Group consolidated accounts have been prepared for the fourth quarter, and full year, which includes the consolidation of NeoDynamics AB, NeoDynamics GmbH and NeoDynamics Inc. These are represented in the financial statements as adjusted numbers, and are the comparative figures used for last year.
Fourth Quarter 2022
Full Year 2022
Significant events during the quarter
Significant events after the end of the quarter
Ready for commercialisation in the US
In September 2022, we reached an essential milestone with the FDA clearance of NeoNavia®. The US approval is a cornerstone in our strategic way forward and path to profitability.
The covid pandemic delayed all FDA applications and made the timing of approvals unpredictable. Thus, it was prudent for a small company such as NeoDynamics to wait for the go-ahead from the FDA before starting to build the US organization.
The recently deployed management team is preparing for fullscale commercialization of Neonavia in 2023. This includes identifying and hiring personnel, locking in attendance at key scientific congresses and building the infrastructure to support sales activities in the field. The first product to market is FlexiPulse. The FlexiPulse needle is unique in its design and allows insertion into challenging locations. Checking lymph nodes in the axilla (armpit) is critical to assessing whether cancer has spread. The introduction of FlexiPulse will allow physicians to safely and effectively simplify biopsy of the lymph nodes in the axilla in a minimally invasive fashion. Shortcomings of existing biopsy systems result in most axillary nodes being removed surgically. A common side effect of surgical removal of axilla lymph nodes is persistent swelling (edema) of the arm, and a FlexiPulse biopsy minimizes this risk. Further, the design of the FlexiPulse makes it ideal for tissue sampling in suspected lesions in the proximity of breast implants, which is an increasingly common problem, especially in the United States.
An ever more critical stakeholder in breast cancer treatment is the patient themselves and related patient advocacy groups. Patient empowerment is an increasingly important aspect of delivering breast cancer care. For this reason, NeoDynamics' hired a US management team with significant backgrounds working with specialty products and associated patient associations. Another advantage of the organization's special markets background is working with key-opinion-leading physicians at the most prestigious treatment centers in the United States.
To ensure cost-effectiveness, NeoDynamics Inc. outsources customer care and logistics functions to its partners Diligent Health Solutions and Uniphar Logistics, both divisions of Uniphar Group of Ireland.
Of course, the deep experience gained in Europe is vital for success in the USA. In more than 30 cancer research centres in Germany, the UK and Sweden, we continue our work and collaboration with key opinion leaders. From this ongoing experience we can conclude that clinics in Europe remain very engaged. We have fine-tuned two needles during 2022, which has resulted in better products, but also in postponed deliveries. It is our firm commitment to make no compromise on product quality.
Also, we continue to run our clinical study program to document the pulse technology and our different needles in clinical practice. The clinical program has resulted in several presentations at congresses during 2022 including the prestigious SBI congress in Savannah in May.
In 2022, we added several senior and experienced members to our team. On December 1, 2022, Matthew E. Colpoys, Jr. (member of the Board of Directors) assumed the position of US CEO for NeoDynamics Inc. We also welcomed Brendan Carney, our national sales director in the US. In February 2022, we also onboarded Aaron Wong as our Group CFO of NeoDynamics AB. We now have an organization that is capable of executing the strategy in both the short and long term.
Our performance in 2022
Our revenue is still modest while we continue to deploy resources in a controlled fashion to develop our products in Europe and the US. We are pleased to have secured short-term funding for the launch in the US.
CEO Anna Eriksrud
All reports are available at the company ́s website: https://www.neodynamics.com/en-gb/reports
This disclosure contains information that NeoDynamics is obliged to make public pursuant to the EU Market Abuse Regulation (EU nr 596/2014). The information was submitted for publication, through the agency of the contact person, on 17-02-2023 08:30 CET.