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.