Upon Approval, GE Healthcare's Oslo Facility Will Provide Stock to the US Becoming Only Contrast Media Manufacturer to Supply Its Own Stock to the US Market

PRINCETON, NJ, January 15, 2013 – GE Healthcare today announced that it has filed a supplemental new drug application (sNDA) that will allow the company to manufacture OptisonTM (Perflutren Protein-Type A Microspheres Injectable Suspension, USP), within its own facility. Optison is a contrast agent that may improve the visualization of the left ventricular border – an area of the heart that is critical to see in order to assess and diagnose certain heart diseases. Upon approval, GE Healthcare will provide supply of Optison to the US market from its manufacturing facility in Oslo, becoming the only contrast media manufacturer to supply its own stock for the US.

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CHICAGO  -- Breast cancer can be detected more accurately with a radiation-free, non-invasive screening test according to a study described today. The findings, released at the International Contrast Ultrasound Society (ICUS) 27th Annual Conference, found contrast-enhanced ultrasound imaging (CEUS) exams provide more accurate results than either MRI or conventional ultrasound imaging.

In a multi-center study of 351 women in Japan,  CEUS identified focal breast lesions with more accuracy, having fewer false positives and fewer false negatives when compared to MRI and unenhanced ultrasound imaging, according to Dr. Fuminori Moriyasu, medical advisor for the study at Tokyo Medical University.

"CEUS is an excellent diagnostic imaging tool that helps differentiate benign from malignant tumors without exposing patients to ionizing radiation," Dr. Moriyasu said. His study led to the recent approval in Japan of Sonozoid, an ultrasound contrast agent marketed by GE Healthcare.
 
Sonozoid is a liquid suspension of tiny gas microbubbles that can be injected into a patient's arm vein during an ultrasound exam to enhance the ultrasound signals, improving the clarity and accuracy of the ultrasound image.  Sonozoid is expelled from the body within minutes.

"These findings provide an exciting new radiation-free option for detecting breast cancer and assessing treatment," according to Dr. Sharon Mulvagh, a cardiologist at Mayo Clinic and women's health researcher.  The Japanese study is especially noteworthy because other studies show that CEUS can lower the overall cost of diagnostic imaging by improving the usefulness of frontline ultrasound scans, thereby reducing the need for redundant downstream testing.

"The potential impact of this is huge for women," Dr. Mulvagh added. She said that CEUS is readily accessible, safe and avoids exposing women to radiation.

The Phase 3 study showed that Sonozoid was accurate in 87% of patients, compared to 69.5% accuracy of MRI and 65.5% accuracy of conventional ultrasound without a contrast agent, according to Dr. Moriyasu.

“A new approval for characterization of breast masses holds great promise for women’s health”, added Stephanie Wilson, a radiologist at the University of Calgary and a Vice president of ICUS.
 
Sonozoid is not approved for use in the United States.  However, two other ultrasound contrast agents -- Optison (GE Healthcare) and Definity (Lantheus Medical Imaging) -- are FDA-approved for cardiac imaging in the United States.  In addition, Sonovue (Bracco) is used in Europe and elsewhere for imaging tumors and organ systems throughout the body. Additional applications of these ultrasound contrast agents are under review worldwide.

ABOUT ICUS: ICUS is an international, multi-disciplinary, not-for-profit medical society that is exclusively dedicated to advancing the use of contrast enhanced ultrasound diagnostic imaging to improve patient care worldwide. Founded in September 2008, ICUS brings together physicians, scientists, and other ultrasound imaging professionals from over 55 countries. ICUS members represent diverse specialties such as cardiology, radiology, vascular imaging, gastro-intestinal imaging, oncology, OB-GYN, and hepatology. For more information about ICUS, please visit www.icus-society.org/2013site.

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Mark Weller, 202.408.3933
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CHICAGO, IL -- Physicians announced today that tiny microbubbles are being used to more effectively deliver a blood clot busting drug to patients while they are in the ambulance during acute heart attack.

"Time is muscle," said Dr. Otto Kamp from VU University Medical Center in the Netherlands, stating that the quicker you deliver therapy the more heart muscle you will save.

Liquid suspensions of tiny gas microbubbles  have traditionally been used as a diagnostic imaging tool.  The microbubble suspensions are routinely used as ultrasound contrast agents to improve the clarity and reliability of an ultrasound image without exposing patients to ionizing radiation.  The microbubbles are about a third the size of a red blood cell and, when they are injected into a patient's arm vein, they improve the clarity and accuracy of diagnostic ultrasound exams. The microbubbles are expelled from the body within minutes.

Dr. Kamp's findings move microbubbles from a diagnostic imaging use to an exciting therapeutic application. He used microbubbles along with TPA, a drug that busts blood clots. When the injected microbubbles reached the clot, increased ultrasound frequencies were applied to cause the microbubbles to burst. The burst bubbles create tiny holes in the clot, allowing the drug to work more effectively in its targeted location.

"This permits a lower and safer dose of TPA with reduced side effects, especially hemorrhage and stroke," according to Dr. Kamp.  "This also permits increased doses of TPA and improves the efficiency of this therapy."

Steve Feinstein, a Rush University cardiologist and ICUS Co-president, said the findings demonstrate the vast potential benefits of using microbubble ultrasound contrast agents as a platform for delivering a range of drugs and genes to specific organ systems and tumors.

"Considerable work is underway showing that microbubbles may be useful in delivering cancer drugs, diabetes drugs, and genes that increase HDL -- good cholesterol -- to targeted sites throughout the body," he said.  "Dr. Kamp's work is especially exciting because it now shows how a related technique works in patients."

The Netherlands research was announced at the 27th Annual Advances in Contrast Ultrasound ICUS Bubble Conference, a gathering of physcians and scientists around the world in the fields of cardiology, radiology, vascular medicine, gastro-intestinal medicine, oncology, and other medical specialties.

ABOUT ICUS: ICUS is an international, multi-disciplinary, not-for-profit medical society that is exclusively dedicated to advancing the use of contrast enhanced ultrasound diagnostic imaging to improve patient care worldwide. Founded in September 2008, ICUS brings together physicians, scientists, and other ultrasound imaging professionals from over 55 countries. ICUS members represent diverse specialties such as cardiology, radiology, vascular imaging, gastro-intestinal imaging, oncology, OB-GYN, and hepatology. For more information about ICUS, please visit www.icus-society.org/2013site.

Contact:

Mark Weller, 202.408.3933
This email address is being protected from spambots. You need JavaScript enabled to view it.