[This entry is marked for removal.]

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.

As low as reasonably achievable (ALARA) is in ultrasound imaging (ultrasonography) as well as in other medical imaging modalities (MRI, X-RAY, etc.) the guiding principle to keep patient exposure as low as possible for the diagnostic result.

Albunex and Infoson, used mainly in cardiac evaluations, are first generation one-pass-only contrast agents and have been replaced by the new-generation contrast media. Albunex and Infoson are the same sonicated human serum albumin microbubbles. Infoson is licensed and manufactured in Europe, while Albunex was produced in the USA.
Albunex, an air-filled microbubble with a denatured albumin shell (modified from air-filled albumin microspheres prepared from sonicated 5% human serum albumin), was the first FDA-approved contrast agent, but is no longer in production.
Cardiac shunts and valve regurgitations are often evaluated with Color Doppler Imaging (CDI), which also improved with injections of Albunex, but this agent is pressure-sensitive and does not recirculate. It is effectively a one-pass-only agent, limiting its clinical efficacy.

See also First generation USCA, Echocardiography and Contrast Enhanced Ultrasound.

Echoes of deep lying structures within the body do not always come from the latest emitted sound pulse and can produce an aliasing artifact. Aliasing lowers the frequency components when the pulse repetition frequency is less than 2 times the highest frequency of a Doppler signal. This artifact can be problematical at Spectral or Color Doppler examinations.
Aliasing of the data displayed in pulsed wave technology is utilized as a benefit in determining transitions from laminar to turbulent flow.

See also Ultrasound Imaging Modes.

California-based research and development company. Alliance Pharmaceutical Corporation. The principal activities of the Company is identifying, designing, and developing novel medical products. The Company is engaged in development of scientific discoveries into medical products and licensing these products to multinational pharmaceutical companies in exchange for fixed payments and royalty or profit sharing payments. The Company has developed three innovative products through initial clinical (human) trials. The products are Oxygent™, Liquivent and Imavist™. The Company's strategy is to identify potential new medical products though its own efforts and scientific collaborations with researchers and clinicians in universities and medical centers. In Dec 2000 the company acquired Molecular Biosystems Inc a developer of intravenous ultrasound contrast agent for the heart.

'September 20, 2001 Alliance Pharmaceutical Corp. announced that it has won a favorable Final Judgment from the United States Patent and Trademark Office's Board of Patent Appeals and Interferences regarding claims in U.S. Patent No. 5,558,854, which is owned by Nycomed Imaging, AS. The Final Judgment determined that claims made in the Nycomed patent with respect to 'microbubbles' that contain perfluorohexane filling gas are invalid and are therefore unpatentable.'
June 04, 2010, the company announced in their quartzerly report: 'We no longer have working capital to fund our operations. Because adequate funds have not been available to us in the past, we have already delayed our Oxygent development efforts and have eliminated our other product development programs.'

Ultrasound Contrast Agents: