Water-based liquid embolic agent for the treatment of vascular rich tumors

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AquaTeX Medical is developing a novel liquid embolic material (LEM) - Aqua Embolic System (AES) - to improve cancer treatment. AES is designed to occlude feeding vessels of hypervascular tumors with superior efficacy and excellent biocompatibility as compared to other trans-arterial embolization (TAE) materials. TAE is a catheter-based treatment to treat hypervascular tumors. Embolic materials are injected via a small catheter placed in the artery occluding the vessels, causing cell death by ischemia. The need for TAE treatment is rapidly growing, and its market forecast is expected to reach $2.164 billion in 2025. Currently, microparticles are the most commonly used embolic materials for TAE. Despite their wide use, microparticles have their limitations, e.g.,1) sub-optimal tissue penetration due to clumping effects or the relatively large size of each particle, 2) incomplete occlusion of the treated vessel leading to high recanalization rate (16-64%), 3) lack of visibility under x-ray requiring the addition of contrast medium, and 4) inability to load many current chemotherapeutic drugs or immunologically active molecules. Therefore, there is a strong need for better embolic materials. LEMs, on the other hand, have 1) superior tissue penetration, 2) capability to achieve permanent occlusion of the target vessels, and 3) good visibility under fluoroscopy. However, the FDA has not yet approved any LEMs to treat hypervascular tumors, due to safety concerns related to the strong adhesiveness or tissue toxicity caused by the organic solvents in current LEMs on the market. To overcome these limitations, we have developed the first single-component water-based LEM called AES. AES is a clear aqueous solution composed of biocompatible polysaccharides. It is activated by the calcium ions in the blood and forms a solid hydrogel cast that shows excellent tissue penetration. With its unique viscosity- controlling technology, AES can be delivered via the currently available smallest single-lumen microcatheter system. It contains no toxic organic solvents, and moreover, the main compositions of the AES have been widely used for cell culture medium and food additives with FDA approval. Our preliminary animal experiments showed consistent efficacy and biocompatibility of the AES. The primary goal of this Phase I STTR project is 1) to confirm the efficacy of the AES using a rabbit hypervascular tumor model, which has been historically used for preclinical evaluation of embolic materials for FDA approval, and 2) to evaluate long-term safety, durability, and biocompatibility using a non-tumor hepatic artery embolization model. Embozene®, which is a micro-particle product currently used in the clinical practice, is used as comparison (commercial control). In our subsequent Phase II SBIR/STTR project, we will pursue the next step of testing needed for investigational device exemption (IDE) approval, followed by the first-in-human study. Our final goal is to improve the safety and efficacy of TAE procedures performed for patients with hypervascular tumors.