공시 • Jun 09
Theraclion Secures AMA CPT Editorial Panel Approval For New Category III CPT Code For Sonovein Theraclion announced that the American Medical Association CPT Editorial Panel has approved the creation of a new Category III CPT code for non-invasive high intensity focused ultrasound (HIFU) treatment of varicose veins, performed using Sonovein. The new code will become effective on January 1, 2027. Category III CPT codes are designed for emerging medical technologies, services and procedures. They provide a standardized mechanism to report procedures, track utilization, collect clinical data and support evidence development. This new code will support future engagement with healthcare providers, payers and clinical investigators as Theraclion prepares for the potential U.S. commercialization of Sonovein. In parallel to the reimbursement pathway effort, the Sonovein market approval application was submitted to the FDA in December 2025 via the De Novo pathway, following a pivotal study demonstrating 96.8% efficacy. Discussions with the FDA are progressing constructively as part of the review process with exchanges underway, and a decision is now expected toward the end of the Third Quarter or the beginning of the Fourth Quarter 2026. Theraclion continues to execute its U.S. market entry plan, with commercial launch preparations advancing toward a targeted launch by year-end 2026. The AMA CPT Editorial Panel’s actions do not constitute endorsement of any specific technology or guarantee reimbursement coverage or payment. Payment, coverage, and coding policies remain subject to individual payer determination. 공시 • Jun 03
Theraclion Presents Promising Preliminary Results From Sonovein SpeedPulse At First International HIFU Congress Theraclion announced the success of the first international HIFU congress, held in Parma on May 22 and 23, 2026, during which promising preliminary results from the clinical study conducted in Prague with its next-generation Sonovein SpeedPulse were presented. The Third International Days of Phlebology congress, held in Parma, Italy, on May 22 and 23, 2026, and presented as the first HIFU congress, allowed the company to present its Sonovein technology to the international phlebology community. Dedicated HIFU sessions and roundtable discussions were organized during the congress, during which 13 Sonovein users and key opinion leaders shared routine clinical practice results, covering hundreds of patients, different types of veins and several years of follow-up. More than one hundred healthcare professionals visited Theraclion’s booth during the congress, confirming the growing interest of the scientific community in the potential of non-invasive HIFU treatment enabled by Sonovein. During this event, preliminary results from the SpeedPulse study, initiated and conducted by Professor Jaroslav Strejcek in Prague, were presented. This study aims to evaluate a new prototype integrating advanced acoustic and robotic technologies designed to significantly accelerate treatment delivery and make the device easier to use. Early observations show a major reduction in procedure duration, with treatments now performed in less than 30 minutes, together with improved physician ergonomics enabled by enhanced robotic range of motion and additional degrees of freedom. These advances address a key adoption challenge: making treatment faster, simpler and easier to integrate into daily practice. Theraclion emphasizes that the current prototype remains under clinical evaluation and is not yet commercially available. Additional development work and regulatory approvals will be required before any potential market introduction. 공시 • May 19
Theraclion SA, Annual General Meeting, Jun 18, 2026 Theraclion SA, Annual General Meeting, Jun 18, 2026. Location: 240 avenue pierre brossolette, malakoff France 공시 • Apr 22
Theraclion SA has filed a Follow-on Equity Offering in the amount of €5.992544 million. Theraclion SA has filed a Follow-on Equity Offering in the amount of €5.992544 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 12,484,467
Price\Range: €0.48
Security Features: Attached Warrants
Transaction Features: Rights Offering 공시 • Jan 30
Theraclion SA to Report Fiscal Year 2025 Results on Apr 16, 2026 Theraclion SA announced that they will report fiscal year 2025 results at 5:40 PM, Central European Standard Time on Apr 16, 2026 공시 • Dec 10
Theraclion Announces Sonovein Fda Submission Following A Strong Year of Regulatory and Clinical Achievements Theraclion announced that the full dataset from the U.S. Food and Drug Administration pivotal study has been submitted to the FDA on schedule as part of the De Novo clearance process for Sonovein®?. Based on typical FDA review timelines for comparable devices, a decision is anticipated around mid-2026. FDA clearance would authorize U.S. commercialization, giving access to the largest varicose vein treatment market. In 2025, Sonovein®? also achieved key regulatory milestones, including EU MDR certification and compliance with China's GB 9706.1-2020 standard, strengthening its pathway to long-term commercialization in Europe and future market access in China. 공시 • Oct 22
Theraclion Secures Key Chinese Certification, Advancing Toward Market Access in China Theraclion SA announced that its Sonovein® has successfully passed China’s GB 9706.1-2020 medical electrical equipment safety standard — the national equivalent of the internationally recognized IEC 60601-1 normative framework. This certification confirms that Sonovein® meets the latest Chinese requirements for electrical safety and focused ultrasound emissions for medical devices, validating the robustness of its design and manufacturing processes. It demonstrates Sonovein®’s ability to meet the stringent technical and safety criteria established by the National Medical Products Administration (NMPA), the Chinese regulatory authority. From a regulatory standpoint, compliance with GB 9706.1-2020 is a pivotal milestone in the NMPA approval pathway, ensuring that Sonovein® fulfills one of the core prerequisites for market authorization in China. This achievement marks significant progress toward market authorization and commercialization in China, one of the world’s largest and most dynamic markets for advanced medical technologies. With this certification secured, Sonovein® remains firmly on track to deliver on its international expansion strategy and bring the benefits of its non-invasive ultrasound innovation to a broader patient population. 공시 • Sep 16
Theraclion Announces Successful U.S. FDA Pivotal Study with 96.8% Occlusion Rate Theraclion announced top-line results from its VEINRESET pivotal U.S. clinical trial today. Primary endpoint met: Occlusion rate at 12 months was 96.8%, confirming strong efficacy. Excellent safety profile: No serious or unanticipated adverse events, only one mild adverse event reported throughout the study. Solid secondary endpoints: Reflux abolition rate of 98.5%. 70 patients across four centers were enrolled and treated in New York (U.S.), New Jersey (U.S.), Vienna (Austria), and Prague (C Czech Republic). The VEINRESET study was a single-arm, prospective, multi-center clinical trial to assess the safety and efficacy of Theraclion's Sonovein device in treating primary insufficiency of Great Saphenous Vein (GSV). The study results showed that 96.8% of treated patients achieved complete vein closure at 12 months, with a 95% confidence interval of 88.3% to 99.2%, thereby meeting the primary endpoint. All secondary endpoints demonstrated favorable device efficacy and safety. At 12-month follow-up, 98.5% of patients did not have reflux. Pain observed in all patients, and symptoms were completely resolved in most patients, according to the Venous Clinical Severity Score (rVCSS). None of the patients underwent complementary procedures. Both patients and investigators were satisfied with the device/procedure outcome. Taken together, the study successfully demonstrated that using HIFU generated by Sonovein is safe and effective for the treatment of symptomatic primary GSV insufficiency. Next steps These results will form the basis of Theraclion's planned submission to the U.S. Food and Drug Administration (FDA). Authorization from FDA would enable Theraclion to access the U.S. market, the largest vein treatment market worldwide. 공시 • Jul 25
Theraclion SA to Report First Half, 2025 Results on Oct 29, 2025 Theraclion SA announced that they will report first half, 2025 results on Oct 29, 2025 공시 • Feb 12
THERACLION Announces Treatment of First Patients with NewONOVEIN®? 'SpeedPulse' Feature Accelerating Treatment THERACLION announced that its latest generation SONOVEIN®? 'SpeedPulse' feature is being tried on patients. SONOVEIN™? achieved a new level of maturity in 2024, with Theraclion maintaining its focus on ongoing R&D and innovation. Key progress has recently been made on the development of new functionalities, particularly in Artificial Intelligence, acoustics and 3D robotics, boosting clinical efficacy and treatment speed. These advancements will drive broader adoption in treatment centers, expanding the addressable market and reinforcing Theraclion's mid-term growth potential. SONOVEIN®®? 'SpeedPulse') significantly reduces treatment time. The tested feature called 'SpeedPulse' integrates improved acoustics and therapeutic ultrasound pulsing, aiming at substantially increasing treatment speed. The trial will span over several months. 공시 • Jan 07
Theraclion SA to Report Fiscal Year 2024 Results on Apr 29, 2025 Theraclion SA announced that they will report fiscal year 2024 results at 5:40 PM, Central European Standard Time on Apr 29, 2025 공시 • Oct 31
Theraclion SA Provides Turnover Guidance for the Year 2025 and 2026 Theraclion SA provided turnover guidance for the year 2025 and 2026. For the year, the company is aiming for a turnover of €2.5 million in 2025.
For the year, the company is aiming for a turnover of €5 million in 2026. 공시 • Jun 25
Sonovein FDA Pivotal Study Treatments Completed: Theraclion Reaches Key Milestone on Schedule THERACLION announced that treatments in the United States’ FDA (Food & Drug Administration) pivotal study for SONOVEIN® have concluded, in accordance with the scheduled timeline. A key milestone in the FDA approval process for SONOVEIN® A total of 70 patients have been treated with Sonovein in the clinical trial. Four leading centers took part in this study, in the U.S. and in Europe. Results to be released after 12-month follow-up Following the successful completion of a feasibility study in 2022, the FDA pivotal study was initiated on schedule at the end of 2023. With the conclusion of the treatment phase, a 12-month follow-up period is now beginning, and the study results will be available in the summer of 2025. The market approval application will be submitted to the FDA as soon as the study report becomes available in the second half of 2025, and an approval is expected early 2026 but will depend on the regulatory agency review time. 공시 • May 15
Theraclion SA, Annual General Meeting, Jun 18, 2024 Theraclion SA, Annual General Meeting, Jun 18, 2024. Location: le vaillant, 240 avenue pierre brossolette, malakoff France 공시 • Oct 25
Theraclion Achieves an Important Milestone on the Road to the U.S. Market: First Patients Treated with Sonovein as Part of the Fda- Approved Pivotal Study Theraclion announced that it launched the first treatments for its FDA-approved pivotal study on the treatment of varicose veins using SONOVEIN in the United States. Theraclion's strategy is to gain access to key markets in the United States and China as early as possible. The first patient treatments are an essential step towards accessing the world's leading varicose vein market. The Food & Drug Administration (FDA) approved this clinical trial a few months ago, following a successful initial feasibility study last year. Renowned doctor Steve Elias, Director of the Center for Vein Disease at a prestigious New Jersey hospital and member of the renowned American Board of Venous and Lymphatic Medicine and American College of Surgeons, is the principal investigator of this trial, which will be conducted at four centers of excellence in the U.S. and Europe. Results will be available after a 12 month follow-up period, in accordance with the FDA-approved protocol.