BioCentury | Mar 9, 2018
Financial News

Humacyte raises $75M series C

...private investments and up to $40 million in government grants and contracts. The company's Humacyl tissue-engineered vascular grafts (TEVGs)...
...III HUMANITY trial as a conduit for hemodialysis in patients with end-stage renal disease (ESRD). Humacyl...
BioCentury | Dec 16, 2017
Regulation

Growth medium

...is more clear,” he told BioCentury. Humacyte Inc. had prepared a breakthrough application for its Humacyl...
...RMAT will encourage the development of innovative products.” Ralph Kern, BrainStorm Cell Humacyte is developing Humacyl...
...October, Humacyte completed enrollment of 350 evaluable ESRD patients in a Phase III trial of Humacyl...
BioCentury | Oct 27, 2017
Clinical News

Humacyte completes enrollment in Phase III of Humacyl for ESRD

...Phase III HUMANITY trial evaluating Humacyl (HumaGraft, Human Acellular Vascular Graft (HAVG), Tissue-engineered vascular grafts (TEVGs)). The open-label, international trial is comparing Humacyl...
...patency. Secondary endpoints include time to loss of primary patency, efficacy of dialysis and safety. Humacyl...
...FDA for the indication. Humacyte Inc. , Research Triangle Park, N.C. Product: Humacyl (HumaGraft, Human Acellular Vascular Graft (HAVG), Tissue-engineered vascular grafts (TEVGs)...
BioCentury | Jul 27, 2017
Strategy

FDA’s regeneration

...T cell-depleted, allogeneic thymic tissue Complete DiGeorge Syndrome (cDGS) Phase III March 20 Humacyte Inc. Humacyl...
BioCentury | Apr 18, 2017
Company News

Enzyvant therapy gets RMAT, breakthrough designations

...the second company to announce an RMAT designation. In March, FDA granted RMAT designation to Humacyl...
BioCentury | Mar 29, 2017
Clinical News

Humacyl regulatory update

...Humacyte said FDA granted regenerative medicine advanced therapy (RMAT) designation to Humacyl for vascular access in...
...Track designation from FDA. Humacyte expects data next year from a Phase III trial of Humacyl...
...respectively. Humacyte Inc. , Research Triangle Park, N.C. Product: Humacyl , Human Acellular Vascular Graft (HAVG) (Tissue-engineered vascular grafts (TEVGs)) Business: Renal Julian Zhu Humacyl Human Acellular Vascular Graft (HAVG) Tissue-engineered vascular grafts (TEVGs) Humacyte...
BioCentury | Mar 20, 2017
Company News

FDA grants new designation to Humacyte regenerative therapy

...Humacyte Inc. (Research Triangle Park, N.C.) said FDA granted regenerative medicine advanced therapy designation to Humacyl...
...vascular access in hemodialysis patients. Created via the 21st Century Cures Act, the designation provides Humacyl...
...afforded drug candidates which receive FDA's breakthrough therapy designation (see BioCentury Extra, Jan. 24) . Humacyl...
BioCentury | Jun 30, 2014
Clinical News

HumaGraft: Completed Phase I enrollment

...trial of HumaGraft. Humacyte Inc. , Research Triangle Park, N.C. Product: HumaGraft , Human Acellular Vascular Graft (HAVG) ( Tissue-engineered vascular grafts (TEVGs)...
BioCentury | Jun 30, 2014
Clinical News

HumaGraft: Pilot trial completed enrollment

...trial of HumaGraft. Last year, interim data from 28 patients in the trial showed that HumaGraft...
...BioCentury, Jan. 6). Humacyte Inc. , Research Triangle Park, N.C. Product: HumaGraft , Human Acellular Vascular Graft (HAVG) ( Tissue-engineered vascular grafts (TEVGs)...
BioCentury | Jan 6, 2014
Clinical News

Human Acellular Vascular Graft: Interim pilot trial data

...patients are expected in 3Q14. Humacyte Inc. , Research Triangle Park, N.C. Product: Human Acellular Vascular Graft (HAVG) ( Tissue-engineered vascular grafts (TEVGs)...
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