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From Acusphere Inc
AI-700 (trade name Imagify™) is an US contrast agent, usable for myocardial perfusion undergoing regulatory FDA approval. The synthetic polymers used in AI-700 (perflubutane polymer microspheres) do not break during the ultrasound imaging procedure. The used perfluorocarbon filling gas is less soluble in water and therefore has the propensity to stay inside the contrast agent particles. As a result, a higher concentration of gas is delivered to the myocardium over a longer period of time, thereby enabling AI-700 to target the broader application of myocardial perfusion assessment.
Imagify is a dry powder consisting of small, porous microparticles filled with perfluoropropane. These microparticles are made of a synthetic biodegradable polymer, called poly (D, L-lactide co-glycolide), or PLGA, that has been used in other drug delivery systems approved by the FDA.
The composition and structure of the phospholipid containing microparticles and the properties of the perfluorocarbon gas slow the rate at which the gas dissolves and prevent the microparticles from being quickly broken down. The powder is to suspend in sterile water and injected by a single intravenous injection prior to ultrasound imaging.

In 2009, Acusphere Inc received feedback from the Food and Drug Administration (FDA) to their New Drug Application (NDA) stating that another clinical trial would be required for U.S. approval, this one demonstrating that Imagify with ultrasound is superior to ultrasound without Imagify.
In June 2004, Acusphere entered into a Collaboration, License and Supply Agreement with Nycomed Danmark APS for the European development and marketing rights to Acusphere's lead product candidate AI-700.
Acusphere's focus will be on preparing the Marketing Authorization Application (MAA) for filing in Q4 2010, building upon the work that the previous partner, Nycomed, had done, in concert with the NDA.


In 2008 the FDA panel rejected the regulatory application for AI-700 (Imagify™) because of safety concerns.

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From POINT Biomedical Corp
CARDIOsphere® is an ultrasound contrast agent for assessment of myocardial perfusion in patients with coronary artery disease composed of highly echogenic bispheres.
PB127 is a new developed microbubble with a bilayer polymer/albumin shell filled with nitrogen gas that has ideal characteristics for power harmonic Doppler. They can be destroyed by high power ultrasound, and spectral decorrelation between ultrasound pulses is maximized by rapid dissolution of the released nitrogen gas.
POINT Biomedical Corp. announced (March 01, 2004) that it has completed two Phase 3 trials of CARDIOsphere®. The Phase 3 trials were designed to evaluate the performance of CARDIOsphere® imaging relative to radionuclide imaging for detecting obstructive coronary artery disease and identifying the anatomic location of perfusion defects.

Lantheus Medical Imaging, Inc. engages in discovering, developing, and marketing medical imaging agents. Lantheus Medical Imaging has headquarters in North Billerica, Massachusetts, and offices in Puerto Rico, Canada, and Australia. During its history, the company launched the products Cardiolite (Technetium Tc99m Sestamibi Preparation Kit), which has become the gold standard for use in myocardial perfusion imaging, and Definity (perflutren lipid microsphere) for use in suboptimal echocardiograms.
From 2001 to 2008 Lantheus was part of the Bristol-Myers Squibb Medical Imaging, Inc. group.

Ultrasound Contrast Agents:

(Perfluorocarbon exposed sonicated dextrose albumin) PESDA are sonicated dextrose albumin microbubbles containing decafluorobutane gas. PESDA is a sonicated self made contrast agent and not a commercial product.
PESDA microbubbles can be used as a blood pool contrast agent in echocardiography to improve the detection of myocardial perfusion abnormalities.

Selective detection of the microbubble contrast medium can be enhanced by Doppler processing that removes signals with zero Doppler frequency shifts. This will remove tissue harmonics. By detecting overlong bursts of inverted pulses and using Doppler detection methods, very high sensitivity to microbubbles can be achieved. The bubbles can be detected at sufficiently low incident power levels to avoid destroying them. Pulse inversion Doppler has demonstrated the first real-time images of myocardial perfusion using perfluorocarbon gas agents.

See also Pulse Inversion Imaging, Myocardial Contrast Echocardiography, and Perfluorochemicals.