NeoDynamics granted Chinese patent for FlexiPulse needle design

STOCKHOLM – March 6, 2023, NeoDynamics AB (publ) (Nasdaq First North Growth Market Stockholm: NEOD.ST), a medical device company dedicated to advancing the diagnosis and care of cancer, today announced that the Company has been granted a Chinese patent for the needle design employed in the NeoNavia® FlexiPulse™ probe.

The front-loaded, open-tip sampling needle is designed to enable maximum tissue yield, with minimal patient trauma. The patent is an important milestone that opens up for a future commercial launch in China and strengthens the protection of the NeoNavia biopsy system. NeoNavia with FlexiPulse is uniquely positioned to address biopsies in the axillary lymph nodes which is a technically and anatomically challenging site due to the proximity to blood vessels and nerves.

The Chinese patent is yet another important milestone that comes on top of a similar patent granted in the US in August 2021, followed by US FDA clearance received in September 2022.

“The novel needle design has shown great results in PULSE, our German multi-center study evaluating safety and performance of the device in the axillary lymph nodes of breast cancer patients”, says Ph.D. Kai-Uwe Schässburger, Director Clinical Development and Medical Affairs, NeoDynamics AB.

“We are very pleased to have reached another important milestone. We expect that the process of product approval in China will be aided by the FDA clearance in the USA. The Chinese market is potentially very interesting with a breast biopsy market above USD 100m growing around 10% annually”, says CEO Anna Eriksrud, NeoDynamics AB.

For further information, please contact:

Anna Eriksrud, CEO NeoDynamics AB, phone +46708 444 966 or e-mail anna.eriksrud@neodynamics.com

Aaron Wong, CFO NeoDynamics AB,  phone +46735 972 011 or e-mail aaron.wong@neodynamics.com

About NeoDynamics

NeoDynamics AB is a Swedish Medical Technology Company dedicated to advancing diagnosis and care of 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 Europe and launches in USA during 2023. NeoDynamic’s shares are listed on Nasdaq First North Growth Market Stockholm (ticker: NEOD). The company’s Certified Adviser is Redeye AB.

About NeoNavia

NeoNavia is a modern biopsy system with a completely new patented pulse technology intended for ultrasound-guided tissue sampling. Each needle type is driven by the pulse technology providing a more controlled needle insertion and precise placement of the needle in the tumor 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.

About Karolinska Institute

The Karolinska Institute is consistently ranked amongst the world's best medical schools, ranking 6th worldwide for medicine in 2021. The Nobel Assembly at the Karolinska Institute awards the Nobel Prize in Physiology or Medicine.