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.

Novel resorbable hydrogel and gelatin-based liquid and particle embolic agents designed for deep, capillary-level penetration and subsequent absorption by the body.

Instylla competes in the embolization device market against large, established players like Boston Scientific, Terumo, and Merit Medical that offer permanent embolic particles and beads. It also competes with other liquid embolics (e.g., Squid, Onyx, Trufill) which are not specifically FDA-approved for hypervascular tumors or are non-resorbable. Its key differentiation is the resorbable nature of its products combined with deep penetration, a claim supported by a randomized controlled trial.