18-month study to be conducted across the U.K will look at the health, cosmetic and financial impact of MarginProbe margin assessment device for lumpectomy patients
PAOLI, Pennsylvania, June 21, 2016 /PRNewswire/ -- Dune Medical Devices announced today that the first patients have been enrolled in a United Kingdom's National Institute of Health Research (NIHR) subdivision of the National Health Service (NHS) sponsored research study on surgical margins in breast conserving surgery using Dune Medical's groundbreaking MarginProbe™ breast-cancer surgical assessment device.
With over 48,000 breast cancers diagnosed in the U.K each year, almost 60% of patients undergo breast-conserving surgery. In order to minimize the amount of tissue removed, excision up to the cancer free margins is undertaken. However one-in-four women who undergo a lumpectomy require additional surgery to remove cancer missed during the initial procedure.
The NHS acknowledges that assessing 'clean' margins during lumpectomies is a significant clinical and economic challenge and has identified MarginProbe as a potential solution. The study, which is being led by Dr. Nigel Bundrud, Professor of Surgical Oncology at the University Hospital of Southern Manchester, will investigate if the inter-operative use of the MarginProbe device reduces the need for further re-excision procedures after conservation surgery for breast cancer. Dr. Mike Dixon, Professor of Surgery and Consultant Surgeon Clinical Director, Breakthrough Research Unit, Edinburgh Breast Unit at Western General Hospital will also participate in this important study.
The study, funded entirely by the NHS, is a randomized, prospective, double arm study, which will included 460 patients enrolled at six breast unit specialty sites throughout the U.K. The study will monitor the number of patients who require additional surgery nine months of the initial procedure while also comparing a patient's quality of life and cosmetic outcomes. Health economic analysis will carried out using cost-effectiveness analysis.
"We are excitedly optimistic for the results of the NHS study. There have been a number of recent research studies that found surgeons who use MarginProbe during lumpectomies have best chance of getting all the cancer during the first surgery," said Dan Hashimshony, President of Dune, Inc. "Getting clean margins in one surgery moves a patient through to recovery more quickly giving them the best possible surgical and cosmetic outcome and ultimately reduces the economic impact."
MarginProbe is the first and only FDA-approved technology that offers surgeons a non-invasive assessment that enables real-time detection of cancer at the surface of excised tissue specimens during surgery. By integrating this technology in the operating room, healthcare providers can offer breast cancer patients the greatest chance of achieving clean margins during a lumpectomy procedure.
About Dune Medical Devices
Dune Medical Devices was founded in 2002 by Dr. Dan Hashimshony, CEO, to realize the extraordinary medical potential of its proprietary tissue characterization technology. Offering surgeons and radiologists the real-time ability to identify cancerous tissues and react immediately, this technology holds the potential for a broad range of surgical and diagnostic applications. Dune Medical Devices is a privately held company with offices in the U.S. and Israel. For more information, please visit www.dunemedical.com and www.marginprobe.com.
SOURCE Dune Medical Devices