Commercialisation of ASTar started

The second quarter of the year was very intense and rewarding. We achieved a number of important milestones, of which I would like to particularly highlight ASTar’s CE-IVD approval. We are now able to commercialise the system and provide sepsis patients with quicker and more accurate care. We also initiated our pivotal US clinical study.

“Partnership with Thermo Fisher Scientific working very well “

In preparation for the launch, we ramped up our training of personnel from our global sales partner Thermo Fisher Scientific. We have had strict internal restrictions in place since the start of the pandemic. In the second quarter – for the first time in over a year – we relaxed some of these restrictions, enabling us to train sales and service personnel from Thermo Fisher Scientific in well-adapted premises on site in Uppsala. Training took place electronically for some time, but real-life hands-on training provides a much stronger connection to the product and the opportunity to complete more advanced training.

The feedback we are receiving remains extremely positive and enthusiastic. We are consistently hearing that the system is easy to manage, smartly designed and thoroughly robust. This feedback is in line with our own argument, and to now be hearing the same opinions from Thermo Fisher Scientific’s organisation bodes very well. Thermo Fisher Scientific is investing in a dedicated support, service and sales force that will expand as sales accelerate. This is a strong indication that Thermo Fisher Scientific has great faith in ASTar. The Company’s own substantial infrastructure is also an enormous asset.

The launch and the next steps

We expect the launch to take place in several stages, in which we essentially hand-pick the first customers to carry out thorough evaluations and ensure that the system delivers a first-rate performance. Only then can we pick up the pace. At this point, we will also have a clear idea of how the system works in practice, and how much support is required. Both Thermo Fisher Scientific and Q-linea anticipate healthy growth for ASTar and are aiming for a long-term, successful and strong expansion. Q-linea’s plan does not involve achieving positive margins for the first year of the launch. Instead, we regard the systems currently being sold as an investment in the Company’s future capacity. It should also be noted that the product mix of systems and even more profitable consumables will shift toward a higher share of consumables as the distribution and use of ASTar increases.

The next step for ASTar is geographical expansion, primarily to the US, but we are also working on broadening the antibiotic panel. Our panel already provide the broadest combination of antimicrobials and dilution ranges in the market, but we want to offer the broadest panel by a significant margin. We are also looking at other applications for ASTar, such as isolates, that could be a follow-up product.

When it comes to our portable blood culture technology, we now have the first fully integrated prototypes ready. We are conducting market studies in Europe and the US that are providing us with good insight into how we can adjust the prototype before it is taken into production. Provided everything goes to plan, we will be able to initiate pivotal studies for the product next year.

Study progressing as planned

We have now begun the analytical part of the US study for ASTar, which is being carried out at Q-linea, and are in the final phase of discussions with a number of US hospitals for the prospective portion of the study. One more US hospital than previously announced will be included, which means that three US hospitals will take part in the study. We made the decision to expand the study in preparation for the launch. We aim to complete the study this year to be able to then submit a 510(k) application for market approval.

The goal is to secure a clear pole position

I am highly confident for the future. 2021 will truly be a year of development. We have received market approval for ASTar, seen that our partnership with Thermo Fisher Scientific is working very well, and before the end of the year, we will have a number of systems at customer sites. Q-linea targets an enormous market with substantial requirements, and has the opportunity to establish a leading position in the next few years. We are investing in order to become the most successful company in the sector in the long term.

In summary, I am proud of what we have achieved and the journey ahead of us remains interesting. During the quarter, we carried out a directed issue that raised gross proceeds of SEK 301 million, which will mainly be used for the commercialisation of ASTar. I would like to take this opportunity to thank you for your confidence and I look forward to continuing this journey with you all.

 

Uppsala, 14 July 2021, Jonas Jarvius, President