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June 24, 2008 FDA Advisory Meeting

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Presentation on theme: "June 24, 2008 FDA Advisory Meeting"— Presentation transcript:

1 June 24, 2008 FDA Advisory Meeting
Maurizio Denaro MD Vice President Bracco Group R&D and Head of Ultrasound Business Unit

2 SonoVue® Composition and Structure
Sulfur hexafluoride (SF6) microbubbles Envelope/shell: Lipid/Phospholipids Microbubble diameter (Dn) 1.5 – 2.5 µm Human imaging dose 2 – 2.4 mL of microbubble suspension (0.03 mL/kg) in saline Volume of gas per human dose is µL Catena idrofobica Phospholipid SF6

3 SonoVue: Marketed in 21 Countries
European Union Switzerland Norway Iceland China Hong Kong South Korea Singapore

4 SonoVue: Approved Indications
Echocardiography … for use in patients with suspected or established cardiovascular disease to provide opacification of cardiac chambers and enhance left ventricular endocardial border delineation Microvascular enhacement …SonoVue® improves visualization of liver and breast lesion vascularity during Doppler Sonography, leading to more specific lesion characterization Macrovascular enhancement … increases the accuracy in detection or exclusion of abnormalities in cerebral arteries and extra-cranial carotid or peripheral arteries by improving the Doppler signal-to-noise ratio.

5 Ultrasound Contrast Agents : Unique Characteristics
SonoVue is a pure blood pool agent that provides real-time information of the vasculature improves the diagnostic information from MACROcirculation has an unique role in providing information of the MICROcirculation (vessels diameter below 200 m) useful for tissue organ perfusion characterization

6 Dr R. Senior, MD, DM, FRCP, FESC, FACC
Bracco Experts Dr R. Senior, MD, DM, FRCP, FESC, FACC Consultant Cardiologist and Director of Cardiac Research, Department of Cardiovascular Medicine, Northwick Park Hospital, Harrow, Middlesex, UK Patricia D. Williams, Ph.D. Chief Operating Officer Summit Drug Development Services, LLC Rockville, MD, USA

7 SonoVue: Key Messages Established safety record Highly positive risk/benefit profile in the approved indications Among the rare serious ADRs (RR 0.014%) the most frequent are allergy-like reactions (RR 0.01%) Nonclinical tools have been identified which may help to profile new agents to reduce potential risks

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