Instylla’s Embrace Hydrogel Embolic System Evaluated in First-In-Human Trial

March 15, 2022—Instylla, Inc., a developer of liquid embolics for peripheral vascular embolotherapy, announced that results from the first-in-human clinical trial of the company’s Embrace hydrogel embolic system (HES) for the treatment of hypervascular tumors were published by Gerard S. Goh, MBBS, et al online ahead of print in the Journal of Vascular and Interventional Radiology.

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 on this study.

Ten embolizations were performed in eight patients with a range of tumor types, including hepatocellular carcinoma (HCC), intrahepatic cholangiocarcinoma, and angiomyolipoma. Tumor sizes ranged from 2.1 to 7.5 cm and were treated with Embrace HES volumes from 0.4 to 4.0 mL with an average delivery time of 15 minutes.

“This phase I first-in-human study of Embrace HES in the embolization of a range of hypervascular tumors has shown promising results,” commented Dr. Goh in Instylla’s press release. “Embrace HES holds great potential with its ease of use, technical success in all patients, and no tumor revascularization in the 30-day follow-up imaging.” Dr. Goh is Head of Interventional Radiology at The Alfred Hospital and Associate Professor at Monash University in Melbourne, Australia.

Jee-Fu Huang, MD, who Professor, Department of Internal Medicine, at Kaohsiung Medical University Hospital in Kaohsiung, Taiwan, added, “Taiwan has one of the highest age-adjusted incident rates of HCC in East Asia, which is also the second leading cause of cancer-related deaths. This novel liquid embolic, designed to achieve capillary level embolization, had favorable patient outcomes in the first-in-human trial, including HCC tumors. We are encouraged by these results.”

Dr. Huang further noted, “Our center is currently enrolling in the Instylla HES Hypervascular Tumor pivotal study, so I look forward to continuing to assess Embrace HES in treating hypervascular tumors.”

According to Instylla, the Embrace HES is an investigational device intended to be used to embolize hypervascular tumors in vessels ≤ 5 mm. The device consists of two low-viscosity 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 is limited by United States law to investigational use only and is not available for sale, advised the company.