MALAKOFF, France--(BUSINESS WIRE)--October 29, 2025--
Regulatory News:
THERACLION (ISIN: FR0010120402; Mnemo: ALTHE), an innovative company developing Sonovein$(R)$ , a robotic platform for non-invasive High-Intensity Focused Ultrasound (HIFU) varicose vein treatment, provides an update on its strategic progress and announces its first-half results.
-- United States: Pivotal study successfully completed with a 12-month
occlusion rate of 96.8%, confirming strong efficacy.
-- Europe: CE MDR certification obtained and commercial rollout continued
with the opening of two new centers in Bulgaria and in Spain.
-- China: Obtained GB 9706.1-2020 certification for the safety of
electromedical equipment, the national equivalent of international
standard IEC 60601-1.
-- Revenue up 89% and operating loss reduced by 23%.
-- Cash position strengthened by the issuance of BEOCA and the exercise of
2023 warrants.
Martin Deterre, Chief Executive Officer of Theraclion, stated: "The results achieved over the past few weeks mark the culmination of several years of dedicated work in the U.S., Europe and China. The major success of our U.S. pivotal study, together with the obtainment of European CE MDR and Chinese GB 9706.1-2020 technical certifications, clearly demonstrate our team's ability to deliver. At the same time, revenue growth--recurring revenue in particular--and reduction in operating losses confirm the strength of our trajectory. Along with a stronger cash position, these achievements reinforce our credibility and support the commercial rollout now at the heart of our efforts."
United States: Successful FDA Pivotal Study
The VEINRESET FDA pivotal study was successfully completed. Results showed that at 12 months, 96.8% of treated patients achieved complete occlusion of the great saphenous vein, meeting the primary endpoint, and 98.5% showed no reflux. All secondary endpoints confirmed the device's efficacy and safety. Pain was eliminated in all patients and symptoms had completely disappeared in most of them.
These results form the basis of the regulatory submission that Theraclion plans to file with the U.S. Food and Drug Administration (FDA) in the coming weeks. FDA clearance, expected in the second quarter of 2026, would allow Theraclion to access the U.S. market -- the world's largest for venous disease treatments -- for which the company is already preparing its operational development plan.
Europe: CE Certification under MDR
In September, Sonovein(R) obtained certification under the Medical Device Regulation (MDR, EU 2017/745). The MDR is the European Union's regulatory framework for medical devices and is considered one of the strictest in the world in terms of safety, quality and performance for the medical technology industry.
Independent assessment confirmed that both the Sonovein(R) device and Theraclion's quality management system fully comply with MDR requirements, paving the way for long-term commercialization of the latest generation of Sonovein(R) .
China: A Key Step toward Market Access
Sonovein(R) successfully passed the GB 9706.1-2020 Chinese standard for the safety of electromedical equipment--the national equivalent of the international IEC 60601-1 standard.
This certification confirms that Sonovein(R) meets China's latest requirements for electrical safety and focused ultrasound emissions, validating the robustness of its design and manufacturing processes. It demonstrates Sonovein(R) 's ability to meet the stringent technical and safety standards established by the National Medical Products Administration (NMPA).
From a regulatory standpoint, compliance with GB 9706.1-2020 is a crucial milestone in the NMPA approval process, fulfilling one of the key prerequisites for market authorization in China.
Commercial Launch in Europe
As part of its intensified commercial efforts, Theraclion is actively building its sales and marketing organization in order to expand sales and pay-per-use (PPU) deployments of Sonovein(R) .
In parallel, Sonovein(R) 's technological credibility and clinical maturity have been further strengthened through the publication of new scientific papers and more than a dozen presentations at major international conferences by leading physicians.
This growing visibility was accompanied by the launch of a new product identity and website (www.sonovein.com), providing the Sonovein(R) brand with a refreshed image that embodies innovation, clinical excellence and ambition. These factors have translated into a marked increase in expressions of interest from potential customers for Sonovein(R) in recent months.
Two new Sonovein(R) PPU contracts were signed in Bulgaria and Spain during the first half of the year, strengthening Theraclion's European presence and expanding the installed base of its technology.
2025 Half-Year Results
In EURK 30/06/2025 30/06/2024 Var Var. %
--------------------------------------- ---------- ---------- ----- ------
Revenue: 834 -239 1,072 450%
Revenue from equipment sales 309 -572 881 154%
Revenue from consumable sales 372 287 85 30%
Revenue from service sales 153 46 107 233%
Grants and subsidies 3 138 -135 -98%
Other income 43 38 5 13%
Inventoried and capitalized production 107 0 107 0%
Other operating income reversals 98 11 87 791%
======================================= ========== ========== ===== ======
Total Production 1,085 -52 1,137 2,182%
======================================= ========== ========== ===== ======
Cost of goods sold and inventory
variation 277 -231 508 -220%
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Gross margin 557 -8 564 7,393%
--------------------------------------- ---------- ---------- ----- ------
% Gross margin 67% -3% 0 2187%
Purchases and other external expenses 1,652 1,640 12 1%
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Salaries and social charges 1 786 1 661 125 7.5%
Depreciation, amortization, and
provisions 174 544 -370 -68%
Other operating expenses 12 12 0%
--------------------------------------- ---------- ---------- ----- ------
Operating income -2,816 -3,666 850 -23%
--------------------------------------- ---------- ---------- ----- ------
Financial income -143 83 -226 -272%
Exceptional income -54 16 -70 -435%
Research tax credit 475 525 -49 -9%
--------------------------------------- ---------- ---------- ----- ------
Net income -2,538 -3,043 505 -17%
--------------------------------------- ---------- ---------- ----- ------
Average headcount 31 28 3 11%
--------------------------------------- ---------- ---------- ----- ------
* These financial statements were subject to a limited review by the company's statutory auditors.
Revenue
Revenue for the first half of 2025 amounted to EUR834K, up 89% compared with EUR442K in the first half of 2024, before the exceptional adjustment of EUR680K relating to the cancellation of Echopulse system sales recorded in 2024.
Consumables, which include recurring pay-per-use (PPU) revenues, increased by 30% compared with the first half of 2024, while service revenues rose by 233% over the same period. This strong momentum is a key indicator of the growing adoption of Sonovein(R) by treatment centers and reflects the technology's sustained commercial traction in the field.
Combined consumables and service revenues, representing recurring revenue streams, increased by 58% compared with 2024.
With the start of commercial deployment, the Company had set revenue targets for fiscal year 2025 in the second half of 2024. As current market demand favors the pay-per-use (PPU) model over system purchases, the company has chosen to align its commercial strategy with this sustainable model. This strong trend in Europe and in the United States supports the immediate adoption of the technology and generates steadily increasing recurring revenues, strengthening the company's long-term growth prospects. System sales, which are subject to longer decision cycles, remain harder to forecast. In this early commercialization phase, accurate forecasting of future revenues therefore still carries a degree of uncertainty.
Operating Performance
Production totaled EUR1,085K, including EUR107K in capitalized production related to a system placed with a customer under a PPU agreement, initially recorded in inventory.
Operating expenses for the period amounted to EUR3,715K, compared with EUR3,578K in 2024--an increase of 4%--and included the following:
-- Purchases of goods: EUR289K vs. EUR287K in the same period of 2024.
-- Personnel expenses (salaries, wages and social charges): EUR1,786K vs.
EUR1,661K in the prior year, up 7.5%, mainly driven by Sales staffing.
-- External expenses: EUR1,652K vs. EUR1,640K in the prior year, remaining
stable.
Considering accrued interests on convertible bonds issued during the first half and an unfavorable foreign exchange revaluation, the financial result was a loss of EUR143K.
The research tax credit $(CIR)$ amounted to EUR475K as of June 30, 2025, compared with EUR525K in 2024.
As a result, net loss stood at EUR2,538K, representing a 17% reduction compared with 2024.
Cash Position and Going Concern
The Board of Directors confirmed the company's ability to carry out its development, taking into account the following:
-- As of June 30, 2025, Theraclion's available cash amounted to EUR3.4
million.
-- On February 20, 2025, the Company issued Convertible Bonds $(OCA)$ with
respective maximum amounts of EUR6 million and EUR580K.
This financing through the issuance of bonds convertible into shares (the "BEOCA") enabled the subscription and payment of an initial tranche of EUR3.3 million in the first half of the year.
An option to subscribe to a second tranche was attached to the subscription to the first tranche. Our shareholders and management renewed their confidence in the strategy by subscribing to the second tranche of "OCA," strengthening the cash with a new contribution of EUR1.25 million.
In addition, the exercise of certain stock warrants issued during the capital increase carried out in June 2023 enabled the collection of EUR284K from existing shareholders.
Additional short-term cash flows include the payment of EUR2.5 million by the Furui group for the subscription of the second tranche of convertible bonds and the exercise of warrants, payment of 2024 Research Tax Credit, amounting to EUR950K, and expected revenue growth for 2025 compared with 2024.
Based on these factors, the Company has sufficient resources to finance its commercial development while continuing its R&D efforts and clinical studies.
About Theraclion
Theraclion is a French MedTech company committed to developing a non-invasive alternative to surgery through the innovative use of focused ultrasound.
High Intensity Focused Ultrasound (HIFU) does not require incisions or an operating room. HIFU treatment concentrates therapeutic ultrasounds on an internal focal point from outside the body.
Theraclion is developing Sonovein(R) , a MDR CE-marked, robotic HIFU platform for varicose vein treatment that could replace millions of surgical procedures every year. To date, Sonovein(R) has been adopted by more than a dozen centers worldwide and used in over 3,500 procedures. In the U.S., Sonovein(R) is not yet available for sale.
For more information, please visit www.theraclion.com and follow the LinkedIn account.
Theraclion is listed on Euronext Growth Paris
Eligible for the PEA-PME scheme
Mnemonic: ALTHE - ISIN code: FR0010120402
LEI: 9695007X7HA7A1GCYD29
View source version on businesswire.com: https://www.businesswire.com/news/home/20251029406656/en/
CONTACT: Theraclion
Martin Deterre
Chief Executive Officer
contact@theraclion.com
(END) Dow Jones Newswires
October 29, 2025 13:30 ET (17:30 GMT)