Humacyte在2025年Delivery Week上展示了ATEV在血液透析患者AV通道中的V007三期临床试验的2年结果

– The ATEV™ was observed to have superior duration of use over 24 months compared to autogenous fistula in high-need subgroups with historically poor outcomes with AV fistula procedures –

– The significantly longer duration of ATEV use in these high-need patients could greatly reduce reliance on catheters for dialysis access, a major cause of complications, morbidity and cost in dialysis patients –
 

DURHAM, N.C., Nov. 10, 2025 (GLOBE NEWSWIRE) -- Humacyte, Inc. (NASDAQ:HUMA), a commercial-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, announced the presentation of positive two-year results from the V007 Phase 3 clinical trial of the acellular tissue engineered vessel (ATEV) in arteriovenous (AV) access for hemodialysis patients at the American Society of Nephrology's (ASN) Kidney Week 2025, the premier nephrology meeting, in Houston.

In the V007 Phase 3 trial, the ATEV was observed to have superior duration of use over 24 months as compared to autogenous fistula in female, obese and diabetic patients. Autogenous fistula is the current gold standard for hemodialysis access across all patients. However, female, obese and diabetic patients comprise high-need subgroups, having historically poor outcomes with AV fistula procedures. The podium presentation, titled "Two-Year Outcomes from a Prospective Randomized Trial of Humacyte's Acellular Tissue Engineered Vessel Versus Autologous Arteriovenous Fistula for Hemodialysis Access," was presented on Saturday, November 8, 2025 by Mohamad A. Hussain, MD, PhD, RPVI, FAHA, FRCSC, FACS, Vascular and Endovascular Surgeon-Scientist at Brigham and Women's Hospital, Core Faculty at the Center for Surgery and Public Health, and Assistant Professor of Surgery at Harvard Medical School.

The V007 Phase 3 trial (NCT03183245) was a prospective, multi-center, randomized clinical study in 242 hemodialysis patients in the United States. Enrolled individuals were randomly assigned to receive either the ATEV or an AV fistula for hemodialysis access and were followed for up to 24 months. Under the statistical analysis plan for the trial, the primary efficacy assessment compared functional patency (usability for hemodialysis access) at six months and secondary patency (blood flow through the conduit) at 12 months, as co-primary endpoints. As previously reported, the ATEV was observed to have superior patency and usability for dialysis at six and 12 months (co-primary endpoints), respectively, compared to autogenous fistula in all patients as well in the high-risk subgroups.

The V007 study also had a secondary endpoint of duration access use over 24 months, which continued to show superiority of the ATEV over AV fistula in female, obese and diabetic patients. In female patients (n=70) over 24 months, patients implanted with the ATEV had 15.8 months of average duration of usage, compared to 10.0 months for patients receiving an AV fistula (p<0.0137). In the target population of females, and males with obesity and diabetes (n=110), patients implanted with the ATEV had 14.8 months of average duration of access use compared to 9.1 months patients receiving an AV fistula (p=0.0114). For all patients in the study (n=242), patients receiving an ATEV had 13.3 months of average duration of access use compared to 12.3 months for AV fistula (p=0.7446). The results are consistent with Humacyte's stated strategy of targeting patients at higher risk of AV fistula failure: Females, and males with obesity and diabetes, which comprise over half of the hemodialysis population.

Researchers concluded that after 24 months of follow up, there were no unexpected side effects observed in patients implanted with the ATEV. In the study, patients implanted with the ATEV had a comparable safety profile to patients receiving an AV fistula with low rates of infection and a lower need for maturation or surgical revision procedures compared to AV fistula. Patients implanted with the ATEV experienced more thrombosis and narrowing/stenosis events requiring interventions than patients receiving an AV fistula, however the majority of these cases were successfully treated.

For uses other than the FDA approval in the extremity vascular trauma indication, the ATEV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency.