SBIR-STTR Award

Long-term objective to be a leader in It is ImaR x s long the development of new techniques and contrast agents for diagnostic imaging. In medicine, it is paramount that to treat disease we must first establish the correct diagnosis and medical imaging has assumed a pivotal role in this regard. ImaR, is developing new functional contrast agents for magnetic resonance imaging (MRI) and ultrasound (US), including vascular (blood pool), liver, spleen, bone marrow and gastrointestinal (GI) contrast agents. MR agents already under development increase detection of tumors in the liver, spleen, and bone marrow and may be useful for evaluating lymph nodes in diseases such as lymphoma. The GI MR contrast agents that ImaR,, has under development increase the echogenicity (signal) from blood, liquids and other tissues. ImaR,, has developed a blood pool agent called AerosomesS. AerosomesS may be targeted to the vascular system to improve measurement of blood flow, cardiac imaging and detection of tumors in organs such as the liver. Aerosomesg have important applications in US for oncology and the cardiovascular system. It is the focus of this grant to continue work on AerosomesS for eventual entry into clinical trials. There is a large potential market for AerosomesS, because stable, bubblebased contrast media for US do not yet exist commercially and will expand the capabilities of diagnostic US and of this cross-section imaging technique. There is a potential savings of health care dollars, as US might be used instead of more expensive techniques such as MRI or computed tomography.Awardee's statement of the potential commercial applications of the research:The potential commercial applications include a potential market wofld-wide of more than $1 billion per year for the agents already under development. The contrast agents can be licensed to corporations already involved in the industry or manufactured by ImaR,, and distributed by ImaRx or distributed under license by one of the contrast agents companies already in the field.Food and Drug Administration (FDA)

Diagnostic ultrasound potentially represents a billion dollar a year market worldwide. The applicants' specific aims and longterm objective involve the development of an efficient and low-cost ultrasound contrast agent with improved image sensitivity such that the applicants believe could become the industry standard for a variety of diagnostic procedures (i.e. hepatosplenic imaging, cardiac imaging and wall-motion studies, blood- pool imaging [hemangiomas], and vascular flow studies). The research methodology would involve critical in vitro, in vivo, and acoustic characterization studies to aid the applicant organization, ImaRx Pharmaceutical, in determining the potential for it's application. The implications of the research could provide a means for substantially reduced health-care costs with regard to diagnostic imaging as the use of Aerosomes with ultrasound potentially could become a high quality and reliable alternative to existing, more costly, diagnostic procedures (MRI, CT, etc.). This could become particularly beneficial for small community hospitals as well as third work health care concerns as Aerosomes with ultrasound could provide high quality, low cost diagnostic healthcare. Goals of Phase II would include: acoustic characterization; shelf life stability determination; conduct of detailed pharmacology and toxicology; conduct of detailed biodistribution studies, conduct of further imaging studies, and initiate planning of Phase I clinical trials.