Acellular Tissue Engineered Vessels platform
approvedplatform · high · Wed Jun 10 2026 00:00:00 GMT+0000 (Coordinated Universal Time)
Develop universally implantable, off-the-shelf regenerative human vascular conduits for tissue repair and replacement across trauma, dialysis access, peripheral artery disease, coronary bypass, and pediatric heart disease applications.
Bioengineered human vascular cells are grown into vessels and decellularized to create acellular tissue engineered vessels intended for implantation.
Symvess is approved in the United States for vascular trauma repair.
Published work reports bioengineered human blood vessels, infection-resistance mechanisms versus ePTFE, and long-term clinical outcomes in dialysis access, PAD bypass, and trauma settings.
ATEV for coronary artery bypass grafting
exploratorydrug program · medium · Thu Jan 01 2026 00:00:00 GMT+0000 (Coordinated Universal Time)
Develop bioengineered vascular conduits for coronary artery bypass grafting.
Application of Humacyte's acellular tissue engineered vessel technology to coronary tissue engineering and bypass grafting.
CABG is listed in the company pipeline; a 2026 publication record discusses coronary tissue engineering model choice and interpretation.
ATEV for hospital-acquired vascular complications
phase 2research program · medium · Thu Jan 01 2026 00:00:00 GMT+0000 (Coordinated Universal Time)
Repair vascular complications from surgery or procedures, including iatrogenic injuries, oncological resections, and steal syndrome after arteriovenous access placement, when autologous vein is unavailable.
Analysis of patients in CLN-PRO-V005 receiving ATEV for hospital-acquired iatrogenic injury or sequelae of vascular procedures.
2026 publication reported outcomes from 12 patients in the V005 study.
At day 30, all 10 evaluable patients had documented patency; by follow-up or cutoff, 11 of 12 retained patency, no treated limbs were lost, no confirmed ATEV infections were reported, and no deaths were related to ATEV.
Symvess for vascular trauma repair
approveddrug program · high · Thu Jan 01 2026 00:00:00 GMT+0000 (Coordinated Universal Time)
Provide an off-the-shelf bioengineered vascular conduit for arterial reconstruction in patients with traumatic vascular injuries when autologous vein is not feasible.
Implantation of Acellular Tissue Engineered Vessel as an interposition vessel or bypass during vascular reconstructive surgery.
United States approval for vascular trauma repair; long-term safety and efficacy outcomes published for extremity arterial trauma repair.
A 2026 publication reported 54 patients followed up to 36 months, 12-month primary patency of 58.3%, secondary patency of 65.7%, limb salvage of 87.3%, low infection rates, no immune-mediated rejection, and no spontaneous rupture or mechanical failure.
Acellular Tissue Engineered Vessel for hemodialysis vascular access
phase 2other · high · Thu Sep 07 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
Create vascular access for hemodialysis in end-stage renal disease patients as an alternative to arteriovenous fistulas, synthetic ePTFE grafts, or autologous grafts.
Clinical studies implanting a Human Acellular Vessel or Human Acellular Vascular Graft for dialysis access, including single-arm Phase 2 evaluation and comparative studies against AVF or ePTFE grafts.
A female ESRD hemodialysis trial is comparing ATEV with standard-of-care AVF over 12 months for catheter-free days and access-related infections.
A five-year outcomes publication in ESRD dialysis-access patients is listed, but detailed results are not supplied in the material.
ATEV for hemodialysis vascular access
phase 2drug program · high · Thu Sep 07 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
Create vascular access for hemodialysis in patients with end-stage renal disease as an alternative to autologous fistulas or synthetic grafts.
Clinical trials implanting Human Acellular Vessel or Human Acellular Vascular Graft for dialysis access, including comparisons with AVF and ePTFE grafts and a female ESRD trial assessing catheter-free days and access-related infections.
A clinical trial comparing ATEV with AVF in female ESRD patients requiring hemodialysis was published on ClinicalTrials.gov in 2023.
A 2022 publication reported five-year outcomes in ESRD patients who received a bioengineered human acellular vessel for dialysis access.
HAV humanitarian trauma repair in Ukrainian patients
phase 2research program · high · Mon May 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
Evaluate safety and efficacy outcomes in Ukrainian patients who received HAV implants for life- or limb-threatening vascular trauma on a humanitarian basis.
Retrospective observational study collecting outcomes from patients implanted with HAVs between June 2022 and May 2023.
ClinicalTrials.gov observational study posted in 2023.
Publication evidence describes use of bioengineered human acellular vessels to treat traumatic injuries in the Ukraine-Russia conflict.
Acellular Tissue Engineered Vessel for pediatric heart disease shunts
preclinicalresearch program · medium · Sun Jan 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
Assess a tissue-engineered human acellular vessel as a Blalock-Taussig-Thomas shunt for pediatric heart disease applications.
Juvenile primate model evaluating tissue-engineered human acellular vessels as BTT shunts.
A juvenile primate model study was published in 2023.
Detailed results are not supplied in the material.
ATEV for pediatric heart disease
preclinicaldrug program · high · Sun Jan 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
Evaluate tissue-engineered human acellular vessels for pediatric heart disease applications such as Blalock-Taussig-Thomas shunts.
Juvenile primate model evaluating tissue-engineered human acellular vessels as a Blalock-Taussig-Thomas shunt.
A 2023 publication evaluated tissue-engineered human acellular vessels as a Blalock-Taussig-Thomas shunt in juvenile primates.
HAV for peripheral artery disease femoro-popliteal bypass
phase 2drug program · high · Sun Jan 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
Improve blood flow in patients with peripheral artery disease using a tissue-engineered vascular prosthesis as an above-knee femoro-popliteal bypass graft.
Surgical implantation of Human Acellular Vessel as an alternative to synthetic materials and autologous grafts for femoro-popliteal bypass.
ClinicalTrials.gov PAD femoro-popliteal bypass studies were published, and six-year Phase II outcomes were published in 2023.
A 2023 publication reported six-year outcomes from a Phase II study of human tissue-engineered blood vessels for peripheral arterial bypass.
Human Acellular Vessel for peripheral artery disease bypass
phase 2other · high · Sun Jan 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
Improve blood flow in patients with peripheral artery disease by serving as an above-knee femoro-popliteal bypass graft alternative to synthetic materials or autologous grafts.
Surgical implantation of a tissue-engineered vascular prosthesis / Human Acellular Vessel as a femoro-popliteal bypass graft in PAD patients.
Six-year outcomes of a Phase II study of human tissue-engineered blood vessels for peripheral arterial bypass were published in 2023.
The supplied material identifies long-term Phase II outcomes but does not provide detailed efficacy or safety figures.
BioVascular pancreas for type 1 diabetes
preclinicalresearch program · high · Fri Jan 01 2021 00:00:00 GMT+0000 (Coordinated Universal Time)
Develop a bioartificial vascularized pancreas approach for type 1 diabetes.
Bioengineered vascular/tissue construct described as development of a bioartificial vascular pancreas.
BioVascular pancreas for type 1 diabetes is listed in the pipeline; a 2021 publication reported development of a bioartificial vascular pancreas.
BioVascular pancreas for Type 1 diabetes
exploratoryresearch program · medium · Fri Jan 01 2021 00:00:00 GMT+0000 (Coordinated Universal Time)
Develop a bioartificial or BioVascular pancreas approach for Type 1 diabetes.
Bioartificial vascular pancreas development program; specific intervention details are not supplied in the material.
A publication titled "Development of a Bioartificial Vascular Pancreas" was listed in 2021, and BioVascular pancreas for Type 1 diabetes appears in the company pipeline list.
Acellular Tissue Engineered Vessel for hospital-acquired vascular complications
phase 2research program · medium
Evaluate whether bioengineered human blood vessels can repair iatrogenic injuries or sequelae of vascular procedures when autologous vein is unavailable.
Subgroup analysis from CLN-PRO-V005 using implanted ATEV conduits for hospital-acquired iatrogenic injury, oncological resection consequences, steal syndrome, or other vascular-procedure complications.
A 12-patient analysis reported follow-up outcomes for hospital-acquired vascular complications from the V005 study.
At day 30, all 10 evaluable patients had documented patency; at final follow-up or cutoff, 11 of 12 retained patency, no treated limbs were lost, and no confirmed ATEV conduit infections were reported.
Advanced Organ Systems
exploratoryplatform · medium
Investigate, develop, and manufacture advanced bioengineered human organ systems intended for regenerative repair or replacement.
Humacyte platform transforming human cells into off-the-shelf, universally implantable regenerative tissues and organs; listed organ-system targets include lung, urinary conduit, tracheal replacement, and esophageal replacement.
Listed as part of Humacyte's pipeline alongside named organ-system applications.
Advanced Organ Systems lung program
exploratoryresearch program · medium
Develop bioengineered lung tissues or organ systems for repair or replacement applications.
Advanced Organ Systems tissue-engineering platform applied to lung constructs.
Lung is listed in Humacyte's pipeline under advanced organ systems.
Advanced Tissue Constructs
exploratoryplatform · medium
Develop regenerative advanced tissue constructs for tissue repair and replacement beyond vascular conduits.
Bioengineered tissue platform using human cells transformed into implantable acellular regenerative constructs.
Listed as one of Humacyte's core pipeline areas.
Esophageal replacement program
exploratoryresearch program · medium
Develop bioengineered tissue for esophageal replacement.
Advanced tissue construct engineering for esophageal replacement.
Esophageal replacement is listed in Humacyte's pipeline.
Symvess / Acellular Tissue Engineered Vessel for vascular trauma repair
approvedother · high
Provide an off-the-shelf bioengineered vascular conduit for arterial replacement, reconstruction, or bypass in vascular trauma when autologous vein is not feasible.
Implantation of a bioengineered human acellular vessel as an interposition vessel or bypass using standard vascular surgical techniques; evaluated in trauma cohorts and humanitarian-use observational data.
Symvess is approved for vascular trauma repair in the United States; long-term trauma follow-up reported outcomes through up to 36 months.
In a 54-patient long-term trauma analysis, month-12 primary patency was 58.3%, secondary patency was 65.7%, limb salvage was 87.3%, infection-free rates were 92.9% from months 3 through 36, and no immune-mediated rejection or spontaneous mechanical failure was observed. Ukrainian humanitarian-use publications also report use in traumatic injuries.
Tracheal replacement program
exploratoryresearch program · medium
Develop bioengineered tissue for tracheal replacement.
Advanced tissue construct engineering for tracheal replacement.
Tracheal replacement is listed in Humacyte's pipeline.
Urinary conduit program
exploratoryresearch program · medium
Develop a bioengineered urinary conduit for tissue repair or replacement.
Advanced tissue construct or organ-system engineering approach for urinary conduit replacement.
Urinary conduit is listed in Humacyte's pipeline.
