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Instylla Completes Enrollment of Landmark Hypervascular Tumor Pivotal Study

Clinical investigators achieve significant milestone by enrolling 150 patients with hypervascular tumors in pivotal randomized study.

BEDFORD, Mass., – May 14, 2024 – Instylla, Inc., a privately held clinical-stage company focused on developing liquid embolics for peripheral vascular embolotherapy, today announced the completion of patient enrollment in the ongoing Instylla HES Hypervascular Tumor Pivotal Study.

The Instylla HES Hypervascular Tumor Pivotal Study is a prospective, multicenter, randomized clinical study to evaluate the safety and effectiveness of Instylla’s Embrace™ Hydrogel Embolic System (HES) compared with standard of care transcatheter arterial embolization or transcatheter arterial chemoembolization for the vascular occlusion of hypervascular tumors. A wide variety of tumors were treated in the study including primary and metastatic liver tumors, metastatic bone tumors, and renal tumors.
Dr. Nadine Abi-Jaoudeh, the study’s National Principal Investigator and Chief of Interventional Radiology at the University of California, Irvine, said, “Congratulations to all the investigators, study coordinators, and the Instylla team on the completion of enrollment for the Instylla HES Hypervascular Tumor Pivotal Study. This marks an exciting milestone in the field of embolization of hypervascular tumors. We hope the study will be positive and demonstrate that this next-generation liquid embolic technology will improve the lives of our patients who have to navigate their challenging clinical conditions. We want to thank all the patients that participated.”

“Enrollment completion represents a significant milestone for Instylla and cancer patients diagnosed with hypervascular tumors,” said Amar Sawhney, CEO of Instylla, Inc. and Managing Director of Incept, LLC. “We look forward to continuing to work with the study investigators to maintain the high quality of patient follow-up as we continue on our pathway to a PMA for Embrace HES.”

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. The Embrace HES embolization uses no organic 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 next-generation liquid embolics for interventional radiology, with initial clinical applications in interventional oncology and peripheral hemostasis. The company's first product, Embrace HES, is designed for controlled, complete, and persistent embolization in these clinical conditions. Instylla was founded in 2017 by Incept LLC and is funded by several leading venture capital groups.

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