ALPHARETTA (June 25, 2019) – 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. This PAS, required by the FDA, seeks to substantiate the vast body of data produced since MarginProbe’s original approval, demonstrating its effectiveness at intraoperatively identifying positive margins and subsequent effects on reducing re-excision rates while maintaining cosmetic outcomes after surgery.
Dr. Mehran Habibi, Medical Director of the Johns Hopkins Breast Center, and Dr. Susan Hoover, Surgical Oncologist for Moffitt Cancer Center’s Department of Breast Oncology, are the participating Principal Investigators (PI) for their respective centers in the trial. Johns Hopkins and Moffitt are the number one and number two highest enrolling centers in the study. Dr. Habibi, the Lead PI of the trial, will be working closely with Dr. Hoover to develop a publication cadence for this meaningful and relevant work.
“Johns Hopkins is continuously pursuing the newest technology and advancements in breast cancer diagnosis and treatment,” Dr. Habibi explained. “Participating in this study has allowed us to face the challenge of positive margin rates after lumpectomy head-on.”
Dr. Hoover has also spoken out about Moffitt Cancer Center’s efforts to stay on top of the latest technology for both breast cancer screening and treatment.
“Moffitt is a thought leader in the world of breast disease. We are in constant motion striving to stay ahead of the latest innovations in breast cancer in order to go beyond the current standard of care for our patients,” said Dr. Hoover. “With MarginProbe’s ability to identify positive margins in real-time and potentially lower re-excision rates, participating in this Post-Approval Study put us one step closer to accomplishing this goal.”
Johns Hopkins and Moffitt now join Pinnacle Health Cancer Institute, Summit Medical Group, and Northshore University HealthSystem as sites which have completed enrollment in the study. The three sites will follow each patient for six months as required in the next phase of the study. To date, over 300 of the study’s 440 patients have been enrolled. Six additional cancer centers across the country will continue accruing patients until August 2019 when enrollment is anticipated to be complete.
The adoption of MarginProbe by major cancer centers such as Johns Hopkins and Moffitt speaks volumes for the device’s credibility and efficacy, as well as the role it plays in improving the healthcare experience for patients. Nearly 200,000 women receive lumpectomy surgery annually, which precedes a period of uncertainty while awaiting final pathology results. A pathology report indicating a positive margin subjects patients to further surgery and a prolonged treatment timeline. Acceptance of MarginProbe as a Standard of Care will provide significantly more women with the peace of mind that their cancer was fully removed during one procedure, and the ability to complete their treatment plan returning them back to their normal life.
The MarginProbe device utilizes radiofrequency spectroscopy to characterize and differentiate cancerous versus healthy tissue, giving surgeons the ability to identify microscopic residual cancer and DCIS in real-time, removing additional tissue if needed. MarginProbe provides greater confidence for both the surgeon and the patient that all of the cancer is successfully removed in the first surgery and reduces the likelihood of costly, burdensome additional surgeries.
For a list of cancer centers currently enrolling patients in the MarginProbe post-approval trial, please visit www.clinicaltrials.govand search “MarginProbe”.
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@example.com.
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