Humacyte Plans Marketing Authorization Application for Symvess® in Israel

DURHAM, N.C., Jan. 05, 2026 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a leading biotechnology platform company, is set to file a Marketing Authorization Application (MAA) with the Israel Ministry of Health. This application seeks approval for its acellular tissue engineered vessel (ATEV™), branded as Symvess, for use in arterial trauma repair during the first quarter of 2026.

Key Details of the MAA Filing

The MAA for Symvess is anticipated to undergo a review period of 120 working days, facilitated by the product's preliminary approval from the Food and Drug Administration (FDA). Humacyte is collaborating with Israeli surgeons who were involved in the V005 Phase 2/3 trial, advocating for immediate access to the product.

Dr. Laura Niklason, M.D., Ph.D., Founder and CEO of Humacyte, expressed enthusiasm about the feedback received from the medical community, stating, “Feedback from surgeons and hospitals supports the need for Symvess in Israel, and we are pleased to be moving aggressively forward with our planned MAA filing this quarter.”

Global Expansion Plans for Symvess

This MAA filing represents just the first step in Humacyte's strategy for global expansion. The company plans to leverage its FDA approval to expedite commercialization in additional territories, including Europe and the Middle East. “We expect that our FDA approval enables expedited commercialization pathways in other territories," added Dr. Niklason.

Clinical Background and Product Advantages

Recent studies have yielded promising results from the V005 Phase 2/3 trial, showcasing the first-ever prospective long-term data in traumatic arterial repair utilizing an off-the-shelf biologic conduit. Symvess addresses a critical need in vascular trauma treatment, where traditional autologous vein grafts—often the standard due to their dependability and low infection rates—are not always an option, especially in urgent situations.

• Immediate availability: Symvess is designed to be ready for use off-the-shelf, significantly reducing surgical time.
• Low infection rates: Consistent data supports low rates of post-operative infection.
• High limb salvage rates: Effectiveness in preserving limb function is documented.

About Humacyte

Humacyte, Inc. (Nasdaq: HUMA) is pioneering a groundbreaking biotechnology platform focused on creating universally implantable bioengineered human tissues. The company specializes in the development and manufacturing of acellular tissues that address various medical challenges, including injuries and chronic conditions. In December 2024, Humacyte's Biologics License Application for ATEV targeting vascular trauma was approved by the FDA.

Additionally, Humacyte is advancing clinical trials for ATEVs in other applications, such as arteriovenous (AV) access for hemodialysis and peripheral artery disease (PAD). Notably, the 6mm ATEV for AV access was the first to receive the FDA's Regenerative Medicine Advanced Therapy (RMAT) designation.

Forward-Looking Statements

This announcement includes forward-looking statements based on current beliefs and assumptions. Actual results may differ significantly due to various risks and uncertainties, including regulatory changes, market acceptance, and operational challenges. Interested parties are encouraged to consult Humacyte's filings with the SEC for comprehensive risk factors related to these projections.