The English text is an unofficial translation of the Swedish report.
Fourth quarter 2020
Full year 2020
Significant events during the quarter
Significant events after the period
The commercialization of the pulse biopsy system NeoNavia has begun. Centers in Germany, UK and Sweden evaluate the system in their own envir-onment, on their own patients and experience the difference to the systems they have used to date. The feedback is positive from both radio-logists and pathologists evaluating the tissue samples.
First order for NeoNavia
During the fourth quarter, we received our first order for NeoNavia, thereby reaching an impor-tant milestone in the company’s history. The order came from Buckinghamshire Healthcare NHS Trust, a reputable hospital in the UK. We expect to complete additional sales in the near future as a number of quotes are out for decisions and evaluation programs are ongoing.
The launch strategy in Europe involves a gradual introduction of NeoNavia to centers in the UK, Sweden and Germany with nearby German-speaking countries. We ensure that centers are confident in using the product, how the different needles work and suit different situations, and also in passing on this knowledge to all doctors at the clinic. This way, we build trust in the product and pave the way for broad use. With reference clinics in place that can convince others to follow their lead, we expect to get a boost in sales later in the year.
Unfortunately, the launch is being slowed down by the pandemic making it difficult to visit clinics and assist doctors in getting to know the new technology. Conferences are digital, a format that does not promote hands-on testing of NeoNavia. However, the team skillfully finds ways around challenges and centers participating in our clinical program will be our early users. Feedback from demonstrations, digital and physical outside of hospitals is positive.
Ready for 2021
During the fourth quarter, we completed a directed issue of SEK 90 million. This is also an important milestone giving us peace of mind to fully focus on what we are to achieve during the year.
Of course, the agenda includes a continued introduction of the system in our markets in Europe. We will show our medical results and we will pursue our plan for the US. Compiling the FDA documentation has also been affected by the pandemic as we have not been able to carry out user studies as planned. We expect to be able to complete these in order for the application to be submitted during the first half of this year. We will do is a 510(k) registration, which is a less complex procedure than a drug approval.
The United States is key
A US registration is a milestone for NeoDynamics and the product. It opens up a very large market and positions NeoDynamics completely differ-ently towards potential partners. Moreover, a US registration also paves the way for an approval in China, the next country in line for NeoNavia. Preparations for transferring the production of disposables to a manufacturer in Thailand are proceeding according to plan. Production is exp-ected to start in mid-2021, and will enable us to achieve our long-term goals for manufacturing costs.I look forward to an eventful 2021.
CEO Anna Eriksrud
This is information that NeoDynamics AB (publ) is obliged to make public pursuant to the Securities Markets Act. The information was submitted for publication at 08.30 CET on February 17, 2021.