NeoDynamics presents first results from PULSE study

NeoDynamics AB (Spotlight Stock Market: NEOD), a med-tech company dedicated to advancing diagnosis and care of breast cancer, presents first results from the PULSE study, an ethically approved German prospective multi-center study (ClinicalTrials.gov ID: NCT03975855) to document the performance of the NeoNavia biopsy device in the axillary lymph nodes at the prestigious British Society of Breast Radiology (BSBR) Annual Scientific Meeting 2021, November 7th – 9th.

Data from 115 procedures across seven German hospitals show that the device is well suited for use in the axillary lymph nodes, with a high success rate and low rate of adverse events in a broad patient cohort. The patented pulse technology was perceived to stabilize the target lesion and enhance needle control during insertion, and it was possible to obtain multiple samples with a single insertion.

The oral presentation, titled “New pulse biopsy device proved to be safe and effective in axillary lymph nodes with pulsed insertion facilitating enhanced needle control: Initial results from the German multi-center PULSE study”, is given by Principial Investigator Prof. Marc Thill, AGAPLESION MARKUS KRANKENHAUS Frankfurt, on behalf of the study group. The submitted abstract has scored highly and will therefore be featured in the online Breast Cancer Research Journal.

“The NeoNavia device has demonstrated great performance in the PULSE study. Management of the axilla in breast cancer patients continues to be a hot topic. Needle biopsies enable an early assessment of whether the cancer has spread to the axillary lymph nodes at the time of breast cancer diagnosis. This information facilitates optimal treatment planning which is crucial for patient outcomes. A biopsy device that increases sampling yield and improves insertion control is very well suited to set a new standard in this area. With performance documented for challenging biopsies in the axillary lymph nodes, we are now looking forward to using the further improved next generation NeoNavia biopsy system in our patients to improve the diagnosis of breast cancer,” says presenting author Prof. Marc Thill.

“We are extremely proud to have reached this milestone and be able to present excellent initial data from our PULSE study. As part of our clinical programme, we are continuing to analyse the data and will successively present further results. The observed performance in PULSE gives us confidence for COMPULSE, our UK multi-centre, randomised study comparing our device with the current clinical standard. Supported by this data we are now very much looking forward to continue the launch of NeoNavia biopsy system with significantly improved usability and the possibility for multiple needle options,” says Kai-Uwe Schässburger, Ph.D., Director of Clinical Development & Medical Affairs.

For further information, please contact:

Anna Eriksrud, CEO NeoDynamics AB, phone +46708 444 966 or e-mail anna.eriksrud@neodynamics.com

Kai-Uwe Schässburger, Ph.D. Director Clinical Development & Medical Affairs, phone +46 762 386 153 or +49 151 688 092 41

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 is evaluated for breast cancer diagnosis at leading clinics in UK, Germany, and Sweden. The pulse biopsy system has been used for tissue sampling in breast and axilla in over 500 patients.

About NeoNavia

NeoNavia is a modern biopsy system with a completely new patented pulse technology intended for ultrasound-guided tissue sampling. It consists of a base unit, a handheld driver and three different types of biopsy needles. Each needle type is driven by the pulse technology providing a more controlled needle insertion and precise placement of the needle in the tumour whilst enabling high-quality tissue samples from both breasts and lymph nodes. The pulse biopsy system NeoNavia is designed to offer clinicians and patients accurate lesion targeting and high tissue yield for correct diagnosis and individualized treatment.