August 8, 2016
Funds to Aid Research on Humacyte’s Investigational Human Acellular Vessel
RESEARCH TRIANGLE PARK, N.C. – August 8, 2016 – Humacyte®, an innovator in biotechnology and regenerative medicine, has received a grant of nearly $10 million from the California Institute for Regenerative Medicine (CIRM). The grant, payable in installments upon satisfaction of certain milestones, will help fund a Phase III clinical trial which commenced in May 2016 on Humacyte’s investigational human acellular vessel (HAV), HUMACYL®. With $3 billion in funding and approximately 300 active stem cell programs in its portfolio, CIRM is dedicated to helping people by bringing the future of cellular medicine closer to reality. CIRM’s mission, under the authority of Proposition 71, is to accelerate stem cell treatments to patients with unmet medical needs.
“This approach has the potential to significantly improve our ability to care for people with kidney disease,” says C. Randal Mills, Ph.D., the President and CEO of CIRM. “Being able to reduce infections and clotting problems, and increase the consistency of care hemodialysis patients receive, would meaningfully impact the quality of their lives.”
Humacyte’s HUMANITY® trial will compare HUMACYL to expanded polytetrafluoroethylene (ePTFE) grafts, the standard of care for End-Stage Renal Disease (ESRD) patients undergoing hemodialysis not suitable for fistula. The trial will be conducted across approximately 35 sites in the U.S., Europe and Israel with 350 evaluable subjects, making it the largest study of any bioengineered vascular tissue to date.
“We are honored to receive this grant from CIRM,” said Carrie S. Cox, Chairman and Chief Executive Officer of Humacyte. “We’ve achieved a significant milestone for the company with the commencement of our Phase III clinical trial. This non-dilutive grant funding will help us make significant strides in the development of our bioengineered human acellular vessel.”
HUMACYL received Fast Track status from the FDA in 2014. If the U.S. Food and Drug Administration (FDA) approves HUMACYL for marketing after the clinical trials on this investigational product are complete, this potentially game-changing technology may provide “off-the-shelf,” or ready-to-use, human tissue products that can be implanted in dialysis patients. If the HUMANITY trials are successfully completed, HUMACYL may lead to more positive, long-term clinical outcomes.
Humacyte, Inc., a privately held company founded 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, sheets, or particulate conformations, 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.
CIRM was created by the people of California to accelerate stem cell treatments to patients with unmet medical needs and act with a sense of urgency to succeed in that mission.
To meet this challenge, CIRM actively partners with both academia and industry in a hands-on, entrepreneurial environment to fast track the development of today’s most promising stem cell technologies.
With $3 billion in funding and approximately 300 active stem cell programs in our portfolio, CIRM is dedicated to helping people by bringing the future of cellular medicine closer to reality.
For more information, go to www.cirm.ca.gov.