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Humacyte Announces Israeli Ministry of Health Acceptance of Marketing Authorization Application for Symvess® for Vascular Trauma Repair

  • The Israel Ministry of Health accepted Humacyte's Marketing Authorization Application (MAA) for Symvess (ATEV) for arterial trauma repair.
  • The Ministry set a 180-working-day review period for the MAA due to existing FDA approval for the product in extremity vascular trauma.
  • This MAA acceptance represents a step in Humacyte's planned global expansion of Symvess beyond the U.S. market.
  • Symvess received FDA Biologics License Application approval in December 2024.
  • Humacyte's 6mm ATEV candidates for hemodialysis access & urgent arterial repair hold FDA Regenerative Medicine Advanced Therapy & Fast Track designations.
  • Additional clinical trials & preclinical development are ongoing for applications including peripheral artery disease, coronary artery bypass grafts, & pediatric heart surgery.