2020-02-03

A clinical study performed at Karolinska Hospital with NeoDynamics’ new biopsy system, NeoNavia, has been accepted as an abstract by the Society for Breast Imaging (SBI) in the US.

Associate professor Edward Azavedo has performed a retrospective study at Karolinska Hospital, where he analyzed tissue samples using NeoDynamics’ new biopsy system, NeoNavia. An abstract with the initial study results has been accepted by SBI for presentation at their annual meeting in Denver, April 16-19, 2020.

NeoDynamics’ biopsy system NeoNavia is built on a patented micropulse technique that enables the physicians performing the biopsy, to insert the biopsy needle into the suspected lesion with greater control and precision. The micropulse technique makes it easier to take a biopsy in locations where it is hard to penetrate or in dense breasts.

“NeoNavia’s micropulse controlled open-tip needle is very useful for biopsies in the breast. The controlled insertion makes it easy to get a more representative sample from a lesion even if the lesions are hard or the surrounding tissue is difficult to penetrate.” says Edward Azavedo, associate professor, Karolinska Hospital.

The study at the Karolinska Hospital included tissue samples from 20 patients (32 – 80 years, mean age 53 years) who had breast biopsies taken in order to evaluate the effect of neoadjuvant breast cancer treatment. The lesions were between 20 – 80 mm in diameter (mean diameter 30 mm) and the biopsied samples were all representative and of very high quality. None of the 20 patients experienced complications after the biopsies.

” We are very pleased to present solid biopsy results from Sweden that shows how helpful the new micropulse technique is when diagnosing and evaluating treatment of breast cancer”, says Anna Eriksrud, CEO for NeoDynamics.

NeoNavia includes three different biopsy needles, where one is an open tip 14G needle developed by NeoDynamics. The open-tip needle enables a high tissue yield from a single insertion. The other two are of core needle- and a vacuum needle-type and all three driven by the micropulse technique. NeoDynamics is planning to introduce the new biopsy system at leading breast cancer centers in Sweden, Germany, and the UK during the second quarter in 2020. The company is also preparing for a regulatory submission to the FDA in the US and the plan is to submit to the FDA in the middle of this year.

For further information about NeoDynamics, please contact:                         

Anna Eriksrud, CEO NeoDynamics AB (publ), telephone: +46 8 522 79 667, e-mail: anna.eriksrud@neodynamics.com, or

Jörgen Vrenning, CFO/IR NeoDynamics AB (publ), Telephone: +46 708 519 648, email: jorgen.vrenning@neodynamics.com

About NeoDynamics

NeoDynamics AB (publ) is a Swedish Medical Technology Company dedicated to advancing diagnosis and care of breast cancer. The company has an innovative biopsy system, NeoNavia®. The precision biopsy system is built on a patented micropulse technology, based on research at the Karolinska Institutet in Sweden. The system is designed to offer clinicians and patients accurate lesion targeting and high tissue yield for correct diagnosis and individualized treatment. NeoNavia® is evaluated at leading clinics in UK, Germany and Sweden. A commercial launch is expected in the second quarter 2020.

About NeoNavia

NeoNavia is the brand name for the entire biopsy system intended to be used under ultrasound guidance.  NeoNavia consists of a base unit, a handheld driver and three different types of biopsy needles. Each needle type is driven by the micropulses enabling high precision and control when inserting and positioning the biopsy needle in a suspicious lesion. The system is designed to offer accurate lesion targeting and high tissue yield for correct diagnosis and individualized treatment.

About the micro-pulse technology

The patented micropulse technology is based on a pneumatically driven mechanism that enables high precision and control when inserting and positioning the biopsy needle, independent of tissue type. The pneumatic driver that generates micropulses is placed in a handheld instrument. With power from the base-unit, 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.