Instylla Inc. said the first commercial procedure has been completed using its Embrace Hydrogel Embolic System. The product made its market premiere courtesy of Dr. Ripal Gandhi of Miami.

“Ongoing innovation is fundamental to how we continue to advance interventional radiology,” stated Dr. Gandhi, an interventional oncologist at Miami Vascular Specialists. “Our field relies on tools that allow us to treat complex diseases with greater precision and procedural confidence. In this case, I was pleased that Embrace HES allowed me to achieve deep, distal penetration into the tumor vascular bed, which helped me tailor the embolization to the patient’s anatomy and treatment goals. It has been encouraging to see how Embrace HES has evolved with a focus on practical ease of use in the clinical setting. I look forward to further experience with this technology as we continue to evaluate how it can best support patient care.”

This first patient treated with Embrace HES follows U.S. Food and Drug Administration (FDA) Premarket Approval, granted in August 2025, for the embolization of hypervascular tumors in peripheral arteries ≤ 5 mm. Approval was based on results from a prospective, randomized, multicenter pivotal study evaluating the safety and effectiveness of Embrace HES compared with standard of care (transcatheter arterial embolization (TAE) and transarterial chemoembolization (cTACE).

Hypervascular tumors, which commonly occur in the liver, kidney, bone, and other organs, are characterized by an abnormal increase in blood vessels and are often associated with poor survival outcomes.¹ Collectively, hypervascular tumors represent a significant portion of solid tumors treated by interventional radiologists, with more than 150,000 embolization procedures² performed each year in the United States as part of the locoregional treatment strategy for these types of tumors. Their high vascularity can make surgical removal difficult due to the elevated risk of bleeding, making embolization a common treatment.

Embrace HES consists of two low-viscosity liquid precursors that combine intravascularly when simultaneously injected, forming a soft, polyethylene glycol (PEG) hydrogel during the embolization procedure. This liquid embolic is designed to deeply penetrate the tumor vascular bed³ to create a rapid and sustained occlusion upon delivery and then liquifies via hydrolysis over approximately 11 months.

“This first commercial procedure represents an important milestone for Instylla and for the physicians who participated in the development of Embrace HES,” Instylla CEO Sean Boyle stated. “Following FDA approval, we are proud to see Embrace HES transition into clinical practice, providing physicians with a transformational embolic platform technology solving critical unmet needs for cancer patients with hypervascular tumors.”

Instylla Inc. is a privately held company based in Bedford, Mass., developing resorbable embolic agents to advance interventional radiology, with initial clinical applications in interventional oncology and peripheral hemostasis. Instylla was founded in 2017 by Incept LLC and is funded by several venture capital groups. 

References
¹ Hotta, Naoki & Ayada, Minoru & Okumura, Akihiko & Ishikawa, Tetsuya & Sato, Ken & Oohashi, Tomohiko & Hijikata, Yasutaka & Kakumu, Shinichi. (2009). Hepatocellular Carcinoma 11 and a Half Years after the Resolution of Chronic Hepatitis C Virus Infection Successfully Treated with Interferon. Case reports in gastroenterology. 3. 175-181. 10.1159/000225244.
² Data on file
³ Ganguli S, Lareau R, Jarrett T, Soulen MC, A Water-based Liquid Embolic: Evaluation of Safety and Efficacy in a Rabbit Kidney Model, Journal of Vascular and Interventional Radiology (2021)