NeoDynamics has developed the NeoNavia biopsy system, which utilizes a patented micropulse technology to simplify and improve precision in biopsy sampling in breast cancer patients. The system’s novel insertion technology and needle design are intended to overcome the technical limitations of today’s outdated needle designs and spring-loaded insertion mechanisms, thus providing enhanced control, precision and sample quality for radiologists and their patients. These technical advantages aim to enable clinicians to address demands for minimally invasive diagnostic approaches, next-generation genetic sequencing and new personalized treatment paradigms, among other growing market trends.
2.1 million women annually are diagnosed with breast cancer. This figure is growing at an annual rate of 5%, due to a combination of improved ultrasound imaging, breast cancer screening programs and a growing global population. As a result, more than six million breast cancer biopsies are performed every year, with a current 10% annual growth rate, as estimated by the Board. This is equivalent to a market value for breast cancer biopsy instruments of USD 500 million, based on the markets of the USA, EU and China alone. NeoDynamics will initially be concentrating on this cancer indication.
The validation version of NeoNavia received CE certification in July 2016 and has been validated in breast and axilla biopsy procedures on more than 300 patients at 15 leading European cancer clinics. The system’s underlying technology is protected by a strong patent portfolio. Clinical trials are performed to demonstrate the stengths and benefits of NeoNavia.
NeoNavia commercial version
A commercial version of NeoNavia is currently under development and will include an expansion of current patent protections as well as additional biopsy needles. These improvements will provide radiologists with significantly greater flexibility in performing breast biopsies in the complete range of clinical cases. The Board’s objective is to apply for CE-certification for the commercial version of NeoNavia in preparation for a commercial launch during Q3-Q4 2019. Following regulatory (FDA) approval in the USA and China, NeoDynamics plans to launch the commercial version in these markets as well.
Potential future indications
Following the successful launch of the commercial version of NeoNavia, together with completion of the additional clinical studies mentioned above, there is strong potential to extend the product’s market in the future to include prostate, thyroid, kidney, liver and bone tissue sampling. NeoDynamics also has the potential to develop a technology intended for biopsy marker clips, optimized for identification under ultrasound visualization.
Safe & flexible sampling in challenging sites
growth rate of breast biopsies performed annually
Commercial version of NeoNavia
“Our patented technology has several significant advantages over today’s outdated methods and can solve many of the current problems within biopsy sampling."