Theraclion (Euronext: ALTHE) reported a 21% decline in first-half FY26 revenue to €663K, while its operating loss widened 36% to €3.9 million. The MedTech firm secured a Category III CPT code for the United States effective January 1, 2027, and signed seven new commercial contracts.

The results were approved by the Board of Directors on September 15, 2026. The financial statements were subject to a limited review by the company’s statutory auditors.

Financial Performance

Total revenue fell from €835K in H1FY25 to €663K in H1FY26. This decline was driven primarily by an 86% drop in service sales, which contracted from €245K to €34K due to the expiration of legacy multi-year contracts in China that had benefited from cyclical factors in the prior year.

Conversely, Pay-Per-Use (PPU) and consumables revenue grew 9% to €333K, up from €305K. Equipment sales rose slightly by 4% to €296K. Other income surged 1,144% to €759K, largely reflecting inventory changes linked to production placed into stock.

Operating expenses increased 42% to €5.3 million, up from €3.8 million. Personnel expenses rose 30% to €2.3 million, while purchases of goods and inventory changes jumped 1,158% to €1.1 million, reflecting ramp-up activities ahead of commercial deployment.

What the Numbers Show

The divergence between top-line revenue decline and bottom-line expense growth highlights the capital-intensive nature of Theraclion’s current phase. While operational revenue contracted, total operating income—including non-recurring other income—grew 59% to €1.4 million. However, this was insufficient to offset the 42% surge in operating expenses, resulting in a widened net loss of €3.6 million. The significant rise in inventory-related costs suggests aggressive production scaling ahead of anticipated market entry.

Regulatory and Commercial Updates

Theraclion is preparing for potential entry into the US market, with an FDA De Novo decision expected between late Q3FY26 and early Q4FY26. The Category III CPT code will allow reimbursement starting January 1, 2027.

Commercially, the company signed seven new contracts across Germany, Greece, Romania, Hungary, France, Spain, and China. Four devices were made available at the end of the half, with installations progressing over coming months. Clinical implementation began in China at Boao Super Hospital in Hainan.

Cash Position and Governance

Cash stood at €5.2 million as of June 30, 2026, following an oversubscribed capital increase that netted €5.8 million in May 2026. The cash runway extends into Q1 or Q2 of 2027, depending on the exercise of share subscription warrants worth up to €2 million.

Vincent Gardès was appointed Chairman of the Board on July 8, 2026, replacing Claude Lenoir. Gardès brings experience in commercial acceleration and international development for MedTech companies.

Theraclion reported 73,543,457 total shares and 86,957,843 real voting rights as on July 31, 2026. The French MedTech firm filed the data under Article 223-16 of the AMF General Regulation.

The disclosure highlights a divergence between share count and voting power. While the company has roughly 73.5 million shares outstanding, theoretical voting rights stand at 88,767,504. Real voting rights, which exclude shares stripped of voting rights, are slightly lower at 86.9 million. This structure indicates that certain shares carry enhanced voting weight or that some shares have been stripped of voting rights, a common feature in French corporate governance to protect control.

Share Capital Details

Theoretical voting rights include all shares attached with voting rights, including those stripped of such rights. Real voting rights correspond to the total exercisable at the Annual General Meeting.

About Theraclion

Theraclion develops non-invasive surgical alternatives using High-Intensity Focused Ultrasound (HIFU). Its flagship product, Sonovein, is a robotic HIFU platform for varicose vein treatment. CE marked under MDR, it has been used in over 4,000 procedures across more than a dozen centers worldwide. The company is listed on Euronext Growth Paris and is PEA PME eligible.