Development

pipeline

Humacyte is paving the way by developing disruptive biotechnology platforms for a new era in regenerative medicine. Our breakthroughs in science and technology aim to turn once-futuristic ideas about patient treatment into reality through the development of bioengineered human tissues. Pioneering three revolutionary platforms – Vascular Conduits, Advanced Tissue Constructs and Advanced Organ Systems – we strive to revolutionize healthcare with solutions for an array of diseases and conditions across diverse clinical needs.

Vascular Conduits

Humacyte has made a significant leap forward in the field of regenerative medicine with the first-of-its-kind, bioengineered human vessel. Designed to be universally implantable and have off-the-shelf availability, The Human Acellular Vessel™ (HAV™) offers a readily available solution for addressing a wide range of vascular diseases and injuries. HAVs suitable for multiple indications including Traumatic Injury, Arteriovenous Access in Hemodialysis, Peripheral Artery Disease (PAD), Pediatric Heart Surgery and Coronary Artery Bypass Grafting (CABG) are undergoing various stages of preclinical and human studies.

The HAV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency.

6 mm and 3.5 mm diameter Human Acellular Vessels

By relentlessly pushing the limits of science with substantial investments in research, the HAV has accumulated a wealth of data:

Vascular Trauma

Humacyte COMPLETED a Phase 2/3 human trial
to evaluate the HAV for vascular replacement or reconstruction in patients with life or limb-threatening vascular trauma. Patients with traumatic injury to an arterial vessel were implanted with a
6 mm HAV as a repair conduit using standard vascular surgical techniques. The HAV was evaluated in over 20 clinical sites in the U.S. and Israel.

Humacyte’s HAV has the potential to reduce complications of traumatic injury, like infections and amputations. The HAV is designed to:

  • be ready off-the-shelf for surgical implantation, without special preparation, such as graft rinsing or thawing
  • save valuable time to restore blood flow to damaged tissues without requiring vein harvesting
  • be universally implantable, thereby enabling treatment for all patients
  • be infection-resistant* which may be well suited for treating traumatic injuries, which are commonly contaminated
  • lower rehospitalizations by reducing patient discomfort and complications

Currently available treatment options for treating vascular injuries can have significant drawbacks:

  • Use of saphenous vein for bypass is the standard of care, but harvesting a vein takes valuable operating time, delaying revascularization of the injured tissues, and possibly risking amputation.
  • Synthetic grafts may offer quicker revascularization, but may have risks of infection and amputation.
  • Ligation of the bleeding artery, and/or amputation of the injured limb, dramatically reduces the patient’s quality of life and increases the risk of comorbidities.

Average costs associated with complications in vascular trauma.1,2

Amputation

Infection

$ 0
$ 0

Harvest Site Infection

$ 0

Average costs associated with complications in vascular trauma1,2..

Amputation

$ 0

Infection

$ 0

Harvest Site Infection

$ 0

Humacyte also supported a year-long humanitarian program in Ukraine, providing the HAV to five hospitals on the frontlines of the conflict, beginning in June 2022. The humanitarian program was initiated in response to Ukrainian surgeon requests. Humacyte worked closely with the International Office of the FDA and the Ukrainian Ministry of Health to obtain approval for the program. Humacyte then trained Ukrainian surgeons by video conference on how to implant the HAV.  Nineteen patients were treated with HAVs for vascular injuries on the limbs during the Humanitarian program.

* Results published in Journal of Vascular Surgery – Vascular Science

Click here to view the press release.

Arteriovenous Access

The HAV™ is being studied as a conduit providing AV access and aims to provide important benefits for hemodialysis patients with End-Stage Renal Disease (ESRD), such as:

  • Shorter time to usability for dialysis (after only 4 weeks), thereby providing the needed hemodialysis treatment sooner
  • Longer durability of the arteriovenous access
  • Reduced risk of infection compared to accesses made from plastic*
  • Reduced costs associated with repeated interventions

These improvements may greatly benefit patients living with ESRD3. Dialysis treatments require establishing a long-lasting point of access to the patient’s blood system, to transfer blood from the patient to the dialysis machine and then back into the patient. However, the current treatment options have significant risks and shortcomings.

  • The current standard of care involves connecting the patient’s artery with a vein, known as an arteriovenous fistula or AV fistula (AVF). AVFs exhibit a high rate of failure, forcing patients to rely on plastic catheters.4-8
  • Plastic catheters can have high rates of infection.4

     

Average costs associated with complications in AV access.9,10

Infection

$ 0

Additional
Access Procedures

$ 0

The HAV characteristics such as off-the-shelf readiness, 6 mm diameter supporting dialysis cannulation, and infection-resistance may help address these shortcomings. Humacyte completed two Phase 1/2, one Phase 2, and two Phase 3 human trials to evaluate the HAV against autologous arteriovenous fistula or ePTFE graft in patients with ESRD.

* Results published in Journal of Vascular Surgery – Vascular Science

Click here to view the press release.

Peripheral Artery Disease

With its unique characteristics, Humacyte’s HAV has been used in arterial bypass procedures and has the potential to reduce amputation of the affected limb, a common outcome in many patients with severe peripheral artery disease (PAD). The HAV is designed to:

  • save valuable time to restore lower extremity blood supply without requiring vein harvesting
  • be ready off-the-shelf without requiring special preparation
  • be universally implantable enabling treatment for all patients
  • be consistent in size to provide consistent blood flow to the limbs
  • be resilient in high-pressure blood circulation
  • be infection-resistant*, thereby decreasing morbidity
  • improve patients’ quality of life by saving the affected limbs, reducing discomfort and complications

Peripheral artery disease can lead to restricted blood flow, pain, tissue damage, open sores, gangrene, and amputation.11 The current treatment options can have significant risks and shortcomings.

  • The standard of care requires a second surgical site to harvest a saphenous vein to restore blood flow. However, approximately 40% of patients do not have a suitable saphenous vein available. Surgical vein removal, even when possible, carries associated risks including infection, nerve damage, and blood clots.12
  • Plastic grafts carry a risk of infection and can have challenges with providing the necessary blood flow to the limbs.

Humacyte completed one Phase 1/2 and one Phase 2 human trial for the evaluation of the safety and efficacy of the 6 mm HAV in patients with peripheral artery disease. The HAV was evaluated at clinical sites in the U.S. and Europe.

* Results published in Journal of Vascular Surgery – Vascular Science

Click here to view the press release.

Click here to view the press release.

Coronary Artery Bypass Grafts

Humacyte’s HAV may one day provide an alternative for coronary artery bypass grafting (CABG).  Right now, using the patient’s veins is the gold standard in this procedure, however there can be challenges with vein availability, consistency, as well as long-term blood flow.

The HAV is designed to:

  • save operating room time to restore coronary artery blood supply to the heart without requiring vein harvesting
  • be ready off-the-shelf without requiring special preparation
  • be universally implantable enabling treatment for all patients
  • be consistent in size and quality to provide consistent blood flow to the heart
  • be resilient in high-pressure coronary circulation
  • improve quality of life by lowering complications such as surgical vein harvesting site numbness, infection, swelling, and rehospitalizations

    CABG is a major surgical procedure where the patient’s blocked coronary arteries are bypassed with harvested veins and/or arteries. The bypass restores blood flow to the heart muscle to allow it to function and relieve the heart attack symptoms. But current treatment options have limitations.

Harvesting saphenous vein is painful and complicated.13

0 %
of patients experience persistent numbness
0 %
of patients develop infection
0 %
of patients have persistent swelling which tends to be worse in obese, diabetic patients, and is 2x worse in women

Saphenous vein grafts may not last long enough.14

0 %
of patients undergo repeat procedures

The Humacyte CABG program is currently in preclinical studies to evaluate the safety and potential benefits of the smaller diameter 3.5 mm HAVs.

Click here to view the press release.

Pediatric Heart Surgery

The Humacyte Pediatric Heart Surgery program is currently in preclinical studies to evaluate the safety and potential benefits of the smaller 3.5 mm diameter HAVs in patients born with congenital heart defects.  Since the HAV becomes populated with cells from the patient, the company believes it is possible that the HAV may grow with pediatric patients, though this has not yet been proven in experimental studies. 

Many babies are born each year with congenital heart disease and will face lifelong challenges. Unfortunately, many will undergo multiple reoperations as their bodies grow because the plastic grafts used to repair the heart do not grow with them. Our research is focused on Tetralogy of Fallot, a heart condition that affects one in every 2,000 babies born each year and aims to assess the potential HAV patency as a conduit to help repair the heart defect.  Animal research conducted using this 3.5 mm HAV configuration highlights the potential of the Humacyte platform to make vessels aimed at treating a range of heart conditions, spanning from pediatric to adult.

Click here to view the press release.

Advanced Organ Systems and Advanced Tissue Constructs

Our preclinical work extends beyond the HAV into two other platforms, Advanced Organ Systems and Advanced Tissue Constructs, further expanding the potential of our breakthrough technology.

BioVascular Pancreas

Humacyte’s BioVascular Pancreas (BVP) is created by modifying the HAV by coating pancreatic islets onto the outer surface of the HAV.

 The BVP, with its distinctive properties, holds immense promise in revolutionizing type 1 diabetes treatment. This innovative cell-replacement therapy offers hope for improved lives for patients and their families, alleviating the burden of this chronic and life-altering disease. The BVP is designed to:

  • deliver insulin-producing islets to replace the pancreas’ lost insulin-producing cells
  • provide long-lasting insulin delivery that may reduce or eliminate the need for insulin shots
  • be implanted in a simple surgical procedure, as a conduit in the arm of the patient
  • improve patients’ quality of life by improving control of blood sugar levels, thereby preventing damage to the kidneys, eyes, nerves, and heart

Type 1 diabetes is an autoimmune condition that causes the pancreas to make very little insulin, or none at all. 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.  Type 1 diabetes can develop at any age, it has nothing to do with diet or lifestyle, and is less common than type 2 diabetes. Currently, no one knows how to prevent type 1 diabetes and there is no cure for it.15

0 %
of type 1 diabetics are poorly-controlled16

The Humacyte BioVascular Pancreas program is currently in preclinical studies to evaluate the safety and potential benefits of the BVP for patients with type 1 diabetes.

Click here to view the press release.

Lung, Urinary, Tracheal, Esophageal

The Humacyte Lung, Urinary, Tracheal, and Esophageal programs are currently in preclinical studies to evaluate the safety and potential benefits.

  1. MacKenzie EJ, et al. Health-care costs associated with amputation or reconstruction of a limb-threatening injury. J Bone Joint Surg Am. 2007 Aug;89(8):1685-92. doi: 10.2106/JBJS.F.01350. PMID: 17671005.
  2. https://evtoday.com/articles/2014-may/cost-benefit-analysis-of-critical-limb-ischemia-in-the-era-of-the-affordable-care-act
  3. https://usrds-adr.niddk.nih.gov/2023/end-stage-renal-disease/1-incidence-prevalence-patient-characteristics-and-treatment-modalities
  4. Allon M, et al. Increasing arteriovenous fistulas in hemodialysis patients: Problems and solutions. Kidney International, Vol. 62 (2002), pp. 1109–1124.
  5. Zeebregts CJ, et al. Determinants of failure of brachiocephalic elbow fistulas for haemodialysis. Eur J Vasc Endovasc Surg. 2005;30:209–214.
  6. Monroy-Cuadros M, et al. Risk factors associated with patency loss of hemodialysis vascular access within 6 months. Clin J Am Soc Nephrol. 2010;5:1787–1792.
  7. Smith GE, et al. Factors affecting the patency of arteriovenous fistulas for dialysis access. J Vasc Surg. 2012;55:849–855.
  8. Lok CE, et al. Risk equation determining unsuccessful cannulation events and failure to maturation in arteriovenous fistulas (REDUCE FTM I) J Am Soc Nephrol. 2006;17:3204–3212.
  9. Chan MR, et al. Stent placement versus angioplasty improves patency of arteriovenous grafts and blood flow of arteriovenous fistulae. Clin J Am Soc Nephrol. 2008 May;3(3):699-705. doi: 10.2215/CJN.04831107. Epub 2008 Feb 6. PMID: 18256373; PMCID: PMC2386706.
  10. Kelsey E. Star, et al. Reducing central line-associated bloodstream infection with a dedicated CLABSI Prevention Registered Nurse role. American Journal of Infection Control, 2023, ISSN 0196-6553. https://doi.org/10.1016/j.ajic.2023.11.021.
  11. https://www.nhlbi.nih.gov/health/peripheral-artery-disease
  12. Park D, et al. Lower Extremity Arterial Bypass with Arm Vein Conduits and Literature Review. Vasc Spec Int 2016;32(4):160-165.
  13. Garland R, et al. A retrospective audit of long-term lower limb complications following leg vein harvesting for coronary artery bypass grafting. Eur J Cardiothorac Surg. 2003 Jun;23(6):950-5. doi: 10.1016/s1010-7940(03)00116-7. PMID: 12829071.
  14. Back L, et al. Saphenous Vein Graft Failure: Current Challenges and a Review of the Contemporary Percutaneous Options for Management. J Clin Med. 2023 Nov 15;12(22):7118. doi: 10.3390/jcm12227118. PMID: 38002729; PMCID: PMC10672592.
  15. https://www.cdc.gov/diabetes/basics/what-is-type-1-diabetes.html
  16. 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.
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