Market Overview

New Research Shows MarginProbe Reduces Re-Excision Rates for Breast Conserving Surgery by 61%, Giving Renewed Hope to Breast Cancer Patients


A study recently published in the American Journal of Surgery
demonstrates that proper use of Dune
Medical Devices'
intraoperative margin assessment device,
MarginProbe, results in a significant identification of positive margins
and a resulting reduction in the re-excision rate for breast conserving
surgery - the standard option for patients with early-stage breast

The research led by Amanda Kupstas, MD, Warda Ibrar, MD, D. Richard
Hayward, PhD, Daniel Ockner, MD, Cheryl Wesen, MD, FACS, and Jeffrey
Falk, MD, FACS, of St. Johns Providence in Detroit, MI, reports an
analysis of MarginProbe's effectiveness by comparing 120 consecutive
breast conserving surgery cases prior to use of the probe and 120
consecutive cases after implementation of its use. Reliability of the
device was determined by confirming findings with post-operative
pathology reports. This study, "Impact of utilizing a real-time,
intraoperative radiofrequency probe for margin assessment in breast
conserving surgery," reported a 61% reduction in the relative
re-excision rate when using the MarginProbe compared to the historical
comparison group. The historical absolute re-excision rate was 18% and
reduced to 7%. The study also showed that there was no difference in
tissue volume removed between the control group and the device group,
demonstrating that a significant reduction in re-excision can be
achieved without a negative impact on cosmetic outcome. These findings
support the ongoing effort to improve patient outcomes and reduce costs
and variability in re-excision rates among surgeons, institutions and

"Any device that yields significantly lower re-excision rates is a tool
that hospitals and breast surgeons should seriously consider using,"
said Falk. "MarginProbe's capacity to reduce instances of costly second
surgeries while improving quality of life is exactly the kind of
value-based proposition that new medical devices need to offer in
today's healthcare environment."

"Thanks to the work of Dr. Kupstas with her mentors Dr. Falk and Dr.
Wesen, we have further compelling evidence that supports a body of
clinical data demonstrating that routine use of MarginProbe in
lumpectomy procedures for breast cancer generates lower re-excision
rates, which should lower overall healthcare costs and improve patient
outcomes," said Lori Chmura, Chief Executive Officer at Dune Medical
Devices. "These results are particularly important as it is well known
that positive margins are a risk factor for delaying the initiation of
adjuvant therapy1; and delays in adjuvant therapy have been
reported to have negative effects on survival rates for women undergoing
breast cancer surgery1. Furthermore, re-excision is
significantly associated with a decrease in breast satisfaction among
women receiving breast conserving therapy2. Giving women the
confidence that all of their cancer has been removed and allowing them
to return to their lives before their cancer diagnosis is our mission."

About Dune Medical Devices

Imagine not having to wonder, did we get it all?
At Dune Medical
Devices, we believe in reducing the anxiety that waiting for pathology
results places on a patient and their families. Our solutions, which are
developed on a first-of-its kind RF Spectroscopy platform, can
differentiate cancerous from healthy tissue based on electromagnetic
properties of tissue, making it increasingly possible for patients and
physicians to answer the question, "did we get it all?"

1. Riba, L.A., Gruner, R.A., Fleishman, A. et al. Ann Surg Oncol (2018).

2. 2. Fuzesi S, et al. Satisfaction with Breast Conserving therapy after
re-excision: A study using the BREAST-Q, A patient reported outcomes
measure in breast surgery. SSO 2018.

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