Humacyte reports positive interim Phase 3 results for ATEV dialysis access device
Humacyte Inc. presented interim data from its V012 Phase 3 trial of the acellular tissue‑engineered vessel (ATEV) in women with end‑stage kidney disease. In the first 80 patients, ATEV achieved 220.4 catheter‑free days versus 129.3 for standard arteriovenous fistula and reached functional access in a median of 1.7 months compared with 5.3 months. The trial met its primary superiority endpoint, prompting an early stop to enrollment, and the company will file a supplemental Biologics License Application to expand the Symvess label this quarter.
Why it matters
The FDA label expansion could allow Humacyte to market ATEV for hemodialysis access, potentially increasing its addressable market and revenue. The company’s statement that it will submit the application this quarter signals a near‑term regulatory milestone for investors.
Key facts
- 1The interim analysis included the first 80 patients of the V012 trial. investing.com
- 2ATEV recipients averaged 220.4 catheter‑free days in the first year, versus 129.3 days for AV fistula recipients. rttnews.com
- 3Median time to functional access was 1.7 months for ATEV and 5.3 months for AV fistula. rttnews.com
- 4Dialysis access infections occurred at approximately 6 per 100 patient‑years with ATEV and 23 per 100 patient‑years with AV fistula. rttnews.com
- 5The V012 trial was designed to enroll approximately 150 women, randomized 1:1 to ATEV or AV fistula. investing.com
- 6Enrollment was stopped after the interim results met the primary endpoint. investing.com
Summary written by AlphAI AI Desk from 2 of 2 sources. Not investment advice. Figures are as stated by the linked sources.