AVITA Medical, Inc. (RCEL)
AVITA Medical, Inc., together with its subsidiaries, operates as a therapeutic acute wound care company in the United States, Japan, the European Union, Australia, and the United Kingdom. The company’s lead product is the RECELL System, a cell harvesting device used for the treatment of thermal burn wounds and full-thickness skin defects, as well as for repigmentation of stable depigmented vitiligo lesions. It also provides RECALL autologous cell harvesting device, which can treat areas of up to 1,920 cm2; RECELL autologous cell harvesting device with ease-of-use, an enhanced ease-of-use device that can treat areas of up to 1,920 cm²; and RECELL GO mini autologous cell harvesting device, a line extension of the RECELL GO system to treat smaller wounds up to 480 cm2, as well as RECELL GO autologous cell harvesting device consisting of RECELL GO processing device, which controls and manages the pressure applied to disaggregate the donor skin cells and controls the incubation time of the RECELL Enzyme to optimize cell yield and promote cell viability; and RECELL GO preparation kit, which can treat areas up to 1,920 cm2. In addition, the company sells and distributes PermeaDerm, a biosynthetic wound matrix and Cohealyx, a collagen-based dermal matrix. It serves hospitals, treatment centers, and distributors. The company was formerly known as AVITA Therapeutics, Inc. and changed its name to AVITA Medical, Inc. in December 2020. AVITA Medical, Inc. is headquartered in Valencia, California.
Sector: Surgical & Medical Instruments & Apparatus
Industry: Medical - Devices
Avita Medical Inc.
Trials need funding. See this company's dilution risk and cash position.
- Phase 4Completed
A Pilot Trial of the Use of ReCell® Autologous Cell Harvesting Device for Venous Leg Ulcers
Standard Care plus ReCell, Standard Care
Venous Leg Ulcers
NCT01743053Enrollment52StartJan 2013Primary CompletionOct 2015CompletionOct 2015 - Phase 4Completed
A Feasibility Study of the ReGenerCell™ Autologous Cell Harvesting Device for Diabetic Foot Ulcers
ReGenerCell™ Autologous Cell Harvesting Device
Diabetic Foot Ulcer
NCT02799121Enrollment16StartMay 2016Primary CompletionMar 2019CompletionMar 2019 - Not applicableCompleted
A Multicenter Comparative Study of the ReCell Device and Autologous Split-thickness Meshed Skin Graft in the Treatment of Acute Burn Injuries
ReCell and Split-thickness skin graft
Burns
NCT01138917Enrollment101StartMay 2010Primary CompletionAug 2014CompletionAug 2015 - Not applicableCompleted
ReCell® Combined With Meshed Skin Graft in the Treatment of Acute Burn Injuries
ReCell Treatment, Skin Graft
Burns
NCT02380612Enrollment30StartJan 2015Primary CompletionJan 2016CompletionFeb 2017 - ObservationalCompleted
Prospective Evaluation of the ReCell® Autologous Cell Harvesting Device For Specific Compassionate Use Cases
-
Burns
NCT02992249Enrollment100StartMay 2014Primary CompletionMay 2019CompletionJun 2020 - Not applicableCompleted
CONTINUED ACCESS PROTOCOL: Demonstration of the Safety and Effectiveness of ReCell® Combined With Meshed Skin Graft for Reduction of Donor Area in the Treatment of Acute Burn Injuries
ReCell
Burns
NCT02994654Enrollment12StartOct 2016Primary CompletionDec 2017CompletionSep 2018 - ObservationalCompleted
Continued Access to the Recell® Device for Treatment of Acute Burn Injuries
ReCell® Autologous Cell Harvesting Device
Burns
NCT03333941Enrollment76StartOct 2017Primary CompletionDec 2018CompletionMay 2019 - Not applicableTerminated
RES Prepared With RECELL® Compared to Conventional Care for Healing of Donor Sites in Ages 1-16 Years
RECELL® Autologous Cell Harvesting Device, Telfa™ Clear and Xeroform™ dressings
Skin; Deformity
NCT03624192Enrollment3StartSep 2018Primary CompletionJan 2020CompletionJan 2020 - Not applicableTerminated
RES® Prepared With RECELL® Compared to Standard of Care Dressings of Partial-thickness Burns in Ages 1-16 Years
RES (Regenerative Epidermal Suspension) prepared using the RECELL® Autologous Cell Harvesting Device, Mepilex® Ag Wound Dressing
Burns
NCT03626701Enrollment19StartMar 2020Primary CompletionJun 2021CompletionJun 2022 - Not applicableCompleted
RECELL® System Combined With Meshed Autograft for Reduction of Donor Skin Harvesting in Soft Tissue Reconstruction
Control Intervention (Conventional Autograft), Investigational Intervention (RECELL + more widely meshed autograft)
Full-thickness Skin Defects, Degloving Injuries +8
NCT04091672Enrollment65StartMar 2020Primary CompletionMar 2022CompletionFeb 2023 - Not applicableTerminated
Feasibility Study to Evaluate RECELL and Melanocyte Keratinocyte Transplantation Procedure for Repigmentation of Stable Vitiligo Lesions
Melanocyte-Keratinocyte Transplantation and Ultraviolet Lamp (UVB), RECELL 1:5 and Ultraviolet Lamp (UVB)
Vitiligo
NCT04271501Enrollment5StartSep 2020Primary CompletionAug 2021CompletionAug 2021 - Not applicableCompleted
Clinical Study to Investigate the Safety and Effectiveness of RECELL for Repigmentation of Stable Vitiligo Lesions
Control Intervention (UVB), Investigational Interventions (Ablative Laser Resurfacing + RECELL + UVB)
Vitiligo
NCT04547998Enrollment25StartSep 2020Primary CompletionJun 2022CompletionJan 2023 - Not applicableCompleted
Repigmentation of Stable Vitiligo Lesions Using Spray-On Skin™ Cells
RECELL® Autologous Cell Harvesting Device
Vitiligo
NCT05971381Enrollment109StartAug 2023Primary CompletionJul 2024CompletionJan 2025 - Not applicableCompleted
Randomized Controlled Trial to Investigate Clinical Outcomes and Associated Costs When PermeaDerm is Used as Temporary Dressing for Surgical Wounds
PermeaDerm Biosynthetic Wound Matrix, Frozen Human Cadaveric Allograft (FHCA)
Surgical Wound, Trauma Wound +3
NCT06750809Enrollment40StartFeb 2025Primary CompletionMar 2026CompletionMay 2026 - Not applicableCompleted
Multicenter Single-arm Trial to Investigate Clinical Outcomes When Cohealyx™ is Used for Full Thickness Wounds
Cohealyx
Burn, Trauma Wound +2
NCT06787690Enrollment41StartMay 2025Primary CompletionFeb 2026CompletionAug 2026
| Drug / Therapy | Link | ||
|---|---|---|---|
| Phase 4 | Completed | Standard Care plus ReCell, Standard Care | NCT01743053 |
| Phase 4 | Completed | ReGenerCell™ Autologous Cell Harvesting Device | NCT02799121 |
| Not applicable | Completed | ReCell and Split-thickness skin graft | NCT01138917 |
| Not applicable | Completed | ReCell Treatment, Skin Graft | NCT02380612 |
| Observational | Completed | - | NCT02992249 |
| Not applicable | Completed | ReCell | NCT02994654 |
| Observational | Completed | ReCell® Autologous Cell Harvesting Device | NCT03333941 |
| Not applicable | Terminated | RECELL® Autologous Cell Harvesting Device, Telfa™ Clear and Xeroform™ dressings | NCT03624192 |
| Not applicable | Terminated | RES (Regenerative Epidermal Suspension) prepared using the RECELL® Autologous Cell Harvesting Device, Mepilex® Ag Wound Dressing | NCT03626701 |
| Not applicable | Completed | Control Intervention (Conventional Autograft), Investigational Intervention (RECELL + more widely meshed autograft) | NCT04091672 |
| Not applicable | Terminated | Melanocyte-Keratinocyte Transplantation and Ultraviolet Lamp (UVB), RECELL 1:5 and Ultraviolet Lamp (UVB) | NCT04271501 |
| Not applicable | Completed | Control Intervention (UVB), Investigational Interventions (Ablative Laser Resurfacing + RECELL + UVB) | NCT04547998 |
| Not applicable | Completed | RECELL® Autologous Cell Harvesting Device | NCT05971381 |
| Not applicable | Completed | PermeaDerm Biosynthetic Wound Matrix, Frozen Human Cadaveric Allograft (FHCA) | NCT06750809 |
| Not applicable | Completed | Cohealyx | NCT06787690 |