FDA approves Dune Medical's breast tumor test

The MarginProbe device improves the results of lumpectomy procedures for removing breast cancer tumors.

Dune Medical Devices Inc. has obtained US Food and Drug Administration (FDA) approval for its MarginProbe device which improves the results of lumpectomy procedures for removing breast cancer tumors.

Dune Medical has raised $30 million since it was founded in 2004. Investors include Apax Partners, Meditech Advisors, Zeev Mozes, and the Office of the Chief Scientist via the Misgav Venture Accelerator.

The approval process was complicated. The MarginProbe successfully underwent a pivotal study with 600 patients, under the FDA premarket approval (PMA) procedure. The study proved that the device's electromagnetic radiation can distinguish between tumor and regular cells, and show in real time during surgery if all the cancerous tissue has been removed. 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. The device can prevent repeated lumpectomies and preserve as much of the breast as possible.

"To the best of my knowledge, competing technologies are in the initial development stages and are 4-5 years from market. Use of the PMA procedure was an advantage; if you have it, you're protected from competition," said Dune Medical chairman and Apax partner Amos Goren.

Dune Medical is developing more products, including a navigation device to help doctors collect biopsy samples from the breast, and a product similar to the MarginProbe for testing the removal of prostate tumors.

The MarginProbe is already sold in Germany. "We've sold 14 units, without any extraordinary marketing effort," said Dune Medical president and CTO Dan Hashimshony.

Published by Globes [online], Israel business news - www.globes-online.com - on January 2, 2013

© Copyright of Globes Publisher Itonut (1983) Ltd. 2013

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