EMDT_European Medical Device Technology

European Medical Device Technology, Spring 2015

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14 | Spring 2015 European Medical Device Technology emdt.co.uk breakthroughs Every year in France alone, 49,000 new cases of breast cancer are detected and more than 11,000 people die. Mammog- raphy has traditionally been the method by which physicians detect lumps in the breast. Then, ultrasound scans establish whether these tumours are malignant or benign; physicians often must carry out painful, intrusive biopsies as well. The start-up Nodea Medical is hop- ing to change the standard of care, how- ever. "We're offering a new technology that helps diagnosis of suspect nodules," explained Florian Chatellier, cofounder and CEO. "Our medical device provides instant results by measuring the natural fluo- rescence of tumour tissue. This will help reduce the number of unnecessary biopsies and further monitoring on benign lesions." The company, located in Villejuif Biopark Cancer Campus, is the result of medical instrumentation research carried out by René Farcy, Nodea Medical's other cofounder and a research professor at Paris-Sud University. The Probea device consists of a fine shapered needle contain- ing an optical fiber, which is polished to a 15° angle to improve tissue penetration. A laser diode then transmits a blue light (at 405 nm) through the fibered needle and excites cells in penetrated tissues. The emission of fluorescence by excited cells is then caught by the same optical fiber and immediately processed by the system. This fluorescence is due to endogenous fluorophores whose expression is modi- fied in cancerous tissues. Tumour explo- ration is carried out under ultrasound guidance. "Since our device does not need mark- ers such as fluorophores to be injected, it presents no toxicological risk to patients," Chatellier noted. The probe provides immediate, precise additional information on whether or not nodules are malignant or benign. Following promising pre- clinical results on surgical specimens, this technology will next be validated by a clinical trial of 350 patients spread across expert French hospitals. —B.B. Fibre-Optic Needle Detects Cancerous Tissue Without Markers

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