Instylla Gains U.S. FDA Premarket Approval for Embrace™ Hydrogel Embolic System

BEDFORD, Mass., Aug. 7, 2025 /PRNewswire/ -- Instylla, Inc., a privately held company developing novel resorbable embolics for peripheral vascular embolization, announced premarket approval (PMA) from the U.S. Food and Drug Administration (FDA) for the company's flagship product Embrace™ Hydrogel Embolic System. Embrace HES has been approved for the embolization of hypervascular tumors in peripheral arteries ≤ 5mm.

Hypervascular tumors (HVTs), which commonly occur in the liver, kidney, bone, and other organs, are characterized by an abnormal increase in blood vessels and are often associated with poor survival outcomes1. Their high vascularity can make surgical removal difficult due to the elevated risk of bleeding. For patients with limited progressive disease or for local tumor control, transcatheter arterial embolization (TAE) and transarterial chemoembolization (cTACE) are established and widely used treatment options.

Embrace HES consists of two low-viscosity aqueous liquid precursors that interact to crosslink intravascularly when simultaneously injected into blood vessels during the embolization procedure to form a soft, polyethylene glycol (PEG) hydrogel. This liquid embolic is designed to deeply penetrate the tumor vascular bed2, crosslink, and stop blood flow.

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