Dune Medical Devices Ltd. has received a favorable recommendation from an US Food and Drug Administration (FDA) advisory panel for the company's flagship product, the MarginProbe, for real-time breast cancer detection of excised tissue in the operating room. Ten of the panel's eleven members voted in favor of approving the device for marketing. The company is now waiting for final FDA approval.
Dune Medical's product tests whether all tumor tissue has been removed in surgery. The first application is for breast cancer. If the test finds that no cancerous tissue remains, the surgical procedure is completed; if it finds cancerous tissue on the margins of the excised tissue, the surgical procedure can continue.
Currently, excised tissue is sent for a biopsy, the results of which are only available a day after the surgical procedures. If the biopsy finds that the margins of the excised tissue are cancerous, the patient has to under another surgery. Dune Medical says that 30-60% of current breast cancer surgical procedures require further procedures.
The MarginProbe successful underwent a pivotal study with 600 patients, under the FDA premarket approval (PMA) procedure.
Published by Globes [online], Israel business news - www.globes-online.com - on June 24, 2012
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