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Fondée en 2005 et basée à Aix-en-Provence (France), SuperSonic Imagine est une entreprise spécialisée dans le secteur de l’imagerie médicale. La société conçoit, développe et commercialise une plateforme échographique nouvelle génération, Aixplorer®, qui exploite une technologie UltraFast™ avec une cadence d’acquisition environ 200 fois plus rapide que les systèmes concurrents. Aixplorer® est le seul échographe à pouvoir imager deux types d’ondes : les ondes ultrasonores permettant de construire des images d’une qualité exceptionnelle ; les ondes de cisaillement permettant aux médecins de visualiser et analyser en temps réel la dureté des tissus, grâce à une procédure fiable, reproductible, et non invasive. Cette innovation, l’Elastographie ShearWave™, améliore la détection et la caractérisation de multiples pathologies dans de nombreuses applications, notamment le sein, la thyroïde, le foie ou la prostate. SuperSonic Imagine dispose des autorisations règlementaires nécessaires pour une commercialisation d’Aixplorer® sur les principaux marchés. Au cours des dernières années, SuperSonic Imagine a bénéficié du soutien de plusieurs investisseurs de premier plan, parmi lesquels Auriga Partners, Edmond de Rothschild Investment Partners, Bpifrance, Omnes Capital, NBGI.


Attendees to see the powerful 60-second non-invasive liver exam performed using SuperSonic Imagine's Aixplorer with ShearWave Elastography™ technology AIX-EN-PROVENCE, FRANCE--(Marketwired - May 4, 2017) - SuperSonic Imagine ( : SSI) (FR0010526814), a company specializing in ultrasound medical imaging, announced today that it will showcase its Aixplorer® platform with real-time ShearWave™ Elastography (SWE™) for the assessment and management of liver diseases at Digestive Disease Week (DDW) Annual Meeting 2017, held May 6 - 9 at McCormick Place in Chicago. Accompanying SuperSonic Imagine will be Diversatek Healthcare, the exclusive distributor of Aixplorer® to Gastroenterologists and Hepatologists in the U.S.A. SuperSonic Imagine and Diversatek Healthcare will be exhibiting during DDW 2017 in the Exhibit Hall at booth #1921. "At SuperSonic Imagine, innovation in liver imaging is a driving passion, so we are thrilled to attend DDW once again and share the clinical benefits of the Aixplorer's SWE technology with specialists from around the world," said Jacques Souquet, Founder and Chief Innovation Officer at SuperSonic Imagine. "With our distribution partner, we are committed to expanding our footprint in the U.S.A., Diversatek Healthcare shares our goal of managing chronic Liver Disease with non invasive diagnostic liver imaging and quantification to assist in diagnosis. At our booth, attendees can see firsthand how SWE technology promises to do just that." "Our mission is to bring our customers in Gastroenterology and Hepatology the latest technologies to improve patient care," said Stuart Wildhorn, Chief Scientific Officer, Diversatek Healthcare. "The Aixplorer platform with SWE technology truly changes the landscape of liver disease management, making it an excellent fit for our customers and our company. Being able to visualize what you are measuring adds to better patient management." Real-time ShearWave Elastography (SWE), available only on the Aixplorer system, is a 60-second non-invasive exam used for imaging chronic liver disease. SWE offers the advantage of real-time imaging of liver anatomy, while also providing not only a color-coded map of liver stiffness, but also a quantification tool for the measurement of stiffness which is an important parameter for liver diagnostic. Over 100 peer reviewed publications have demonstrated the reliability and effectiveness of SuperSonic Imagine's SWE in imaging liver pathologies. Recently, the results of an international multicenter study on 1134 patients were published in Hepatology, and confirmed the benefit of SWE in the non-invasive assessment of liver stiffness1, including for patients with diseases such as hepatitis C that may require repeated follow-up evaluations. Although biopsy has been considered the standard for assessing liver fibrosis severity, the drawbacks of this invasive approach include significant incidence of morbidity, high procedure costs due to longer hospitalisation, and clinical shortcomings. Stiffness is even sometimes underestimated in 10-30% of cases.2,3 1 Herrmann E. 2D-Shear Wave Elastography Is Equivalent or Superior to Transient Elastography for Liver Fibrosis Assessment: Results from an Individual Patient Data Based Meta-analysis. The International Liver Congress, Vienna, April 23, 2015. 2 Sampling error and intraobserver variation in liver biopsy in patients with chronic HCV infection. Regev A, Berho, M, Jeffers LJ, Milikowski C, Molina EG, Pyrsopoulos NT, Feng ZZ, Reddy KR, Schiff ER. Am J Gastroenterol. 2002 Oct;97(10):2614-8. 3 Sources of variability in histological scoring of chronic viral hepatitis. Rousselet MC, Michalak S, Dupré F, Croué, A, Bedossa P, Saint-André JP, Calès P; Hepatitis Network 49. Hepatology. 2005 Feb;41(2):257-64. About Diversatek Healthcare Headquartered in Milwaukee, Wisconsin, Diversatek Healthcare is a wholly-owned subsidiary of Diversatek Inc. A leader in gastroenterological medical devices and diagnostics, Diversatek Healthcare's tenured management team is committed to making business personal again through a hands-on approach to understanding clinical and patient needs. Diversatek Healthcare is driving science in the GI space while providing comprehensive educational offerings through Diversatek University, including on-site training and virtual platforms. The company offers an extensive range of state-of-the-art diagnostic and therapeutic GI applications from esophageal dilators and endoscopic accessories to high-resolution impedance manometry systems and impedance/pH total reflux monitoring. Diversatek Inc. recently united two complementary subsidiaries, Sandhill Scientific and Medovations, to form one singular organization committed to technologies that simplify the complex medical marketplace. For additional information, visit www.diversatekhealthcare.com or contact us at 800-558-6408. Founded in 2005 and based in Aix-en-Provence (France), SuperSonic Imagine is a company specializing in medical imaging. The company designs, develops and markets a revolutionary ultrasound system, Aixplorer®, with an UltraFast™ platform that can acquire images 200 times faster than conventional ultrasound systems. In addition to providing exceptional image quality, this unique technology is the foundation of several innovations which have changed the paradigm of ultrasound imaging: ShearWave™ Elastography (SWE™), UltraFast™ Doppler, Angio PL.U.S - Planewave UltraSensitive™ Imaging and more recently TriVu. ShearWave Elastography allows physicians to visualize and analyze the stiffness of tissue in a real-time, reliable, reproducible and non-invasive manner. This criteria has become an important parameter in diagnosing potentially malignant tissue or other diseased tissue. As of today, over 300 peer-reviewed publications have demonstrated the value of SWE for the clinical management of patients with a wide range of diseases. SuperSonic Imagine has been granted regulatory clearances for the commercialization of Aixplorer in key global markets. SuperSonic Imagine is a listed company since April 2014 on the Euronext, symbol SSI. For more information about SuperSonic Imagine, please go to www.supersonicimagine.com.


THERACLION (Paris:ALTHE) (Alternext, FR0010120402 - ALTHE), a company specialized in leading-edge medical equipment for echotherapy, today announced its sales for 2017 first half, ended June 30, 2017. David Caumartin, CEO of Theraclion, declares: « Theraclion accelerates its growth in the first half of 2017 with the signature of 11 commercial agreements1 compared with 5 the previous year over the same period. Germany, where several health insurances already reimburse the procedure, remains the main market for the company. In the first half of the year, the continuing expansion of the number of insurance companies covering the use of echotherapy has driven growth in treatment volumes and allowed the signature of three new commercial agreements. Three orders are registered in new countries, reflecting the growing adoption of our echotherapy solution. Given this dynamic commercial development, Theraclion expects to double the number of commercial agreements1 concluded in 2017 compared to 2016. » New orders: already 11 commercial agreements1 signed during 2017 first half During the first half of 2017, the Company recorded 11 commercial agreements1: 8 Echopulse® orders, 2 of which have been already transferred2, and 3 contracts for the provision of equipment against pay per use, including 1 in Hong Kong. Equipment rent decreased compared to the first half of 2016 due to the exercise of the Echopulse purchase option at two of the three sites leasing Echopulse at the end of the 2016 financial year. While the number of clinical routine treatments increased by 77%, the sale of consumables decreased by 7% compared to the first half of 2016. As the supply chain matures and the delivery time reduces, customers are maintaining lower inventory levels than they did in 2016. The increase in service sales reflects the subscription of maintenance contracts for systems that have come out of the warranty period. Clinical routine: 77% growth in the number of treatments performed The total number of treatments increased by 52% in the first half. The number of clinical routine treatments (i.e.: treatments outside a Theraclion-sponsored clinical trial) increased by 77%, reflecting the growing clinical adoption of echotherapy. In Germany, the leading country in terms of number of treatment sites, routine clinical treatment volume increased by 89%. FDA Authorization to Start U.S. Trial for Immunotherapy and Echotherapy Combination in Breast Cancer Treatment The University of Virginia (UVA), one of Theraclion’s long-term academic partner, has received authorization from the U.S. Food and Drug Administration (FDA) to proceed with a new clinical study. This study aims at evaluating the potential of treatment combining echotherapy delivered with Theraclion’s Echopulse (also known as High Intensity Focused Ultrasound, HIFU) with pembrolizumab, an immunotherapy drug targeting PD-1 checkpoint Inhibitor. UVA has been equipped with Theraclion’s Echopulse® since 2014. Echopulse is being evaluated in a feasibility study in the US for non-invasive treatment of breast fibroadenomas. Immunotherapy stimulates the body’s own immune system to fight tumor cells. HIFU, which has already demonstrated its efficacy in the treatment of malignant and benign tumors, could have a major impact on the efficacy of immunotherapy when delivered as a combined treatment as it may locally potentiate the immune response induced by the combined treatment of drugs and HIFU. Theraclion also announces that it has obtained new funding under its TUCE project in collaboration with SuperSonic Imagine (Euronext: SSI, FR0010526814, eligible for PEA-PME). The TUCE project aims to combine the technology of echotherapy with SuperSonic Imagine’s innovative imaging solution of. The effect of the treatment on the tissues can be monitored and validated in real time. This new funding of € 1,036,000 in July from Bpifrance, in the form of recoverable advances of € 703,000 and grants of € 333,000, follows on the € 433,000 received in July 2016. This new funding rewards a key milestone in development that includes the results of clinical trials in Europe and the FDA authorization of the launch of breast fibroadenoma trials in the United States. «We are delighted to see the advances of TUCE project, which is being promoted by Theraclion as part of our “Industrial Strategic Innovation” program. We support the future champions of the French industry and today we renew our support for Theraclion, which is developing an innovative medical device for the non-invasive treatment of tumors. We look forward to the success of the first treatments», says Nicole Tannières, Head of Follow-up of projects to the Bpifrance Expertise Department. Theraclion continue its funding efforts to secure its cash needs for 2018. About Theraclion Theraclion is a French company specializing in high-tech medical equipment using therapeutic ultrasound. Drawing on leading-edge technologies, Theraclion has designed and manufactured an innovative solution for echotherapy, the Echopulse®, allowing non-invasive tumor treatment through ultrasound-guided high-intensity focused ultrasound. Theraclion is ISO 13485 certified and has received the CE mark for non-invasive ablation of breast fibroadenomas and thyroid nodules. Based in Malakoff, near Paris, France Theraclion has brought together a team of 34 people, 50% of whom are dedicated to R&D and clinical trials. For more information, please visit Theraclion’s website: www.theraclion.com. 1 Commercial agreements cover sales of equipment and the provision of equipment for which Theraclion invoices either rent or "on a fee" basis. 2 These sales of equipment include a return clause within 12 months. This practice is commonly used by Theraclion to facilitate the adoption of its innovative technology. To date, no customer has exercised this clause. 3 These sales of equipment include a return clause within 12 months. This practice is commonly used by Theraclion to facilitate the adoption of its innovative technology. To date, no customer has exercised this clause.


Tandis que le nombre de traitements en routine clinique augmente de 77%, la vente de consommables s’inscrit en retrait de 7% par rapport au premier semestre 2016. Au fur et à mesure que la chaîne d'approvisionnement mûrit et que les délais de livraison diminuent, les clients ne constituent plus de stocks prévisionnels comme ils l'ont fait en 2016. Le projet TUCE vise à associer la technologie d’échothérapie à la solution d’imagerie innovante de SuperSonic Imagine. L’effet du traitement sur les tissus pourra être monitoré et validé en temps réel. L’obtention de ce nouveau financement de 1 036 K€ de Bpifrance en juillet, sous forme d’avances remboursables pour 703 K€ et de subventions pour 333 K€, fait suite à celui de 433 K€ de juillet 2016. Ce nouveau financement récompense le succès d’une étape clé dans le développement qui inclut notamment les résultats des études cliniques en Europe et l’autorisation de la FDA du lancement des essais sur le fibroadénome du sein menés aux Etats-Unis. « Nous sommes ravis de constater les avancées du projet TUCE, porté par Theraclion, qui s’inscrit dans le cadre de notre programme « Innovation Stratégique Industrielle ». Nous soutenons les futurs champions de l’industrie française et nous renouvelons aujourd’hui notre soutien à Theraclion qui développe un dispositif médical innovant dans le traitement non invasif des tumeurs et nous nous réjouissons du succès des premiers traitements », déclare Nicole Tannières, Responsable de suivi de projets à la direction de l’Expertise de Bpifrance. Theraclion est une société française spécialisée dans l’équipement médical de haute technologie utilisant les ultrasons thérapeutiques. S’appuyant sur les technologies les plus avancées, Theraclion conçoit et commercialise une solution innovante d’échothérapie, l’Echopulse®, qui permet le traitement des tumeurs par Ultrasons Focalisés sous guidage échographique. Theraclion est certifiée ISO 13 485 et a reçu le marquage CE pour l’ablation non invasive des adénofibromes du sein et des nodules thyroïdiens. Localisée à Malakoff, près de Paris, Theraclion rassemble une équipe de 34 personnes dont 50% sont dédiées à la R&D et aux essais cliniques.


À propos de SuperSonic Imagine Fondée en 2005 et basée à Aix-en-Provence (France), SuperSonic Imagine est une entreprise spécialisée dans le secteur de l’imagerie médicale. La société conçoit, développe et commercialise une plateforme échographique nouvelle génération, Aixplorer®, qui exploite une technologie UltraFast™ avec une cadence d’acquisition environ 200 fois plus rapide que les systèmes concurrents. Aixplorer® est le seul échographe à pouvoir imager deux types d’ondes : les ondes ultrasonores permettant de construire des images d’une qualité exceptionnelle ; les ondes de cisaillement permettant aux médecins de visualiser et analyser en temps réel la dureté des tissus, grâce à une procédure fiable, reproductible, et non invasive. Cette innovation, l’Elastographie ShearWave™, améliore la détection et la caractérisation de multiples pathologies dans de nombreuses applications, notamment le sein, la thyroïde, le foie ou la prostate. SuperSonic Imagine dispose des autorisations règlementaires nécessaires pour une commercialisation d’Aixplorer® sur les principaux marchés. Au cours des dernières années, SuperSonic Imagine a bénéficié du soutien de plusieurs investisseurs de premier plan, parmi lesquels Auriga Partners, Edmond de Rothschild Investment Partners, Bpifrance, Omnes Capital, NBGI.


Grant
Agency: European Commission | Branch: H2020 | Program: RIA | Phase: ICT-29-2016 | Award Amount: 3.82M | Year: 2016

SOLUS is a trans-disciplinary 48-month project bringing together 9 partners: industries (4), academic and clinical institutions from 5 countries (engineers, physicists and radiologists) representing cutting-edge expertise in their fields, to develop an innovative non-invasive, point-of-care, low-cost, easy-to-operate, multi-modal imaging system (diffuse optics and ultrasounds/shear wave elastography) for high-specificity diagnosis of breast cancer, the most common female cancer in Europe. Mammographic screening is effective in reducing mortality, however the 10-year cumulative false-positive risk is 50-60%, leading to needless additional invasive procedures (e.g. biopsy). The project addresses the unmet clinical need for higher specificity in breast cancer imaging following screening by fully combining photonics with non-photonics techniques, developing and clinically validating innovative and previously unthinkable photonics concepts and components: time-domain small source-detector distance optical tomography, miniaturized picosecond pulsed laser sources, high-dynamic-range time-gated single-photons detectors to achieve unprecedented sensitivity and depth penetration. For the first time, this allows a comprehensive quantitative characterization of breast tissue including composition (water, lipids, collagen), functional blood parameters, morphologic information and mechanical parameters (stiffness). This innovative multi-parametric characterization will significantly improve the specificity of breast screening, with great impact on the quality of life of millions of European women every year, and huge savings for the healthcare systems. The strong involvement of leading industrial players at all levels in the value chain will push the European innovation process and make a significant contribution to ensuring Europes industrial leadership in the biophotonics healthcare market, while addressing one of the largest societal challenges in health and well-being.


AIX-EN-PROVENCE, France--(BUSINESS WIRE)--Regulatory News: SuperSonic Imagine (Euronext: SSI, FR0010526814) (Paris:SSI), a company specializing in ultrasound medical imaging, today announced that it has received 510(k) clearance from the Food & Drug Administration (FDA) for additional probes and significant clinical innovations on the Aixplorer® platform. This authorization includes numerous new imaging modes recently developed by SuperSonic Imagine: Angio PL.U.S. - PlaneWave UltraSensitive


News Article | November 24, 2016
Site: www.businesswire.com

AIX-EN-PROVENCE, France--(BUSINESS WIRE)--Regulatory News: SuperSonic Imagine (Paris:SSI) (Euronext: SSI, FR0010526814, PEA-PME eligible), the highly-innovative ultrasound company, today announces the appointment of Michèle Lesieur as President and CEO, thus replacing Bernard Doorenbos. Michael Brock, Chairman of the Supervisory Board, says: “SuperSonic Imagine’s Supervisory Board is enthusiastic about Michèle Lesieur becoming the Company’s President and CEO. Her expertise, her leadership and h


AIX-EN-PROVENCE, France--(BUSINESS WIRE)--Regulatory News: SuperSonic Imagine (Paris:SSI) (Euronext: SSI, FR0010526814), a company specializing in ultrasound medical imaging, today announced the installation of its flagship Aixplorer ultrasound system at Knoxville Comprehensive Breast Center in Tennessee. The Aixplorer system provides premium breast imaging and unique innovations including real-time ShearWave™ Elastography (SWETM). SWE is a quick, non-invasive exam that gives practitioners a co


SuperSonic Imagine hosts a symposium where key opinion leaders will discuss how UltraFast™ imaging innovations are improving their diagnostic efficiency and patient management AIX-EN-PROVENCE, FRANCE--(Marketwired - Feb 28, 2017) - SuperSonic Imagine ( : SSI) (FR0010526814), a company specializing in ultrasound medical imaging, today announced that it will feature Aixplorer®'s latest advances at the European Congress of Radiology (ECR) March 1 - 5, in Vienna, Austria. The upgrade to Aixplorer is the only UltraFast™ ultrasound system, with enhanced performance, improved workflow and diagnostic efficiency, while providing both impeccable image quality and unprecedented ultrasound innovations. SuperSonic Imagine will demonstrate live on the show floor its new innovative modes (booth #3 in Hall X5). "Meeting with colleagues from across Europe, we are excited to share the Aixplorer's new capabilities, especially the exclusive TriVu real-time simultaneous mode, which combines anatomical and functional imaging in one single acquisition," said Jacques Souquet, Founder and Chief Innovation Officer of SuperSonic Imagine. "We are also proud to show our new fusion and navigation mode. We received very positive feedback from the first users who specially appreciated its intuitive and simplistic user-interface as well as the exclusive innovative modes also available while in fusion imaging mode." Aixplorer's latest version demonstrates advancements in several respects. The new comprehensive breast package is a combination of new probes designed especially for breast imaging, resulting in a significantly improved B-mode image quality. Three essential innovations aid visualization: SWE to improve diagnostic specificity, 3D Ultrasound for improved visualization of tissue stiffness, and the unique TriVu mode combining breast anatomy, flow information and tissue stiffness in a single acquisition. Planned demonstrations include Aixplorer's new Fusion, Navigation & Needle Guidance technology, which enable users to fuse real-time ultrasound images with magnetic resonance imaging, computed tomography, positron emission tomography and 3D ultrasound, as well as with other exclusive Aixplorer modes such as SWE, Angio PL.U.S. or TriVu. This combined visualization is designed to leverage the simultaneous real-time benefits of multiple modalities for exams in complex cases, as well as for interventional imaging such as biopsy guidance or for therapy such as RF ablation. SuperSonic Imagine will also host a clinical symposium (March 1st, 12:30 - 13:30pm, Room N), "UltraFast Imaging: Innovations in ultrasound for daily practice". Prof. F.K.W. Schäfer, Dr. M. Garcovich, Dr. L. Masci and Prof. J.M. Correas will present how the use of innovative ultrasound in their daily practice help them to better assess and monitor chronic liver disease and breast and prostate cancers, as well as sports medicine conditions. The event will be LiveTweet, to follow it #SympoUltraFast. Founded in 2005 and based in Aix-en-Provence (France), SuperSonic Imagine is a company specializing in medical imaging. The company designs, develops and markets a revolutionary ultrasound system, Aixplorer®, with an UltraFast™ platform that can acquire images 200 times faster than conventional ultrasound systems. In addition to providing exceptional image quality, this unique technology is the foundation of several innovations which have changed the paradigm of ultrasound imaging: ShearWave™ Elastography (SWE™), UltraFast™ Doppler, Angio PL.U.S - Planewave UltraSensitive™ Imaging and more recently TriVu. ShearWave Elastography allows physicians to visualize and analyze the stiffness of tissue in a real-time, reliable, reproducible and non-invasive manner. This criteria has become an important parameter in diagnosing potentially malignant tissue or other diseased tissue. As of today, over 300 peer-reviewed publications have demonstrated the value of SWE for the clinical management of patients with a wide range of diseases. UltraFast Doppler combines Color Flow Imaging and Pulsed Wave Doppler into one simple exam, providing physicians with exam results simultaneously and helping to increase patient throughput. The latest innovation, Angio PL.U.S, provides a new level of microvascular imaging through significantly improved color sensitivity and spatial resolution while maintaining exceptional 2D imaging. SuperSonic Imagine has been granted regulatory clearances for the commercialization of Aixplorer in key global markets. SuperSonic Imagine is a listed company since April 2014 on the Euronext, symbol SSI. For more information about SuperSonic Imagine, please go to www.supersonicimagine.com.

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