Pivotal Trial Begins for Instylla’s Embrace Hydrogel Embolic System to Treat Hypervascular Tumors

March 30, 2021—Instylla, Inc. announced the enrollment of the first patients in the pivotal Embrace Hydrogel Embolic System (HES) global randomized clinical trial for the treatment of hypervascular tumors.

According to the company, the investigational Embrace HES is a peripheral vascular embolotherapy. This liquid embolic is designed to deeply penetrate the tumor vascular bed, solidify, and stop blood flow. 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, which has a long history of safe use in implantable medical devices.

Previously, the completed first-in-human study of the device demonstrated that the Embrace HES was effective at embolizing malignant and benign hypervascular tumors by blocking tumor blood supply with complete technical success and persistent embolization as confirmed by imaging follow-up at 30-days.

Gerard Goh, MBBS, who is Head of Interventional Radiology at The Alfred Hospital in Melbourne Australia, and President of the Interventional Radiology Society of Australasia, commented in the company’s announcement, “I am pleased to be evaluating this new technology for hypervascular tumor embolization. While participating in the first-in-human study prior to this trial, Embrace showed great promise with good control, favorable patient outcomes, and no tumor revascularization. We are excited to be the first center to enroll in this global, randomized trial.”

Edgar D. St. Amour, MD, an interventional radiologist at CARTI Cancer Center in Little Rock, Arkansas, added, “We are thrilled to be the first center in the United States to treat a patient on this study. Embrace’s predictability helps me embolize the tumor while avoiding nontarget embolization. I look forward to continued evaluation of this new advancement in treating hypervascular tumors.”

Embrace HES is limited to investigational use and is not available for sale, advised the company.