Clinical Data

Real-time intraoperative margin assessment

(Subset of Pivotal)
PurposeSubstantiate diagnostic capabilitiesIsraeli Pivotal Trial
Intended Use
MP in pure DCISUS Pivotal Trial
FDA Approval
Compare site results in Pivotal trial vs Pivotal as a wholePost-Market
Routine Use
Routine Use with Gross AssessmentRoutine Use
Full Cavity Shave
Routine Use
PublishedJ Surg Research (2010)
160, 277-281
Am J Surg (2008)
196, 483–489
The Breast (2014)
23, 94-96
Ann Surg Oncol (2014)
ASBS 2015
SpringerPlus (2015)
Arch Gynecol Obstet (2016)
Am J Surg (2017)
213, 627-630
Am J Surg (2017)
215(3): 400-403
Ann Surg Oncol (2019) 26:1729
Study DesignDirect point by point comparison to pathologyProspective, Double Arm, Randomized, ControlledProspective, Single Arm, Controlled, Comparison to Historical Control in DCISProspective, Double Arm, Randomized, ControlledRetrospective Review of Pivotal Study DataRetrospective, Single Arm, Comparison to Historical ControlProspective, Single Arm, Controlled, Comparison to Historical Control Gross AssessmentRetrospective, Single Arm, Comparison to Historical Control Full Cavity Shave Retrospective, Single Arm, Comparison to Historical Control post No Tumor on Ink GuidelineRetrospective Chart Review, Single Arm
Number of Patients753 Measurements29310959646351322256240341
Number of sites/surgeons3 sites11 sites/35 surgeons3 Sites/3 Surgeons21 Sites/53 Surgeons1 site/3 Surgeons3 sites/4 Surgeons1 Site/5 Surgeons1 Site/1 Surgeon1 Site/2 Surgeons1 Site/5 Surgeons
Historical Re-ex rateN/A12.7%39%25.8%0.3525.8%30%15%15%N/A
MarginProbe Re-ex rateN/A5.6%17%19.8%0.049.7%14.5%6.6%5.8%9.7%
Relative ReductionN/A56%56%23% - re-ex
62% reduction positive margins
0.88562%52%56%61.1%75% reduction positive margins
Cosmesis or Volume NotesN/ACosmesis favorableCosmesis Favorable Thin margin shavings resulted in high number of identified margins remaining positive despite significant MP performance
8-10cc additional tissue volume
Consistent performance across all historical re-ex rates
44-17% = 61%
30-10% = 67%
16-8% = 50%
12-4% = 67%
No difference in overall volume tissue32% reduction in overall tissue volumeNo difference in overall tissue volumePerformance maintained regardless of density

Dr. Rabia Z. Bhatti with the AMITA Resurrection Medical Center has always had a strong interest in the art of surgery. “I actually love the way that patients recover,” she explained. “There’s a gratification behind treating patients and watching them get better. And after practicing general surgery for 15 years, I realized I could provide even better care to my patients by focusing, and staying ahead, on one specialty. That’s when I made the switch to breast surgery.”

“From now on, I’m going to use MarginProbe on all of my lumpectomy cases,” the Coordinated Health surgeon shared. “Somehow we have been losing control of how to use new technology to better the lives of patients and their care. That has been our battle and I think it is becoming more pronounced."

"One of the fun things about my job is that NO day is typical," Lisa explained. "I can start the day reviewing pathology reports and analyzing MarginProbe’s contribution to a surgeon’s outcomes in preparation for a data review, and then end the day by updating a training deck for our new hire training class. My position is never boring, and I get to have my fingers in everything!"

With 30 years in practice, Dr. Daniel Howard, a General Surgeon at Mercy Health — Lourdes Hospital, can still define exactly what attracted him to surgery. Dr. Howard’s practice at Mercy Health is the only facility in the state of Kentucky to take advantage of MarginProbe, and it’s leading the state, and the nation, in many other areas of breast cancer treatment.

Every breast cancer survivor has a unique story to tell, and Alexa G is no exception. Her experience highlights the importance of patients becoming their own strongest advocate.

The Johns Hopkins Breast Center at Johns Hopkins Hospital, the #3 hospital in the U.S. News & World Report’s 2018–19 Best Hospitals list, announced that it will be adding MarginProbe® as a regular part of its program after its participation in Dune Medical’s MarginProbe® Post Approval Study (PAS).

Dune Medical Devices has reached another milestone in their MarginProbe® Post Approval Study (PAS) as Johns Hopkins Hospital and Moffitt Cancer Center complete their patient enrollments for the trial.

Dune Medical Devices was thrilled to host Congresswoman Lucy McBath in a recent visit to their Alpharetta office. McBath is a member of the United States House of Representatives from Georgia's 6th congressional district. Since joining Congress in January of this year, she has shown support for multiple bills seeking to lower costs of healthcare for patients and help advance medical innovation.

As part of their whole-person care strategy, Dr. Wilson’s practice uses a new tool, known as MarginProbe, to ensure that a safe margin of tissue is removed around a cancerous tumor as that tumor is removed during surgery.

Dune Medical Devices has just completed the first in-man cases for Smart Biopsy, its percutaneous soft tissue biopsy device which leverages the real-time tissue characterization capability of its radio-frequency (RF) spectroscopy technology.

Lori Chmura and Tom Melba attended the 24th Annual Multidisciplinary Symposium on Breast Disease to exhibit MarginProbe, the only FDA approved intraoperative tool for margin assessment. Here are some of their favorite moments from the symposium.

Global breast surgeon thought leaders from the United States, Germany, Israel, the UK and Japan came together during an international investigator reception at the San Antonio Breast Cancer Symposium, hosted by Dune Medical.

After being awarded Medtech Woman of the Year for 2018 by MW@S, Lori joined Jason Rupp on the webinar to discuss her work with Dune Medical Devices, the challenges she faced as a woman in the medtech industry, and more.

Dune Medical CEO Lori Chmura and Chairman of the Board of Directors Amos Goren started the year off by attending the 37th Annual J.P. Morgan Healthcare Conference

With the year coming to an end we put together an overview of the many developments in breast cancer research and treatment from 2018.

The American Society of Breast Surgeons (ASBrS) united thought leaders, payment and reimbursement experts, and Industry Relations Council members to develop a strategic approach to prepare its physician members to lead enhancements in breast cancer surgery, therapeutics and technology for the future.

At the HBA: Diary of a Leader event, Lori Chmura addressed bridging the gender gap in leadership at the executive level within the healthcare industry.

“I think for breast cancer, every few months there's something new and exciting,” the physician shared. “I think there's always some new technology, new drugs, or new study that comes out that changes our outlook."

“I realized breast surgery put me in the operating room, which I love to do, but it also allowed me to take care of my patients hands-on and I could follow my patients practically forever,” explained Dr. Karen Karsif.

The team at Dune Medical is heartbroken over the passing of Nancy M. Cappello, Ph.D. and would like to extend sincere condolences to her family, especially her husband Joseph Cappello, friends, colleagues, and supporters.

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