WARRENDALE, Pa., July 6, 2010 – MEDRAD, Inc. a business of Bayer Medical Care has received FDA clearance* to market the MEDRAD Intego PET Infusion System (Intego) for Sodium Fluoride (F¹⁸-NaF) administration in Positron Emission Tomography (PET) imaging.  F¹⁸-NaF PET is most frequently used in oncology to find and assess bone metastases.     

With its rapid uptake in the bone and quick bone clearance, there is growing clinical evidence of the value of F¹⁸-NaF as a very effective diagnostic imaging agent in bone cancer imaging. PET technology provides high resolution images that may be quantified for detailed and comparative analysis.  It is these benefits, in part, that led the Center for Medicare and Medicaid Services (CMS) to announce plans in February 2010 to cover F¹⁸-NaF PET imaging for beneficiaries under a Coverage with Evidence Development program.**  

Receiving FDA clearance for F¹⁸ fluoro-deoxy-glucose (F¹⁸-FDG) administration in 2008, Intego is the only multi-PET agent infusion system currently cleared by the FDA.  The system is loaded with a multi-dose vial and nuclear medicine technologists can dose on demand from a touchscreen to enable precise, flexible, safe, and efficient administration of PET agents.  MEDRAD Intego systems are in place in hospitals and clinics throughout the US, Europe, Australia, and the Middle East.     

“MEDRAD believes in the power and potential of molecular imaging and diagnostics.  We plan to continue to innovate and create solutions for clinicians and researchers to enable the science and provide benefit to patients,” said Doug Descalzi, executive director of molecular imaging for MEDRAD.    

* FDA Clearance Letter, K100798.
** Decision Memo for Positron Emission Tomography to Identify Bone Metastasis of Cancer (CAG-00065R) http://www.cms.gov/mcd/viewdecisionmemo.asp

About MEDRAD, Inc.
MEDRAD, Inc. develops, markets and services medical devices used to diagnose and treat disease. Its product offerings include fluid injection systems for radiology and cardiology, endovascular devices for the safe treatment of cardiovascular disease, magnetic resonance-compatible accessories and equipment services. The company’s world headquarters is near Pittsburgh, Pennsylvania, in the United States. MEDRAD is a business of Bayer Medical Care. More company information is available at www.medrad.com.

About Bayer HealthCare
The Bayer Group is a global enterprise with core competencies in the fields of health care, nutrition and high-tech materials. Bayer HealthCare, a subsidiary of Bayer AG, is one of the world’s leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Medical Care and Pharmaceuticals divisions. The pharmaceuticals business operates under the name Bayer Schering Pharma. Bayer HealthCare’s aim is to discover and manufacture products that will improve human and animal health worldwide. Find more information at www.bayerhealthcare.com.

Forward-looking statements
This news release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

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