Dune Medical Devices recently reached the halfway point in a Post-Approval Study (PAS) for MarginProbe, with over 275 patients enrolled in the third Randomized Controlled trial on MarginProbe. The post-approval study follows two previously published prospective, randomized, controlled trials, 10 peer-reviewed publications and 35 abstracts demonstrating the efficacy of MarginProbe over the current standard of care margin assessment alone.
The study focuses on the accuracy with which MarginProbe can identify malignant tissue on the lumpectomy margin, reduce re-excision rates, and impact volume of tissue removed and resulting cosmetic results after using MarginProbe at the time of surgery. Previously published trials in real-world use have shown that the MarginProbe device has reduced re-excision rates by over 50% and enabled surgeons to take smaller lumpectomy specimens, resulting in an improved cosmetic outcome for women facing breast cancer surgery.
There are 7 well-respected cancer centers across the country participating in the trial, including two additional academic medical centers, Montefiore Medical Center in New York and Baptist MD Anderson in Florida. Both are scheduled to begin enrolling patients this month. Study enrollment is expected to be complete by August 2019, with a total enrollment of 440 patients.
Reducing re-excision rates due to positive margins is a significant focus of the breast cancer medical community. Recent SSO-ASTRO guidelines defining positive margins for early-stage invasive breast cancer as No Tumor on Ink have not shown a significant effect on re-excision rates. The largest compilation of data reporting on over 38,000 patients found a relative reduction of 15%, while MarginProbe has reported a 61% reduction in lumpectomy re-excision after implementation of the consensus guidelines.
Separately, data published in the New England Journal of Medicine on the use of Full Cavity Shave technique report a decrease in re-excision of 50% but increases the volume of tissue removed by 55%. Comparatively, published data in 336 patients report transitioning from full cavity shave to a directed shave approach utilizing MarginProbe, resulted in a 57% decrease in re-excisions and a decrease in the amount of tissue removed of 32%, an important positive implication for cosmesis.
As the only FDA-approved device for intraoperative margin assessment, MarginProbe has been used in more than 18,000 surgeries and has demonstrated statistically significant results in published pre-approval studies as well as commercial use trials reporting on over 2,400 patients, making it the most consequential advance in managing lumpectomy margins during breast-conserving surgery. The PAS results will continue to strengthen the compendium of data already available on the use of MarginProbe for identifying positive margins intraoperatively.
MarginProbe utilizes radiofrequency spectroscopy to characterize and differentiate cancerous versus healthy tissue, providing surgeons the ability to identify microscopic residual cancer at the surgical margin, in real-time. With this device, surgeons can immediately respond by taking additional tissue. This provides greater confidence for both the surgeon and the patient that all of the cancer was successfully removed in the first surgery, reducing costly, burdensome additional surgeries. By reducing avoidable surgeries, the use of MarginProbe is offering a significant improvement in surgical care for breast cancer patients.
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, making it possible for patients and physicians to answer the question, did we get it all? For more information, contact [email protected].
Write2Market for Dune Medical Devices