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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. logo

Avita Medical Inc.

NASDAQ:RCELHealthcare
-6.34%$15.65
AH$15.96+1.98%vs close
Mkt Cap$484.01M
Float30.03M
O/S30.93M
Vol
$ Vol
RVOL
Inst Own16.0%
SI9.4%
Earnings
Dilution
Phase Distribution
15 lead-sponsored trials·0 active·12 completed
Phase 42
Not applicable13
(3 more as collaborator)
Status Overview
Completed12
Stopped3

Trials need funding. See this company's dilution risk and cash position.

Clinical Trials
Sponsor role
Status
Phase
  • Phase 4
    Completed

    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

    Enrollment
    52
    Start
    Jan 2013
    Primary Completion
    Oct 2015
    Completion
    Oct 2015
    NCT01743053
  • Phase 4
    Completed

    A Feasibility Study of the ReGenerCell™ Autologous Cell Harvesting Device for Diabetic Foot Ulcers

    ReGenerCell™ Autologous Cell Harvesting Device

    Diabetic Foot Ulcer

    Enrollment
    16
    Start
    May 2016
    Primary Completion
    Mar 2019
    Completion
    Mar 2019
    NCT02799121
  • Not applicable
    Completed

    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

    Enrollment
    101
    Start
    May 2010
    Primary Completion
    Aug 2014
    Completion
    Aug 2015
    NCT01138917
  • Not applicable
    Completed

    ReCell® Combined With Meshed Skin Graft in the Treatment of Acute Burn Injuries

    ReCell Treatment, Skin Graft

    Burns

    Enrollment
    30
    Start
    Jan 2015
    Primary Completion
    Jan 2016
    Completion
    Feb 2017
    NCT02380612
  • Observational
    Completed

    Prospective Evaluation of the ReCell® Autologous Cell Harvesting Device For Specific Compassionate Use Cases

    -

    Burns

    Enrollment
    100
    Start
    May 2014
    Primary Completion
    May 2019
    Completion
    Jun 2020
    NCT02992249
  • Not applicable
    Completed

    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

    Enrollment
    12
    Start
    Oct 2016
    Primary Completion
    Dec 2017
    Completion
    Sep 2018
    NCT02994654
  • Observational
    Completed

    Continued Access to the Recell® Device for Treatment of Acute Burn Injuries

    ReCell® Autologous Cell Harvesting Device

    Burns

    Enrollment
    76
    Start
    Oct 2017
    Primary Completion
    Dec 2018
    Completion
    May 2019
    NCT03333941
  • Not applicable
    Terminated

    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

    Enrollment
    3
    Start
    Sep 2018
    Primary Completion
    Jan 2020
    Completion
    Jan 2020
    NCT03624192
  • Not applicable
    Terminated

    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

    Enrollment
    19
    Start
    Mar 2020
    Primary Completion
    Jun 2021
    Completion
    Jun 2022
    NCT03626701
  • Not applicable
    Completed

    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

    Enrollment
    65
    Start
    Mar 2020
    Primary Completion
    Mar 2022
    Completion
    Feb 2023
    NCT04091672
  • Not applicable
    Terminated

    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

    Enrollment
    5
    Start
    Sep 2020
    Primary Completion
    Aug 2021
    Completion
    Aug 2021
    NCT04271501
  • Not applicable
    Completed

    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

    Enrollment
    25
    Start
    Sep 2020
    Primary Completion
    Jun 2022
    Completion
    Jan 2023
    NCT04547998
  • Not applicable
    Completed

    Repigmentation of Stable Vitiligo Lesions Using Spray-On Skin™ Cells

    RECELL® Autologous Cell Harvesting Device

    Vitiligo

    Enrollment
    109
    Start
    Aug 2023
    Primary Completion
    Jul 2024
    Completion
    Jan 2025
    NCT05971381
  • Not applicable
    Completed

    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

    Enrollment
    40
    Start
    Feb 2025
    Primary Completion
    Mar 2026
    Completion
    May 2026
    NCT06750809
  • Not applicable
    Completed

    Multicenter Single-arm Trial to Investigate Clinical Outcomes When Cohealyx™ is Used for Full Thickness Wounds

    Cohealyx

    Burn, Trauma Wound +2

    Enrollment
    41
    Start
    May 2025
    Primary Completion
    Feb 2026
    Completion
    Aug 2026
    NCT06787690