SYN, Daily, Devices & Diagnostics

Dune Medical gets 3 million euro grant to develop new biopsy device

Dune Medical has received a grant from EU's largest innovation program in history that seeks to spur the translation of novel research breakthroughs into commercialized products.

Euros

Dune Medical has received a €3 million ($3 million) grant from the European Union to develop a new biopsy device based on the technology that created its MarginProbe device used by surgeons to detect breast cancer at the margins following tumor removal.

The money comes from Horizon 2020, the largest EU research and innovation program in its history with nearly €80 billion ($90.6 million) of funding available over 7 years from 2014 to 2020.

“This three million euro grant will expedite bringing our soft tissue biopsy system to the market,” says Dan Hashimshony, founder and CEO of Dune Medical, in the news release. “It will provide radiologists and surgeons immediate graphic characterizations of tissue abnormalities along the tip of the biopsy needle, just before samples are taken. This real-time insight can help reduce the time to a definite diagnosis and repeated biopsies. Our propriety biopsy device can also be used in combination with other existing devices.”

The statement added that Dune Medical was among 1,167 applicants in the small and medium (SME) instrument category that applied for the grant and among the 65 ultimately selected to receive the funding.

In the U.S., Dune Medical has commercialized a product called the MarginProbe, which was cleared in 2013 by the Food and Drug Administration.  That device is used by a surgeon in the operating room following a lumpectomy to detect cancer at the margins. This is done in real time to ensure that women whose breast cancer tumor is being removed don’t have to return for a repeat surgery because all the cancer wasn’t detected and removed the first time around. Repeat surgeries in breast cancer are fairly common and is a problem that other companies besides Dune Medical are also addressing.

The new biopsy device will leverage the technology being used in the MarginProbe called radio frequency spectroscopy, explained Lori Chmura, president of Dune Medical’s U.S. operations, which is based in Paoli, Pennsylvania, in a phone interview Monday.

While the grant will aid the commercialization of the biopsy product in the EU, Chmura said she isn’t exactly sure how FDA will view it. Will the pathway be a 510(k) being given that biopsy technology exists with four or five players in the market, or will the device require a premarket approval given that the technology that Dune Medical is using is different?

“Doing the tissue characterization using radio frequency spectroscopy doesn’t exist today except for on the MarginProbe,” Chmura said.

In essence the biopsy device being developed would be a new application of the tissue characterization technology that exists in the MarginProbe. So far the device, whose name Chmura declined to provide, has a finished design. Now the grant will be used to commercialize the device  and bring it to market in Europe first and eventually in the U.S.

 

Photo Credit: Flickr user Images Money

 

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