse pipeline. Hover any row for the parsed outcome detail.
RECELL System's own upcoming catalysts alongside class-defining historical readouts and upcoming primary completion dates in the same mechanism classes. Each event moves the broader thesis for RECELL System. Showing past 6 months and next 12 months · 6 later hidden.
Same axes, same units. Discontinued and historical pivotal trials excluded; see Competitor Landscape below for the full set.
| Trial | Sponsor | Class | Phase / Line | Design | Primary endpoint | Dosing | Key eligibility | n |
|---|---|---|---|---|---|---|---|---|
| RECELL System | AVITA Medical | Surgical Device | Approved (FDA PMA)[ TODO: fill in ] | Post-approval studies include: a completed, single-centre study (NCT05971381); a randomised controlled trial comparing wound coverings (NCT06750809); and a multicenter single-arm trial (NCT06787690). All are registered under device/not-applicable phase categories. | [ TODO: fill in ] (primary endpoints for NCT06750809 and NCT06787690 not specified in provided trial data; NCT05971381 assessed repigmentation of vitiligo lesions) | [ TODO: fill in ] | 40 patients (per ClinicalTrials.gov NCT06750809); 41 patients (per ClinicalTrials.gov NCT06787690); 109 patients completed (per ClinicalTrials.gov NCT05971381) |
Read-across commentary attached per trial. Phase ordering preserved within each group.
| Mechanism | Speed to patient | Manufacturing | Best approved result | Durability | Moat |
|---|---|---|---|---|---|
| Mesenchymal Stem CellAllo MSC | Off-the-shelf | Batch (donor) | Ryoncil (GvHD only) | Transient | Low |
"Sponsor guided" dates come from IR materials and earnings calls; hover for the cited source. "CT.gov proxy" dates fall back to the registry primary completion date — actual readouts typically follow by 3-6 months.
| 109 |
| Microsurfaced Grafts in Deep Burn Wounds | CellTherX | — | Phase 4 | — | — | — | — | — |
| Pilot Study: KeraStat® Gel for Topical Delivery of Morphine for Management of Non-Healing, Painful Open Wounds and Ulcers | The Metis Foundation | — | Phase 4 | — | — | — | — | — |
| Low-Dose Ketamine Infusion During Burn Wound Care | University of Tennessee | — | Phase 4 | — | — | — | — | — |
| Liposomal Bupivacaine Versus Lidocaine for Skin Graft Donor Site Pain | University of Kansas Medical Center | — | Phase 4 | — | — | — | — | — |
| Perioperative Lidocaine Infusions for the Management of Pain From Burn Injury | University of Washington | — | Phase 4 | — | — | — | — | — |
| Acute Partial Thickness Burn Study Comparing Transforming Powder Dressing to Standard of Care Dressing | ULURU Inc. | — | Phase 4 | — | — | — | — | — |
| Optimizing Fluid Resuscitation in Adults With Major Burns: A Randomized Trial of Burn Navigator™ Versus Parkland Formula | Alnas Hospital | — | Phase 4 | — | — | — | — | — |
| Burn Study- Tranexamic Acid Versus Thrombin in Split Thickness Skin Graft | University of Kansas Medical Center | — | Phase 4 | — | — | — | — | — |
| Pharmacokinetic Analysis of Cefiderocol in Patients With Acute Burn Injuries | University of Tennessee | — | Phase 4 | — | — | — | — | — |
| Evaluation of the Safety and Efficacy of Dehydrated Human Amnion-Intermediate-Chorion Membrane (dHAICM) Allograft vs Standard of Care in the Treatment of Partial Thickness Thermal Burns | Cellution Biologics | — | Phase 4 | — | — | — | — | — |
| Evaluating Whether Intact Fish Skin Graft Can Decrease the Need for Autograft in the Treatment of Deep Partial-Thickness Burns | Kerecis Ltd. | — | Phase 4 | — | — | — | — | — |
| Strategy to Avoid Excessive Oxygen in Major Burn Patients | University of Colorado, Denver | — | Phase 3 | — | — | — | — | — |
| Strategy to Avoid Excessive Oxygen for Critically Ill Trauma Patients | University of Colorado, Denver | — | Phase 3 | — | — | — | — | — |
| Tranexamic Acid During Excisional Burn Surgery | Maasstad Hospital | — | Phase 3 | — | — | — | — | — |
| Safety and Efficacy of realSKIN® to Provide Complete Wound Closure of Burn Wounds as an Alternative to Autografting | XenoTherapeutics, Inc. | — | Phase 3 | — | — | — | — | — |
| Phase III Study with an Autologous Dermo-epidermal Skin Substitute for the Treatment of Burns in Adults and Adolescents | CUTISS AG | — | Phase 3 | — | — | — | — | — |
| Novel Strategies for Reducing Burn Scar Itch | The University of Texas Medical Branch, Galveston | — | Phase 3 | — | — | — | — | — |
| Undergraduate Skin Cancer Prevention Trial | University of Utah | — | Phase 3 | — | — | — | — | — |
| Efficacy of Carbonlife Amniotic Tissue Product in the Treatment of Chronic Wounds | Bardia Anvar | — | Phase 3 | — | — | — | — | — |
| Effect of Early Dexamethasone on Major Complications and All-cause Mortality in Severe Burns | Nantes University Hospital | — | Phase 3 | — | — | — | — | — |
| Plasma Resuscitation Early for Evaluating Volume and Endotheliopathy of Thermal Injury (PREEVEnT) Trial | Jason Sperry | — | Phase 3 | — | — | — | — | — |
| Post-Operative Use of FS2 to Mitigate Scarring in Burn Patients | Birch BioMed Inc | — | PHASE2/PHASE3 | — | — | — | — | — |
| Study With an Autologous Dermo-epidermal Skin Substitute for the Treatment of Burns in Adults and Adolescents | CUTISS AG | — | Phase 2 | — | — | — | — | — |
| Safety, Tolerability and Efficacy of Nefopam Cream in Burn Patients | University of Alberta | — | Phase 2 | — | — | — | — | — |
| Phase II Clinical Trial of KJ101in the Treatment of Deep II Degree Burns | Shanghai Bao Pharmaceuticals Co., Ltd. | — | Phase 2 | — | — | — | — | — |
| Study With an Autologous Dermo-epidermal Skin Substitute for the Treatment of Burns in Children | CUTISS AG | — | Phase 2 | — | — | — | — | — |
| Phase 2 Pilot Study of the Safety and Efficacy of Topical MW-III in Thermal Burns | Skingenix, Inc. | — | Phase 2 | — | — | — | — | — |
| Evolution of the Initial Distribution Volume of Glucose in the Severe Burned Adults | Centre Hospitalier Régional Metz-Thionville | — | Phase 2 | — | — | — | — | — |
| The Effects of Metformin on Morbidity and Mortality in Elderly Patients | Hamilton Health Sciences Corporation | — | Phase 2 | — | — | — | — | — |
| 4-Aminopyridine to Treat Skin Burns | John Elfar | — | Phase 2 | — | — | — | — | — |
| Treatment of Severe Ocular Chemical Burns by Subconjunctival Injection of Allogeneic Mesenchymal Stem Cells: An Open-Label, Single-Arm, Multicenter Phase II Trial | Fondation Ophtalmologique Adolphe de Rothschild | — | Phase 2 | — | — | — | — | — |
| A Study to Evaluate the Safety, Tolerability and Efficacy in Patients With Burn(s) | Primoris Therapeutics | — | PHASE1/PHASE2 | — | — | — | — | — |
| Comparison Between Carbapenems and Noncarbapenem Beta-lactam Antibiotics in Septic Burn Patients | Ain Shams University | — | PHASE1/PHASE2 | — | — | — | — | — |
| SN514-066b Enzyme in Deep Partial Thickness Burns | SERDA bv | — | PHASE1/PHASE2 | — | — | — | — | — |
| A Between Patient Study of Plurogel® Compared to Standard Topical Dressing in Burn Injuries | University of Manitoba | — | PHASE1/PHASE2 | — | — | — | — | — |
| A Study of Plurogel® Compared to Standard Topical Dressing in Burn Injuries | University of Manitoba | — | PHASE1/PHASE2 | — | — | — | — | — |
| HUMSCs Combined With Col I to Third-Degree Burn Wound | The First Affiliated Hospital of Xinxiang Medical College | — | PHASE1/PHASE2 | — | — | — | — | — |
| SASS 2 : Self Assembled Skin Substitute for the Autologous Treatment of Severe Burn Wounds in Acute Stage of Burn Trauma | CHU de Quebec-Universite Laval | — | PHASE1/PHASE2 | — | — | — | — | — |
| Topical Methylene Blue-Photodynamic Therapy (MB-PDT) for Burn Wound Infection | University of Oklahoma | — | PHASE1/PHASE2 | — | — | — | — | — |
| Wound Healing Endpoint and Recurrence | Sashwati Roy | — | PHASE1/PHASE2 | — | — | — | — | — |