Humacyte (HUMA) said Wednesday that its bioengineered blood vessel, the acellular tissue engineered vessel, or ATEV, met the primary endpoint in a late-stage study of female patients requiring dialysis access.
In the interim analysis of the study, the first 80 patients who received ATEV had an average of 91 more catheter-free days than patients who received the current standard of care, an autologous arteriovenous fistula, according to a statement.
The company said it plans to file a supplemental biologic license application with the US Food and Drug Administration in the second half of the year.
The biotechnology company has also launched a public offering of common stock to fund the commercialization of Symvess, the filing of a Biologics License Application supplement for a hemodialysis indication, and the development of product candidates in its pipeline.
Underwriters are expected to have a 30-day option to buy up to an additional 15% of the shares offered, it said.
Shares of the company fell over 11% in after-hours trading.