NeoDynamics AB (publ) a Swedish medical technology company dedicated to advancing the diagnostics and treatment of cancer. The company has created an innovative biopsy system called NeoNavia®. This biopsy system builds on a patented pulse technology, based on research at the Karolinska Institutet in Sweden. The innovative pulse biopsy system is designed to offer clinicians and patients reliable tissue sampling with high tissue yield for correct diagnosis and individualised treatment. NeoNavia has been launched on the Swedish, German, and British market.
Growing market for breast biopsies
Annually, at least 6 million breast biopsies are performed to diagnose suspected cancer. Every year about 2.1 million women globally are diagnosed with breast cancer and this number is increasing by 5% yearly. The market for breast cancer diagnosis is estimated at $500 million annually.
As the share of non-surgical biopsies increases, the share of surgical biopsies decreases. More tumours are detected earlier thanks to extended screening programs and new screening techniques. New treatments have increased the need for biopsies both for diagnoses but also for monitoring their effectiveness.
NeoNavia – a unique biopsy system
NeoNavia is the registered trademark for the entire biopsy system that is intended for ultrasound-guided tissue sampling. NeoNavia consists of a base unit, a hand-held driver, and three types of biopsy needles. All three needle types are driven by pulses that facilitate needle insertion and precise placement of the needle in the suspected tumour. The system is designed to designed to offer clinicians and patients precise and reliable tissue sampling for correct diagnosis and individualised treatment.
A new innovative technology
The patented pulse technology is based on a pneumatic mechanism that enables high precision and control during needle insertion and placement, irrespective of the tissue type. The pneumatic driver generating the pulses is located in a hand-held instrument. With the help of pulses from the base unit, the biopsy needle is advanced with high precision even across short distances, thus enabling a distinct, stepwise needle insertion without affecting the surrounding tissue. The technology thus ensures precise access and flexibility for tissue samples even from challenging lesion locations and dense breast tissue.
The technology has been protected in bigger European countries, in China, and the USA. Design-specific patents for the design of the self-developed needle have been granted in Europe, USA, and China. The company's patents extend into 2034 and further patent applications have been submitted.
Clinical trials in key markets
NeoDynamics' new biopsy technology has been tried for breast and axillary lymph node biopsies in more than 600 patients. Clinical studies are being conducted in Germany and Great Britain to evaluate the technology.
The future of breast cancer biopsy
It is our vision that NeoDynamics' pulse technology becomes the new standard for all ultrasound-guided breast cancer biopsies, improving both precision and reliability, and contributing to correct diagnoses and enable individualised treatment without delays for every individual breast cancer patient.
"The NeoNavia biopsy system can safely increase the precision of ultrasound-guided, technically challenging biopsies such as in axillary lymph nodes."
Biopsy markers. NeoDynamics is developing a technology for ultrasound-optimised biopsy markers. These markers will be a valuable addition to the NeoNavia system and will facilitate the continuous monitoring of patients undergoing treatment.
Skin biopsy instrument. NeoDynamics NeoDynamics is also conducting a development project as a separate company, Szafran Biopsy AB which is held in shared ownership with dermatologist Rebecca Szafran. The company will advance an improved punch biopsy instrument for more effective sampling of skin tissue changes. NeoDynamics supports the project with its key competencies.