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A lab-grown blood vessel for dialysis patients whose fistulas fail is set for an FDA filing in November

Humacyte plans a November FDA filing for its bioengineered blood vessel for dialysis, as sales of the trauma graft, Symvess, doubled in Q3.

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Humacyte plans to ask the FDA in November 2026 to approve its bioengineered blood vessel for dialysis access, a second use for a graft already sold for limb-threatening arterial injuries. The Durham, North Carolina, company said on November 10, 2026, that sales of that graft, Symvess, more than doubled in the third quarter to $1.0 million.

Key points

  • Humacyte reported $1.0 million in Symvess sales for the third quarter of 2026, up 151% on the second quarter, followed by $0.8 million in October alone.
  • The number of hospitals that had ordered Symvess rose from 34 at the end of June to 49 at the end of September, the company says.
  • Humacyte says it will file a supplemental Biologics License Application in November 2026 to add hemodialysis access to the vessel's approved uses.
  • In the V007 Phase 3 trial, 81.3% of patients given the engineered vessel had working access at six months, against 66.4% given a fistula (The Lancet Digital Health, via PubMed).
  • The company has also opened the first site of a Phase 2a study of a coronary version of the vessel in bypass surgery.

Why do dialysis patients need another access option?

Because the access doctors prefer, a fistula made from the patient's own artery and vein, often never becomes usable. A meta-analysis of more than 12,000 patients in the American Journal of Kidney Diseases found that 23% of fistulas failed outright, and only 60% were still working without a repair one year after surgery (Al-Jaishi et al., via PubMed).

The V007 trial's authors note that women and patients with diabetes or obesity see lower rates of fistula maturation, so many of them stay on catheters or synthetic grafts while they wait (The Lancet Digital Health, via PubMed). Those are the patients Humacyte is aiming at.

What is the bioengineered blood vessel for dialysis?

It is Humacyte's acellular tissue engineered vessel, or ATEV: a human blood vessel the company manufactures at commercial scale and says can be implanted in any patient. The FDA approved it in December 2024, under the name Symvess, for adults with an arterial injury in an arm or leg who need blood flow restored urgently and cannot use a vein of their own.

For dialysis, the company rests its filing on three Phase 3 studies of its own. Its V007 trial, run at 31 U.S. centers with 242 patients, found the vessel superior to a fistula on its two coprimary patency measures: 81.3% against 66.4% for working access at six months, and 67.5% against 62.2% for secondary patency at 12 months (The Lancet Digital Health, via PubMed). In the V012 trial, presented at the American Society of Nephrology's Kidney Week in October, Humacyte says women given the vessel reached usable access more than three months sooner than women given a fistula, and spent more of their first year free of catheters.

In our future targeted market in dialysis access, our plan is to file a supplemental BLA for the ATEV in November 2026, supported by results from three Phase 3 studies.

— Laura Niklason, M.D., Ph.D., Founder and Chief Executive Officer, Humacyte

According to the company, no product candidate earned the FDA's Regenerative Medicine Advanced Therapy designation before its dialysis vessel did, and the vessel also holds Fast Track designation.

What did Humacyte report for the quarter?

Symvess revenue more than doubled from the second quarter, and the company expects fourth-quarter sales to at least double again. Humacyte credits commercial changes it made in the first half of 2026 and expects to add at least 20 hospitals in the second half of the year.

Symvess sales revenue for the third quarter was $1.0 million, more than double our results for the second quarter, and achieved the goal we set for the period.

— Jim Mercadante, Chief Commercial Officer, Humacyte

The company reported a net loss of $15.5 million for the quarter, down from $17.5 million a year earlier, as research spending fell to $14.1 million. It held $64.9 million in cash, cash equivalents and restricted cash on September 30.

What does the filing mean for dialysis access teams?

Our analysis: if the FDA adds dialysis access to the label, surgeons would have an off-the-shelf vessel for patients whose own veins are unlikely to mature into a fistula, which is the group the company's trials point to. Many hospitals would not be starting from zero: the 49 that have ordered Symvess already buy it for trauma care. Humacyte has named two nephrologists, Robert J. Kossmann and Prabir Roy-Chaudhury, as advisors to prepare its dialysis launch, including its health economic, reimbursement and market access plans.

For more on how new therapies move from trials to clinics, see our roundups on breakthrough trends in drug and therapy development and how technology is changing clinical trials.

Frequently asked questions

Is Symvess approved by the FDA?

Yes, since December 2024, for adults with an extremity arterial injury who need urgent revascularization when a vein graft of their own is not feasible. Its use in dialysis access is still investigational.

How much Symvess did Humacyte sell in the first nine months of 2026?

The company reported $1.9 million in Symvess sales for the nine months to September 30, 2026, up from $1.0 million in the same period of 2025.

Is the vessel being tested in heart bypass surgery?

Yes. The FDA accepted Humacyte's application for a first-in-human Phase 2a study of its coronary tissue engineered vessel in bypass surgery, and the company activated the first clinical site in November 2026.

How long could patients use their access in the V007 trial?

Over the first year, patients given the engineered vessel could use their access for 7.4 months on average, against 6.0 months for those given a fistula, according to the published trial (The Lancet Digital Health, via PubMed).

Where does Humacyte's stock trade?

On the Nasdaq, under the ticker HUMA.

Sources

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