This Potentially Groundbreaking Artery Replacement Is Developed Right Here In Durham
A company with roots in a Duke University lab has created an implantable human tissue device that may help avoid amputations and even save lives.
Devin Barnett is a classic multi-sport athlete. She's constantly on the go and feels at home on any field or court.
"All my life I played sports," she says. "I played softball, field hockey, ran track, you name it and I did it. … I've even tried Quidditch."
She officiated games as well, sometimes as many as 10 youth or intramural games on a Saturday. She thought about pursuing a career as a college referee. After college, she moved back home to Farmingdale, New Jersey, and instead took a job as a longshoreman. She liked the blue-collar nature of the work, and it kept her physically active, something she also liked. She started shifting career goals and considered becoming a crane operator.
Then came the accident.
On October 5, 2020, Barnett's team was loading and unloading those massive containers that ship all over the world.
"I went to go move a vehicle out of the way of the crane and I didn't move quickly enough. And, unfortunately, I was caught between the ladder on the crane and the van," she recalls. "And that's when I had the crushing injury to my leg."
An ambulance rushed her to the hospital where she learned that, among other injuries, the crushing blow to her left leg severed her femoral artery, the main blood supply to the thigh and leg. If she lost too much blood, or if surgeons couldn't repair the artery in time, she would lose her leg – something any athlete, let alone one as active as Barnett – fears.
But despite the gruesome injury less than a year ago, Barnett has already regained some function in her leg. She was able to avoid amputation, and even she marvels at how quickly recovery has gone.
That recovery is a testament to her work ethic and physical training, but also to a groundbreaking medical implant device that could soon become standard of care for these kinds of injuries, potentially saving thousands of limbs and even the lives of some patients.
'Barbaric’ Standard Of Care Inspired Innovation
Humacyte, a company with roots in a Duke University lab, is developing implantable human tissue right here in Research Triangle Park. Specifically, Human Acellular Vessel (HAV) to replace human blood vessels. Humacyte Co-Founder and Chief Executive Dr. Laura Niklason, a physician by training, remembers taking care of a heart bypass patient where during the operation, surgeons determined the patient didn't have suitable veins to bypass the arteries around his heart, even cutting into legs and arms to look. Finally, surgeons had to cut into the patient's abdomen to take an artery out of his stomach to revascularize his heart.
"And I watched that and – frankly – it seemed barbaric that we had to do this to patients. That we had to cut them up from top to bottom to find spare parts or replacement tissues. That really motivated me to begin this work," she says. "And that has carried me forward for the last 20 years."
Importantly, these vessels are acellular - not made up of cells - so they have the potential to be universally implantable.
"When they're implanted, they don't get rejected," Niklason explains about this acellular property. “But what does happen is cells from the patient then migrate into this tissue, and then turn it into the patient's own. So after a few months, the vessel becomes really a new artery in a new location that the patient didn't have before."
Not only that, but the device can be stored on the shelf, meaning hospitals could one day have them in stock in case of emergency. The device has not yet received Food and Drug Administration approval. In Barnett's case, she was taken to a hospital participating in a clinical trial.
Vessels Could Have Many Uses
The device will have other uses as well, notably for patients with end-stage renal disease (ESRD) to receive hemodialysis, a process in which blood is taken from patients with kidney failure, purified in a machine and then put back in the body.
Because the vessel becomes part of the patient's own biological system, it can also grow with the body, which opens up uses for pediatric heart surgeries, something of particular interest to Dr. Christopher Breuer, physician scientist at Nationwide Children's Hospital in Columbus, Ohio.
"One of the fundamental problems in children requiring heart surgery is that they can actually outgrow their operation just like they can outgrow their clothes," he says. "Unfortunately, it's a lot harder to redo an operation than to replace a pair of pants."
Investors have taken note as well. Humacyte has raised nearly $480 million from private investors, and in February announced it would go public this year sometime in the second quarter through a reverse merger with a special purpose acquisition company, or SPAC, an increasingly popular option to access public markets. The transaction makes an additional $255 million available to Humacyte for development and commercialization, and values the company at $1.1 billion.
Niklason says she and her executive team considered a more traditional initial public offering, but decided against it.
"These days, the typical IPO process involves this whirlwind roadshow, where there's three, or four, or five days of a million Zoom meetings, and they're all each 45 minutes," she says. "And if you're really kind of a revolutionary company – the way I believe Humacyte is – it can be hard to tell your whole story and to really educate the investor about the potential of the technology in one 45 minute go. And so the SPAC process really allows us to engage with investors more completely."
The Home Stretch
Humacyte's success could mean a boost for the Durham economy. The company used some of its funds to build a research and development hub that can already grow 8,000 HAVs per year, and has the space to grow up to 40,000 HAVs per year. The company employs 130 workers, mostly in scientific roles, and Niklason says the company will "have to aggressively grow" their commercial team and sales force in coming years.
Drug and medical device development often seem to operate on a glacial time frame. Humacyte received a fast-track FDA designation in 2014 and expedited review designation in 2017. Niklason hopes to have a final application to the FDA soon, though wasn't specific about a submission time. Some of her work has turned away from research and development and toward a commercialization plan. At this point in development, chief executives of developmental-stage biotechnology companies must find out how to sell their product, and ensure that health insurance providers will cover it.
"Again, we won't know what our reimbursement price is for a while, but we estimate that the sales from the product just made in this building in Durham could be $1 billion a year," Niklason said.
Niklason says she knows of no other companies anywhere near as close to the finish line with this kind of product, which means she faces less pressure.
"We've used that advantage, to enable us to really get the product right, and to make sure that it functions well. And the fact that our clinical trials have gone as well as they have is really testament to that," she says, adding that it's exactly that first-to-market potential that attracts big money. "That combination of being very advanced on the clinical side, with being very new and sort of out there in front. That is a very attractive story for investors. It's been wonderful to see."