News | Embolization devices | March 31, 2022

Instylla First-In-Human Clinical Trial Published Results Demonstrate Technical Success and Persistent Embolization Across All Patients

Prospective multicenter study evaluated the safety and efficacy of a PEG-based liquid embolic in treating hypervascular tumors

Instylla, Inc., a privately held company developing next-generation liquid embolics for peripheral vascular embolotherapy, today announced the publication of results from the first-in-human clinical trial of Embrace Hydrogel Embolic System (HES) for the treatment of hypervascular tumors, in the Journal of Vascular and Interventional Radiology (JVIR).

Figure 1: Before and after embolization images for hepatocellular carcinoma treated with Embrace HES on the FIH study. Images courtesy of Dr. Lu.


March 31, 2022 – Instylla, Inc., a privately held company developing next-generation liquid embolics for peripheral vascular embolotherapy, today announced the publication of results from the first-in-human clinical trial of Embrace Hydrogel Embolic System (HES) for the treatment of hypervascular tumors, in the Journal of Vascular and Interventional Radiology (JVIR). This 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 embolizationi, as noted in imaging follow-up at 30-days, in all eight patients treated on this study.

"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. Gerard Goh, Head of Interventional Radiology at The Alfred Hospital and Associate Professor at Monash University, Melbourne, Australia, and lead author on the study. "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."

Ten embolizations were performed in 8 patients with a range of tumor types, including hepatocellular carcinoma (HCC), intrahepatic cholangiocarcinoma (ICC), and angiomyolipoma (AML). Tumor sizes ranged from 2.1 – 7.5 cm in size and were treated with Embrace HES volumes from 0.4 to 4.0 mL, with an average delivery time of 15 minutes.

Dr. Jee-Fu Huang, Professor, Department of Internal Medicine, Kaohsiung Medical University Hospital, 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 embolizationii, had favorable patient outcomes in the FIH trial, including HCC tumors. We are encouraged by these results. Our center is currently enrolling in the Instylla HES HVT pivotal study, so I look forward to continuing to assess Embrace HES in treating hypervascular tumors."

For more information: https://instylla.com/

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