Instylla Pivotal HALT Study of Embrace Hydrogel Embolic System Begins Enrollment

January 10, 2023—Instylla, Inc. announced the enrollment of the first patient in the pivotal HALT study of the company’s first product, the Embrace hydrogel embolic system (HES) for the treatment of arterial bleeds in the peripheral vasculature.

According to the company, HALT is a prospective, multicenter, single-arm study to evaluate the safety and effectiveness of the Embrace HES for the embolization of arterial bleeding in solid organs and peripheral arteries.

The study is estimated to enroll 118 patients in up to 25 sites in the United States. Patients with upper gastrointestinal bleeds; kidney, liver, or spleen end-organ bleeds; spontaneous hematomas; or other peripheral arterial bleeds such as pelvic hemorrhage may be considered suitable for this study.

The HALT study is led by Suvranu Ganguli, MD, Section Chief, Interventional Radiology, at Boston Medical Center in Boston, Massachusetts.

The first patient in the study was enrolled by David Tahour, MD, Chief of Vascular and Interventional Radiology at MemorialCare Long Beach Medical Center in Long Beach, California.

“We are excited to have enrolled the first patient nationally in the prospective HALT study, evaluating an innovative in-situ forming liquid embolic for hemorrhage control in patients,” commented Dr. Tahour in the company’s press release. “Embrace HES has demonstrated rapid and durable hemostasis in preclinical studies while reducing the risk of nontarget embolization. I look forward to being involved with this innovative technology, which will change the standard of care for future embolizations.”

Instylla is a privately held company based in Bedford, Massachusetts, focused on developing next-generation liquid embolics for peripheral vascular embolotherapy.

The company’s Embrace HES is an investigational device intended to be used to embolize peripheral arterial bleeds in vessels ≤ 6 mm. The device is composed of two injectable liquid precursors that solidify when simultaneously delivered into blood vessels, forming a soft hydrogel that fills the vessel lumens during the embolization procedure. The 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, noted the company.