September 4, 2018 (Alpharetta, Ga.) – Capitalizing on the European Union Horizon 2020 research and innovation program, Dune Medical has completed the first phase in the 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?”
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