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November 21, 2006 November 21st – November 27th 27th November: AngioDynamics Announces FDA Clearance for Irreversible Electroporation Technology AngioDynamics, Inc. (Nasdaq:ANGO ) announces that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for Oncobionic, Inc. to market Irreversible Electroporation (IRE) - a technology indicated for surgical ablation of soft tissue, including cardiac and smooth muscle. As previously announced, AngioDynamics has initiated the process to acquire Oncobionic through an initial, non-refundable, cash deposit of $5 million, with an additional $20 million in cash payments to be paid over two years, subsequent to achievement of specified milestones. The acquisition of Oncobionic will close upon successful human use of its IRE technology, for which testing is expected to commence in mid calendar 2007. Irreversible electroporation uses needles and image guidance similar to existing thermal ablation technologies, but instead of "cooking" or "freezing" the targeted tissue, IRE disrupts the cell membrane, thereby destroying the targeted cells. In IRE, needle electrodes are placed through the skin by image guidance in the center or at the edge of the targeted tissue. A certain electrical field is then generated within the electrode array, causing permanent nanoscale defects (pores) in the cell membranes. The permanently impaired cells are left in the body to be removed by the body's natural immune system. IRE potentially offers significant advantages over radiofrequency and cryoablation, the two leading thermal ablation technologies in the market today, including:
Cancer is the leading cause of death in the United States of people under age 85. Cancerous tumors within the liver, lung, breast, prostate, kidney and bone have been successfully treated with focal ablation technologies, and the company estimates an annual potential market opportunity in the United States in excess of $1.6 billion. In addition, the company estimates an annual $4.4 billion potential market in the United States for the treatment of Benign Prostatic Hyperplasia (BPH), more commonly known as enlargement of the prostate. AngioDynamics notes that it continues to expect fiscal 2007 research and development expense to be 8.3% of net sales, as previously announced. 27th November: Toshiba Announces FDA Clearance for New Vantage Atlas MRI System Toshiba America Medical Systems, Inc. today announced that the Food and Drug Administration has cleared for market its new EXCELART Vantage(TM) powered by Atlas 1.5T magnetic resonance imaging (MRI) system. The system will be showcased at the Radiological Society of North America's (RSNA) annual meeting in Chicago, Nov. 26-Dec. 1, 2006. The Vantage Atlas 1.5T MRI system features a complete redesign of the system. The new 128-element system will meet clinical demands for an MRI system that delivers high-resolution images across the entire body with faster imaging times, rendering quick and accurate diagnosis, and will increase patient comfort. The new Atlas system design is an integrated coil concept that will allow clinicians to perform multiple exams without repositioning the patient. This will mean more comfortable exam experiences and will result in enhanced workflow and technologist productivity. Also, the Vantage Atlas' optional 205-cm acquisition range allows for feet-first imaging for the entire body, except the neck and head. "The Vantage Atlas features state-of-the-art technology and is designed with exceptional patient care and comfort in mind," said Bob Giegerich, director, MR Business Unit, Toshiba. "The system not only decreases imaging time and broadens future upgrade capabilities, its imaging quality is second-to-none." Featuring some of the most advanced MRI applications available in the industry, the Vantage offers a wide range of optional packages for cardiac imaging, including advanced Echo Planar Imaging, Diffusion and Perfusion Imaging, Peripheral Angiography and Fresh Blood Imaging, SuperFASE (Fast Advanced Spin Echo) Imaging and Body Vision. In addition, Toshiba's SPEEDER parallel imaging allows for increased acquisition speed and reduced examination times. 27th November: Spectrum Dynamics Receives 510(K) Clearance for the D-SPECT(TM) Cardiac System SPECTRUM DYNAMICS today announced at the Radiological Society of North America (RSNA) annual meeting in Chicago that its D-SPECT(TM) Cardiac System has received 510(k) clearance from the U.S. Food and Drug Administration (FDA), and is expected to begin commercial shipments next year once the initial clinical studies are completed. The D-SPECT system with BroadView(TM) imaging technology represents a breakthrough in almost every component of nuclear cardiology imaging workflow and diagnostics. The D-SPECT is an entirely new technology designed to transform the nuclear medicine imaging market by significantly reducing acquisition time while improving sensitivity and resolution. "We are pleased that Spectrum Dynamics has obtained 510(k) clearance for the D-SPECT Cardiac System and we are confident that the D-SPECT will be extremely well received by the nuclear medicine marketplace," states Dr. Michael ("Miki") Nagler, CEO of SPECTRUM DYNAMICS. BroadView imaging technology provides significantly improved sensitivity by collecting photons using larger collection angles, a novel design of scanning solid state detectors and proprietary image reconstruction techniques. This technology has produced an imaging platform capable of acquiring patient data up to 10 times faster than a conventional sodium iodide based system, and with up to twice the resolution. "The D-SPECT opens the door to new possibilities and enables high definition personalized imaging and the use of low-dose radiopharmaceuticals," states Josh Gurewitz, Vice President of Marketing. "In the future, dynamic imaging and the use of multiple radiopharmaceutical cocktails will create vast opportunities for new diagnostic procedures." SPECTRUM DYNAMICS will revolutionize the practice of nuclear cardiology, and eventually all nuclear medicine applications, by dramatically enhancing workflow and providing new clinical applications not possible with conventional technology.
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