View Future GrowthTheraclion 過去の業績過去 基準チェック /06Theraclionの収益は年間平均-7.5%の割合で減少していますが、 Medical Equipment業界の収益は年間 増加しています。収益は年間14.8% 1.5%割合で 減少しています。主要情報-7.54%収益成長率20.02%EPS成長率Medical Equipment 業界の成長8.90%収益成長率-1.52%株主資本利益率n/aネット・マージン-872.70%前回の決算情報31 Dec 2025最近の業績更新お知らせ • 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お知らせ • 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お知らせ • 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すべての更新を表示Recent updatesお知らせ • 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.お知らせ • Jun 03Theraclion 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.お知らせ • May 19Theraclion SA, Annual General Meeting, Jun 18, 2026Theraclion SA, Annual General Meeting, Jun 18, 2026. Location: 240 avenue pierre brossolette, malakoff Franceお知らせ • Apr 22Theraclion 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お知らせ • 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お知らせ • 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.お知らせ • 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.お知らせ • 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.お知らせ • 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お知らせ • 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.お知らせ • 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お知らせ • 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.お知らせ • 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.お知らせ • 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お知らせ • 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.収支内訳Theraclion の稼ぎ方とお金の使い方。LTMベースの直近の報告された収益に基づく。収益と収入の歴史OTCPK:TCLI.F 収益、費用、利益 ( )EUR Millions日付収益収益G+A経費研究開発費31 Dec 251-64030 Sep 251-54030 Jun 252-53031 Mar 251-63031 Dec 241-63030 Sep 241-53030 Jun 241-43031 Mar 241-43031 Dec 232-43030 Sep 232-43030 Jun 232-53031 Mar 232-53031 Dec 221-53030 Sep 221-54030 Jun 221-54031 Mar 221-43031 Dec 211-43030 Sep 212-41030 Jun 212-42031 Mar 211-42031 Dec 201-42030 Sep 201-43030 Jun 202-42031 Mar 203-42031 Dec 193-42030 Sep 193-44030 Jun 192-41031 Mar 192-52031 Dec 182-63030 Sep 182-62030 Jun 183-64031 Mar 183-64031 Dec 173-63030 Sep 173-64030 Jun 172-64031 Mar 172-64031 Dec 162-74030 Sep 162-74030 Jun 162-74031 Mar 162-74031 Dec 152-64030 Sep 151-63030 Jun 150-630質の高い収益: TCLI.Fは現在利益が出ていません。利益率の向上: TCLI.Fは現在利益が出ていません。フリー・キャッシュフローと収益の比較過去の収益成長分析収益動向: TCLI.Fは利益が出ておらず、過去 5 年間で損失は年間7.5%の割合で増加しています。成長の加速: TCLI.Fの過去 1 年間の収益成長を 5 年間の平均と比較することはできません。現在は利益が出ていないためです。収益対業界: TCLI.Fは利益が出ていないため、過去 1 年間の収益成長をMedical Equipment業界 ( 15.7% ) と比較することは困難です。株主資本利益率高いROE: TCLI.Fの負債は資産を上回っているため、自己資本利益率を計算することは困難です。総資産利益率使用総資本利益率過去の好業績企業の発掘7D1Y7D1Y7D1YHealthcare 、過去の業績が好調な企業。View Financial Health企業分析と財務データの現状データ最終更新日（UTC時間）企業分析2026/06/10 22:01終値2026/04/08 00:00収益2025/12/31年間収益2025/12/31データソース企業分析に使用したデータはS&P Global Market Intelligence LLC のものです。本レポートを作成するための分析モデルでは、以下のデータを使用しています。データは正規化されているため、ソースが利用可能になるまでに時間がかかる場合があります。パッケージデータタイムフレーム米国ソース例会社財務10年損益計算書キャッシュ・フロー計算書貸借対照表SECフォーム10-KSECフォーム10-Qアナリストのコンセンサス予想+プラス3年予想財務アナリストの目標株価アナリストリサーチレポートBlue Matrix市場価格30年株価配当、分割、措置ICEマーケットデータSECフォームS-1所有権10年トップ株主インサイダー取引SECフォーム4SECフォーム13Dマネジメント10年リーダーシップ・チーム取締役会SECフォーム10-KSECフォームDEF 14A主な進展10年会社からのお知らせSECフォーム8-K* 米国証券を対象とした例であり、非米国証券については、同等の規制書式および情報源を使用。特に断りのない限り、すべての財務データは1年ごとの期間に基づいていますが、四半期ごとに更新されます。これは、TTM（Trailing Twelve Month）またはLTM（Last Twelve Month）データとして知られています。詳細はこちら。分析モデルとスノーフレーク本レポートを生成するために使用した分析モデルの詳細は当社のGithubページでご覧いただけます。また、レポートの使用方法に関するガイドやYoutubeのチュートリアルも掲載しています。シンプリー・ウォールストリート分析モデルを設計・構築した世界トップクラスのチームについてご紹介します。業界およびセクターの指標私たちの業界とセクションの指標は、Simply Wall Stによって6時間ごとに計算されます。アナリスト筋Theraclion SA 0 これらのアナリストのうち、弊社レポートのインプットとして使用した売上高または利益の予想を提出したのは、 。アナリストの投稿は一日中更新されます。2 アナリスト機関Fanny MeindreCIC Market Solutions (ESN)Arnaud GuérinPortzamparc BNP Paribas
お知らせ • 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
お知らせ • 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
お知らせ • 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
お知らせ • 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.
お知らせ • Jun 03Theraclion 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.
お知らせ • May 19Theraclion SA, Annual General Meeting, Jun 18, 2026Theraclion SA, Annual General Meeting, Jun 18, 2026. Location: 240 avenue pierre brossolette, malakoff France
お知らせ • Apr 22Theraclion 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
お知らせ • 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
お知らせ • 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.
お知らせ • 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.
お知らせ • 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.
お知らせ • 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
お知らせ • 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.
お知らせ • 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
お知らせ • 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.
お知らせ • 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.
お知らせ • 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
お知らせ • 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.