2cureX Q4 2022: An efficient year

Research Note

2023-02-23

14:11

Redeye comments on 2cureX’s Q4’22 report. The company summarizes the past year and highlights its strong enrollment for the IGNITE program. Furthermore, 2cureX explains the processes of how new medical technologies become mainstream.

EL

Ethel Luvall

2cureX reported its Q4 results earlier today. According to the company, the results for the period have been impacted by the increasing efforts to build market awareness of the company’s InidTreat® technology and commercial efforts to market IndiTreat®.

2cureX strategic focus for 2022 was to build market awareness of the company’s IndiTreat® technology and commercial efforts to market IndiTreat®. Just before the Christmas holidays, 2cureX announced that it had reached its 2022 geographic rollout goal of 20 countries. IndiTreat® is now actively promoted in 20 countries in Europe and the Middle East. The goal for 2023 is to be present in 25 countries, focusing on covering some of the important European markets where IndiTreat® is not yet offered.

Source: 2cureX

By the end of Q3 2022, 15 hospitals had been enrolled on the IGNITE program, and according to 2cureX, the main reason for the delay was longer decision-making times due to the summer holiday season and the long processes to formalize the agreements. Consequently, 2cureX revised the end-of-year goal from 30 to 20 hospitals, wherein the company aimed to enrol five new hospitals during the fourth quarter. The actual enrollment in Q4 2022 was nine hospitals, and 2cureX will continue to offer IndiTreat® in 2023 in order to expose potential customers to the technology and, thus, aims to have at least 500 patient samples tested with IndiTreat®.

Furthermore, in the fourth quarter, 2cureX disclosed that additional clinical studies to support clinical practice and reimbursement activities for its current product are planned. Moreover, the company aims to advance the development of its next improved IndiTreat® test, IndiTreat®Neo, to continue its geographic expansion within Europe and the expansion of the IndiTreat® user base and the number of patients tested. With the current burn rate, we believe the financial position will be sufficient to keep the company financed at least through 2023. However, many of the planned activities, in particular, clinical trials may be associated with high costs. Thus, we cannot disregard that 2cureX may potentially need to raise funds.

The journey of becoming mainstream

In the quarterly report, 2cureX highlights the process and challenges of becoming mainstream. Firstly, regulatory approval is necessary as it guarantees the new technology’s safety and efficacy. Authorities, through Notified Bodies review and establish the conformity of the product and wherein the CE-mark is issued if approved, and the product becomes authorized for its use.

Secondly, the company needs to navigate through the reimbursement systems. Reimbursement and healthcare coverage in Europe are the concern of the individual states. The systems differ in organization, financing and delivery of healthcare based on a wide range of philosophies of need, medical standards, quality of care and ethical aspects. Each country has a different configuration in terms of its healthcare systems. A few countries have National schemes with clearly defined rules. In other countries, the decision is left to regional schemes or even to each individual hospital. Consequently, a hospital-by-hospital negotiation process with uncertain decision-making criteria is required.

Thirdly, the clinical practice needs to be changed, which is mainly dependent on the different healthcare systems. In some cases, the new technology will be adopted even if it’s not in official guidelines, as long as it is CE-marked. In others, the new technology will only be used when it’s included in official guidelines. According to 2cureX, the clinical uptake depends on the different healthcare systems and how much freedom they allow their healthcare professionals to make decisions. It also depends on the individual profiles of the healthcare professionals and how much they are willing to take the lead in adopting innovation.

We continue to believe that navigation in the European healthcare system is one of the challenges. European healthcare systems are quite conservative and traditionally adopt new technologies relatively slowly. Healthcare providers also have strict requirements for new technologies, going beyond CE-marking. We believe clinical, and market uptake will take time, and additional evaluations and clinical evidence are needed.

Furthermore, we believe 2cureX need to convince healthcare providers to pay/reimburse for IndiTreat® testing to secure sizeable uptake.

Going into 2023

We are optimistic that IndiTreat® will be present in 25 countries and have 500 patient samples tested. We look forward to learning more about IndiTreat® Neo as 2cureX aims to have its performance assessment phase completed, as well as the first prototype of IndiTreat® automation tested at hospital. Furthermore, as a part of 2cureX’s commercialization strategy and goal for 2023, the company aims at having IndiTreat® test run directly at a hospital, and the company also aim to report SEK6m in revenues, of which SEK3m is expected to come from sales.

Disclosures and disclaimers

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