Humacyte lifts Symvess sales, plans November dialysis filing

By Amara Osei

Humacyte reported third-quarter Symvess sales of approximately $1 million, up 151% from the preceding quarter, and expects fourth-quarter sales to at least double again as more hospitals adopt the product.

The biotechnology company also plans to submit an application to the U.S. Food and Drug Administration later in November to expand use of its acellular tissue-engineered vessel, or ATEV, into dialysis access. It has separately initiated a first-in-human study of a coronary tissue-engineered vessel in patients undergoing coronary artery bypass grafting.

Founder and CEO Laura Niklason said: “I believe that the momentum that we have demonstrated this quarter, along with the upcoming filings and clinical trials, have set the stage for a very significant value creation story.”

What drove Symvess sales higher?

Chief Commercial Officer Jim Mercadante said 49 hospitals were ordering Symvess at the end of September, up from 34 at the end of June. October sales reached $800,000, and Humacyte expects at least 20 additional hospitals to order the product by year-end.

Mercadante credited changes in the commercial team, marketing and training, plus introductory pricing for some health systems. He said the average price, around list price, was about $17,000 per unit, but declined to provide a specific third-quarter average selling price or unit volume.

Niklason said the company continues to target busy trauma centers and vascular surgery practices for its existing vascular injury indication. An application for marketing authorization in Israel is under review, and Humacyte is examining other opportunities in the Middle East.

More hospitals ordered Symvess; the company did not disclose enough unit and pricing detail to show how much of the sales gain came from volume.

When could the FDA review dialysis access?

Niklason said the planned supplemental biologics license application for dialysis access will rest on three Phase 3 studies. In one, V012, women treated with ATEV achieved functional dialysis access more than three months sooner than women receiving an arteriovenous fistula and spent significantly more time without dialysis catheters during the first year.

The proposed indication has not been approved. Niklason said Humacyte intends to seek coverage for all women and men with certain risk factors for fistula non-maturation.

After submission, the FDA has 60 days to decide whether to accept the filing. Niklason expects to learn in January whether the agency accepts it and grants priority review. Under that scenario, an FDA decision could come in May, with a potential launch in June; without priority review, a decision could come in September, followed by a launch if approved.

Mercadante estimated the annual U.S. dialysis market opportunity at $2 billion to $3 billion. He said existing relationships could support a launch because many vascular surgeons using Symvess for its current indication also perform dialysis access procedures.

The dialysis opportunity is worth $2 billion to $3 billion a year, but launch timing still depends on regulatory review.

What does the coronary study change?

Humacyte’s Phase 2a coronary vessel study is open and screening patients, Niklason said. The company has completed the first large-scale manufacturing lot of the investigational product for the study. Preclinical results suggested the vessel could serve as a potential off-the-shelf alternative to saphenous vein grafts.

The coronary program has entered human testing, and the next proof point will come from that study.

How did losses and cash use change?

The company reported a third-quarter net loss of $15.5 million, compared with $17.5 million a year earlier. Research and development expenses fell to $14.1 million from $17.3 million, primarily because of fewer noncommercial manufacturing runs and the wind-down of certain programs, Chief Financial Officer Dale Sander said.

Cost of goods sold rose to $1.4 million from $0.3 million. Of the latest quarter’s total, $0.8 million was primarily overhead tied to unused production capacity. Sander expects those costs to continue through cost of goods sold in the fourth quarter, while a more active production schedule is planned for 2027.

Humacyte held $64.9 million in cash, cash equivalents and restricted cash at September 30. Cash used in operating activities fell to $15 million for the quarter from $23.9 million a year earlier, which Sander attributed primarily to lower inventory production costs and earlier cost-reduction measures.

Niklason said the company continues benchtop work on its BioVascular Pancreas program but concentrates resources on manufacturing and the commercial sales ramp. She said Humacyte may devote more resources to the program next year.

The quarter showed lower net loss and operating cash use, but rising cost of goods sold kept manufacturing efficiency in focus.

What is Symvess?

Humacyte develops bioengineered human tissues for regenerative medicine and vascular repair. Its platform aims to create implantable, off-the-shelf tissues that can be stored and used when needed without collecting tissue from the patient.

Its primary product, SYMVESS, is an acellular tissue-engineered vessel intended to replace or repair damaged blood vessels. In December 2024, the FDA approved SYMVESS for urgent treatment of extremity arterial injuries when emergency vascular reconstruction is required.

Approved Symvess sales carry the commercial case for now, while dialysis and coronary expansion remain unapproved and investigational.