Funding to Extend Humacyte’s Investigational Human Acellular Vessel (HAV) for Vascular Trauma

RESEARCH TRIANGLE PARK, N.C.  – Humacyte, an innovator in biotechnology and regenerative medicine, announced today that the company has received a Broad Agency Announcement (BAA) contract award of $3.4 million from the United States Department of Defense (DoD). The funding will help support the addition of clinical sites for Humacyte’s Phase II vascular trauma trial in the US. The trial is being conducted to study Humacyte’s investigational human acellular vessel (HAV), or HUMACYL®, to treat patients with traumatic vascular injuries from violent civilian or military events, such as automobile crashes, industrial accidents, or injuries of war.

“We are honored to be recognized and now supported by the Department of Defense for our research and development in patients with vascular trauma. Vascular trauma remains a major cause of morbidity and mortality among warfighters. While civilian trauma can be significant, the battlefield environment presents an even greater surgical challenge to manage trauma and prevent infection for vascular and nonvascular wounds,” said Jeffrey H. Lawson, M.D., Ph.D., Chief Medical Officer of Humacyte. “This funding will help us continue to make important medical strides in the development of our bioengineered HAV, beyond our ongoing pivotal study for patients requiring hemodialysis.

Utilizing a soldier’s own vessel for vascular reconstruction is frequently difficult or not possible due to the nature and extent of common combat-related injuries. Furthermore, currently used synthetic materials may be poorly suited for vascular reconstruction in the setting of combat related injuries, due to the extreme risk infection with these injuries,” notes Lawson. “Our goal is to provide military — and civilian – – surgeons with a safe and effective tool for long-term restoration of blood flow.

The DoD is America’s oldest and largest government agency, with over 1.3 million men and women on active duty, and 742,000 civilian personnel. Advancing the agency’s mission to provide the military forces with the support needed to deter war and to protect the security of our country, the DoD US Army’s Medical Unit recently began working with Humacyte and other partners in the biomedical space to find solutions for injured warfighters.

In May 2016, Humacyte announced the commencement of the HUMANITY® study, a Phase III study of HUMACYL as a conduit for hemodialysis in patients with end-stage renal disease (kidney failure) who are not candidates for fistula placement. In September, Humacyte announced the completion of enrollment of 350 evaluable subjects this study. The company expects 12-month post-implantation patient data from the study to be available in late-2018. With this data, Humacyte plans to file a BLA to seek marketing authorization for HUMACYL.

In addition to its clinical studies for hemodialysis and vascular trauma, Humacyte is developing and plans to seek regulatory approval for additional clinical applications for its HAV, and the company recently announced the commencement of a U.S. Phase II clinical trial of the bioengineered vessel as a bypass graft in patients with peripheral arterial disease (PAD). The company is also continuing its efforts in advancing the development of future pipeline products that may improve treatment outcomes for patients suffering from both vascular and non-vascular diseases.