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Embrace™ Hydrogel Embolic System (HES)

Embolization of hypervascular tumors

ApprovedCommercial

Key Facts

Indication
Embolization of hypervascular tumors
Phase
Approved
Status
Commercial
Company

About Instylla

Instylla is a clinical-stage medical device company that achieved a significant milestone in August 2025 with U.S. FDA premarket approval for its Embrace™ Hydrogel Embolic System (HES), the first and only liquid embolic approved for hypervascular tumor embolization. The approval was supported by a prospective, randomized, controlled pivotal trial demonstrating superior safety and effectiveness versus standard of care. The company initiated its commercial launch in January 2026 and is also developing a next-generation resorbable embolic platform, including the Tembo™ particle system, to expand its portfolio in interventional radiology and oncology.

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Therapeutic Areas