NeoNavia ready for market
The English text is an unofficial translation of the Swedish report.
Second quarter 2020
Half year 2020
Significant events during the second quarter
Significant events after the period
NeoNavia ready for market
After several years of development work, NeoNavia, a system for ultrasound-guided tissue sampling, is ready for launch and thus to improve diagnostic quality for women who are diagnosed with breast cancer. The launch will start in Europe where the system is being used at specialist clinics in Germany, UK and in Sweden. The market introduction of NeoNavia will focus on these markets. In 2021, NeoDynamics also plan to be present on the US market.
So far in 2020, NeoDynamics has focused on finalizing the new products to further increase their competitiveness. The Base unit, Driver and the needles (three different forms of probes/needles that can replace other ultrasound guided tissue sampling) have been fine-tuned so that each sampling will give high-quality tissue with ample volume.
Adequate samples in sufficient volume provide the basis that modern cancer diagnosis requires for an early and conclusive diagnosis. The facts that it is also time-saving for the clinics and results in fewer needle insertions for the patients, add to the advantages.
NeoDynamics have methodically reviewed the new products and also carried out bench studies to document the results. NeoNavia has already in its study version been shown to provide three times as much tissue as traditional technology. At the end of 2020, these new studies will be published to show the performance of the finetuned products. This will provide powerful arguments when showing clinics the superiority of NeoDynamics’ versus existing biopsy technology.
In parallel, studies with NeoNavia continue in clinical practice in hospitals in Germany and the United Kingdom. After the UK gave special priority to cancer care, patient recruitment in the COMPULSE study resumed in July after a temporary hiatus due to the pandemic. New patients have since been included in the studies that compare NeoNavia to the current standard for ultrasound-guided breast biopsy.
The use of NeoNavia in German hospitals greatly contributed to NeoDynamics being able to start a collaboration with leading German breast cancer clinics in early July, which in a role as reference centres will also support the introduction of NeoNavia at other clinics. These reference centres are also expected to become the first buyers of the new system.
Work continues to secure sufficient funding for the coming years.
I am impressed by how focused the organization worked during the first half of the year and I am sensing the impatience in getting started with selling NeoNavia.
NeoDynamics is heading for a very exciting autumn.
CEO Anna Eriksrud
For further information about NeoDynamics, please contact:
Anna Eriksrud, CEO NeoDynamics AB (publ), telephone: +46 708 444 966 , e-mail: firstname.lastname@example.org, or
Jörgen Vrenning, CFO/IR NeoDynamics AB (publ), Telephone: +46 708 519 648, email: email@example.com
NeoDynamics AB (publ) is a Swedish Medical Technology Company dedicated to advancing diagnosis and care of breast cancer. The company has an innovative biopsy system, NeoNavia®. The precision biopsy system is built on a patented micro-pulse technology, based on research at the Karolinska Institutet in Sweden. The system is designed to offer clinicians and patients accurate lesion targeting and high tissue yield for correct diagnosis and individualized treatment. NeoNavia® is evaluated at leading clinics in UK, Germany and Sweden. A commercial launch is expected in 2020.
NeoNavia is the brand name for the entire biopsy system intended to be used under ultrasound guidance. NeoNavia consists of a base unit, a handheld driver and three different types of biopsy needles. Each needle type is driven by the micro-pulses enabling high precision and control when inserting and positioning the biopsy needle in a suspicious lesion. The system is designed to offer accurate lesion targeting and high tissue yield for correct diagnosis and individualized treatment.
About the micro-pulse technology
The patented micro-pulse technology is based on a pneumatically driven mechanism that enables high precision and control when inserting and positioning the biopsy needle, independent of tissue type. The pneumatic driver that generates micro-pulses is placed in a handheld instrument. With power from the base-unit, the driver accelerates the needle with great control even over a short distance, enabling its distinct stepwise insertion without the risk of destroying surrounding tissue. This facilitates ease of access and flexibility in sampling, even in very small lesions in delicate and difficult locations.