Instylla Completes Submission of Premarket Approval Application for Embrace™ Hydrogel Embolic System
BEDFORD, Mass., March 11, 2025 /PRNewswire/ -- Instylla, Inc., a privately held clinical-stage company developing solutions for peripheral vascular embolotherapy, announced that it recently submitted to the U.S. Food and Drug Administration (FDA) the final module of its premarket approval application (PMA) for the Embrace™ Hydrogel Embolic System (HES).
In this final PMA module, Instylla has submitted clinical study results to the FDA, advancing our pursuit of the indication for the embolization of hypervascular tumors. With previous modules covering pre-clinical testing and manufacturing already completed, this marks a key step toward bringing our novel solution to the market.
"This submission marks a significant milestone for Instylla, demonstrating our team's dedication and execution," said Amar Sawhney, CEO of Instylla, Inc. and Managing Director of Incept, LLC. "We have leveraged the FDA's modular submission program to streamline the approval process, enhance efficiency, and accelerate our path to market."
About Embrace Hydrogel Embolic System
Embrace HES is an investigational device intended to embolize hypervascular tumors in vessels ≤ 5 mm. Embrace HES consists of two injectable liquid precursors that solidify when simultaneously delivered into blood vessels, forming a soft hydrogel that fills the vessel lumens during embolization. Embrace HES embolization uses no solvents, does not need sizing to the vessel diameter, and eliminates the possibility of catheter entrapment. Its main components are water and polyethylene glycol (PEG).
About Instylla
Instylla, Inc. is a privately held company based in Bedford, MA, focused on developing novel resorbable embolic agents to advance interventional radiology, with initial clinical applications in interventional oncology and the peripheral vasculature. Instylla was founded in 2017 by Incept LLC and is funded by several leading venture capital groups.
To learn more, please visit https://www.instylla.com/
Caution: Investigational Device. Limited by Federal (or US) law to investigational use only. Not available for sale.
