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SurgVision announces initiation of a Phase II clinical trial on fluorescent Image Guided Surgery

‘t Harde, The Netherlands, November 4, 2015 – SurgVision BV, A high-tech innovative start-up company specialized in developing Fluorescence Image Guided Surgery platform solutions using high-definition cameras and tracers, today announces that it has initiated the start of a Phase II clinical trial in collaboration with the University Medical Center Groningen and the Martini Hospital in Groningen.

Among early-stage breast cancer patients who undergo an initial lumpectomy procedure, 23% to 41% require repeat surgery due to positive margins1,2. When patients learn of this, it is not uncommon for between 10% to 36% percent of them to elect a full mastectomy to ensure all the cancer is removed1.

The SurgVision platform solution consists of the F2 high-definition camera and a targeted fluorescent tracer that will provide guidance to the surgeon while performing the surgery. Using this platform the surgeon will be able to efficiently remove cancer lesions while preserving healthy tissue. As a result of this the number of initial surgeries with positive margin will be reduced, the number of repeat surgeries is consequently also reduced.

Prior and ongoing clinical studies confirm the safety and efficacy of a single microdose of the fluorescent tracer. The primary aim of the new Phase II trial is to test whether the administration of a higher dose of the fluorescent tracer will lead to an even more sensitive in-vivo identification of cancer lesions.

The study will commence in the Netherlands at the University Medical Center in Groningen and the Martini Hospital in Groningen. SurgVision can report already that the first patients are enrolled since early November 2015.

Ton van den Hoven, Chief Executive Officer of SurgVision, commented: “We are excited to initiate this Phase II study in cooperation with the UMCG and Martini hospitals. Breast tissue can not be reliably tested intra-operatively by routine histopathology evaluation, and other modalities must be developed to reduce the need for reoperation which leads to delay in initiation of chemotherapy or radiation, increased infection rate, increased cost and a negative psychological impact on the patient. Fluorescent imaging has the potential to address this problem.

Prof Dr Gooitzen van Dam, Professor of Surgical Oncology at the University Medical Center in Groningen: “At the UMCG we have broad experience in translating both nuclear and optical tracers into the clinic for reasons of personalized medicine and surgery. Our frontline clinical expertise and GMP facilities combined with the above mentioned state-of-the-art platform will deliver the necessary data to take fluorescence-guided surgery one step closer to routine clinical practice and may serve the future patients of preventing unnecessary repeat surgery. Furthermore, our close collaboration with the training hospital Martini Hospital is essential for this purpose”

1. McCahill et al. (2012) JAMA 307(5):467-475
2. Waljee et al. (2008) Ann Surg Oncol 15(5):1297-1303

About SurgVision

SurgVision is a high-tech innovative start-up company specialized in developing Fluorescence Image Guided Surgery platform solutions using high-definition cameras and tracers. The Company believes that its innovative products have the potential to address the current impact of positive resection margins in breast conserving surgery.

SurgVision is founded in August 2013, as a spin-off of the Technical University of Munich and funded by DFZ Partcipaties BV and BioGeneration Ventures BV and headquartered in ‘t Harde, The Netherlands. Since its inception SurgVision has established a close cooperation with the University Medical Center Groningen, where the technology has been evaluated and clinically applied in various exploratory studies in the field of image-guided surgery and endoscopy.