Humacyte reported third-quarter 2026 results alongside commercial and clinical updates. Sales of its Symvess vascular product rose as more hospitals began ordering it, while the company advanced a second potential use for its engineered vessel product in dialysis access and started a first-in-human study of a separate product for coronary bypass surgery.
Key details
- Symvess sales increased, but costs remained higher. Third-quarter sales were $1.0 million, up from $0.4 million in the second quarter of 2026 and $0.7 million a year earlier. For the first nine months of 2026, sales were $1.9 million, compared with $1.0 million in the same period of 2025.
- Hospital adoption broadened. The number of hospitals ordering Symvess rose 44% during the third quarter, from 34 at the end of June to 49 at the end of September. New orders increased each month in the quarter.
- October sales and the fourth-quarter outlook point to further near-term growth. Symvess sales reached $0.8 million in October. Humacyte expects fourth-quarter sales to be at least twice the third-quarter total and anticipates adding at least 20 hospitals in the second half of 2026.
- Costs exceeded sales in the quarter. Cost of goods sold was $1.4 million, compared with $0.3 million in the third quarter of 2025. Of the 2026 amount, $0.6 million related to units recorded as sold and $0.8 million was primarily overhead. Contract revenue was minimal in the third quarter; it was also minimal for the first nine months of 2026, versus $0.6 million in the comparable 2025 period.
- Dialysis-access trial results support a planned FDA application. Interim results from the Phase 3 V012 trial in women receiving hemodialysis were presented in October. Humacyte said women who received its acellular tissue engineered vessel (ATEV) achieved functional access more than three months sooner and spent significantly more time free of dialysis catheters during the first year than women who received a standard arteriovenous fistula.
- Humacyte plans to seek a dialysis-access indication. The company plans to submit a supplemental application to the FDA in November 2026, combining V012 results with previously reported findings from the V007 Phase 3 trial. The V007 results, now published in The Lancet Digital Health, showed advantages for ATEV over fistulas after one year, particularly among women and men with obesity and diabetes—groups that can face higher fistula-failure rates.
- Advisers were added ahead of a possible dialysis launch. Nephrologists Robert Kossmann and Prabir Roy-Chaudhury will advise on potential commercialization, including health economics, reimbursement, market access and medical education. Their work is contingent on FDA approval for the dialysis use.
- A coronary-bypass product entered human testing. After the FDA accepted its investigational application, Humacyte began a Phase 2a study of its coronary tissue engineered vessel (CTEV) in November, with the first clinical site activated. The company also completed its first large-scale CTEV manufacturing lot at its commercial-scale facilities.
- CTEV research was presented at a heart-science meeting. Presentations at the American Heart Association’s November scientific sessions covered the Phase 2a trial protocol, preclinical findings supporting human testing and possible use of regenerative-medicine products in children with congenital heart disease.
- The board gained commercialization and operations experience. Humacyte said Scott Coward and Paul Kuznik joined its board in September, bringing backgrounds in commercialization, enterprise leadership and global operations.
Plain-English implications
Symvess is gaining hospital customers and sales are accelerating, but the reported cost of goods sold was greater than third-quarter sales. Separately, Humacyte’s dialysis-access program is moving toward an FDA application, while its coronary-bypass program has begun early-stage human testing. The dialysis use remains subject to FDA approval.