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CARTI To Serve As First Center In Us To Treat Patients Through Embrace Hydrogel Embolic System Global Randomized Multi-Center Clinical Trial

Pivotal study to evaluate the use of novel liquid embolic verses standard of care in treating malignant and benign hypervascular tumors

CARTI today announced its participation in the Instylla, Inc. Embrace Hydrogel Embolic System (HES™) global randomized clinical trial for the treatment of hypervascular tumors. As demonstrated previously in the completed First-in-Human (FIH) study, Embrace HES was found to be effective at embolizing malignant and benign hypervascular tumors by blocking tumor blood supply with complete technical success and persistent embolization[i] as noted in imaging follow up at 30-days.

“We are thrilled to be the first center in the United States to treat a patient on this study,” said Dr. Edgar D. St. Amour, interventional radiologist at CARTI. ”Embrace’s predictability helps me embolize the tumor while avoiding non-target embolization. I look forward to continued evaluation of this new advancement in treating hypervascular tumors.”

A hypervascular tumor, which can be found in the liver, kidney, or elsewhere, has an increased number of blood vessels, relative to other tissues. These tumors are often associated with low survival rates.[ii] Due to the increased risk of bleeding, hypervascular tumors can be challenging to remove. Transcatheter arterial embolization (TAE) and transarterial chemoembolization (cTACE) are established treatments for hypervascular tumors, particularly for patients with limited progressive disease.

Embrace HES, an investigational product, is a liquid embolic that is designed to deeply penetrate the tumor vascular bed[iii], solidify, and stop the blood flow. 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 (PEG). PEG has a long history of safe use in implantable medical devices.

“I would like to thank Dr. St. Amour, and our other global trial sites for their efforts and collaboration in achieving this significant clinical milestone,” said Amar Sawhney, Instylla CEO. “Hypervascular tumors can cause significant morbidity and mortality. At Instylla, we are focused on creating novel solutions to improve outcomes for these patients.”

About Instylla
Instylla, Inc. is a privately held Company based in Bedford, MA focused on developing next-generation liquid embolics for interventional radiology, with initial clinical applications in interventional oncology and peripheral hemostasis. The company’s first product, Embrace HES, is designed for controlled, complete, and persistent embolization in these clinical conditions. Instylla was founded in 2017 by Incept LLC and is funded by several leading venture capital groups.

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[i] Manuscript submitted for publication

[ii] 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.

[iii] 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)

Caution: Investigational Device. Limited by Federal (or US) law to investigational use only. Not available for sale.