SurgicEye® receives FDA clearance and signs distribution agreement with Dilon Diagnostics®

Press Release Source: SurgicEye On Tuesday September 27, 2011 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 usefor 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 providingthe 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

SurgicEye offers solutions for intraoperative 3-D imaging and instrument navigation. The recent product declipseSPECT of SurgicEye implements the so-called freehand SPECT technology for detection, localization and guided biopsy of sentinel lymph nodes in breast cancer, melanoma and head & neck malignancies. Clinical investigations in other tumor surgery domains promise a wide application domain and huge potential for quality assurance during surgery. It enables surgical procedures to be more sensitive, more reliable and less invasive. For more information on SurgicEye, please visit
www.surgiceye.com

Contact:
Claudia Ramirez-Wiesner
SurgicEye O: +49 89 54 99 89 001
E: claudia.ramirez@surgiceye.com

About Dilon Diagnostics

Dilon Diagnostics, a brand of Dilon Technologies Inc., is bringing innovative medical imaging products to the global medical marketplace. Dilon’s cornerstone product, the Dilon 6800, is a digital high-resolution, compact gamma camera optimized to perform BSGI, a molecular breast imaging procedure which images the metabolic activity of breast lesions through radiotracer uptake, indicating the presenceor absence of cancer. Many leading medical centers around the world are now offering BSGI to their patients, including: Cornell University Medical Center, New York; The George Washington University Medical Center, Washington, D.C.; and the Hotel Dieu, Paris, France. For more information on Dilon Diagnostics, please visit
www.dilon.com