Humacyte's Symvess Shelf Life Extended to 36 Months Following FDA Authorization
核心洞察
The FDA has authorized extending Symvess (搜索)'s expiration dating period from 18 months to 36 months under approved refrigerated storage conditions.
Symvess (搜索) is a first-in-class acellular tissue-engineered vessel (搜索) approved in December 2024 for extremity arterial injury (搜索) requiring urgent revascularization.
Humacyte plans to file a supplemental Biologics License Application in November 2026 to add dialysis access as a second indication.
Humacyte Inc. said the U.S. FDA has authorized an extension of the expiration dating period for Symvess (搜索), its acellular tissue-engineered vessel (搜索) (ATEV), from 18 months to 36 months when stored under approved refrigerated conditions.
Symvess (搜索) was approved by the FDA in December 2024 as a vascular conduit for adults with extremity arterial injury (搜索) when urgent revascularization is needed to avoid imminent limb loss and an autologous vein graft is not feasible. As a first-in-class, off-the-shelf bioengineered human tissue, it can be used on demand in the operating room, sparing surgeons the time required to harvest a vein and avoiding a second surgical site in critically injured patients. The extension was supported by additional stability data showing Symvess continues to meet all established quality specifications throughout the 36-month dating period, which Humacyte expects to help hospitals maintain inventory for urgent vascular repairs while reducing product waste.
Humacyte expects to file a supplemental Biologics License Application in November 2026 to add dialysis access as the second approved indication for the ATEV. For use beyond the current extremity vascular trauma setting, Symvess (搜索) remains investigational.
Source: rttnews.com