March 24, 2017 10:38 AM ET

Healthcare Equipment and Supplies

Company Overview of Humacyte, Inc.

Company Overview

Humacyte, Inc., a medical research, discovery, and development company, focuses on developing and commercializing a proprietary technology based on human tissue-based products for application in regenerative medicine and vascular surgery. It designs acellular extracellular matrices, which are formed in vitro from banked vascular smooth muscle cells and decellularized to eliminate the risk of rejection; and used as tissue-engineered grafts for patients in need of vascular repair or replacement. The company was incorporated in 2004 and is headquartered in Morrisville, North Carolina.

7020 Kit Creek Road

Morrisville, NC 27560

United States

Founded in 2004

Phone:

919-313-9633

Fax:

919-313-9634

Key Executives for Humacyte, Inc.

Chairman and Chief Executive Officer
Age: 58
Founder and Director
Co-Founder and Vice-President of Business Operations & Tissue Services
Co-Founder and Vice President of Technology & Pipeline Development
Chief Financial Officer
Compensation as of Fiscal Year 2016.

Humacyte, Inc. Key Developments

Humacyte Receives FDA Regenerative Medicine Advanced Therapy (RMAT) Expedited Review Designation for HUMACYL® in Vascular Access for Hemodialysis

Humacyte announced that the U.S. Food and Drug Administration (FDA) has granted HUMACYL®, its investigational human acellular vessel (HAV), the Regenerative Medicine Advanced Therapy (RMAT) designation. This designation means that the FDA will help facilitate the efficient development and expedited review of the HAV for vascular access to patients in need of life-sustaining hemodialysis. Carved from the model of other FDA expedited programs such as Breakthrough Therapy, the RMAT designation is a new expedited program for regenerative medicine products. Since receiving the FDA’s Fast Track Designation in 2014, Humacyte has continued to develop clinical evidence indicating that HUMACYL has the potential to address unmet medical needs for hemodialysis patients by decreasing vascular access complications, that in turn may result in more favorable morbidity and mortality outcomes. More than 400,000 people with end-stage renal disease (ESRD) undergo hemodialysis procedures to eliminate deadly toxins from blood when their kidneys fail. Alternative methods are needed to establish durable long-term vascular access for dialysis with infection rates, and other complications as low as possible, to help patients obtain better health care. Humacyte is currently undertaking a Phase III clinical trial of HUMACYL compared to an expanded polytetrafluoroethylene (ePTFE) graft in 350 patients with kidney failure who are not candidates for fistula placement. The trial involves approximately 35 sites in the U.S., Europe and Israel. The Phase III study’s primary objective is to compare the durable use (secondary patency) of the HAV with that of the ePTFE graft during its use as a conduit for hemodialysis. The company published Phase II results in May 2016, showing HUMACYL may have the potential for long-term use and safety in patients suffering from ESRD who require renal replacement therapy and are not candidates for fistula.

Humacyte Commences U.S. Phase II Arterial Bypass Clinical Trial

Humacyte announced the initiation of a U.S. Phase II arterial bypass clinical trial of HUMACYL®, its investigational human acellular vessel (HAV), to test the safety and efficacy as a lower extremity arterial bypass vessel in patients with peripheral arterial disease (PAD). In this non-randomized trial with a target to enroll 20 patients over the next 12 months, HUMACYL will be surgically implanted in the above-the-knee, femoral-to-popliteal arterial position in the legs of patients who suffer from PAD to improve blood circulation. This study goal is to assess whether the vessel performs in the arterial bypass position, and is usable and suitable for repairing human arterial blood vessels. The initiation of the Phase II trial in the United States is a continuation of previous arterial trial surgeries that were begun across multiple sites in Poland in 2013, and completed in 2015. Humacyte enrolled its first U.S. patient in the trial for arterial bypass at Brigham and Women’s Hospital in Boston, Massachusetts, under an FDA approved protocol. Patients will be enrolled in at least three other sites in the United States, including the UCSF Medical Center in San Francisco, California, Michigan Vascular Center in Flint, Michigan, and Duke University Hospital in Durham, North Carolina. In addition to the arterial bypass study, Humacyte’s HAV is also currently undergoing a Phase III clinical trial for vascular access in patients with End Stage Renal Disease (ESRD) requiring renal replacement therapy and who are not candidates for fistula. The company is also planning the development of future pipeline products that may improve treatment outcomes for patients suffering from both vascular and non-vascular diseases.

Allosource Distributes First Bioengineered Blood Vessels for Humacyte Phase III Clinical Trial

AlloSource announced the distribution of investigational bioengineered blood vessels for Humacyte's Phase III clinical trials. The first shipment of vessels will be used in the upcoming Phase III clinical trial, which will investigate the potential of Humacyte's blood vessels to improve vascular access for hemodialysis patients with end-stage renal disease. The clinical trial will compare the efficacy of Humacyte's vessels to the current standard of care, synthetic blood vessel replacement with Polytetrafluoroethylene (PTFE) grafts. AlloSource and Humacyte entered into a strategic partnership in 2013, with AlloSource serving as the sole manufacturing partner for Humacyte's blood vessels. The investigational bioengineered vessels are produced using donated human vascular cells that are decellularized to remove the donor identity from the newly created vessels. This process results in the production of investigational human vascular grafts with the potential for implantation into any patient at the time of medical need.

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