Humacyte Highlights Dialysis Access Data; Women Show Strong ATEV Edge, V012 Results Due in June

Key Points

• V007 showed a clear female advantage: women receiving Humacyte’s acellular tissue engineered vessel (ATEV) had six‑month functional patency of 89% vs 54% for AVF and 12‑month secondary patency of 81% vs 48% (joint relative patency 1.65, p<0.0001), with much faster and higher maturation (≈5–6 weeks and 94% vs ~4.5 months and 55%).
• Safety profile: no infections or ruptures were reported for ATEV in V007, though rates of thrombosis, stenosis and pseudoaneurysm were higher than AVF but were mostly treatable (83% of women with thrombosis successfully managed).
• V012 interim results due in June: the women‑focused phase III trial (target 150, 126 randomized) reached its interim milestone and Humacyte expects adjudicated interim data in the second week of June, with presentation planned at the SVS meeting on June 11; the primary endpoint is freedom from catheter over 12 months.

Humacyte NASDAQ: HUMA outlined the unmet need in hemodialysis vascular access and highlighted data from its clinical program evaluating the company’s acellular tissue engineered vessel (ATEV) as an alternative to autologous arteriovenous fistulas (AVFs), with a particular focus on women, during a virtual webinar led by Founder, President and CEO Dr. Laura Niklason.

Dialysis access remains a major clinical and economic challenge

Prabir Roy-Chaudhury, co-director of the UNC Kidney Center, said there are roughly 550,000 patients on dialysis in the U.S. who require vascular access for hemodialysis. While AVFs are considered the preferred access, he argued outcomes remain poor and have not materially changed in decades.

Roy-Chaudhury said that “about 40” out of 100 newly created fistulas function “without a problem,” and emphasized that catheter use is widespread and harmful. He said roughly 80% of patients begin hemodialysis with a tunneled dialysis catheter, and when fistulas fail to mature, patients can face prolonged catheter exposure that increases risks of infection, thrombosis and central vein stenosis. He described catheters as “the white tube of death,” arguing they materially degrade patient quality of life and can lead to ICU admissions and hospitalizations.

He also pointed to sex-based disparities in catheter dependence. Citing U.S. Renal Data System data, Roy-Chaudhury said women remain on catheters at higher rates than men at six, nine and 12 months after starting dialysis, attributing this to smaller arteries and veins and poorer fistula maturation. He also said a higher proportion of women remain catheter-dependent even among long-term dialysis patients.

Humacyte clinical trial data highlighted improved outcomes in women

Mohamad A. Hussain, a vascular and endovascular surgeon-scientist at Brigham and Women’s Hospital, presented a two-year subgroup analysis from Humacyte’s V007 randomized controlled phase III trial comparing ATEV to AVF, focusing on enrolled women.

Hussain said V007 was a prospective, multicenter randomized controlled trial conducted at 31 U.S. centers, enrolling 242 end-stage kidney disease patients on hemodialysis with tunneled dialysis catheters. Patients were randomized 1:1 to ATEV or AVF and followed for two years. He noted the trial excluded patients eligible for “the perfect optimal fistula” in the hand/distal forearm, excluded uncontrolled diabetes, and excluded those requiring two-stage access procedures.

In the overall V007 population, Hussain said functional patency at six months was 81% for ATEV versus 66% for AVF, with secondary patency at 12 months of 67% versus 62%, respectively (p=0.009; joint relative patency 1.17 in favor of ATEV).

Hussain said the benefit was larger in women. In the female subgroup, he reported:

• Six-month functional patency of 89% with ATEV versus 54% with AVF
• 12-month secondary patency of 81% with ATEV versus 48% with AVF
• Joint relative patency of 1.65 (p<0.0001)

He also highlighted differences in access usability and time to maturation. In women, Hussain said AVF was used about 10 months of the first two years compared with about 15 months for ATEV (p=0.0137). He said median time to maturation in women was about 4.5 months for fistulas versus about five to six weeks for ATEV, and reported maturation rates of 55% for women receiving AVF versus 94% for women receiving ATEV.

Safety profile: no infections or ruptures reported for ATEV in V007

On safety, Hussain emphasized infection and rupture risk. He said graft infections were “zero in the ATEV group and zero in the AV fistula group,” and reported the rupture rate was zero for ATEV (with one rupture in the AVF arm). He said rates of thrombosis, stenosis and pseudoaneurysm were higher with ATEV, as expected with non-autogenous conduits, but added that most thrombotic events were treatable; he reported that 83% of females experiencing thrombosis were successfully treated using standard vascular techniques.

During Q&A, Hussain said the female subgroup sample size limited identification of specific drivers of thrombosis and stenosis, and described venous anastomosis stenosis as a common mechanism in non-autologous accesses. He also noted patients in the trial were required to receive antiplatelet therapy and suggested contraindications to antiplatelet therapy could be a factor in patient selection.

Humacyte Chief Medical Officer Dr. Shamik Parikh added that V007 ran for about six years and overlapped with the COVID period, which he said disrupted hemodialysis access care and training. He said this disruption was not present in the ongoing V012 study.

V012 trial design targets catheter dependence in women; interim results expected in June

Parikh introduced Humacyte’s V012 phase III study evaluating ATEV versus AVF specifically in women with end-stage kidney disease on hemodialysis catheters who need permanent access. He said the trial is a prospective, randomized multicenter study across “over 25 centers” in the U.S. with 1:1 randomization. The trial began in 2023 and aimed to randomize 150 patients; Parikh said 126 have been randomized.

Parikh said V012 is more inclusive than V007, allowing enrollment of patients who may require two-stage AVF procedures, with stratification by upper arm versus forearm access and by one-stage versus two-stage AVF. The primary endpoint is “freedom from catheter over 12 months,” measured as catheter-free days over a 12-month period. The primary safety endpoint is infections through 12 months post-implant, with additional secondary efficacy and safety endpoints including patency and durability.

Parikh said the protocol includes an interim analysis after the first 80 patients complete one year, and that this milestone has been reached. He said data is being cleaned by the clinical research organization and will then be sent to an independent adjudication committee to assess endpoints such as catheter-free days, patency, infections and access abandonment. Parikh said Humacyte expects results in the second week of June and plans to present the data at the Society for Vascular Surgery (SVS) meeting in Boston on June 11 at a women’s forum session.

Adoption discussions centered on reducing catheter time and evolving payment models

Responding to analyst questions on potential uptake, Hussain said surgical adoption would likely be straightforward because surgeons already create accesses using prosthetic conduits and the ATEV does not require fundamentally new technical skills.

Roy-Chaudhury said the kidney community is focused on reducing catheter prevalence due to impacts on morbidity, mortality, quality of life, and reimbursement, calling catheter-free days a “very important” endpoint. Niklason added that prolonged catheter use can add “$20,000, $30,000, $40,000, $50,000 more” in annual care costs than if the catheter were removed, and said the studies are designed to show that in high-risk patients, ATEV could improve clinical outcomes and generate system savings.

Roy-Chaudhury also discussed a shift toward more individualized access planning and a move toward global payment models in kidney care, arguing that spending “upstream” to reduce downstream complications could be financially rational within bundled or capitated structures.

In closing remarks, Niklason said the dialysis population—particularly women—has seen “very little genuine innovation” for decades, adding that she was “very excited” to see additional results expected in June.

About Humacyte NASDAQ: HUMA

Humacyte, Inc is a clinical-stage biotechnology company focused on the development and manufacturing of off-the-shelf, regenerative human acellular vessels (HAVs) designed to address critical vascular access needs. The company's proprietary vessels are engineered from human donor cells and then decellularized to create a biocompatible scaffold capable of integrating with a patient's own tissue. Humacyte's primary business activities encompass process development, large-scale manufacturing, and clinical evaluation of HAVs for use in end-stage renal disease, peripheral arterial disease and other vascular repair applications.

The company's lead product candidate, the HAV, has advanced through multiple clinical trials for arteriovenous access in hemodialysis patients, demonstrating durability, reduced infection rates and compatibility with repeated cannulation.

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