| SurgicEye® receives FDA clearance and signs distribution agreement with Dilon Diagnostics® |
| Tuesday, 27 September 2011 00:00 |
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Intraoperative 3-D Imaging for Radio-guidance of Tumors and Sentinel Lymph Nodes Munich, Germany -- SurgicEye®, the leading provider of intraoperative soft tissue imaging and navigation solutions, today announced its FDA clearance and that Dilon Diagnostics®, the world leader in molecular breast imaging, has become the exclusive distributor of SurgicEye products in the United States. SurgicEye's declipseSPECT® / CSS300 provides intraoperative 3-D image visualization and navigation for gamma probes during radio-guided surgery. The solution extends commonly used gamma probes and combines imaging and image viewing as a tool to resect radioactively labeled structures like primary breast tumors, metastases, and sentinel lymph nodes in a minimally invasive approach. This intraoperative imaging technology contributes to quality assurance and provides evidence for complete sentinel lymph node (SLN) and tumor resection during the surgery. SurgicEye recently received U.S. Food and Drug Administration (FDA) clearance of its flagship product, the declipseSPECT / CSS300 intraoperative gamma probe 3D visualization device. "The declipseSPECT technology and its intraoperative use for navigated sentinel lymph node dissection will enable safer surgeries, and less invasive procedures. This can ensure a high quality outcome for every individual patient," said Prof. Dr. Marion Kiechle, Director of the Women's Hospital at Klinikum Rechts der Isar in Munich, Germany. Prof. Kiechle and her leading breast surgeons, Dr. Stefan Paepke and Dr. Andreas Schnelzer, are the primary European investigators of declipseSPECT in breast cancer applications. Robert Moussa, CEO of Dilon Diagnostics, said, "DeclipseSPECT enhances Dilon's product portfolio in women's digital imaging solutions with a state-of-the-art device that makes the localization and resection of radioactive structures extremely intuitive, reliable and minimally invasive." He notes that the SurgicEye technology fits within Dilon's strategic vision of providing the most clinically advanced solutions for patient-tailored care. The founder and CEO of SurgicEye, Dr. Joerg Traub, is convinced that, "The cooperation between the two companies will provide high-quality products and services to the medical device market. The joint portfolio of our products will provide added confidence to surgeons in treatment delivery and safety for the patient community, and Dilon is the ideal partner for high-tech and high-quality solutions supporting women's health in the U.S." About SurgicEye Contact: Claudia Ramirez-Wiesner About Dilon Diagnostics Contact: Nancy Morter
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