New technology from NeoDynamics approved for study in Germany

German multi-center study (“PULSE”) receives ethical approval and endorsement of the German Society of Gynecology and Obstetrics

–“Together with my colleagues from other university hospitals we have collaborated with NeoDynamics during the last couple of years in the development of the NeoNavia biopsy system. Innovation in this field has been scarce and thus the interest for new technology among clinicians is high. The developed technology has unique characteristics which enable a more precise and controllable needle insertion, something that is an advantage in all procedures but especially in those that are considered challenging. After initial positive experience in our hospital we now want to take the next step and commence with the PULSE study”, says Priv.-Doz. Dr. med. Marc Thill of the Agaplesion Markuskrankenhaus in Frankfurt and leading Principal Investigator.

Performing needle biopsies in axillary lymph nodes poses specific challenging with regards to precision and control. The micropulse technology incorporated in NeoNavia is based on a pneumatic driver that enables a user-controlled stepwise needle insertion without noticeable deformation or displacement of surrounding tissue. In Addition, a new needle design facilitates maximum sampling yield with minimal patient trauma.

The PULSE study has been designed together with leading German physicians to demonstrate performance characteristics of the NeoNavia biopsy system for biopsies in the axillary lymph nodes.

The PULSE study has now received ethical approval and patient recruitment for this prospective multi-center study is planned to start in November at the Agaplesion Markuskrankenhaus in Frankfurt. At least seven additional university hospitals in Munich, Berlin, Rostock, Greifswald, Tübingen, Esslingen and Essen will successively join the clinical study team.

Furthermore, the working group of esthetic, plastic and reconstructive surgical interventions (the AWOgyn e.V.) of the German Society of Gynecology and Obstetrics (DGGG) has included PULSE into their clinical study portfolio. This provides access to the group’s infrastructure and regular exposure at scientific meetings.

­– “We are happy to get started with the PULSE-study and continue to demonstrate what our technology is capable of. With Dr. Thill we have a high profile Principal Investigator on board with vast experience in evaluating new medical technology. We are especially proud of the endorsement by the DGGG which shows that we pursue ideas of clinical relevance and ensures support of the medical community", says Kai-Uwe Schässburger, Director of Clinical Development and Medical Affairs at NeoDynamics.