View Financial HealthTheraclion 배당 및 자사주 매입배당 기준 점검 0/6Theraclion 배당금을 지급한 기록이 없습니다.핵심 정보n/a배당 수익률n/a자사주 매입 수익률총 주주 수익률n/a미래 배당 수익률n/a배당 성장률n/a다음 배당 지급일n/a배당락일n/a주당 배당금n/a배당 성향n/a최근 배당 및 자사주 매입 업데이트업데이트 없음모든 업데이트 보기Recent updates공고 • Jul 09Theraclion Announces Board ChangesTHERACLION announced that its Board of Directors, which met on July 8, 2026, has appointed Mr. Vincent Gardès as Chairman of the Board of Directors, with immediate effect. A Director of Theraclion since the General Meeting of June 18, 2026, after having served as an observer over recent months, Vincent Gardès succeeds Mr. Claude Lenoir, who had served as Interim Chairman of the Board of Directors since that date and who remains a Director of the Company. Vincent Gardès is a recognised MedTech executive, with 30 years of value creation in innovative medical devices. As CEO of Vexim, he led the company’s growth through to its acquisition by the US group Stryker. He then led Germitec, structuring its commercial development in Europe and its entry into the US market, and currently leads Amber Implants through its commercialisation phase.공고 • Jun 19Theraclion Announces Board ChangesTheraclion announced that Yann Duchesne decided not to stand for re-election as Director and Chairman of the Board following the General Meeting held on June 18, 2026, positions he had held since January 24, 2022. Following the General Meeting held on June 18, 2026, the shareholders appointed a new Board of Directors composed of Lijuan Deng, Claude Lenoir, Cédric Bellanger, Mehdi El Glaoui and Vincent Gardès, the latter joining the Board of Directors of Theraclion after having served as an observer over recent months. The new Board of Directors subsequently appointed Claude Lenoir as Interim Chairman of the Board of Directors, with immediate effect. Yann Duchesne is an experienced French business leader and former Managing Partner of McKinsey & Company France. He has advised numerous major French and international companies on growth, transformation and organizational strategy. He subsequently held responsibilities in private equity in London, before serving in senior executive roles in industry. Over the past twenty years, he has served on numerous boards of directors of listed and private equity-backed companies, often as Chairman. Claude Lenoir is an experienced executive in the MedTech sector, with a career distinguished by leading international medical device and diagnostics companies. He notably served as CEO of Echosens from 2013 to 2018, during which the company continued its international development around FibroScan and non-invasive liver disease diagnostics. He also led Air Liquide Medical Systems, reinforcing his profile as an executive specialising in medical technologies and healthcare equipment and their international commercial deployment. Since 2023, he has been a member of the Board of Directors of Theraclion, where he contributes his experience in MedTech growth, internationalisation, governance and the transition of innovative medical technology toward broad market adoption. Vincent Gardès is an experienced MedTech executive, recognised for his role in the international development of innovative companies, particularly in the United States. A former leader of Vexim, which he guided through its growth to its acquisition by Stryker, he also held management positions at Germitec, contributing to its organisational development and commercial growth. He is currently CEO of Amber Implants, with a key role in its commercialisation phase and US expansion. His background brings strong expertise in international strategy, US market access, commercial structuring and value creation in innovative medical devices.공고 • Jun 09Theraclion Secures AMA CPT Editorial Panel Approval For New Category III CPT Code For SonoveinTheraclion 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.공고 • Jun 02Theraclion Presents Promising Preliminary Results From Sonovein SpeedPulse At First International HIFU CongressTheraclion 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.공고 • May 19Theraclion SA, Annual General Meeting, Jun 18, 2026Theraclion SA, Annual General Meeting, Jun 18, 2026. Location: 240 avenue pierre brossolette, malakoff France공고 • Apr 20Theraclion 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 Offering공고 • Jan 30Theraclion SA to Report Fiscal Year 2025 Results on Apr 16, 2026Theraclion SA announced that they will report fiscal year 2025 results at 5:40 PM, Central European Standard Time on Apr 16, 2026공고 • Dec 10Theraclion Announces Sonovein Fda Submission Following A Strong Year of Regulatory and Clinical AchievementsTheraclion 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.공고 • Oct 22Theraclion Secures Key Chinese Certification, Advancing Toward Market Access in ChinaTheraclion 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.공고 • Sep 16Theraclion Announces Successful U.S. FDA Pivotal Study with 96.8% Occlusion RateTheraclion 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.공고 • Jul 25Theraclion SA to Report First Half, 2025 Results on Oct 29, 2025Theraclion SA announced that they will report first half, 2025 results on Oct 29, 2025공고 • Feb 12THERACLION Announces Treatment of First Patients with NewONOVEIN®? 'SpeedPulse' Feature Accelerating TreatmentTHERACLION 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.공고 • Jan 07Theraclion SA to Report Fiscal Year 2024 Results on Apr 29, 2025Theraclion SA announced that they will report fiscal year 2024 results at 5:40 PM, Central European Standard Time on Apr 29, 2025공고 • Oct 31Theraclion SA Provides Turnover Guidance for the Year 2025 and 2026Theraclion 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.공고 • Jun 25Sonovein FDA Pivotal Study Treatments Completed: Theraclion Reaches Key Milestone on ScheduleTHERACLION 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.공고 • May 15Theraclion SA, Annual General Meeting, Jun 18, 2024Theraclion SA, Annual General Meeting, Jun 18, 2024. Location: le vaillant, 240 avenue pierre brossolette, malakoff France공고 • Oct 25Theraclion Achieves an Important Milestone on the Road to the U.S. Market: First Patients Treated with Sonovein as Part of the Fda- Approved Pivotal StudyTheraclion 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.지급의 안정성과 성장배당 데이터 가져오는 중안정적인 배당: 과거에 TCLI.F 의 주당 배당금이 안정적이었는지 판단하기에는 데이터가 부족합니다.배당금 증가: TCLI.F 의 배당금 지급이 증가했는지 판단하기에는 데이터가 부족합니다.배당 수익률 vs 시장Theraclion 배당 수익률 vs 시장TCLI.F의 배당 수익률은 시장과 어떻게 비교되나요?구분배당 수익률회사 (TCLI.F)n/a시장 하위 25% (US)1.3%시장 상위 25% (US)4.1%업계 평균 (Medical Equipment)2.0%분석가 예측 (TCLI.F) (최대 3년)n/a주목할만한 배당금: 회사가 최근 지급을 보고하지 않았기 때문에 하위 25%의 배당금 지급자에 대해 TCLI.F 의 배당 수익률을 평가할 수 없습니다.고배당: 회사가 최근 지급을 보고하지 않았기 때문에 배당금 지급자의 상위 25%에 대해 TCLI.F 의 배당 수익률을 평가할 수 없습니다.주주 대상 이익 배당수익 보장: 배당금 지급이 수익으로 충당되는지 확인하기 위해 TCLI.F 의 지급 비율을 계산하기에는 데이터가 부족합니다.주주 현금 배당현금 흐름 범위: TCLI.F 에서 지급을 보고하지 않았기 때문에 배당 지속 가능성을 계산할 수 없습니다.높은 배당을 제공하는 우량 기업 찾기7D1Y7D1Y7D1YUS 시장에서 배당이 강한 기업.View Management기업 분석 및 재무 데이터 상태데이터최종 업데이트 (UTC 시간)기업 분석2026/07/06 21:07종가2026/04/08 00:00수익2025/12/31연간 수익2025/12/31데이터 소스당사의 기업 분석에 사용되는 데이터는 S&P Global Market Intelligence LLC에서 제공됩니다. 아래 데이터는 이 보고서를 생성하기 위해 분석 모델에서 사용됩니다. 데이터는 정규화되므로 소스가 제공된 후 지연이 발생할 수 있습니다.패키지데이터기간미국 소스 예시 *기업 재무제표10년손익계산서현금흐름표대차대조표SEC 양식 10-KSEC 양식 10-Q분석가 컨센서스 추정치+3년재무 예측분석가 목표주가분석가 리서치 보고서Blue Matrix시장 가격30년주가배당, 분할 및 기타 조치ICE 시장 데이터SEC 양식 S-1지분 구조10년주요 주주내부자 거래SEC 양식 4SEC 양식 13D경영진10년리더십 팀이사회SEC 양식 10-KSEC 양식 DEF 14A주요 개발10년회사 공시SEC 양식 8-K* 미국 증권에 대한 예시이며, 비(非)미국 증권에는 해당 국가의 규제 서식 및 자료원을 사용합니다.별도로 명시되지 않는 한 모든 재무 데이터는 연간 기간을 기준으로 하지만 분기별로 업데이트됩니다. 이를 TTM(최근 12개월) 또는 LTM(지난 12개월) 데이터라고 합니다. 자세히 알아보기.분석 모델 및 스노우플레이크이 보고서를 생성하는 데 사용된 분석 모델의 세부 정보는 당사의 GitHub 페이지에서 확인하실 수 있습니다. 또한 보고서 사용 방법에 대한 가이드와 YouTube 튜토리얼도 제공하고 있습니다.Simply Wall St 분석 모델을 설계하고 구축한 세계적 수준의 팀에 대해 알아보세요.산업 및 섹터 지표산업 및 섹터 지표는 Simply Wall St가 6시간마다 계산하며, 프로세스에 대한 자세한 내용은 Github에서 확인할 수 있습니다.분석가 소스Theraclion SA는 2명의 분석가가 다루고 있습니다. 이 중 0명의 분석가가 우리 보고서에 입력 데이터로 사용되는 매출 또는 수익 추정치를 제출했습니다. 분석가의 제출 자료는 하루 종일 업데이트됩니다.분석가기관Fanny MeindreCIC Market Solutions (ESN)Arnaud GuérinPortzamparc BNP Paribas
공고 • Jul 09Theraclion Announces Board ChangesTHERACLION announced that its Board of Directors, which met on July 8, 2026, has appointed Mr. Vincent Gardès as Chairman of the Board of Directors, with immediate effect. A Director of Theraclion since the General Meeting of June 18, 2026, after having served as an observer over recent months, Vincent Gardès succeeds Mr. Claude Lenoir, who had served as Interim Chairman of the Board of Directors since that date and who remains a Director of the Company. Vincent Gardès is a recognised MedTech executive, with 30 years of value creation in innovative medical devices. As CEO of Vexim, he led the company’s growth through to its acquisition by the US group Stryker. He then led Germitec, structuring its commercial development in Europe and its entry into the US market, and currently leads Amber Implants through its commercialisation phase.
공고 • Jun 19Theraclion Announces Board ChangesTheraclion announced that Yann Duchesne decided not to stand for re-election as Director and Chairman of the Board following the General Meeting held on June 18, 2026, positions he had held since January 24, 2022. Following the General Meeting held on June 18, 2026, the shareholders appointed a new Board of Directors composed of Lijuan Deng, Claude Lenoir, Cédric Bellanger, Mehdi El Glaoui and Vincent Gardès, the latter joining the Board of Directors of Theraclion after having served as an observer over recent months. The new Board of Directors subsequently appointed Claude Lenoir as Interim Chairman of the Board of Directors, with immediate effect. Yann Duchesne is an experienced French business leader and former Managing Partner of McKinsey & Company France. He has advised numerous major French and international companies on growth, transformation and organizational strategy. He subsequently held responsibilities in private equity in London, before serving in senior executive roles in industry. Over the past twenty years, he has served on numerous boards of directors of listed and private equity-backed companies, often as Chairman. Claude Lenoir is an experienced executive in the MedTech sector, with a career distinguished by leading international medical device and diagnostics companies. He notably served as CEO of Echosens from 2013 to 2018, during which the company continued its international development around FibroScan and non-invasive liver disease diagnostics. He also led Air Liquide Medical Systems, reinforcing his profile as an executive specialising in medical technologies and healthcare equipment and their international commercial deployment. Since 2023, he has been a member of the Board of Directors of Theraclion, where he contributes his experience in MedTech growth, internationalisation, governance and the transition of innovative medical technology toward broad market adoption. Vincent Gardès is an experienced MedTech executive, recognised for his role in the international development of innovative companies, particularly in the United States. A former leader of Vexim, which he guided through its growth to its acquisition by Stryker, he also held management positions at Germitec, contributing to its organisational development and commercial growth. He is currently CEO of Amber Implants, with a key role in its commercialisation phase and US expansion. His background brings strong expertise in international strategy, US market access, commercial structuring and value creation in innovative medical devices.
공고 • Jun 09Theraclion Secures AMA CPT Editorial Panel Approval For New Category III CPT Code For SonoveinTheraclion 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.
공고 • Jun 02Theraclion Presents Promising Preliminary Results From Sonovein SpeedPulse At First International HIFU CongressTheraclion 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.
공고 • May 19Theraclion SA, Annual General Meeting, Jun 18, 2026Theraclion SA, Annual General Meeting, Jun 18, 2026. Location: 240 avenue pierre brossolette, malakoff France
공고 • Apr 20Theraclion 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
공고 • Jan 30Theraclion SA to Report Fiscal Year 2025 Results on Apr 16, 2026Theraclion SA announced that they will report fiscal year 2025 results at 5:40 PM, Central European Standard Time on Apr 16, 2026
공고 • Dec 10Theraclion Announces Sonovein Fda Submission Following A Strong Year of Regulatory and Clinical AchievementsTheraclion 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.
공고 • Oct 22Theraclion Secures Key Chinese Certification, Advancing Toward Market Access in ChinaTheraclion 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.
공고 • Sep 16Theraclion Announces Successful U.S. FDA Pivotal Study with 96.8% Occlusion RateTheraclion 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.
공고 • Jul 25Theraclion SA to Report First Half, 2025 Results on Oct 29, 2025Theraclion SA announced that they will report first half, 2025 results on Oct 29, 2025
공고 • Feb 12THERACLION Announces Treatment of First Patients with NewONOVEIN®? 'SpeedPulse' Feature Accelerating TreatmentTHERACLION 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.
공고 • Jan 07Theraclion SA to Report Fiscal Year 2024 Results on Apr 29, 2025Theraclion SA announced that they will report fiscal year 2024 results at 5:40 PM, Central European Standard Time on Apr 29, 2025
공고 • Oct 31Theraclion SA Provides Turnover Guidance for the Year 2025 and 2026Theraclion 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.
공고 • Jun 25Sonovein FDA Pivotal Study Treatments Completed: Theraclion Reaches Key Milestone on ScheduleTHERACLION 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.
공고 • May 15Theraclion SA, Annual General Meeting, Jun 18, 2024Theraclion SA, Annual General Meeting, Jun 18, 2024. Location: le vaillant, 240 avenue pierre brossolette, malakoff France
공고 • Oct 25Theraclion Achieves an Important Milestone on the Road to the U.S. Market: First Patients Treated with Sonovein as Part of the Fda- Approved Pivotal StudyTheraclion 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.