NeoDynamics receives ethical approval for German device registry
The MedTech company NeoDynamics AB (publ) has received a favorable decision by the ethical committee of the Medical Association of Hesse, to establish a device registry in Germany for its novel biopsy device NeoNavia. The registry will be used to gather and evaluate real world data from the use of NeoNavia.
By establishing the registry, data from the use of NeoNavia in clinics around Germany will be proactively gathered and evaluated in a structured process. The registry differs from a classic clinical program where patients are included or excluded based on predefined criteria.
“The registry is an efficient tool to obtain real-world-data from the use of our device in routine clinical practice. We can use it to confirm the benefits of the device, monitor safety, and even document off-label use. By proactively collecting and evaluating quality controlled clinical data we strive to meet and exceed the highest regulatory requirements on post-market clinical follow-up as set forth by the new Medical Device Regulation in Europe,” says Kai-Uwe Schässburger, Director of Clinical Development and Medical Affairs at NeoDynamics.
With the favorable decision from the ethical committee, NeoDynamics can proceed with the project and recruit clinics to participate in the process by gathering data.
For further information, please contact:
CEO Anna Eriksrud, phone +46 708 444 966 or e-mail [email protected]
Director Clinical Development & Medical Affairs Kai-Uwe Schässburger, phone + 49 151 68809241 or e-mail kai.uww@[email protected]
General Manager DACH Renate Reiss, phone +49 151 4188 6209 or e-mail [email protected]
About NeoDynamics
NeoDynamics AB (publ) is a Swedish Medical Technology Company dedicated to advancing diagnosis and care of breast cancer. The company’s first product NeoNavia®, a new innovative pulse biopsy system for ultrasound guided tissue sampling, is currently being introduced to the market. The biopsy system is built on a patented pulse technology, based on research at the Karolinska Institutet in Sweden. NeoNavia has received CE approval and is bing marketed in UK, Germany, and Sweden. The pulse biopsy system has been used for tissue sampling in breast and axilla in over 500 patients. NeoDynamic´s share is listed on Nasdaq First North Growth Market Stockholm (ticker: NEOD). The company’s Certified Adviser is Redeye AB, e-mail address: [email protected] and telephone number +46 8 121 576 90.