On August 8th, Nasdaq featured a congratulatory message on the Nasdaq Tower in Times Square.
Biotechnology and Regenerative Medicine Company Recognized for its Innovation in Creating Investigational Off-the-Shelf Bioengineered Human Blood Vessels
RESEARCH TRIANGLE PARK, N.C. – Humacyte, an innovator in biotechnology and regenerative medicine, has been recognized on this year’s CNBC Disruptor 50 list. Now in its fourth year, the list is a compilation of the most promising private companies that CNBC believes will transform the economy with their revolutionary products and services.
Humacyte developed the world’s first investigational bioengineered blood vessel, a potential future option for providing vascular access for patients with End-Stage Renal Disease (ESRD) who require hemodialysis, a process of removing waste from the blood of patients whose kidneys no longer do so adequately on their own.
“Many years in the lab, and many brilliant minds have led Humacyte to where it is today, and we are humbled to be recognized by CNBC as one of the top private companies disrupting the healthcare industry,” said Laura Niklason, M.D., Ph.D., founder of Humacyte and the Nicholas Greene Professor of Anesthesiology and Professor of Biomedical Engineering at Yale University. “Our hope is to improve the healthcare for the thousands of patients who undergo hemodialysis treatment, and potentially down the road, to use our technology for additional applications such as Coronary Artery Bypass, bypass for Peripheral Arterial Disease, and vascular trauma.”
Humacyte’s vessel, known as HUMACYL®, is an investigational product being studied in patients requiring vascular access. HUMACYL is being evaluated as a potential alternative to synthetic polytetrafluoroethylene (PTFE) grafts in hemodialysis patients who are not candidates for fistula placement. HUMACYL is being studied in part for its potential to reduce the number of complications such as infection and multiple surgical interventions to maintain a functioning graft.
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 be able to provide ‘off-the-shelf,’ or ready-to-use, human tissue products that can be implanted in dialysis patients and that may lead to more positive, long-term clinical outcomes. HUMACYL received Fast Track status from the FDA in 2014.
“We are immensely proud to earn this distinction,” said Carrie S. Cox, Chairman and Chief Executive Officer of Humacyte. “The past year has been one of great successes for our company – from securing a $150 million Series B funding commitment, to commencing our Phase III clinical trial – and we are honored to be listed among outstanding previous and current honorees who are also working to transform the quality of patient care.”
Last month, Humacyte announced the commencement of a Phase III clinical trial for its investigational vessel. In the trial, HUMACYL will be compared to ePTFE grafts, the current standard of care for patients not suitable for fistula. The HUMANITY trial will be conducted at 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.
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.