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Company Overview of Humacyte, Inc.
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
Founded in 2004
Key Executives for Humacyte, Inc.
Chairman and Chief Executive Officer
Co-Founder and Vice-President of Business Operations & Tissue Services
Co-Founder and Vice President of Technology & Pipeline Development
Compensation as of Fiscal Year 2017.
Humacyte, Inc. Key Developments
Humacyte Wins $3.4 Million Contract
Oct 2 17
Humacyte announced that the company has received a Broad Agency Announcement (BAA) contract award of $3.4 million from the United States Department of Defense (DoD). The funding will help support the addition of clinical sites for Humacyte’s Phase II vascular trauma trial in the US. The trial is being conducted to study Humacyte’s investigational human acellular vessel (HAV), or HUMACYL®, to treat patients with traumatic
vascular injuries from violent civilian or military events, such as automobile crashes, industrial accidents, or injuries of war. The DoD is America's oldest and largest government agency, with over 1.3 million men and women on active duty, and 742,000 civilian personnel. Advancing the agency’s mission to provide the military forces with the support needed to deter war and to protect the security of country, the DoD US Army’s Medical Unit recently began working with Humacyte and other partners in the biomedical space to find solutions for injured warfighters. In addition to its clinical studies for hemodialysis and vascular trauma, Humacyte is developing and plans to seek regulatory approval for additional clinical applications for its HAV, and the company 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). The company is also continuing its efforts in advancing the development of future pipeline products that may improve treatment outcomes for patients suffering from both vascular and non-vascular diseases.
Humacyte, Inc. Presents at Morgan Stanley 15th Annual Global Healthcare Conference, Sep-11-2017
Sep 11 17
Humacyte, Inc. Presents at Morgan Stanley 15th Annual Global Healthcare Conference, Sep-11-2017 . Venue: Grand Hyatt New York, 109 E. 42nd Street, New York, New York, United States.
Humacyte Completes Patient Enrollment for Phase III Clinical Trial of Human Acellular Vessel
Sep 7 17
Humacyte announced that it has completed enrollment of 350 evaluable subjects for its Phase III HUMANITY study of HUMACYL, Humacyte's investigational human acellular vessel. Conducted across 40 sites in the U.S., Europe and Israel, this pivotal Phase III clinical trial evaluates the efficacy and safety of the bioengineered blood vessel as a conduit for hemodialysis in patients with End-Stage Renal Disease requiring renal replacement therapy and who are not candidates for fistula. Humacyte expects 12-month post-implantation patient data from the study to be available in late-2018. After analyzing this data, the company plans to file a BLA to seek marketing authorization for HUMACYL. To expedite the review process, Humacytewas granted the Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration's earlier this year. A key objective and a clinical endpoint of the Phase III study is to compare the secondary patency of the HAV to that of ePTFE grafts, as a conduit for hemodialysis. The study population includes patients suffering with ESRD requiring hemodialysis, who are not candidates for fistula but are suitable targets for implantation with an arteriovenous prosthesis for dialysis access. Based on the Phase II clinical study outcomes published in The Lancet, Humacyte anticipates that HUMACYL will offer a safe and effective alternative for vascular access that can become the patient's own over time. Results of this prospective, open-label, randomized, two-arm, comparative study are planned to support an application for marketing authorization of the vascular access conduit in the US, Europe, and Israel. The company also expects to obtain data from this study to determine whether the patency of HUMACYL, together with other potential positive, long-term, clinical outcomes with use of the HAV, may result in reduced health care costs in the care of hemodialysis patients. Humacyte announced the commencement of the Phase III study of HUMACYL in May 2016. In addition to this Phase III trial, Humacyte is developing and plans to seek regulatory approval for additional clinical applications for its HAV, and the company 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. The company is also planning to develop future pipeline products that may improve treatment outcomes for patients suffering from both vascular and non-vascular diseases.
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