Skip to content

Our Pipeline
Advanced Organ Systems

ADVANCED Organ Systems
Some information below relates to investigational products and/or uses for which safety and efficacy have not been established. There is no guarantee that pipeline products or investigational uses will receive approval from health authorities.
Preclinical
Phase 2
Phase 3
Biovascular pancreas™ (Type 1 diabetes)
Lung
Last updated August, 2024

Our preclinical work extends beyond the Accellular Tissue Engineered Vessel (ATEV™) platform, including investigations into Advanced Organ Systems, further expanding the potential of our technology.

Biovascular pancreas (Type 1 diabetes)

Type 1 diabetes is a lifelong autoimmune condition where the pancreas makes little or no insulin, and requires daily glucose level monitoring and insulin shots to balance blood sugar levels. Humacyte’s investigational BioVascular Pancreas (BVP™) is created by coating pancreatic islets onto the outer surface of our Acellular Tissue Engineered Vessel. Once implanted into the vasculature, the BVP is designed to normalize glucose levels in patients with Type 1 diabetes by providing much needed oxygen and nutrients to the islets. This innovative cell replacement therapy holds potential in advancing the treatment of Type 1 diabetes.

  • Without insulin, blood sugar builds up causing many complications. This leads to dependence on insulin therapy and the risk of short or long-term complications, which can include highs and lows in blood sugar, and organ damage.1
  • Type 1 diabetes can develop at any age, it has nothing to do with diet or lifestyle. Currently, no one knows how to prevent Type 1 diabetes and there is no cure for it.1
  • Type 1 diabetes can impact patient and caregiver quality of life including the stress of lifestyle changes needed to manage the disease and concerns surrounding the potential for complications.1
2 million
Americans
have Type 1 diabetes2
It is estimated that
17- 30%
of Type 1 diabetics
are poorly controlled3
The per year out-of-pocket
cost
to properly manage
Type 1 diabetes
$25,7004

The Humacyte® BioVascular Pancreas program is currently in preclinical studies to evaluate the safety and efficacy of the BVP for patients with Type 1 diabetes, in preparation of planned advancement to human clinical trials.

Lung

End-stage lung disease is a severe and advanced stage of lung disease characterized by irreversible damage to the lungs, significantly impairing their function and ability to provide adequate oxygen to the body.5 It can be caused by chronic obstructive pulmonary disease (COPD), pulmonary fibrosis, emphysema, or systemic progressive diseases like cystic fibrosis.5

  • There are limited options to cure end stage lung disease and diseases can progress and worsen over time.
  • Not all patients are candidates for surgery due to overall health or severity of disease.
  • There are limited lung transplant donors and there is a risk of transplant rejection.6
150,000
lives are lost
annually to end stage
lung disease
7
There are
> 2,000
annual lung transplants
in the United States6

The Humacyte Lung Program is currently in preclinical development.

Reference
  1. Mayo Clinic. Type 1 Diabetes - Symptoms and Causes. mayo clinic. Published September 15, 2023. https://www.mayoclinic.org/diseases-conditions/type-1-diabetes/symptoms-causes/syc-20353011.
  2. American Diabetes Association. Statistics about diabetes. diabetes.org. Published November 2, 2023. https://diabetes.org/about-diabetes/statistics/about-diabetes.
  3. Najafipour H, et al. Prevalence and Incidence Rate of Diabetes, Pre-diabetes, Uncontrolled Diabetes, and Their Predictors in the Adult Population in Southeastern Iran: Findings From KERCADR Study. Front Public Health. 2021 Nov 1;9:611652. doi: 10.3389/fpubh.2021.611652. PMID: 34790639; PMCID: PMC8591105.
  4. https://www.usnews.com/news/health-news/articles/2024-02-21/out-of-pocket-costs-are-tough-on-americans-with-diabetes.
  5. End-Stage Lung Disease. Yale Medicine. https://www.yalemedicine.org/clinical-keywords/end-stage-lung-disease#:~:text=Definition.
  6. MN 1Scientific R of TR Hennepin Healthcare Research Institute, Minneapolis,. Lung. srtr.transplant.hrsa.gov. https://srtr.transplant.hrsa.gov/annual_reports/2021/Lung.aspx.
  7. Association AL. Lung Association Increases Access to Vital Information as More Americans are Impacted by Lung Disease. www.lung.org. Published January 12, 2022. https://www.lung.org/media/press-releases/lung-association-increases-access-to-vital-informa.

You are now leaving humacyte.com.