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

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R41CA277860-01A1
Agency Tracking Number: R41CA277860
Amount: $399,528.00
Phase: Phase I
Program: STTR
Solicitation Topic Code: 102
Solicitation Number: PA22-178
Timeline
Solicitation Year: 2022
Award Year: 2023
Award Start Date (Proposal Award Date): 2023-07-05
Award End Date (Contract End Date): 2024-06-30
Small Business Information
575 COLTRANE CT
Irvine, CA 92617-5357
United States
DUNS: 117628317
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: Yes
Principal Investigator
 ICHIRO YUKI
 (949) 410-6828
 ichiroyuki@gmail.com
Business Contact
 ICHIRO YUKI
Phone: (949) 410-6828
Email: ichiroyuki@gmail.com
Research Institution
 UNIVERSITY OF CALIFORNIA-IRVINE
 
160 ALDRICH HALL
IRVINE, CA 92697-0001
United States

 Nonprofit College or University
Abstract

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.

* Information listed above is at the time of submission. *

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