RegulatoryCompany release

Humacyte Q3: Symvess Sales Reach $1.0M as Dialysis Filing and CABG Study Advance

🇺🇸 Humacyte, Inc. (HUMA) · Tue 10 Nov 2026

Humacyte reports Symvess sales of $1.0 million for the third quarter, plans a November dialysis sBLA, and has begun a Phase 2a coronary bypass study.

Humacyte reported its third-quarter 2026 results on 10 November 2026. Sales of Symvess, its product for vascular trauma repair, were $1.0 million, up from $0.4 million in the second quarter. The number of hospitals ordering the product rose to 49.

The company plans to submit a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration in November 2026. The filing would seek to add dialysis access to the uses of the acellular tissue engineered vessel (ATEV).

Humacyte has also started a Phase 2a first-in-human study of its coronary tissue engineered vessel (CTEV) in coronary artery bypass grafting (CABG). The study began after the FDA accepted the company's Investigational New Drug (IND) application.

For context, an sBLA is the route by which a sponsor asks the FDA to approve a new indication or other significant change for an already licensed biologic. The summary available does not give further detail on the filing's contents, the study design or the company's wider financial results.

What it means for your team

  • Regulatory teams should watch for confirmation that the dialysis access sBLA has been submitted in November, and for the FDA's subsequent filing decision.
  • Market-access teams can note the rise in ordering hospitals to 49 and quarterly sales to $1.0 million as early indicators of Symvess uptake.
  • The CTEV Phase 2a study in CABG marks the start of clinical development in a new indication, following FDA acceptance of the IND.

Company's press release (SEC filing): Humacyte, Inc. ↗

Article written by VigiEye from the official source (Humacyte, Inc.). Claims are the company's own. AI-assisted; check the source before acting.

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