# Flow Responsive Embolic Agent for the Complete Devascularization of Meningiomas

> **NIH NIH R44** · ARSENAL MEDICAL, INC. · 2021 · $791,378

## Abstract

PROJECT SUMMARY
Significance: Pre-operative embolization (POE) of meningiomas is an established neuroendovascular procedure
performed to reduce the extensive amount of blood loss that occurs during tumor resection. The current practice
is significantly hampered because of efficacy and safety deficiencies of current embolic agents used off-label for
this indication (none of which are designed specifically for POE). Polyvinyl alcohol particles are the most used
embolic agent, but efficacy data raise concerns of their clinical benefit. Trufill and Onyx are liquid-based embolic
alternatives but are fraught with limitations of their own. For example, Onyx contains toxic solvent that causes
patient pain and discomfort while the technical risks associated with Trufill have negated its wide-spread adoption
in the United States. Thus, there is a need for an easy-to-use, on-label embolic agent designed specifically for POE
of meningiomas that provides safe and complete devascularization. Such an embolic would result in faster and
safer surgical resection, representing a significant evolution in the treatment of meningioma patients.
Approach: In this Direct to Phase II SBIR, Arsenal Medical will advance its shear-thinning biomaterial technology,
a flow responsive embolic (FRE) agent, as a therapy for the POE of meningiomas. For POE to be effective, complete
devascularization of the meningioma is desired, which is achieved by total occlusion of all distal vessels that supply
the tumor. Our Phase I results have demonstrated that the FRE exhibits superior distal penetration compared to
commercial liquid embolics, is biocompatible, and can be manually injected through a neurovascular
microcatheter. The goal of this proposal is to advance the proof-of-concept formulation towards a product
configuration that is ready for clinical testing via an early feasibility study (EFS), enabling an efficient path to
commercialization. In Aim 1, we will finalize the delivery system and affirm the product’s usability with clinicians.
Aim 2 will consist of selection of a commercially viable sterilization method, followed by confirmation of product
shelf-life. Biocompatibility of the FRE will be confirmed via a pre-clinical study to determine the neurovascular
response and safety (Aim 3) and ISO10993 biocompatibility testing through biological and chemical
characterization assays (Aim 4). The proposed work provides a foundational data set that will be complemented
with post-Phase II activities to advance towards commercialization.
Innovation: The FRE biomaterial has adaptive properties enabling it to become a low viscosity fluid under high
shear that penetrates and fills the distal vessels supplying the meningioma. As embolization progresses, flow and
shear will continually decrease; in response, the FRE progressively increases in viscosity becoming a viscous paste
for controlled injection. The result is complete casting and occlusion of the entire vasculature. Compared to other...

## Key facts

- **NIH application ID:** 10256541
- **Project number:** 1R44CA257802-01A1
- **Recipient organization:** ARSENAL MEDICAL, INC.
- **Principal Investigator:** QUYNH P PHAM
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $791,378
- **Award type:** 1
- **Project period:** 2021-05-15 → 2023-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10256541

## Citation

> US National Institutes of Health, RePORTER application 10256541, Flow Responsive Embolic Agent for the Complete Devascularization of Meningiomas (1R44CA257802-01A1). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10256541. Licensed CC0.

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