DURHAM, N.C., Dec. 12, 2023 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, today announced that it has submitted a Biologics License Application (BLA) to U.S. Food and Drug Administration (FDA) seeking approval of the Human Acellular Vessel (HAV) in urgent arterial repair following extremity vascular trauma when synthetic graft is not indicated, and when autologous vein use is not feasible. The BLA submission is supported by positive results from the V005 Phase 2/3 clinical trial as well as from the treatment of wartime injuries in Ukraine. The HAV was observed to have higher rates of patency (blood flow), and lower rates of amputation and infection, as compared to historic synthetic graft benchmarks.

“Submitting the BLA to the FDA is a pivotal milestone in achieving our goal of providing regenerative human tissues to injured patients, at commercial scale,” said Laura Niklason, MD, PhD, Chief Executive Officer of Humacyte. “I want to thank the patients and medical professionals who participated in our clinical studies, and our Humacyte, team for their tremendous effort and dedication in completing the BLA submission for this first-in-class product candidate.”

The FDA has a 60-day review period to determine whether the BLA is complete and acceptable for filing. Humacyte has requested Priority Review of the application and, if granted, the review should be completed within six months of the filing acceptance date. In May 2023 the FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation for use of the HAV in urgent arterial repair following extremity vascular trauma. In addition, the HAV was assigned a priority designation by the Secretary of Defense under Public Law 115-92, enacted to expedite the FDA’s review of products that are intended to diagnose, treat or prevent serious or life-threatening conditions facing American military personnel, such as traumatic injuries.

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Aaron Bushnell, 25, died after being transported to a local hospital on Sunday afternoon, a spokesperson for the Metropolitan Police Department (MPD) told Newsweek via email.

"My name is Aaron Bushnell, I am an active-duty member of the United States Air Force and I will no longer be complicit in genocide," he says in a video of the incident. "I am about to engage in an extreme act of protest, but compared to what people have been experiencing in Palestine at the hands of their colonizers, it's not extreme at all. This is what our ruling class has decided will be normal."

The video shows Bushnell walk up to the driveway of the Israeli embassy, set his phone down on the ground and pour an unknown liquid from a bottle over himself and ignite it while yelling, "Free Palestine" repeatedly.

Law enforcement officers are heard screaming at Bushnell to get on the ground. One points a gun at him while he is collapsed on the ground, screaming in pain.

That officer's gun remains drawn as another sprays him with a fire extinguisher. "I don't need guns, I need fire extinguishers!" one officer is heard yelling as other officers arrive on the scene.

The fire had already been extinguished by the U.S. Secret Service when firefighters arrived at the scene, D.C. Fire and EMS said in a post on X, formerly Twitter.

The MPD spokesperson said that officers had responded at around 1 p.m. to assist the Secret Service. The department is working with the Secret Service and the Bureau of Alcohol, Tobacco, Firearms and Explosives to investigate the incident, the spokesperson added.

The Air Force said Bushnell was a cyber defense operations specialist with the 531st Intelligence Support Squadron at Joint Base San Antonio. He had served on active duty since May 2020.

"When a tragedy like this occurs, every member of the Air Force feels it," Col. Celina Noyes, commander the 70th Intelligence, Surveillance and Reconnaissance Wing, said. "We extend our deepest sympathies to the family and friends of Senior Airman Bushnell."

Independent reporter Talia Jane wrote on X that Bushnell's loved ones gave consent for a blurred version of the video to be posted online.

He was described as "the kindest, gentlest, silliest little kid in the Air Force" by Errico, a friend who met him in 2022, according to Jane. "He's always trying to think about how we can actually achieve liberation for all with a smile on his face," Errico said.

A LinkedIn account apparently belonging to Bushnell showed he had been in the Air Force since 2020 and was most recently a DevOps engineer.

The page describes him as an "aspiring software engineer" with "a talent and passion for solving complex problems with code."

It says: "Throughout my time in the military in both leadership and followership roles, as well as prior work experience in a variety of civil roles, I have thrived in team environments and gained very good communication skills."

He was pursuing a bachelor's degree in software engineering at Western Governor's University, according to the page. He previously studied software development at Southern New Hampshire University and computer science at the University of Maryland Global Campus.

Bushnell's protest comes as Israel's war on Hamas has killed about 30,000 Palestinians, The Associated Press reported, citing the Health Ministry in Gaza.

Israel declared war following the Hamas attack on southern Israel on October 7, in which about 1,200 people were killed. Israel's air and ground offensive has since driven about 80 percent of Gaza's population from their homes.