FDA approval fortifies Dune Medical Devices
A 10-year-old medical device company headed to the Hub’s Innovation District has won crucial U.S. Food and Drug Administration approval to sell its breast cancer tissue assessment tool nationwide.
Surgeons using the MarginProbe System from Dune Medical Devices can better detect cancer cells along the margins of excised breast tissue via a device sensor that emits electromagnetic energy.
“We think it can be a very important addition to the surgeon’s ability to perform a complete lumpectomy with one surgery,” Dune Medical CEO Dan Levangie, 62, told the Herald, adding the U.S. rate of second operations for patients who have lumpectomies ranges from 30 percent to 60 percent. “It is indeed a breakthrough and a first-of-its-kind device.”
MarginProbe, which is now available nationwide, is currently sold in Germany, Switzerland and Italy, Levangie said.
FDA approval of the device was based on results from a 664- patient device effectiveness study.
This month, Dune Medical will also move its U.S. operations from Framingham to 25 Thomson Place in Boston’s Fort Point neighborhood, next door to where car-sharing service Zipcar will park its new headquarters.
The privately held Dune Medical has been financed by Apax Partners, a London-based private equity firm, since 2004.
It also has offices in Switzerland and Israel, where the majority of its employees are based.
Dune Medical founder and former CEO Dan Hashimshony was previously chief scientist of X-Technologies, a company acquired by Guidant Corp., the medical device giant swallowed by Boston Scientific in 2006.
Levangie said Dune Medical may hire as many as 25 new employees within the year based on MarginProbe’s market response.
Research and development is also under way to explore how the device’s technology can be applied to other diseases, such as prostate cancer.
“The market has been waiting for this and there’s a lot of enthusiasm out there,” said Levangie, who previously held executive positions with Cytyc Corp., which was acquired by Hologic Inc. in 2007.
“This really represents the culmination of almost 10 years of very hard work by a small group of individuals that now have the approval to bring the device to the largest market in the world,” he said. “We’re excited to bring it to market.”
Tool OK’d to help find all cancerous breast tissue
Dune Medical will build its sales force at a new Boston office
Photo: DUNE MEDICAL DEVICES INC.
The MarginProbe system already is used in Israel, Germany, and Switzerland to ensure all cancer cells are found in breast surgery.
Federal regulators have approved a new instrument made by Dune Medical Devices Inc. that enables breast cancer surgeons to determine immediately whether they have removed all of the cancer tissue during lumpectomy procedures, the company is set to disclose Wednesday.
Dune Medical, based in Caesarea, Israel, plans to move its US office from Framingham to Boston’s Innovation District next week as it builds a sales force to market the device, called the MarginProbe system, to breast cancer surgeons across the nation.
The company expects to have 25 to 30 sales, finance, and administrative employees in Massachusetts by the end of the year, up from about six today, said Daniel Levangie, the Boston-based chief executive of 11-year-old Dune Medical. Dune Medical’s research and development team and its founder, Dr. Dan Hashimshony, remain in Israel.
Dune Medical’s new device, already in use in Israel, Germany, and Switzerland, got the green light from the Food and Drug Administration eight months after the privately held company filed its application for premarket approval. That followed clinical trials involving 664 patients at two dozen sites in the United States and Israel. MarginProbe was shown to be effective in identifying cancer along the edge of breast tissue during lumpectomy surgery.
“It supports the performance of breast-conserving surgery,” said Dr. Freya Schnabel, director of breast surgery at NYU Langone Medical Center in New York, who was principal investigator for the clinical trial at NYU Langone. “It can be very difficult in the operating room to understand where the cancer ends. This device gives surgeons information intra-operatively — at the time of surgery — to determine whether more tissue needs to be taken.”
‘This is a first-of-a-kind device. But the technology can be applied to a wide variety of other cancers.’
Lumpectomies account for roughly two-thirds of breast cancer surgeries. Their numbers have been growing in Western countries as surgeons seek to conserve breast tissue and avoid mastectomies, the surgical removal of the breast, whenever possible. But after a lumpectomy, it can take up to a week to send tissue samples to a pathology lab and learn whether there is “cancer on the margin,” necessitating a second procedure.
MarginProbe, using disposable probes attached to a console containing detection software, can be deployed during the initial lumpectomy to see if more tissue should be cut away. The device uses radio frequency energy to identify the “signature” of tissue and differentiate between healthy and abnormal cells.
“This is the only device that will identify microscopic cancer on the margin,” Levangie said, noting that MarginProbe is his company’s first approved product. “This is a first-of-a-kind device. But the technology can be applied to a wide variety of other cancers.”
Among other things, Dune Medical scientists are working on a tissue-assessment device for use during prostate cancer procedures and a device to aid in breast biopsies, he said.
MarginProbe’s FDA approval had been widely anticipated since the agency sent Dune Medical a so-called approvable letter in November, indicating it planned to OK the device, subject to final agreement with the company on a post-approval study.
MarginProbe, including the console and probes, will cost health care providers about $2,000, a fraction of the cost of screening equipment used to make the initial diagnosis of breast cancer.
The device is designed to be used only during breast-conserving surgeries; the goal is to eliminate second surgeries, which now occur in more than 20 percent of cases and can cost about $7,000 each, Levangie said.
With about 285,000 cases of breast cancer diagnosed in the United States each year, and at least 400,000 in Europe, the potential market for MarginProbe is large, Levangie said.
Dune Medical is backed by a London private equity firm, Apax Partners.
Levangie, who has worked for Abbott Laboratories and Cytyc Corp., a Marlborough company sold to Hologic Inc. in 2007, said it is too soon to determine whether Dune Medical will eventually go public or be sold to a larger life-sciences company.
Robert Weisman can be reached at firstname.lastname@example.org.