Humacyte

Humacyte

HUMAPhase 3

Humacyte is transforming regenerative medicine with its proprietary platform for developing acellular, bioengineered human tissues designed to be universally implantable without immune rejection. The company achieved a landmark FDA approval in December 2024 for Symvess™ for vascular trauma and is advancing a broad pipeline targeting vascular access, coronary artery disease, and complex organ replacement. Led by founder and renowned physician-scientist Dr. Laura Niklason, Humacyte aims to address a wide range of injuries and chronic conditions with its off-the-shelf, regenerative tissue products.

Market Cap
$151.1M
Focus
Tissue Engineering

HUMA · Stock Price

USD 0.785.67 (-87.86%)

Historical price data

AI Company Overview

Humacyte is transforming regenerative medicine with its proprietary platform for developing acellular, bioengineered human tissues designed to be universally implantable without immune rejection. The company achieved a landmark FDA approval in December 2024 for Symvess™ for vascular trauma and is advancing a broad pipeline targeting vascular access, coronary artery disease, and complex organ replacement. Led by founder and renowned physician-scientist Dr. Laura Niklason, Humacyte aims to address a wide range of injuries and chronic conditions with its off-the-shelf, regenerative tissue products.

Technology Platform

A scalable bioengineering platform that creates acellular, universally implantable human tissues from human cells. The proprietary process involves decellularization to remove immunogenic components, resulting in off-the-shelf, regenerative scaffolds that the patient's body can repopulate.

Pipeline Snapshot

11

11 drugs in pipeline, 4 in Phase 3

DrugIndicationStage
Human Acellular Vessel (HAV)Renal FailurePhase 3
Acellular Tissue Engineered Vessel (ATEV)End Stage Renal Disease (ESRD)Phase 3
Human Acellular Vessel (HAV)Renal FailurePhase 3
Human Acellular Vessel (HAV)TraumaPhase 2/3
Human Acellular Vessel (HAV)Peripheral Artery DiseasePhase 2

Funding History

5

Total raised: $690M

IPO$240MUndisclosedAug 20, 2021
Series D$225MFresenius Medical CareJun 15, 2020
Series C$150MFresenius Medical CareJun 15, 2016
Series B$50MUndisclosedJun 15, 2010

Opportunities

Humacyte's growth opportunities are substantial, anchored by the commercial launch of Symvess™ in vascular trauma and the large, underserved market for durable dialysis access.
Success in its Phase 3 dialysis trial could unlock a blockbuster indication.
Long-term, the platform's application in coronary bypass, PAD, and complex organ systems like the BioVascular Pancreas represents transformative potential in multi-billion dollar chronic disease markets.

Risk Factors

Key risks include commercial execution challenges as a newly launched product company, the high cost and uncertainty of ongoing Phase 3 clinical trials, potential future dilution from capital needs to fund development, and scaling manufacturing to meet potential demand.
Regulatory hurdles remain for all pipeline programs.

Competitive Landscape

Humacyte competes with synthetic grafts (e.g., Gore-Tex) and autologous vein grafts in vascular surgery. Its key differentiation is offering a universally implantable, off-the-shelf, regenerative biologic vessel that becomes living tissue and shows low infection rates—a profile not matched by existing synthetic or biologic alternatives.

Company Info

TypeTherapeutics
LocationUnited States
StagePhase 3
RevenueRevenue Generating

Trading

TickerHUMA
ExchangeNASDAQ

Therapeutic Areas

Vascular SurgeryNephrologyCardiologyEndocrinologyPulmonologyUrologyOtolaryngologyGastroenterologyTrauma
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