Breast Cancer Surgery Tool Gains FDA Approval

Small Business Spotlight: Dune Medical

Who: Dan Hashimshony, Founder

What: A tool that detects cancerous cells to make sure doctors “get it all” when removing breast cancer tumors

When: 2002

Where: Israel and Boston, Massachusetts

How: Founder Dan Hashimshony is a physicist by training who was doing research and development at a medical device company, where he developed miniature x-rays to treat arteries. “I started Dune when I was looking for a new problem to solve. I look for difficult challenges, and when I started to explore the surgical margin issue, I decided that that was a major issue,” he says. Surgical margins are the area around a tumor; if the doctor leaves margins that contain cancerous cells, it results in additional surgeries for the patient.

“MarginProbe is a handheld probe that can distinguish between cancer cells and normal breast cells immediately when in touch with the patient,” says Hashimshony. “It sends radiation to the surface of the tissue, collecting and analyzing the tissue based on a stored library of tissues.”

In 2002, Hashimshony says he raised half a million dollars to build a prototype; in 2004, he raised $7.5 million from a large private equity firm. MarginProbe received FDA approval in January 2013.

Biggest challenge:  Hashimshony says FDA approval was the biggest hurdle for the company. “It’s a new category of product, and it took the FDA a while to understand it.”

One moment in time: The founder says that one of the things he’s proudest of is keeping his team together for more than 10 years. “Most of the people who started with me are still working here today. We had lots of ups and downs, but we were able to keep the group together,” says Hashimshony.

Best business advice: “Make sure you have the right people on board before any challenge.”

Most influential book: Hashimshony points to “Zen and the Art of Motorcycle Maintenance” as having a major impact. “Fixing machines gives you a lot to understand both about the world and about yourself,” he explains.