2021-08-25 Regulatorisch

NeoDynamics granted a U.S. patent for its biopsy needle

STOCKHOLM – AUGUST 25, 2021, NeoDynamics AB (publ) (Spotlight Stock Market: NEOD), a MedTech company dedicated to advancing diagnosis and care of breast cancer, today announced that the Company has been granted a U.S. patent for its needle design employed in the NeoNavia FlexiPulse probe.

The patent is an important milestone for the planned commercial launch in the U.S. and strengthens the protection of the NeoNavia biopsy system. The front-loaded, open-tip sampling needle is designed to enable maximum tissue yield, with minimal patient trauma.

“This is exciting news for NeoDynamics. We have received very promising results in selective patient populations, when using the biopsy needle in breast and axilla in our clinical program”, says Ph.D. Kai-Uwe Schässburger, Director Clinical Development and Medical Affairs, NeoDynamics AB. “The needle is utilized in the ongoing PULSE trial, a German multi-center study, evaluating safety and performance in the axillary lymph nodes”.“The American market is the largest biopsy market in the world, and it is a strategic market for NeoDynamics. The U.S. patent provides an excellent platform for the upcoming filing, registration and launch in the U.S.”, says Anna Eriksrud, CEO NeoDynamics AB. “Our technology is designed to offer clinicians and patients accurate lesion targeting and high-quality tissue yield, and our pulse biopsy system NeoNavia has been very well received by reference centers in Europe and has the potential to become the leading biopsy system for ultrasound-guided biopsy procedures in the breast and axilla.”

This disclosure contains information that NeoDynamics is obliged to make public pursuant to the EU Market Abuse Regulation (EU nr 596/2014). The information was submitted for publication, through the agency of the contact person, on 25-08-2021 13:15 CET.

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.