July 23, 2014
RESEARCH TRIANGLE PARK, N.C. — Humacyte, Inc., a pioneer in regenerative medicine, has announced that the U.S. Food and Drug Administration (FDA) has designated the HumaGraft™ development program for vascular access in hemodialysis patients as a Fast Track Development Program. HumaGraft™ is being developed to help provide reliable and robust vascular access for hemodialysis patients with End Stage Renal Disease and to reduce or avoid certain serious complications that arise with the current standards of care associated with the current forms of vascular access for hemodialysis.
“The fast track designation for HumaGraft™ recognizes the significant unmet need that exists and provides options for vascular access in hemodialysis patients. We will continue to work closely with the FDA to ensure the most efficient review process as we advance the development of HumaGraft™ for patients needing hemodialysis access.”
Fast Track designation means that the U.S. FDA will take actions to facilitate the development and review of the product for the designated medical use. Fast Track Development Programs are eligible for more frequent meetings and written correspondence with FDA, for priority review if relevant criteria are met at the time when an application for approval is submitted, and potentially for “rolling review,” under which parts of the application may be accepted earlier than usual.
Carrie Cox, Chairman and CEO, commented, “The fast track designation for HumaGraft™ recognizes the significant unmet need that exists and provides options for vascular access in hemodialysis patients. We will continue to work closely with the FDA to ensure the most efficient review process as we advance the development of HumaGraft™ for patients needing hemodialysis access.”
Potential Better Alternative to Current Synthetic Grafts
Current standard of care for patients with End Stage Renal Disease requiring hemodialysis includes surgery to create a fistula in the patient or the use of synthetic polytetrafluoroethylene (PTFE) grafts. Up to 70% of high risk patients (e.g., certain combinations of obese, diabetic patients, etc.) may not be candidates for a fistula. Likewise, PFTE grafts are subject to a range of complications, including clotting, high rates of stenosis (an abnormal narrowing in a blood vessel that can lead to occlusion), and high intervention rates to maintain blood flow. Preliminary clinical findings suggested that HumaGraftTM may provide an alternative to these current surgical options to maintain long term vascular patency in hemodialysis patients. HumaGraftTM is designed to be available off-the-shelf in the Operating Room, with the potential to help reduce or avoid surgical interventions and hospitalizations for patients with End Stage Renal Disease.
Humacyte recently announced that it has completed recruitment for two Phase I/II studies (one in Europe and one in the United States) for HumaGraftTM as a vascular access for hemodialysis. A separate investigational trial involving 20 patients with peripheral arterial disease who received a HumaGraftTM implant as a femoropopliteal bypass is fully enrolled and ongoing in Poland.
For more information visit: http://humacyte.com.
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.