Instylla’s Embrace Hydrogel Embolic System Evaluated in Preclinical Hemorrhage Models

July 26, 2022—Instylla, Inc., a developer of liquid embolics for peripheral vascular embolotherapy, announced two publications of studies that evaluated the company’s Embrace hydrogel embolic system (HES) in preclinical porcine hemorrhage models.

Embrace HES, which is Instylla’s first product, is designed for controlled, complete, and persistent embolization in applications in interventional oncology and peripheral hemostasis. Embrace HES is an investigational device, limited by Federal law in the United States to investigational use only. The device is not available for sale. Instylla was founded in 2017 by Incept LLC.

According to the company, Embrace HES is an investigational device intended to be used to embolize peripheral arterial bleeds in vessels ≤ 6 mm. The device consists of two 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 Instylla.

The first study was published by Eric John Gandras, MD, et al in Journal of Vascular and Interventional Radiology (2022;33:653-659).

The investigators evaluated the ability of Embrace HES to achieve hemostasis in a porcine mesenteric artery hemorrhage model that replicates injury in humans.

The company stated that the results demonstrated that Embrace HES achieved complete, rapid, and durable embolization in 100% of the injured arteries with a mean delivery time of 5.3 minutes. There was no angiographic evidence of non-target embolization.

“Embrace was effective in achieving hemostasis in an animal hemorrhage model without evidence of nontarget embolization,” commented Dr. Gandras in the company’s press release. “This next-generation liquid embolic has tremendous potential to play an important therapeutic role in a wide variety of clinical applications including hemorrhage and interventional oncology.” Dr. Gandras is Associate Chief, Vascular and Interventional Radiology at North Shore University Hospital in Manhasset, New York.

The second study was an independent investigation conducted by Davis S. Kauva, MD, et al and published in Journal of Vascular Surgery-Science (2021;2:43-51).

According to Instylla, the investigators induced splenic injury and resulting hemorrhage in swine models. A comparison was made between a control group having no embolic treatment versus treatment groups that received embolization with Embrace HES, gel foam slurry, or coils.

Under coagulopathic conditions, Embrace HES showed improved survival time and a significant reduction in bleeding compared to the control group, gel foam slurry, and coil treatments, reported Instylla in the company’s press release.

In March 2022, Instylla announced that results from the pilot first-in-human clinical trial of the Embrace HES for the treatment of hypervascular tumors were published by Gerard S. Goh, MBBS, et al in the Journal of Vascular and Interventional Radiology (2022;33:660-667). The company stated that the prospective, single-arm multicenter study demonstrated that Embrace HES effectively embolized malignant and benign hypervascular tumors by blocking tumor blood supply with technical success and persistent embolization, which was observed in imaging follow-up at 30-days, in all eight patients treated in the study.