The company is a member of the Bracco Group, a highly innovative health care group and world leader in global integrated solutions for the diagnostic imaging field. The Bracco Group is headquartered in Milan, Italy. Its North American operations consist of Bracco Diagnostics and Bracco Research USA, both located in Princeton, New Jersey. Bracco Diagnostics is one of the fastest growing developers and marketers of diagnostic pharmaceuticals in North America, with products for various imaging applications, including Isovue® (iopamidol) X-ray contrast agent, ProHance®, (gadoteridol), MRI contrast agent, and nuclear medicine products.
Gadoteridol has been available in Europe and the USA for several years. Holder of the Marketing Authorization: Bracco International B.V. - Strawinskylaan 3051 - 1077 ZX Amsterdam The Netherlands. (Contact: Kirk Deeter, Phone: +NL-303-838-8708)

The Bracco Group is the world's leading provider of global diagnostic imaging solutions, with net sales of more than 1 billion euro, of which more than 64% from international sales; it has operations in 115 countries and about 3,500 employees, of whom more than 600 work in R&D. Bracco invests around 15% of its turnover in R&D and has a portfolio of 1,500 patents worldwide. The Bracco Group deploys an integrated approach to diagnostic imaging, with an offer that encompasses contrast media, its core business where it is one of the world's top players, biomedical equipment from Esaote, one of the world's primary producers of magnetic resonance and ultrasonographic medical equipment, contrast media delivery systems from Acist Medical Systems, a top US company in advanced contrast media injection systems, and medical application software from EBIT-AET and Singapore's Volume Interactions, the leading developer of advanced medical software. Bracco has formed a high-level international research network, whose three centers in Milan, Geneva and Princeton study and develop products for the latest-generation diagnostic techniques, from X-rays and computerized axial tomography to magnetic resonance and echo contrast.

Ultrasound Contrast Agents:

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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.

The Italian based company is a member of the Bracco Group.
In 1988 Ote-Biomedica Elettronica S.p.A. and the biomedical division of Esacontrol S.p.A. were consolidated into a single company, Esaote Biomedica S.p.A., operating as a division of IRI-Finmeccanica.
In 1987 the company began marketing its products in the United States through Biosound Inc., which it subsequently acquired in 1990.
In the 1990's, the company began to strengthen its presence in Europe, establishing Esaote Biomedica France Sarl and Esaote Biomedica Deutschland GmbH.
In July 1994 business activities and assets of Esaote Biomedica S.p.A. were transferred to the new company Esaote S.p.A.
1995-1998 the Bracco Group becoming the main Esaote shareholder with 50% of the share capital.
In February 1997, Esaote established Esaote China Ltd. located in Hong Kong, and in April 1998 acquired Pie Medical Group, based in Maastricht - The Netherlands, which primarily operates in medical diagnostic ultrasound. Esaote-Pie Medical, is exclusively dedicated to the development and marketing of veterinary diagnostic ultrasound equipment.
GE Healthcare is the exclusive U.S. distributor of devices manufactured by Esaote Biomedica.

'The Esaote Group is a global leader in research, production and marketing of medical diagnostic equipment and related services focused on solving the medical needs of our customers worldwide. With over 16% of its employees actively engaged in Research & Development, Esaote is pursuing new diagnostic technologies to be introduced in international healthcare markets.'

Ultrasound Related Product Lines:
For products dedicated to the veterinarian practice see Esaotes Pie Medical Equipment B.V.
For products distributed in the United States see Biosound Esaote, Inc.

Ultrasound Systems:

Imagent® is an injectable suspension for intravenous administration during a sonogram. This diagnostic contrast agent for enhancement of ultrasound images contains perflexane lipid microspheres. Imagent® US is indicated in the assessment of heart function and perfusion, as well as the detection of tumors and blood flow abnormalities by using gray scale, color Doppler, and harmonic ultrasound imaging techniques.
During the course of its development, the brand name for this product has changed from Imagent to Imavist (between August 2000 and March 2002) back to Imagent. The manufacturer's 06/03/02 press release announcing FDA approval refers to the product as 'Imagent (formerly Imavist),' and the approval notice and monograph posted at the FDA site refers to the product as Imagent.
Jointly developed by Alliance Pharmaceutical Corp and Bayer Schering Pharma AG (Germany). Source: PR Newswire - 10/10/96, 03/31/98, 10/13/99, 03/13/01, 10/08/01; FDA approvals - 05/31/02; Alliance Pharmaceutical press release - 06/03/02.
Currently the production of Imagent® is discontinued.

See also Imagent®.
June 19, 2003
Alliance Pharmaceutical Corporation and Photogen Technologies, Inc. announced that they have closed the previously announced transaction whereby Photogen has acquired all of the assets of Alliance related to medical imaging, including all manufacturing and marketing rights to Imagent (formerly Imavist). Terms of the transaction were not disclosed.

June 03, 2002
Alliance Pharmaceutical Corp. announced that its ultrasound imaging agent, Imagent (perflexane lipid microspheres), has been approved for marketing by the U.S. Food and Drug Administration. The product will be marketed by Alliance in partnership with Cardinal Health, Inc., a provider of products and services to the healthcare industry, and inChord Communications, Inc., an independent healthcare communications company.

March 01, 2002
'Alliance Pharmaceutical Corp. announced that it has entered into a partnership with Bayer Schering Pharma AG, Germany and Cardinal Health Inc. for the marketing of Imavist (perflexane lipid microspheres), an ultrasound contrast agent. Schering licensed worldwide marketing rights for Imavist from Alliance in September 1997. The companies have agreed to modify this agreement to allow Alliance to increase its participation in the marketing of the product. Under the terms of the modified agreement, Alliance will have exclusive marketing rights to Imavist for cardiology indications in the U.S. for five years, and Schering will receive a royalty on product sales. Schering retains marketing rights for other indications in the U.S. and all indications in the rest of the world, subject to Alliance's option to obtain additional indications and territories. Under certain circumstances, Schering would co-market the product at the end of five years. Concurrently, Alliance has entered into a five-year exclusive agreement with Cardinal Health Inc., a provider of products and services to the health-care industry, to assist in the marketing of Imavist.'

October 08, 2001
'Alliance Pharmaceutical Corp. announced a clinical study to take place at Thomas Jefferson University Hospital, Philadelphia, using Alliance's Imavist (AF0150) contrast agent with ultrasound imaging to improve detection of prostate cancer. The study, which will involve 300 adult men with suspected prostate cancer, is being funded by the U.S. Department of Defense under a competitive grant awarded to Thomas Jefferson University for investigators at Jefferson's Prostate Center. Imavist is being developed jointly by Alliance and Bayer Schering Pharma AG Germany, and is awaiting final approval from the U.S. Food and Drug Administration.'

August 21, 2000
Alliance Pharmaceutical Corp. announced that it has received a letter from the U.S. Food and Drug Administration (FDA) stating that the FDA has completed its review of the New Drug Application (NDA) for Imagent (AF0150), and found it to be approvable. Imagent, an ultrasound contrast agent, is being developed jointly by Alliance and Bayer Schering Pharma AG, Germany

Notes:
The manufacturer is pursuing additional radiology indications such as ultrasound imaging of the prostate and liver, and clinical trials are currently being conducted to evaluate Imagent in conjunction with ultrasound imaging for use in the detection of prostate cancer. During the course of its development, the brand name for this product has changed from Imagent to Imavist back to Imagent. Initially reported on by the manufacturer as Imagent and then, between August 2000 and March 2002, as 'Imavist (formerly Imagent).' The manufacturer's 06/03/02 press release announcing FDA approval refers to the product as 'Imagent (formerly Imavist),' and the approval notice and monograph posted at the FDA site refers to the product as Imagent. Jointly developed by Alliance Pharmaceutical Corp and Bayer Schering Pharma AG, (Germany). Source: PR Newswire - 10/10/96, 03/31/98, 10/13/99, 03/13/01, 10/08/01; FDA approvals - 05/31/02; Alliance Pharmaceutical press release - 06/03/02.