The Market

The market for breast biopsies is growing

• 2.3 million new female breast cancer cases globally,³ 
• In UK 55.200 women are diagnosed with breast cancer each year [based on 2015-2017 data].² 
• Recent years  breast cancer incidence rates have increased in the US by 0.5% per year.³ 
• Moderate but significant increases have also been reported in many other countries in Europe. ³
• Annually, at least 6 million breast biopsies are performed to diagnose suspected cancer.
• $ 500 million - The market for breast cancer diagnosis is worth $ 500 million annually merely based on US, EU, China and Japan markets.

Needle biopsies are increasing

• At the expense of surgical biopsies.
• More tumours are detected (thanks to extended screening programs and new screening techniques).

Biopsies are needed throughout the treatment process

• To determine diagnosis.
• To choose the right type of treatment.
• To follow the effects of the treatments.¹

Strategy and commercialisation

EU: Our prioritized markets for launch are the UK, Germany and Sweden. Commercialization of NeoNavia has begun and centers in Germany, UK and Sweden have started to evaluate the system in their own environment.

Outside the EU: The work to file for FDA approval in the US is ongoing and the US registration will pave the way for initiating an approval process in China.
The plan is to follow up with launches in both markets immediately after approved applications. In China, we have a stable and long-term owner in Boai NKY Medical Holdings Ltd, an established and respected player in the Chinese MedTech market.

Development projects

Biopsy Marker. We are developing a technology for a biopsy marker optimized for ultrasound. The marker will be a valuable addition to the NeoNavia system and will facilitate further tissue sampling for patients undergoing treatment.

Skin biopsy instrument. We also run a development project in a separate company, Szafran Biopsy AB, together with dermatologist Rebecca Szafran. The company will further develop an improved punch biopsy instrument for more efficient sampling of skin changes. NeoDynamics supports the project with key competence.