2019-04-26 Regulatory

NeoDynamics AB (publ) receives advance notice from U.S. Patent Office for a granted biopsy instrument patent

NeoDynamics AB (publ) has received notification, a “Notice of Allowance”, from the US Patent Authority that patent will be granted provided that the grant fee is paid

The announcement from the US patent authority means that NeoDynamic's unique biopsy device with front-loaded needle and integrated trocar, an important component of the NeoNavia® biopsy system, will be approved shortly. The patent increases the protection of the NeoNavia biopsy system, which further strengthens the competitiveness.

“This notice is very positive for our shareholders. The American market is the single largest biopsy market and an important part of our global strategy. Together with our other patents this is a confirmation of our unique technology and a good springboard for our upcoming registration and launch in the US. The focus on our biopsy system means that we offer several different needle types with different functions, all with micropulse technology. This patent is important as it further increases the protection of one of our needle types. This micropulse needle type enables the radiologist to get reliable tissue samples with high quality. The patented needle function is currently used in the products used in our clinical studies in Europe. The launch of the biopsy system will commence early 2020, as soon as we receive regulatory approvals in the EU and the US.”, says Anna Eriksrud, CEO of NeoDynamics.

For further information about NeoDynamics, please contact:              

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

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

This information is information that NeoDynamics AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication by the contact person above on 26 April, 2019

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® , in late stage development. The precision biopsy system is built on a patented micro-pulse 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 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 micro-pulses 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 micro-pulse 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 micro-pulses 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.