Focus shifting towards the US
Second Quarter 2022
First Half 2022
Significant events during the quarter
Focus shifting towards the US
The groundwork for the US commercialization and subsequent launch are in full swing. The team is working in parallel with the FDA approval process to ensure that there are no unnecessary delays, but the 510(k) application process is dependent on the FDA’s internal processes. The dialogue with the authority has been constructive and we expect that the process will be concluded before long. I remain convinced that NeoDynamics will be able to take the first steps in commercialising the NeoNavia system in the US before the year-end.
Meanwhile, NeoDynamics has set up an agile, external organization that will allow us to swiftly initiate a launch for NeoNavia, while also taking care of administrative requirements. Once up and running, we will start to build-up internal resources to maintain an effective and cost efficient start. To help locate the sweet spots for NeoNavia, a market research report was commissioned which continues to build our knowledge and understanding of the market, including different aspects on reimbursement.
Europe paves the way
The efforts to enter the US market began when NeoDynamics started to engage with key clinics in Europe, designing a study program that would showcase the value of the products within a clinical setting. These activities have paved the way to where NeoDynamics stand today, presenting at important congresses and seeing the benefits of independent advocates with clinical experience using our product. This is an important point of reference when entering a large market such as the USA. We will ensure that this job on key centres in the German speaking part of Europe as well as the UK, Ireland and Sweden is continued . We are strengthening our product experience and confirm we are a reliable partner.
Fine-tuning the product
In Europe, the team has engaged in dialogue with key centers to further optimize the system ahead of the US launch. This has resulted in small, but necessary, fine-tuning of the needles that has led to a temporary pause in production and sales. Deliveries are expected to resume with the CorePulse needle , and the VacuPulse needle during the the last months of the year, both from our Asian supplier. This suits operations well, as the CorePulse needle is in high demand in Europe while the FlexiPulse needle and the VacuPulse needle are expected to become the center of attention in the US. The interruption in supply has not deterred interest in the product with over 35 clinics having introduced NeoNavia in their clinical practice, and some 30 running pilots. Their feedback continues to be very encouraging and I feel confident that we will have great support in our continued efforts.
I look forward to an eventful autumn, during which NeoDynamics will share important news. To stay up to date with development, you can register for our monthly newsletter on the website www.neodynamics.com.
CEO Anna Eriksrud
The report in full is attached as a pdf file to this press release and can also be found on the company's website on the following link: https://www.neodynamics.com/en-gb/reports
Watch our for a video link with CFO comment available on our website from the 19th of August.
For further information, please contact
CEO Anna Eriksrud, phone +46 (0)708 444 966, e-mail firstname.lastname@example.org
CFO Aaron Wong, phone +46 (0)79 010 1714, e-mail email@example.com
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This information is information that NeoDynamics AB is obliged to make public pursuant to the Financial Instruments Trading Act. The information was submitted for publication at 2022-08-18 at 08.00 CET.