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Pervasis hemodialysis treatment lands FDA fast-track review

Tue, 02/08/2011 - 9:38am
Mass High Tech: The Journal of New England Technology

The U.S. Food and Drug Administration has granted fast track review status to Cambridge biotech Pervasis Therapeutics Inc. for Vascugel, its lead drug program, a prevention treatment of kidney dialysis access failure in patients with end stage renal disease.

Vascugel was tested in two Phase 2 clinical trials on patients with end stage renal disease, and it returned positive safety and efficacy results. According to a news release from Pervasis, the cell-based treatment is intended to “regulate the body’s healing response following surgical interventions.”

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