Dune Medical Devices said this week that the U.K.’s National Health Service is launching a study of its MarginProbe device, which is designed to spot cancerous cells on the margins of breast tumors.
Paoli, Pa.-based Dune said the NHS’s National Institute of Health Research arm is funding a study to see whether MarginProbe reduces the need for further re-excision procedures after lumpectomy procedures.
The 460-patient study, led by Dr. Nigel Bundrud of the University Hospital of Southern Manchester, is a randomized, prospective, double arm trial. It’s designed to monitor the number of patients who require additional surgery at 9 months and compare quality-of-life and cosmetic outcomes; a health economics analysis is also part of the study, Dune said.
“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 the best chance of getting all the cancer during the first surgery,” CEO Dan Hashimshony said in prepared remarks. “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.”
Dune said in March that it won pre-market approval from the FDA for modifications to MarginProbe; the original device won pre-market approval back in January 2013.