MarginProbe is the first commercial product based on Dune Medical’s proprietary radio frequency (RF) spectroscopy technology. Receiving U.S. FDA Premarket Approval in December 2012, it has been helping surgeons ensure clear margins in lumpectomy procedures since 2013. Peer-reviewed studies show MarginProbe reduces re-excision rates in lumpectomy procedures by 50 – 79 percent.
Recent reports show that 21.6% of patients undergoing initial lumpectomy for cancer had one or more re-excisions. Additionally, “researchers found that in the past 10 years more U.S. women diagnosed with early-stage breast cancer who were eligible for lumpectomy chose mastectomy or double mastectomy followed by reconstruction.” These decisions are often made without full knowledge of individual risk factors and knowledge that mastectomy involves a higher level of risk of complications and longer recovery times compared to lumpectomy plus radiation.
With MarginProbe, surgeons have a greater chance of getting clean margins in the first lumpectomy surgery. To date, 10,000 patients have been given that advantage with that number growing every day.
What breast cancer surgeons say about MarginProbe.
“Since I’ve been using the MarginProbe, when I do a lumpectomy for DCIS, I actually use the MarginProbe in the operating room. If it tells me I need to remove additional tissue from any of those edges, we can do it right at that time. It significantly increases the chance of getting good margins on the first surgery.” – Dr. Melanie Friedlander, South Bay Surgeons & Clinical Instructor of Surgery, University of Southern California
“After looking at our preliminary data we’ve found MarginProbe has significantly reduced our incidence of a positive margin. That means that I’m taking patients much less frequently back to the operating room for re-excisions now. In fact, with our first 36 cases using MarginProbe, we looked at our data and, our re-excision rate was 2.8%, which is far, far less than what you’d expect.” – Dr. Jeffrey Falk, Surgical Oncologist, St. John Health Breast Care Program
“We put unique clinically actionable information into the hands of surgeons while in the OR to help them make the best possible decisions for patient care,” says Dune Medical CEO Lori Chmura. “Improving the standard of care around cancer surgery is what we strive for each and every day.”
The MarginProbe System
The MarginProbe System consists of three primary components — the Sensor, the Attachment Mechanism and the Algorithm — designed to provide reliable performance and ease of use for surgeons within the operating room environment. The system utilizes RF Spectroscopy to analyze tissue to identify both normal and malignant cells.
The Science – RF Spectroscopy for Margin Assessment
Cancerous cells and healthy cells have very different electromagnetic properties. The bioelectric differences between them can be detected using RF spectroscopy.
Once detected, the electromagnetic “signature” of cancerous cells can be compared to thousands of other cell signatures using Dune’s proprietary algorithm. A binary result is then reported to the surgeon in real time to support a decision regarding the removal of additional tissue from the breast.
About Dune Medical Devices
Dune Medical Devices was founded in 2002 by Dr. Dan Hashimshony to realize the extraordinary medical potential of its proprietary tissue characterization technology. With initial indications in breast, this technology holds the promise for a broad range of surgical and diagnostic applications. Dune Medical Devices is a privately held company with offices in the U.S. and Israel. For more information, please visit www.dunemedical.com .
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