Market Overview

Radio Frequency Spectroscopy Platform Development Enters Feasibility Testing Phase Supported by Prestigious Horizon 2020 Grant

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Capitalizing on the European Union Horizon
2020
research and innovation program, Dune
Medical
has completed the first phase in development of its
percutaneous soft tissue biopsy device. The Horizon 2020 program was
developed to help entrepreneurs take great ideas from lab to market
while removing barriers to innovation.

The Smart Biopsy Device is a project which leverages the well
documented, real-time, tissue characterization capability of its
radio-frequency (RF) spectroscopy technology. Miniaturizing the sensors,
a key component of the project, represents an important step forward in
the future development of Dune Medical's multi-cancer applications.

MarginProbe, Dune Medical's first commercial product has been used in
over 16,000 patients in the US, Israel and abroad. The radio-frequency
spectroscopy technology inherent in the MarginProbe device has
consistently demonstrated an improvement in the reduction of positive
margin rate after breast-conserving surgery, subsequently helping women
avoid a second surgery in 50-79% of cases. With Dune's deep and
extensive expertise in differentiating types of breast tissue with its
MarginProbe device, the biopsy application will first be utilized as a
tool in the diagnosis of breast cancer.

The Smart Biopsy Device has entered into feasibility testing, which
includes ex-vivo verification within mastectomy tissue. The first study
site, Meir Medical Center in Kfar Saba, Israel has used the device in
twelve ex-vivo cases to date, with two additional locations in Israel
and sites in Europe to follow in the near future. The outcome of these
trials are expected to verify the accuracy of the Smart Biopsy Device
technology in real-time identification of the tissue type that is
sampled and extracted with the needle. This information will direct Dune
Medical in preparing for in-vivo clinical trials anticipated to commence
in Q4 2018.

"I think this tool will be valuable not only for me, but for the
surgeon as well,
" said Dr. Noemi Weisenberg, Director of the Nancy
Reuben Comprehensive Breast Imaging Center at Meir Hospital who has
tested the device. "In certain cases, the biopsy that the surgeon
performs can be much more accurate if they do it with this kind of
needle so that they can be sure that they're taking the sample from the
right place.
"

Despite improvements in imaging modalities that guide breast biopsy
procedures, challenges remain in both identifying and sampling certain
tissue types, particularly in DCIS and atypical hyperplasia. The Smart
Biopsy Device is not intended to replace the need for histological
analysis and diagnosis.

"This device ensures that the specimen core represents the most
advanced stage of the disease at the time of the biopsy procedure,
increasing the likelihood of an accurate diagnosis
," said Lori
Chmura, Dune Medical CEO. "The development of this Smart Biopsy
Device substantiates the application of radio-frequency spectroscopy and
establishes Dune as a leader in tissue characterization for cancer
."

About Dune Medical Devices

Imagine not having to wonder, did we get the right tissue sample out or
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, making it possible for
patients and physicians to answer the question, "Did we get it all and
did we get right?"

Learn more at dunemedical.com

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