# Innovative Voltage-Activated Ultrasound Imaging Agent for Selective Myocardial Enhancement

> **NIH NIH R44** · SONNEST, INC. · 2021 · $833,724

## Abstract

ABSTRACT
Significance: Heart disease is the leading cause of death in the United States and coronary heart
disease (CHD), which impacts approximately 18M Americans, is the most common form of heart
disease. CHD can cause chest pain and shortness of breath, increases the likelihood a person will
experience a myocardial infarction and accounts for 1 of every 7 deaths in the United States. The
Problem: It is challenging to visualize myocardial perfusion without expensive centralized equipment,
exposure to ionizing radiation and/or invasive coronary angiography. The Solution: A voltage-
activated ultrasound imaging agent call Electrast™ that can transform the way cardiologists diagnose
and monitor CHD. Unlike other ultrasound enhancement agents, Electrast™ is in an inactive state as
it circulates through the bloodstream and is selectively activated in viable, perfused myocardium by the
electrical depolarization wave that makes the heart beat, allowing clinicians to assess the
microperfusion of the heart at the bedside in real time without the need for ionizing radiation.
Preliminary Data: Proof-of-principle validation data demonstrating that Electrast™ can selectively
enhance myocardial tissue has been generated in small (rodent) and large (swine) animal studies.
Specific Aims: This project will support the scale-up and cGMP manufacturing work necessary to
produce sterile Electrast™ for the preclinical safety, toxicity and verification and validation testing
required to secure approval of a Phase I Investigational New Drug (IND) application for Electrast™
from the FDA. In Specific Aim 1 the team will validate in swine that Electrast™ provides selective
enhancement of viable, perfused myocardium using core perfluorocarbon droplets synthesized by
microfluidization in place of sonication and comprised in part or in full of C4F10 in place of pure C5F12.
In Specific Aim 2 will support transfer of manufacturing to a current good manufacturing practices
(cGMP)-certified contract organization for scale-up and production of a 10 L lot of sterile Electrast™
that meets specified product release criteria for particle size, concentration, and stability. Finally, in
Specific Aim 3 Sonnest will confirm, via internal and third-party testing, that Electrast™ meets the
company’s product specification and release criteria and FDA pre-clinical safety and toxicity
requirements for approval of a Phase I IND application. Expected Outcomes: At the end of this
Direct to Phase II SBIR Grant, Sonnest will have validated cGMP manufacturing to make Electrast™
at scale, robust preclinical safety and toxicity data, and an approved IND for the Phase I clinical
investigation of Electrast™.
.

## Key facts

- **NIH application ID:** 10256398
- **Project number:** 1R44HL156733-01A1
- **Recipient organization:** SONNEST, INC.
- **Principal Investigator:** Michael Cimorelli
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $833,724
- **Award type:** 1
- **Project period:** 2021-07-01 → 2023-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10256398

## Citation

> US National Institutes of Health, RePORTER application 10256398, Innovative Voltage-Activated Ultrasound Imaging Agent for Selective Myocardial Enhancement (1R44HL156733-01A1). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10256398. Licensed CC0.

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