Our Pipeline
Acellular Tissue Engineered Vessels
Acellular Tissue Engineered Vessels are tissue structures designed to resemble the body’s natural vasculature and aim to restore, replace, or enhance the function of damaged or diseased vascular tissue.
Our product candidates are currently in various stages of preclinical and human clinical studies to test the safety, efficacy, and viability of a first-of-its-kind investigational Acellular Tissue Engineered Vessel (ATEVTM) platform across a breadth of potential uses including Vascular Trauma Repair, Arteriovenous Access in Hemodialysis, Peripheral Artery Disease (PAD), Coronary Artery Bypass Grafting (CABG), and Pediatric Heart Surgery.
Stats from Acellular Tissue Engineered Vessel Clinical Trials and Expanded Access Patients
across multiple clinical applications
Vascular trauma injuries threaten life and limb. Repairing an injured vessel may involve surgical reconstruction or bypass procedures. Surgeons may use the patient’s own vein (usually harvested from the thigh), or a synthetic or biologic graft. Patients with arterial extremity injuries face risks such as infection and amputation. Humacyte’s ATEV is being investigated for use as a vascular conduit for extremity arterial injury when urgent revascularization is needed.
Current repair 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, which can delay revascularization of the injured tissues, and possibly increase the risk of amputation.
- Synthetic grafts offer faster revascularization, but may have risks of infection and amputation.
- 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 trauma1:
Humacyte completed a Phase 2/3 human trial to evaluate the ATEV for vascular replacement or reconstruction in patients with life or limb-threatening vascular trauma. The investigational ATEV was evaluated in over 20 clinical sites in the U.S. and Israel. Humacyte also supported a year-long humanitarian program in Ukraine, providing the ATEV to five hospitals on the frontlines of the conflict, beginning in June 2022. Nineteen patients were treated with ATEVs for vascular extremity injuries during the humanitarian program.
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In order to administer dialysis, a long-standing point of access to the patient’s blood system is needed. It is through this point of access that blood is transferred between the patient and the dialysis machine. The current standard of care involves connecting the patient’s artery with a vein, known as an arteriovenous fistula or AV fistula (AVF). Humacyte’s investigational ATEV is designed to provide an alternative to current standards of care for hemodialysis patients with End-Stage Renal Disease (ESRD).
- Infection is the leading cause of morbidity and mortality in hemodialysis patients. This treatment puts patients at higher risk for serious infections because it requires frequent access to the bloodstream using needles.3
- Central venous catheters, which are long, thin tubes placed into a large vein for access to the bloodstream, carry the highest risk of infection for hemodialysis access, but patients may require them while Arterial Venous Fistulas (AVFs) are unusable.3
- AVFs can take weeks or months to mature and become usable for hemodialysis. Some AVFs may never mature, or may fail over time, all of which may result in longer catheter use while establishing a new access site.4,5
- Some patients can lack adequate veins to create an AVF and require other access options.6
annually3
Humacyte completed two Phase 2 studies and two Phase 3 trials to evaluate the ATEV in AV Access; including studies comparing to autologous arteriovenous fistula or ePTFE graft in patients with ESRD. An additional Phase 3 trial is ongoing.
*Results published in Journal of Vascular Surgery – Vascular Science
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Peripheral artery disease (PAD) is a condition in which narrowed arteries restrict blood flow to a person’s arms or legs. PAD may cause pain, tissue damage, open sores, gangrene, and amputation.7 The ATEV platform is being investigated for use in PAD for arterial bypass procedures to determine its potential as a long-term option to restore blood flow to the affected limb and ultimately reduce the risk of amputation.
- 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.10
- Saphenous vein harvest, even when possible, carries associated risks including infection, nerve damage, and blood clots.9
have a suitable
saphenous vein available.10
Humacyte completed two Phase 2 human trials for the evaluation of the safety and efficacy of the 6mm ATEV in patients with peripheral artery disease (PAD). The Mayo Clinic, Rochester, MN, is conducting a study in approximately 30 patients with CLTI, the end stage of PAD, under an investigator-initiated Investigational New Drug (IND) application cleared by the FDA.
*Results published in Journal of Vascular Surgery – Vascular Science
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Coronary artery bypass surgery, also known as CABG, is a procedure to improve blood flow to the heart. Diseased arteries can limit oxygen reaching the heart muscle. In CABG, surgeons create detours around the blockages using healthy blood vessels from elsewhere in the body. This improves blood flow and can relieve chest pain and lower the risk of heart attack.
Using the patient’s veins is the standard in this procedure11 but, some patients may not have an available or suitable saphenous vein, for bypass procedures due to preexisting conditions, such as vascular disease, vein stripping, or vein harvesting for prior vascular procedures.12 Humacyte’s ATEV platform is being investigated as an alternative conduit for coronary artery bypass grafting (CABG).
- In some cases, more than one vessel is needed to create multiple bypasses. This occurs when there are multiple blocked coronary arteries that require revascularization.13 Often the targeted donor vessels are unavailable or diseased, thereby providing a less than desired outcome.
- When suitable veins are available, surgeons perform a surgical harvesting procedure to obtain them. However, this procedure carries potential risks, including pain and complications associated with surgery.14
- Even if the harvested veins are successfully implanted, they don’t always remain open or patent. Over time, they may become narrowed or blocked again. As a result, some patients require a second procedure to restore blood flow and additional vein may need to be harvested or may not be available.15
Saphenous vein grafts may not be a durable solution for all patients:
Second surgical sites to harvest vein can be painful and complicated:
The Humacyte Coronary Artery Bypass Grafting (CABG) Program is currently in preclinical studies to evaluate safety and potential benefits of the smaller diameter 3.5mm ATEVs.
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Congenital heart defects (CHD) are associated with lifelong challenges, health services needs, and may require repeat surgical interventions. The Humacyte Pediatric Heart Surgery program is investigating the potential benefits of a smaller 3.5mm diameter ATEV in patients born with congenital heart defects.
Many babies are born each year with congenital heart disease and will face lifelong challenges. Unfortunately, many will undergo several reoperations as their bodies grow as some treatment options may not grow with the patient.
defects result in
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 ATEV platform as a conduit to help repair the heart defect.18 The Humacyte Pediatric Heart Surgery Program is currently in preclinical studies to evaluate the safety and efficacy of the smaller 3.5mm diameter ATEVs in patients born with congenital heart defects. Since the ATEV becomes populated with cells from the patient, we believe it is possible that the ATEV may grow with pediatric patients, though this has not yet been proven in experimental studies.
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- 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.
- Ziegler-Graham K, MacKenzie EJ, Ephraim PL, Travison TG, Brookmeyer R. Estimating the Prevalence of Limb Loss in the United States: 2005 to 2050. Archives of Physical Medicine and Rehabilitation. 2008;89(3):422-9.
- Rha B, See I, Dunham L, et al. Vital Signs: Health Disparities in Hemodialysis-Associated Staphylococcus aureus Bloodstream Infections — United States, 2017–2020. MMWR Morb Mortal Wkly Rep 2023;72:153–159.
- Li H, Jen S, Ramayya T, Bowers HG, Rotem E. Unanticipated late maturation of an arteriovenous fistula after creation of separate graft access. Quant Imaging Med Surg. 2018;8(4):444-446. doi:10.21037/qims.2018.01.03.
- Schinstock CA, Albright RC, Williams AW, et al. Outcomes of arteriovenous fistula creation after the Fistula First Initiative. Clin J Am Soc Nephrol. 2011;6(8):1996-2002. doi:10.2215/CJN.11251210.
- Malovrh M. Non-matured arteriovenous fistulae for haemodialysis: diagnosis, endovascular and surgical treatment. Bosn J Basic Med Sci. 2010;10 (Suppl 1):S13-S17.
- Peripheral Artery Disease - Living With | NHLBI, NIH. www.nhlbi.nih.gov. https://www.nhlbi.nih.gov/health/peripheral-artery-disease/living-with.
- Guez D, Hansberry DR, Gonsalves CF, et al. Recent Trends in Endovascular and Surgical Treatment of Peripheral Arterial Disease in the Medicare Population. American Journal of Roentgenology. 2020;214(5):962-966. doi:https://doi.org/10.2214/ajr.19.21967.
- Radial Artery & Saphenous Vein Harvesting. Cleveland Clinic. https://my.clevelandclinic.org/health/treatments/17406-radial-artery--saphenous-vein-harvesting.
- Taylor LM, Edwards JM, Brant B, Phinney ES, Porter JM. Autogenous reversed vein bypass for lower extremity ischemia in patients with absent or inadequate greater saphenous vein. The American Journal of Surgery. 1987;153(5):505-510. doi:https://doi.org/10.1016/0002-9610(87)90803-8.
- Caliskan E, de Souza DR, Böning A, et al. Saphenous vein grafts in contemporary coronary artery bypass graft surgery. Nature Reviews Cardiology. 2019;17(3):155-169. doi:https://doi.org/10.1038/s41569-019-0249-3.
- Lloyd M Taylor, James M Edwards, Bolek Brant, Edward S Phinney, John M Porter, Autogenous reversed vein bypass for lower extremity ischemia in patients with absent or inadequate greater saphenous vein, The American Journal of Surgery, Volume 153, Issue 5, 1987, Pages 505-510, ISSN 0002-9610, https://doi.org/10.1016/0002-9610(87)90803-8.
- Cleveland Clinic. Coronary Artery Bypass Surgery | Cleveland Clinic. Cleveland Clinic. Published 2018. https://my.clevelandclinic.org/health/treatments/16897-coronary-artery-bypass-surgery.
- 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.
- Collins P., Webb C.M., Chong C.F., Moat N.E. Radial artery versus saphenous vein patency (RSVP) trial investigators. Radial artery versus saphenous vein patency randomized trial: five-year angiographic follow-up. Circulation. 2008;117:2859–2864.
- Fitzgibbon GM, Kafka HP, Leach AJ, Keon WJ, Hooper GDavid, Burton JR. Coronary bypass graft fate and patient outcome: Angiographic follow-up of 5,065 grafts related to survival and reoperation in 1,388 patients during 25 years. Journal of the American College of Cardiology. 1996;28(3):616-626. doi:https://doi.org/10.1016/0735-1097(96)00206-9.
- Gilboa SM, Devine OJ, Kucik JE, et al. Congenital Heart Defects in the United States. Circulation. 2016;134(2):101-109. doi:https://doi.org/10.1161/circulationaha.115.019307.
- Van der Linde D, Konings EEM, Slager MA, et al. Birth Prevalence of Congenital Heart Disease Worldwide. Journal of the American College of Cardiology. 2011;58(21):2241-2247. doi:https://doi.org/10.1016/j.jacc.2011.08.025.