Dear Shareholders,

The early commercialization took significant steps in the right direction during the second quarter of 2021. Year-on-year, net sales grew by 230%, gross order-intake grew by 45%, the number of active surgeons during the quarter increased by 37%, and the number of countries in which we sold implants grew by 38%. We aim at a high level of activity, with many surgeons in many countries – every quarter. We are continuing to establish a solid foundation for growth globally, and I can confidently say that based on the now available clinical results for the Episealer®, our operating environment is improving substantially. As the clinical acceptance for a mini-metal implant with excellent clinical results grows in the orthopaedic community, our growth rates will increase in several markets. Moreover, the interest in the Episealer® Talus implant technology is exceeding our expectations. Of course, we are yet to see the full financial impact of this positive development, but we are increasingly confident that this will come in the next steps of our journey.

Several factors will drive generation of net sales in the years to come, and the key indicators for those are developing in a very positive way. Let me explain: First, we are seeing strong growth in the number of surgeons using the Episealer®. This will be key to our growth. And as mentioned above, our strategy is to ensure that this happens in several markets. Secondly, as orthopaedic surgeons’ confidence in the technology grows and patient outcomes continue to be highly positive, the activity with each surgeon is growing. Thirdly, given the presence of strong clinical results, our ability to charge is improving. The combined effect from these three factors speaks for a favorable development as we advance. Episurf and I frequently receive questions about the sale process and what it takes for a surgeon to adopt new technologies. The reality is that the first surgery for a new customer, especially with a new technology, is the most challenging one to arrange. This surgery requires the most from us as well as from the surgeon. During the years up to and including 2020, it was evident that we only worked with the surgeons who are referred to as “early innovators”, and in large, surgeons tested the technology on a small scale. During those years, we did not see any significant growth in the user base. During the fall of 2020, results from the first larger studies on the Episealer® were published. From that point onwards, these results have been available to us in our sales processes. Despite the pandemic, we have seen strong growth in the user base, both during Q1 2021 and Q2 2021. We have just recently been able to commercialize with the help of data, which is crucial for establishing a new implant technology with clinics, payors, and patients. Of course, it is difficult to disregard from the impact of COVD-19. We clearly see an improvement regarding the pandemic-related restrictions, but we are not yet back to a normal scenario. We have talked about this several times, and we do not need to repeat ourselves on this point, but we are looking forward to a normalization for elective surgery levels in the months to come.

On the back of the strong momentum we are experiencing, we have decided to expand our commercial organization in our core markets. Today, we have announced that we have entered into an agent agreement with JAMO Orthopaedics for specific regions in the UK midlands. JAMO Orthopaedics will complement our current UK sales force by selling both Episealer Knee and Episealer Talus. In addition, Episurf Medical has today communicated that we are re-activating our efforts towards the Benelux region. The Benelux region was a critical region for Episurf in the initial years. However, since 2019 the region has been de-prioritized. As clinical data for broader commercialization is available, we have decided to focus on the region by hiring a senior sales rep.

We are looking forward to several important milestones during the second half of 2021. First, three important clinical papers are submitted for publication in scientific journals. Moreover, and very important, is that an investigator-initiated European multicentre study with 5 years’ follow-up of 50 Episealer® Knee patients is ongoing. Preliminary results from the follow-up are expected during the fourth quarter of 2021, while full results are expected in early 2022. It is highly exciting to have such a milestone ahead of us already this year. The available 2-year results have led to significant improvement in our sales processes, and the value of 5-year data cannot be emphasized enough.

Concerning our strategy for the US market, we have today communicated that our product development project of the Episealer® Patellofemoral System is progressing according to plan. We confirm our target of submitting a 510(k) application for this implant technology later this year. We are also preparing for the commercialization of the Episealer® Patellofemoral System in the US market during 2022. We are in a dialogue with the FDA regarding the EPIC-knee clinical trial where we intend to carry out certain adjustments to the clinical protocol, aiming at significantly speeding up patient recruitment as COVID-19 related restrictions are lifted, and the trial can properly start again at all sites.

The third quarter has started very well, and we are highly optimistic about the future. Short-term, we cannot rule out the impact of COVID-19 on our figures. However, with a little bit of perspective; we are optimistic about delivering strong growth, solid performance in our clinical trials and in our product development projects. More and more clinics are integrating the Episealer® technology in their treatment algorithm for lesions in the knee and in the ankle, and we believe we are the market leading supplier of treatment solutions for treating these challenging lesions.

Stockholm, July 2021

Pål Ryfors, CEO