New data from NeoDynamics PULSE study accepted for presentation at major US breast imaging conference
NeoDynamics AB (Spotlight Stock Market: NEOD), a medtech company dedicated to advancing diagnosis and care of breast cancer, will present results from the PULSE study illustrating the benefits of the novel biopsy device NeoNavia in challenging axillary lymph nodes, at the SBI/ACR Breast Imaging Symposium in Savannah, Georgia, taking place on May 16-19. The symposium is held to be the most important annual meeting for US breast imaging professionals.
A subgroup analysis from the ethically approved German prospective multi-center study PULSE (ClinicalTrials.gov ID: NCT03975855), shows that the biopsy device NeoNavia was safe and effective for percutaneous tissue sampling also in axillary lymph nodes presenting parameters indicating high anatomic complexity and procedural difficulty. The system’s pulses were perceived to stabilize the target lesion and provide needle control during insertion. It was also possible to obtain multiple samples with a single insertion.
The scientific abstract has been accepted for oral presentation at the symposium. The presentation will be carried out by the Principial Investigator, Prof. Marc Thill, AGAPLESION MARKUS KRANKENHAUS Frankfurt, under the title "New pulse biopsy device safe and effective in challenging cases of axillary biopsies: Subgroup analysis of initial PULSE data for lymph nodes of small size and difficult anatomic location".
“The NeoNavia device has demonstrated great performance in the most challenging subgroup of cases 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 Prof. Marc Thill.
The SBI/ACR Breast Imaging Symposium is the most important annual meeting for breast imaging professionals in the US, usually attracting over 1 000 participants. NeoDynamics plans to file for registration of NeoNavia in the US during the first quarter 2022.
NeoNavia is an innovative biopsy system built on a patented pulse technology for controlled and precise needle insertion and is based on research at the Karolinska Institutet in Sweden. A pneumatic hand-held driver is driven by a base unit and pulses are activated by pressing a button. With the help of these pulses, the biopsy needle is advanced in steps of 1-2 mm, allowing a distinct, stepwise needle insertion into the tissue and a precise placement of the needle in the suspected lesion.
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.
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