2021-05-19 Regulatory

First quarter - Introduction underway

First Quarter 2021

  • Revenue amounted to SEK 405 (6,269) thousand, of which SEK 378 (6,303) thousand were capitalized costs.
  • Cash flow from operating activities amounted to SEK -10,510 (-9,534) thousand.
  • Loss after tax amounted to SEK -17,261 (-7,235) thousand.
  • Loss per share SEK -0.29 (-0.41).
  • The equity / assets ratio was 94 (78) percent.

Significant events during the quarter

  • The European Patent Office EPO issued a European patent for the company's pulse biopsy instrument, including a multifunctional handset that can be used for several different types of biopsy needles.

  • In March, Dr. Stefan Paepke presented preclinical results with NeoDynamic's innovative biopsy system, which show that tissue samples taken with all of NeoNavia's three needle types provide significantly larger tissue samples than today's “gold standard” techniques achieve.

  • The development work of NeoDynamics marker, the company's second project after NeoNavia, is increasing in scope.

Significant events after period-end

  • NeoDynamics has received an approval for a scientific abstract, to be presented at the annual surgery conference ABS, Association of Breast Surgeons, in Birmingham, describing how the company's FlexiPulse needle surpasses standard biopsy in preclinical models by almost 300 percent in terms of volume.

CEO comment

Introduction underway

The commercialization of the pulse biopsy system NeoNavia has begun. Clinics in Germany, England and Sweden are evaluating the system in their own environment, on their own patients and experience the difference compared to the systems they have used so far. The feedback we receive is positive from both the radiologist and the person evaluating the sample, i.e., the pathologist.

Step by step introduction and launch

The strategy NeoDynamics has chosen is to focus on the most important clinics in the UK, Sweden, and Germany. We make sure that these top clinics feel safe with how the product is to be used and that they are also willing to pass on this knowledge to all doctors at their own clinic as well as at other clinics. We are sensitive to the clinics' experiences of using the product in clinical everyday life and make minor adjustments. In this way, we build trust in the product and pave the way for wider use in the long run. Our goal is to have run workshops with NeoNavia at the most important clinics within ultrasound lead biopsy this spring and summer provided that the pandemic allows us. In parallel, we expect that the purchasing processes will be in place and first orders will follow. These well-known clinics will be our reference clinics that can convince others to follow their example and we expect sales to follow later in the year.

FDA registration

We continue the work with our documentation for the registration file in dialogue with the FDA. As we have said earlier, the work with our registration file has also been affected by the pandemic, among other things  through the authority’s focus on and allocation of  resources to covid-related applications. We expect to submit the application to the FDA in the autumn of 2021. The submission date is important, but even more important is the quality of the file we submit.

This is where the dialogue with the authorities comes in to guide us so that what we submit is what the FDA expects to see. If we succeed in this, the processing time for the file can be considerably shorter. What we do is a 510 (k) registration, which is a less complicated procedure than a drug approval.

The registration in the USA is a milestone for NeoDynamics and the product. It opens up a very large market and strengthens NeoDynamics' position in relation to potential partners. A US registration also lays a good foundation for an approval in China, which is the next country in line for NeoNavia.

A unique marker for ultrasound

In parallel with NeoNavia, we have also worked on developing a marker. Markers are inserted during biopsy to make it easier to follow how the tumor develops during treatment and are removed when the patient has completed treatment. It is a product that is well suited to sell together with NeoNavia. There are several different markers today, that can be seen on X-rays, but no commercially available marker that can be seen well enough on ultrasound. The idea to create the marker was born by one of the USA's foremost ultrasound specialists who also supports us in the development work. We expect to be able to complete the design phase at the end of the year.

I look forward to a continued eventful 2021.

CEO Anna Eriksrud