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Durham Company Seeks FDA Approval for Life-Saving Product

| Manufacturing

A Durham company recently filed an application with a federal government agency.

That company and the product behind its application could revolutionize medical care for certain patients and save countless lives in the future.

“There’s really no other company on Earth like this,” said Matt Panning, senior director of manufacturing with Humacyte. “We’re leagues ahead of any other tissue-manufacturing company.”

Humacyte is a Durham-based biotechnology company that develops universally implantable, bioengineered human tissue.

Specifically, the company has developed methods to use human cells to manufacture new arteries and blood vessels for use in people.

“For example, we’ve treated patients with injuries from car accidents and gunshot wounds here in the United States,” said Laura Niklason, MD, PhD, Humacyte’s founder and CEO. “We’ve also treated injured soldiers in Ukraine. Some of these injuries have been terrible and life threatening or limb threatening. I do believe there are patients who are walking around today who would not be if it weren’t for our engineered blood vessels.”

Niklason said surgeons in Ukraine requested Humacyte’s blood vessels to treat their patients.

On December 12, Humacyte submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking approval of the blood vessels.

“The FDA, if they approve this license application, then that’s our authorization to sell the product,” said Panning.

That means that they could soon be coming to a hospital near you.

The blood vessel, called an Acellular Tissue Engineered Vessel (ATEV), is about 40 centimeters long and six millimeters in diameter.

To date, it has been used in clinical trials in about 550 patients.

“Our clinical trials show that it resists infection and it’s very durable,” said Niklason. “So, if you’re treating a soldier who is badly injured with a contaminated wound, our engineered vessel may be ideal.”

The blood vessels could be used to treat many different types of patients.

“The 550 people that we’ve treated over the last decade have actually had a range of diseases,” said Niklason. “Some of them have been injured soldiers or civilians. Some of them have been regular people with vascular disease or with kidney failure.”

There was a lot of excitement at Humacyte the day the application was filed.

It took a long time and a lot of work to get to this day.

“Humacyte was started here in the Triangle in 2005 and, at the time, we were just three people,” said Niklason. “It was me and two students in 150 square feet and no pencils, just dust bunnies.”

From those humble beginnings, the company has expanded to an 80,000-square-foot facility and 190 employees.

Panning has been with Humacyte for the past seven years.

“As cool as our science is, and I do think it’s very cool, what’s kept me here for seven years, it’s the people that I work with,” said Panning. “It’s rare to have that combination of a really good team that you enjoy working with and the cool science that we all love.”

Niklason said the work that her company is doing requires great talent.

“We also have scientific experimentation that we’re doing here,” she said. “We have people who are running our clinical trials and people who are assuring the quality of the product that we produce. So, we have multiple different departments and we’re hiring more in 2024.”

Finding that talent is one of the main reasons that she decided to locate Humacyte in Durham.

“Being in North Carolina for a groundbreaking technology like this actually makes a lot of sense,” said Niklason. “We need so many different types of people with so many different types of education and backgrounds and the Research Triangle Park area is just filled with that type of talent. So, that’s really important.”

She also highlighted the universities and medical centers.

“It really helps us get our clinical trials done and get the expertise and the advice that we need,” said Niklason.

Another key component is our state’s business climate.

“North Carolina really is a standout, as we all know, in terms of being a business-friendly environment, not just for high technology and medical devices such as ours, but for a whole range of applications,” she said. “Also, NC Chamber is really a great partner working between industry and the state government to ensure that the government does everything it can to support business and support livelihoods and job growth, as well as breakthrough technologies that help patients.”

Niklason and Panning hope the breakthrough technology will gain FDA approval in 2024.

The work being done at Humacyte has caught the eye, too, of the U.S. Department of Defense given the practicality in treating wounded soldiers.

“The Department of Defense made us a priority product for gaining approval a few years ago and they’ve even sponsored some of our

clinical trials,” said Niklason.

Panning said 2024 will be a major year for the company.

“Really, this is just a first step for us,” said Panning. “The vessels that we make are kind of an initial entry. We have plans to make biovascular pancreases to cure diabetes and even further beyond that.”

Niklason echoed that.

“I think the sky’s the limit and I look forward to bring multiple products to market in the coming years,” she said.

To learn more about Humacyte’s application with the FDA and its timeline for response, please read Humacyte’s press release.

 

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