Instylla HES Hypervascular Tumor Pivotal Study Completes Enrollment

May 14, 2024—Instylla, Inc., a developer of liquid embolics for peripheral vascular embolotherapy, announced the completion of patient enrollment in the Instylla HES hypervascular tumor pivotal study of the company’s Embrace hydrogel embolic system (HES).

According to the company, the prospective, multicenter, randomized clinical study enrolled 150 patients with hypervascular tumors.

The study is evaluating the safety and effectiveness of the Embrace 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, noted Instylla.

The study’s national principal investigator is Nadine Abi-Jaoudeh, MD, Chief of Interventional Radiology at the University of California, Irvine, in Irvine, California.

“Congratulations to all the investigators, study coordinators, and the Instylla team on the completion of enrollment for the Instylla HES hypervascular tumor pivotal study,” commented Dr. Abi-Jaoudeh in the company’s press release. “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.”

Instylla stated that the Embrace HES is intended to embolize hypervascular tumors in vessels ≤ 5 mm. The system 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. Its main components are water and polyethylene glycol.

The Embrace HES embolization uses no organic solvents, does not need sizing to the vessel diameter, and eliminates the possibility of catheter entrapment, advised the company.