2019-04-10

New breast biopsy device is evaluated at Karolinska University Hospital in Stockholm

NeoDynamics has received ethical approval to retrospectively analyse data from biopsy procedures that were performed using the NeoNavia biopsy system at Karolinska University Hospital in Stockholm (This pressrelease was originally published in a Swedish version on 8 April, 2019)

Results obtained from biopsy procedures performed with NeoDynamics’ new micro-pulse biopsy system will be analysed and evaluated in a retrospective clinical study.

The micro-pulse technology incorporated in NeoNavia is designed to enable more precise needle insertion, particularly useful in accessing difficult to access lesions whilst also enabling larger tissue samples to be captured. The hope being that the system will contribute to improving breast cancer diagnosis by requiring fewer biopsies as well as obtaining larger and more representative tissue samples. This is crucial for fast and effective individualized treatment decisions to be made and to enable follow-up of tumour response during the course of therapy.

“Being able to accurately position the needle as well as to obtain great quality tissue samples is very valuable. As a breast radiologist, my experience is that the size and representativeness of the tissue sample is crucial in order to be able to make a correct diagnosis and also to give the information needed to choose the right type of treatment, adapted to the individual, taking into account the characteristics of the tumour. For the patient this is of course a great comfort,” says Edward Azavedo, associate professor Karolinska Institute and responsible for the study.

"We are keen to be able to demonstrate the relevance of the new micro-pulse technology for Swedish patients," says Anna Eriksrud, CEO of NeoDynamics. “Even though we are still a small company, we have the ambition to lead the development in precision biopsy and drive change in breast cancer diagnostics. Therefore, we are delighted to see the interest and commitment shown by key opinion leaders in Germany, UK and here in Sweden who are evaluating NeoNavia. We want as many women as possible to benefit from innovative technology that can help improve their potential outcomes,”says Anna Eriksrud, CEO of NeoDynamics.

About NeoDynamics

NeoDynamics AB (publ) is a Swedish Medical Technology Company dedicated to advancing diagnosis and management of breast cancer. The company has an innovative biopsy system, NeoNavia® , in late stage development. The precision biopsy system is built on a proprietary micro- pulse technology, based on early research at the Karolinska Institute in Sweden. The system is designed to offer clinicians and patients accurate lesion targeting, high quality tissue yield and thus the best possible conditions for a correct diagnosis and individualized treatment. NeoNavia® is evaluated at leading clinics in UK, Germany and Sweden. A commercial launch is expected in 2020.

About NeoNavia

NeoNavia is the brand name for the entire biopsy system intended to be used under ultrasound guided imaging. NeoNavia consists of a base unit, a handheld driver and three types of biopsy needles (a proprietary front-loaded needle, a CNB and a VAB), all three driven by the micro-pulses that enable high precision and control when inserting and positioning the biopsy needle in the suspicious lesion. The system is designed to offer more accurate lesion targeting and large tissue yield and thus best possible conditions for a correct diagnosis and individualized treatment.

About the micro-pulse technology

The patented micro-pulse technology is based on a pneumatically driven mechanism that enables high precision and control when positioning and inserting the biopsy needle independent of tissue type. The pneumatic driver that generates micro-pulses is placed in a handheld instrument. The driver accelerates the needle with great control even over a short distance, enabling its distinct stepwise insertion without the risk of destroying surrounding tissue. This facilitates ease of access and flexibility in sampling, even in very small lesions in delicate and difficult locations.