NeoNavia® is gaining ground
Fourth quarter October-December 2021
Full year January-December 2021
Significant events during the fourth quarter
Significant events after the end of the period
NeoNavia® is gaining ground step by step
Our introduction of NeoNavia in Germany and other German speaking countries, the United Kingdom and Sweden continues, and we are meeting a strong interest from radiologists and gynecologists.
Good impact on scientific meetings
The interest from the profession is also reflected in that we are being selected to present at prestigious radiologist meetings. In the fourth quarter, the first results from the PULSE study were presented at the British Society of Breast Radiologists’ annual scientific meeting. The study shows that NeoNavia can successfully, and with a low occurrence of side effects, be used widely in both very difficult and more clear-cut sampling in the axilla - which is a strong argument for choosing NeoNavia over exisiting products on the market. As this data is unique in the scientific world and has great relevance to clinical practice, it has attracted a significant amount interest. At the beginning of the year, the results of a subgroup in the PULSE study with particularly challenging biopsy conditions was accepted for oral presentation at the most important U.S. breast radiologist meeting, SBI / ACR (Society of Breast Imaging / American College of Radiologists), and their Breast Imaging Symposium held in Savannah, Georgia, in early May. Oral presentation is an opportunity that is only offered to the few, and is usually meet with a great deal of interest from the conference participants.
The US introduction draws near
This presentation at SBI / ACR is expected to underpin the planned introduction of NeoNavia in the US. The registration application is planned to be submitted to the FDA within the next few weeks, and an approval of NeoNavia in the US may follow a few months after submission of the documentation. Together with specialist consultants, we have prepared a high quality registration application, which we expect will facilitate a smoother process with the authorites. The aim is to minimize the subsequent interaction with the authorities in order to reduce the risk of pandemic-related delays. Once the product is registered, it can start to be marketed within a reasonable preparation time since the product already has codes and compensation in place for similar products, unlike pharmaceuticals where you in practice need to wait for decisions on various insurance claims.
As the pandemic has flared up again we have encountered delayes our processes, both in the registration application in the USA and in the launch. However, this does not mean at all that the business is at a standstill.
NeoDynamics is undergoing a transformation
The study version of NeoNavia that was created in 2016, has been used in the clinical studies that are now published and gives us traction in the launch of the innovative biopsy technology. Late in 2019, a commercial version of NeoNavia with three needle types was CE approved. This version began to be presented to the market in the spring of 2020. After some intital fine-tuning, the system and needles can now be delivered in commercial form and in volume. A transfer of our needle production to Asia will be completed during the spring, lowering the production cost of these disposable needles.
We are currently working on the financing for the continued launch of NeoNavia in Europe, to prepare for the launch in the U.S. and to begin registration work in China, as well as to complete the clinical development program with NeoNavia. A small part of the planned fund raising will finance continued work with product development, both to strengthen our current offering with a tissue marker as well as to expand the use of NeoNavia from breast cancer to other cancers. We have good support from major shareholders in these efforts.
I look forward to an eventful 2022!
CEO Anna Eriksrud
This is information that NeoDynamics AB is obliged to make public pursuant to the EU Market Abuse Regulation and the Securities Markets Act. The information was submitted for publication, through the agency of the contact person set out above, on February 16, 2022, at 8.30 CET.