Dune Medical Devices Ltd. reports that its breast cancer diagnostic probe has been found safe and effective in an Israeli medical trial. The trial will include 300 patients, at 11 medical centers.
The company called the trial a "general rehearsal" for an US Food and Drug Administration (FDA) approved medical trial at multiple medical center. The company hopes to begin marketing of its product in late 2008 or early 2009, a year later than the date announced 18 months ago.
Dune Medical also plans to open an office in New Jersey as part of preparations for the market launch.
"Globes": Why did you decide to conduct a medical trial in Israel? Most medical devices companies initiate multi-hospital trials after a small initial trial.
Dune Medical VP business development Gil Rosen: "Because we could. The trial in Israel was cheaper and we wanted to ensure that we would get the results we wanted before making the big investment needed to conduct a trial overseas. Three of the medical centers participating in the trial will be included in the data file of the large trial."
Dune Medical raised $12.5 million a year ago, and will probably have to raise more ahead of the trial in the US. This financing round, whenever it is held, will be a private placement. Rosen said, "We'll consider an IPO only when we have sales, even repeat sales."
Dune Medical's breast cancer product is aimed at diagnosing in real time whether the margins of tumors removed are malignant (which indicates the probability that not all the cancerous tissue was removed), or healthy (indicated the probability that the entire tumor was removed). This tissue is currently sent to a pathologist, who conducts a number of chemical procedures which make it possible to view the margins of the tumor. If the margins are cancerous, a repeat surgery is needed.
Published by Globes [online], Israel business news - www.globes-online.com - on January 8, 2008
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