Humacyte Awarded ‘Large Project Prototype of the Year’ from The Medical Technology Enterprise Consortium

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Honor Recognizes Humacyte’s Progress in Accelerating the Manufacturing Platform and Process for Producing Vascular Conduits for Hemodialysis and Vascular Trauma

Durham, N.C. –April 8, 2019. Humacyte, an innovator in biotechnology and regenerative medicine, received the Medical Technology Enterprise Consortium (MTEC) Large Project Prototype of the Year Award, in recognition of the development of its human acellular vessel (HAV). The MTEC Prototype of the Year program honors leading-edge companies for outstanding scientific and technical progress in developing therapies that align with MTEC’s mission to accelerate solutions that restore health for America’s military and veterans.

The U.S. Department of Defense (DoD) and MTEC have highlighted a critical need to harness the potential of regenerative medicine to treat traumatic vascular injuries of war. Humacyte’s HAV, HUMACYL®, is an investigational, off-the-shelf bioengineered blood vessel that is being studied for use in the repair and reconstruction of vascular injuries from violent civilian or military events, limiting blood loss and restoring blood flow to extremities.

“This remarkable recognition is a result of breakthrough technology developed by an enthusiastic and agile team pushing the boundaries of innovation in vascular research and the regenerative medicine space,” said Theodore Lithgow, PhD, Chief Commercial Officer of Humacyte and Principle Investigator of the MTEC project. “We are honored that MTEC recognizes the potential of our HAV being investigated in the clinic as a potential solution for patients with life- or limb-threatening vascular trauma. Restoring blood flow is a critical first step in addressing any traumatic injury.  We are grateful for the support from MTEC and the US Military. Our team is investigating the potential of our technology to positively impact the lives of injured civilians and the courageous members of our military through care of vascular trauma.”

MTEC is a national biomedical technology consortium with members from industry, academia and the nonprofit sector. The organization’s mission is to assist the U.S. Army Medical Research and Materiel Command (USAMRMC) by providing cutting-edge technologies to transition medical solutions to industry that protect, treat, and optimize warfighters’ health and performance across the full spectrum of military operations.

“Medical pioneers like Humacyte help MTEC live our mission to bring forward the most innovative and effective therapies that preserve life and enhance the recovery of injured warfighters,” Lauren Palestrini, PhD, Director of Research, MTEC. “Through programs like ours, the hope is that the novel work of this great organization may one day serve a noble cause.”

Humacyte is a medical research, discovery and development company with clinical and pre-clinical stage investigational products having potential therapeutic applications across illnesses such as end-stage renal disease, repair or replacement of damaged arteries, coronary artery bypass surgery, and vascular trauma. In October 2017, Humacyte announced that the company received a Broad Agency Announcement (BAA) contract award from the DoD to help support the addition of clinical sites for Humacyte’s Phase II vascular trauma trial in the US. In September 2017, the company also received an award from MTEC to help support the ongoing development and future commercialization of Humacyte’s HAV.

Humacyte’s HAV is currently in a Phase III pivotal trial in the U.S. and Europe as a conduit for hemodialysis in patients with end-stage renal disease. The company plans to seek regulatory approval in both regions upon completion of the trial. The company is also conducting a U.S. Phase II clinical trial of the HAV as a bypass graft in patients with peripheral arterial disease (PAD). Humacyte 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.

About Humacyte:

Humacyte, Inc., a privately held company founded by Dr. Laura E. Niklason, M.D., Ph.D., in 2004, is a medical research, discovery and development company with clinical and pre-clinical stage investigational products. Humacyte is primarily focused on developing and commercializing a proprietary novel technology based on human tissue-based products for key applications in regenerative medicine and vascular surgery. The company uses its innovative, proprietary platform technology to engineer human, extracellular matrix-based tissues that can be shaped into tubes or sheets, with properties similar to native tissues. These are being developed for potential use in many specific applications, with the goal to significantly improve treatment outcomes for many patients, including those with vascular disease and those requiring hemodialysis. The company’s proprietary technologies are designed to create off-the-shelf products that, once approved, can be utilized in any patient. The company web site is www.humacyte.com.

All statements, other than statements of historical fact, included in this announcement are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “will”, “anticipate”, “expect”, “believe”, “intend” and “should” or the negative of these terms or other comparable terminology. These statements relate to future events or Humacyte’s clinical development programs, reflect management’s current beliefs and expectations and involve known and unknown risks, uncertainties and other factors that may cause Humacyte’s actual results, performance or achievements to be materially different. Except as required by law, Humacyte assumes no obligation to update these forward-looking statements.

About MTEC:

MTEC is a biomedical technology consortium collaborating with multiple government agencies under a 10-year renewable Other Transaction Agreement with the U.S. Army Medical Research and Materiel Command.  To find out more about MTEC, visit mtec-sc.org.

 

Media Contact:  

Nirav Suchak

ICR, PR for Humacyte

646.277.1257

Nirav.Suchak@icrinc.com