RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--Humacyte, an innovator in biotechnology and regenerative medicine, announced today that Fortune Magazine has recognized Company founder Laura Niklason, M.D., Ph.D., as a leading change agent in healthcare, on Fortune’s Leaders Transforming Health and Medicine list. Dr. Niklason was recognized for her contributions to the advancement of regenerative medicine, in creating investigational human acellular vessels (HAV).
Dr. Niklason was the innovator who envisioned HUMACYL®, an off-the-shelf investigational bioengineered blood vessel, which was developed and is being investigated in the clinic. Humacyte is currently conducting a global Phase III clinical trial of HUMACYL, comparing its functional and durable use (secondary patency) to an expanded polytetrafluoroethylene (ePTFE) graft in 350 patients with kidney failure who are not candidates for fistula placement. Last month, Humacyte announced that the FDA designated HUMACYL a Regenerative Medicine Advanced Therapy (RMAT), one of the first regenerative medicines to receive the new designation under the 21st Century Cures Act. Humacyte also plans to seek regulatory approval for other HAV applications under development, and 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).
“Through innovative research and study, Dr. Niklason daily demonstrates her premier standing among the foremost leaders shaping regenerative medicine,” said Carrie S. Cox, Chairman and Chief Executive Officer of Humacyte. “As a friend and a colleague of Dr. Niklason, it is gratifying to see her recognized so prominently for her tireless dedication to innovation and leadership in tissue engineering and cellular therapies.”
In addition to her work at Humacyte, Dr. Niklason is the Nicolas Greene Professor of Anesthesiology and Professor of Biomedical Engineering at Yale University. Dr. Niklason received her doctor of philosophy in Biophysics from the University of Chicago, and a doctor of medicine from the University of Michigan. She completed her residency training in anesthesia and intensive care unit medicine at the Massachusetts General Hospital in Boston, and completed post-doctoral scientific training under the world-renowned scientist, Dr. Robert Langer.
Fortune Magazine’s Leaders Transforming Health and Medicine list honors nearly three dozen healthcare change agents, consisting of visionaries, disrupters, innovators, advocates, discoverers, and risk-takers. Dr. Niklason is joined on the list by Joe Biden, the 47th Vice President of the United States, Bill and Melinda Gates, Arianna Huffington, Sean Parker and other leaders that are driving progress in healthcare.
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, 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.