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Humacyte, Inc. (HUMA)

Humacyte, Inc. focuses on developing and manufacturing readily available, implantable human tissues engineered in a laboratory setting. These bioengineered tissues are designed to treat a wide array of diseases and conditions across various anatomical locations and therapeutic fields. The company employs its distinct scientific and proprietary technology platform to produce human acellular vessels (HAVs). These investigational HAVs are specifically crafted for universal compatibility, enabling easy implantation into any patient without inducing an immune rejection or an adverse foreign body response. Humacyte is currently building a pipeline of HAVs targeting the substantial market for vascular repair, reconstruction, and replacement. This includes applications such as treating vascular trauma, providing arteriovenous access for hemodialysis, addressing peripheral arterial disease, and facilitating coronary artery bypass grafting. Furthermore, the company is exploring the use of its HAVs for pediatric heart surgeries and for cellular therapeutic delivery, including the transplantation of pancreatic islet cells to manage Type 1 diabetes. Founded in 2004, Humacyte maintains its headquarters in Durham, North Carolina.

Sector: Biological Products, (No Diagnostic Substances)

Industry: Biotechnology

Humacyte, Inc. logo

Humacyte, Inc.

NASDAQ:HUMAHealthcare
-12.47%$0.4112
AH$0.4289+4.30%vs close
Mkt Cap$114.23M
Float275.6M
O/S277.8M
Vol
$ Vol
RVOL
Inst Own26.5%
SI11.0%
Earnings
Dilution
Upcoming Catalysts
  • SymvessSUBMISSIONsBLA PLANNED
    Cash runway at this date: 4mo
    This year~8w8-K
  • Cash runway at this date: 6mo
    Oct 22, 202611d ago8-K
Phase Distribution
15 lead-sponsored trials·1 active·9 completed
Phase 11
Phase 23
Phase 2/31
Phase 34
Phase 41
Not applicable5

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

Clinical Trials
Status
Phase
  • Phase 4
    Not yet recruiting

    Multicenter Study to Evaluate the Safety and Efficacy of SYMVESS™ in a Real World Setting in Patients With Extremity Arterial Injury Requiring Urgent Repair

    Acellular Tissue Engineered Vessel

    Vascular Injury, Arterial Injury +1

    Enrollment
    125
    Start
    Sep 2026est.
    Primary Completion
    Sep 2030est.
    Completion
    Sep 2030est.
    NCT07762794
  • Phase 3
    Completed

    Comparison of the Human Acellular Vessel (HAV) With ePTFE Grafts as Conduits for Hemodialysis

    Human Acellular Vessel (HAV)

    Renal Failure, End Stage Renal Disease +2

    Enrollment
    355
    Start
    May 2016
    Primary Completion
    May 2019
    Completion
    Sep 2023
    NCT02644941
  • Phase 3
    Completed

    Comparison of the Human Acellular Vessel (HAV) With Fistulas as Conduits for Hemodialysis

    Human Acellular Vessel (HAV)

    Renal Failure, End Stage Renal Disease +2

    Enrollment
    242
    Start
    Sep 2017
    Primary Completion
    Apr 2024
    Completion
    Jun 2025
    NCT03183245
  • Phase 3
    Active, not recruiting

    To Compare the Efficacy and Safety of the ATEV With AVF in Female Patients With End-Stage Renal Disease Requiring Hemodialysis

    Acellular Tissue Engineered Vessel (ATEV)

    End Stage Renal Disease (ESRD)

    Enrollment
    121
    Start
    Sep 2023
    Primary Completion
    Jun 2027est.READOUT • p=0.001
    Completion
    Jun 2028est.
    NCT05908084
  • Phase 3
    Not yet recruiting

    An Open-label Study to Assess the Safety and Efficacy of SYMVESS® as a Vascular Conduit in Adolescents With Extremity Arterial Injury.

    Acellular Tissue Engineered Vessel (Symvess)

    Vascular Trauma, Arterial Injury +1

    Enrollment
    10
    Start
    Sep 2026est.
    Primary Completion
    Dec 2028est.
    Completion
    Dec 2028est.
    NCT07762313
  • Phase 2/3
    Completed

    Humacyte Acellular Tissue Engineered Vessel (ATEV) in Patients With Vascular Trauma

    Acellular Tissue Engineered Vessel (ATEV)

    Trauma, Vascular System Injury

    Enrollment
    72
    Start
    Sep 2018
    Primary Completion
    Sep 2023
    Completion
    May 2026
    NCT03005418
  • Phase 2
    Completed

    Humacyte's HAV for Femoro-Popliteal Bypass in Patients With PAD

    Human Acellular Vessel (HAV)

    Peripheral Artery Disease

    Enrollment
    15
    Start
    Dec 2016
    Primary Completion
    Dec 2020
    Completion
    Dec 2023
    NCT02887859
  • Phase 2
    Completed

    Safety and Efficacy Assessment of HAV in Patients Needing Vascular Access for Dialysis

    HAV

    Renal Failure, End Stage Renal Disease +2

    Enrollment
    30
    Start
    Nov 2019
    Primary Completion
    May 2021
    Completion
    Mar 2022
    NCT04135417
  • Phase 2
    Not yet recruiting

    Study to Evaluate the Safety and Efficacy of Humacyte's Coronary Tissue Engineered Vessel (CTEV) in Patients With Coronary Artery Disease Requiring Coronary Artery Bypass Grafting (CABG)

    Humacyte Coronary Tissue Engineered Vessel (CTEV)

    Coronary Artery Disease

    Enrollment
    10
    Start
    Sep 2026est.
    Primary Completion
    Sep 2030est.
    Completion
    Sep 2030est.
    NCT07730528
  • Phase 1
    Completed

    Safety and Efficacy of a Vascular Prosthesis for Hemodialysis Access in Patients With End-Stage Renal Disease

    HAVG

    End-stage Renal Disease, Kidney Failure, Chronic

    Enrollment
    20
    Start
    May 2013
    Primary Completion
    Apr 2016
    Completion
    Apr 2016
    NCT01840956
  • Not applicable
    Completed

    Evaluation of the Safety and Efficacy of a Vascular Prosthesis for Hemodialysis Access in Patients With ESRD

    HAVG graft implantation

    End-stage Renal Disease, Kidney Failure, Chronic

    Enrollment
    40
    Start
    Nov 2012
    Primary Completion
    Dec 2014
    Completion
    Mar 2024
    NCT01744418
  • Not applicable
    Completed

    Evaluation of the Safety and Efficacy of a Vascular Prosthesis as an Above-Knee Bypass Graft in Patients With PAD

    HAV implantation

    Peripheral Arterial Disease, Peripheral Vascular Disease

    Enrollment
    20
    Start
    Oct 2013
    Primary Completion
    May 2016
    Completion
    Jul 2024
    NCT01872208
  • Expanded access
    Approved for marketing

    Individual Patient Expanded Access for Acellular Tissue Engineered Vessel (ATEV) for Vascular System Injuries

    Acellular Tissue Engineered Vessel (ATEV) / Human Acellular Vessel (HAV)

    Vascular System Injuries

    Enrollment
    -
    Start
    -
    Primary Completion
    -
    Completion
    -
    NCT03631056
  • Observational
    Completed

    An Observational Study to Evaluate the Safety and Efficacy of Humacyte's HAV for Arterial Replacement or Reconstruction in Ukrainian Patients With Life or Limb-threatening Vascular Trauma

    HAV implantation

    Trauma, Trauma Injury +2

    Enrollment
    17
    Start
    May 2023
    Primary Completion
    May 2023
    Completion
    Jan 2024
    NCT05873959
  • Expanded access
    Temporarily not available

    Individual Patient Expanded Access for Acellular Tissue Engineered Vessel (ATEV) for Vascular Disease and Dialysis Access

    Acellular Tissue Engineered Vessel (ATEV)

    Vascular Diseases, End Stage Renal Disease on Dialysis

    Enrollment
    -
    Start
    -
    Primary Completion
    -
    Completion
    -
    NCT07141641