Theraclion: Revenue Down 21% in First Half, FDA Decision Expected Between Late September and Early Fourth Quarter 2026
Theraclion is approaching a major regulatory milestone: the FDA decision on the De Novo application for Sonovein is expected between the end of the third and the beginning of the fourth quarter of 2026.
In the first half of 2026, the group posted revenue of €663k and an operating result of -€3.9m, during a period described as dedicated to preparing a possible entry into the American market and strengthening its commercial and industrial operations.
Revenue at €663k, Pay-Per-Use Income Up 9%
In the first half of 2026, Theraclion's revenue stood at €663k, compared to €835k a year earlier, a decline of 21%. According to the company, this change primarily reflects the decline in sales of services, consumables and goods in China, which had benefited from cyclical factors in the first half of 2025.
In detail, equipment sales increased by 4% to €296k and Pay-Per-Use and consumables revenue increased by 9% to €333k (compared to €305k a year earlier). Services sales declined by 86% to €34k, a decline that the group attributes largely to the end of historical multi-year contracts not yet renewed.
The operating result came in at -€3.9m, compared to -€2.9m in the first half of 2025. The net result stood at -€3.6m, compared to -€2.5m a year earlier.
Expenses Committed in Advance of Commercial Rollout
According to Theraclion, the deterioration in operating results reflects in particular expenses incurred to prepare the next stages of development, notably regulatory work related to the American submission, strengthening of sales teams and ramping up of production.
Personnel costs increased by 30% to €2.3m and external expenses declined by 9% to €1.5m. The group has signed seven new contracts since the beginning of the year, covering centers in Germany, Greece, Romania, Hungary, France, Spain and China, of which four devices were made available at the end of the semester.
As installations took place mainly at the end of the semester, their contribution to revenue in the first half remains marginal, with the company indicating that it will become visible from the second half of 2026. Sonovein is furthermore now being used clinically at Boao Super Hospital in Hainan, the first clinical installation in China.
Cash Position of €5.2m and Visibility Through Second Quarter 2027
At 30 June 2026, Theraclion's available cash stood at €5.2m, following an oversubscribed capital increase completed in spring 2026 (net amount received of €5.8m in May 2026). This transaction was accompanied by the issuance of share subscription warrants that could bring up to an additional €2m if fully exercised.
Depending on the exercise of these warrants and the pace of commercial rollout in the United States, cash visibility extends between the end of the first and the end of the second quarter of 2027. The company is exploring various financing solutions, including pre-financing of the research tax credit (approximately €0.9m).
On the regulatory front, Theraclion now has a Category III CPT code effective 1 January 2027, while the FDA's review of the De Novo application continues, with a decision expected between the end of the third quarter and the beginning of the fourth quarter of 2026.
