Higher pace after relief in restrictions
Third quarter 2021
First nine months of 2021
Significant events during the third quarter
Significant events after the end of the period
Higher pace after relief in restrictions
The market has begun to return to normality as the pandemic restrictions have eased. This means that the team was recently able to participate in person at several congresses and in connection with this also conducted workshops with doctors from several different clinics. The launch of NeoNavia can thus begin to take place in the way we planned for before the pandemic, which means a faster rollout than has been possible so far. The introduction continues with 2-3 months of pilot evaluations, where the team initially supports the clinics so that the doctors can evaluate and feel confident in how the system should function. It is a model that is appreciated by customers.
The product has been well received. During the fourth quarter, NeoDynamics will deliver and invoice probes to about 20 clinics that participate in pilot studies and where several also use the biopsy system in parallel in patients not participating in studies. If a clinic chooses to include the system in their practice, they will also pay for base and hand units. The use of the system that has now been initiated will provide a fantastic platform for NeoNavia and further processing in 2022.
The interest in the system is also reflected in the fact that abstracts on studies with NeoNavia have been accepted at congresses, which provides good visibility and contributes to a broader acceptance of the new technology in hospitals. The studies show the product's high quality and clinical benefit. We are particularly pleased to present data from our first prospective multicenter study at the prestigious annual scientific congress of the BSBR (British Society of Breast Radiology). In this study, which we called our German PULSE study, NeoNavia was used to take tissue samples in axillary lymph nodes in over 100 breast cancer patients with very good results.
Approaching the US
The work of preparing an introduction to the United States is progressing but is slower than desired as the US FDA has re-prioritized resources during the covid-19 pandemic. The registration application is nearing, but the exact timing is dependent on the FDA and the dialogue we have with them. A submission at the beginning of next year, but a faster processing because the file holds up well – can be a better option than a hasty submission before the turn of the year since questions from the authority risk to delay the process even further. Therefore, the team seeks to submit a high-quality application, thereby minimizing the interaction with the authority after submission. Once the product is registered, it can begin to be marketed immediately, in contrast to what is the case for medicines, where in practice you also need to wait for decisions in various insurance companies.
NeoDynamics has a small but very competent organization for the US market. Country Manager Anna Forsberg, who is heading the FDA registration, has more than 30 years of relevant experience in the US market. Magnus Precht is equally experienced in US commercial operations and will be sure to recruit highly skilled and well-established salespeople. To their aid, they have strong support from Matt Colpoys, who was elected to NeoDynamics’ board of directors this spring.
Preparations for China
During the autumn, the team also started preparations for registering NeoNavia in China. The work has good guidance from the company’s largest owner Huasheng Fang, who is strongly connected to local breast centers, as well as board members Jie Bao and Xiao-Jun Xu.
A few weeks ago, NeoDynamics appointed a legal advisor for the work in the Chinese market. The next step is to appoint a regulatory advisor. During this process, the company will have good help from the work done in other markets, not least in the United States.
I look forward to an intense end to 2021, and a successful 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 November 17, 2021, at 8.30 CET.