From Sonus Pharmaceuticals
QW7437 (SonoGen) is a perfluorocarbon-based ultrasound contrast agent under development. This anionically charge-stabilized emulsion, similar to EchoGen, has been designed for echocardiographic examinations with greater safety and efficacy.

Reflux sonography, as an alternative to micturating cystography (MCU), evaluates vesico-ureteral reflux (VUR), a common problem in children. Contrast enhanced pulse-inversion imaging shows best results. During the instillation of an ultrasound contrast agent into the bladder, (as for a conventional MCU) the lower ureters and renal pelves are scanned transabdominally as the bladder is filled to stimulate micturition.
Advantages for reflux sonography are a high sensitivity and the avoidance of X-rays. A disadvantage is the poorer depiction of the posterior urethra. However, for girls and for all follow-up studies, the ultrasound MCU has become standard in many pediatric ultrasound departments.

See also Urologic Ultrasound, Kidney Ultrasound, Ultrasound Safety, Ultrasound Imaging Modes.

SonoGen (QW7437) is an anionically charged 2% perfluorocarbon emulsion under development as a transpulmonary myocardial ultrasound contrast agent (UCA). The SonoGen microbubbles have a reduced adherence to the negatively charged vascular endothelium and reduced coalescence. SonoGen, a second generation USCA has the theoretical potential to provide high safety and efficacy and improved tissue grayscale persistence compared to first generation fluorocarbon contrast agents.

Ultrasound is the ideal tool to examine children of all ages. It is fast, painless, uses no ionizing radiation, and does not require a baby to remain still for long periods. Real-time modes show movement of internal tissues and organs. Advanced ultrasound imaging techniques such as color Doppler, 4D ultrasound, harmonic imaging, and higher resolution, as well as the application of ultrasound contrast agents broaden the potential of ultrasound.
Pediatric [paediatric, Brit.] ultrasound can be used in all body regions and reduce the number of more invasive or radiating examinations that often additionally need sedation or intravenous iodinated contrast agents.

See also Fetal Ultrasound, Reflux Sonography, Ultrasound Safety, Abdominal Ultrasound and Pregnancy Ultrasound.

[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.