Foch Hospital

Suresnes, France

Foch Hospital

Suresnes, France
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Uhrig L.,CEA Saclay Nuclear Research Center | Uhrig L.,Institute National Of La Sante Et Of La Recherche Medicale Avenir Bettencourt Schueller | Uhrig L.,French Institute of Health and Medical Research | Dehaene S.,CEA Saclay Nuclear Research Center | And 7 more authors.
Journal of Neuroscience | Year: 2014

Can monkeys learn simple auditory sequences and detect when a new sequence deviates from the stored pattern? Here we tested the predictive-coding hypothesis, which postulates that cortical areas encode internal models of sensory sequences at multiple hierarchical levels, and use these predictive models to detect deviant stimuli. In humans, hierarchical predictive coding has been supported by studies of auditory sequence processing, but it is unclear whether internal hierarchical models of auditory sequences are also available to nonhuman animals. Using fMRI, we evaluated the encoding of auditory regularities in awake monkeys listening to first- and secondorder sequence violations. We observed distinct fMRI responses to first-order violations in auditory cortex and to second-order violations in a frontoparietal network, a distinction only demonstrated in conscious humans so far. The results indicate that the capacity to represent and predict the structure of auditory sequences is shared by humans and nonhuman primates. © 2014 the authors.


Vignon P.,University of Limoges | Repesse X.,University Hospital Ambroise Pare | Begot E.,University of Limoges | Leger J.,University of Tours | And 6 more authors.
American Journal of Respiratory and Critical Care Medicine | Year: 2017

Rationale: Assessment of fluid responsiveness relies on dynamic echocardiographic parameters that have not yet been compared in large cohorts. Objectives: To determine the diagnostic accuracy of dynamic parameters used to predict fluid responsiveness in ventilated patients with a circulatory failure of any cause. Methods: In this multicenter prospective study, respiratory variations of superior vena cava diameter (ASVC) measured using transesophageal echocardiography, of inferior vena cava diameter (AIVC) measured using transthoracic echocardiography, of the maximal Doppler velocity in left ventricular outflow tract (AVmaxAo) measured using either approach, and pulse pressure variations (APP) were recorded with the patient in the semirecumbent position. In each patient, a passive leg raise was performed and an increase of aortic velocity time integral greater than or equal to 10% defined fluid responsiveness. Measurements and Main Results: Among 540 patients (379 men; age, 65 ± 13 yr; Simplified Acute Physiological Score II, 59 ± 18; Sequential Organ Failure Assessment, 10 ± 3), 229 exhibited fluid responsiveness (42%). APP, AVmaxAo, ASVC, and AIVC could be measured in 78.5%, 78.0%, 99.6%, and 78.1% of cases, respectively. ASVC greater than or equal to 21%, AVmaxAo greater than or equal to 10%, and AIVC greater than or equal to 8% had a sensitivity of 61% (95% confidence interval, 57-66%), 79% (75-83%), and 55% (50-59%), respectively, and a specificity of 84% (81-87%), 64% (59-69%), and 70% (66-75%), respectively. The area under the receiver operating characteristic curve of ASVC was significantly greater than that of AIVC (P = 0.02) and APP (P = 0.01). Conclusions: AVmaxAo had the best sensitivity and ASVC the best specificity in predicting fluid responsiveness. ASVC had a greater diagnostic accuracy than AIVC and APP, but its measurement requires transesophageal echocardiography. Copyright © 2017 by the American Thoracic Society.


Gakis G.,University of Tübingen | Witjes J.A.,Radboud University Nijmegen | Comperat E.,Groupe Hospitalier Pitie Salpetriere | Cowan N.C.,Queen Elizabeth Hospital Birmingham | And 4 more authors.
European Urology | Year: 2013

Context The European Association of Urology (EAU) Guidelines Group on Muscle-Invasive and Metastatic Bladder Cancer prepared these guidelines to deliver current evidence-based information on the diagnosis and treatment of patients with primary urethral carcinoma (UC). Objective To review the current literature on the diagnosis and treatment of patients with primary UC and assess its level of scientific evidence. Evidence acquisition A systematic literature search was performed to identify studies reporting urethral malignancies. Medline was searched using the controlled vocabulary of the Medical Subject Headings database, along with a free-text protocol. Evidence synthesis Primary UC is considered a rare cancer, accounting for <1% of all malignancies. Risk factors for survival include age, tumour stage and grade, nodal stage, presence of distant metastasis, histologic type, tumour size, tumour location, and modality of treatment. Pelvic magnetic resonance imaging is the preferred method to assess the local extent of urethral tumour; computed tomography of the thorax and abdomen should be used to assess distant metastasis. In localised anterior UC, urethra-sparing surgery is an alternative to primary urethrectomy in both sexes, provided negative surgical margins can be achieved. Patients with locally advanced UC should be discussed by a multidisciplinary team of urologists, radiation oncologists, and oncologists. Patients with noninvasive UC or carcinoma in situ of the prostatic urethra and prostatic ducts can be treated with a urethra-sparing approach with transurethral resection and bacillus Calmette-Guérin (BCG). Cystoprostatectomy with extended pelvic lymphadenectomy should be reserved for patients not responding to BCG or as a primary treatment option in patients with extensive ductal or stromal involvement. Conclusions The 2013 guidelines document on primary UC is the first publication on this topic by the EAU. It aims to increase awareness in the urologic community and provide scientific transparency to improve outcomes of this rare urogenital malignancy. © 2013 European Association of Urology.


Objective To report the experience of 1 hospital in the transition from the microscopic approach to the endoscopic endonasal approach for pituitary disease and skull base tumor surgery.Methods From 2006 to August 2011, 1000 procedures to treat pituitary disease and skull base tumors were performed in our department by a single neurosurgeon using the endoscopic endonasal approach.Results The endonasal endoscopic approach for pituitary adenoma surgery decreased nasal complications, increased patient comfort by avoiding postoperative nasal packing, provided a better view of the intrasellar and suprasellar areas, obtained the same endocrinologic results as the microscopic approach, provided better control of the invasion of the cavernous sinus, and allowed removal of tumors of the cavernous sinus in some cases.Conclusions It is important to separate the 2 approaches, the endoscopic endonasal transsellar approach and the endoscopic endonasal extended approach, and to avoid unnecessary extended approaches. The use of an endoscopic endonasal approach has added value for lesions localized between the tuberculum sellae and the odontoid. The added value of endoscopic endonasal approaches for lesions in front of the tuberculum sellae is less clear and must be evaluated in the future. © 2014 Elsevier Inc. All rights reserved.


Pierot L.,University of Reims | Pierot L.,Reims University Hospital Center | Portefaix C.,University of Reims | Boulin A.,Foch Hospital | Gauvrit J.-Y.,Rennes University Hospital Center
European Radiology | Year: 2012

Objectives To compare 3D-TOF magnetic resonance angiography (MRA) and contrast-enhanced MRA (CE-MRA) sequences at 3T in the follow-up of coiled aneurysms with digital subtracted angiography (DSA) as the gold standard. Methods DSA, 3D-TOF and CE-MRA were performed in a prospective series of 126 aneurysms in 96 patients (57 female, 39 male; age: 25-75 years, mean: 51.3±11.3 years). The quality of aneurysm occlusion was assessed independently and anonymously by a core laboratory. Results Using DSA (gold standard technique), total occlusion was depicted in 57 aneurysms (45.2%), neck remnant in 34 aneurysms (27.0%) and aneurysm remnant in 35 aneurysms (27.8%). Sensitivity, specificity, positive predictive value and negative predictive value were very similar with 3D-TOF and CE-MRA. Visibility of coils was much better with 3DTOF (95.2%) than with CE-MRA (23.0%) (P<0.001). Also, substantial artefacts were less frequent with 3D-TOF (4.0%) than with CE-MRA (11.9%; P=0.012). Conclusions In this large prospective series of patients with coiled aneurysms, at 3T 3D-TOF MRA was equivalent to CEMRAfor the evaluation of aneurysmocclusion, but coil visibility was superior at 3D-TOF. Thus the use of 3D-TOF at 3T is recommended for the follow-up of coiled intracranial aneurysms. © European Society of Radiology 2012.


Devillier P.,CNRS Laboratory for Molecular and Pharmacological Mechanisms of Bronchial Obstruction | Devillier P.,Foch Hospital | Dreyfus J.-F.,Foch Hospital | Demoly P.,Montpellier University | And 2 more authors.
BMC Medicine | Year: 2014

Background: The capacity of sublingual allergen immunotherapy (SLIT) to provide effective symptom relief in pollen-induced seasonal allergic rhinitis is often questioned, despite evidence of clinical efficacy from meta-analyses and well-powered, double-blind, placebo-controlled randomized clinical trials. In the absence of direct, head-to-head, comparative trials of SLIT and symptomatic medication, only indirect comparisons are possible.Methods: We performed a meta-analysis of classes of products (second-generation H1-antihistamines, nasal corticosteroids and grass pollen SLIT tablet formulations) and single products (the azelastine-fluticasone combination MP29-02, and the leukotriene receptor antagonist montelukast) for the treatment of seasonal allergic rhinitis in adults, adolescents and/or children. We searched the literature for large (n >100 in the smallest treatment arm) double-blind, placebo-controlled randomized clinical trials. For each drug or drug class, we performed a meta-analysis of the effect on symptom scores. For each selected trial, we calculated the relative clinical impact (according to a previously published method) on the basis of the reported post-treatment or season-long nasal or total symptom scores: 100 × (scorePlacebo - scoreActive)/scorePlacebo.Results: Twenty-eight publications on symptomatic medication trials and ten on SLIT trials met our selection criteria (total number of patients: n = 21,223). The Hedges' g values from the meta-analyses confirmed the presence of a treatment effect for all drug classes. In an indirect comparison, the weighted mean (range) relative clinical impacts were -29.6% (-23% to -37%) for five-grass pollen SLIT tablets, -19.2% (-6% to -29%) for timothy pollen SLIT tablets, -23.5% (-7% to -54%) for nasal corticosteroids, -17.1% (-15% to -20%) for MP29-02, -15.0% (-3% to -26%) for H1-antihistamines and -6.5% (-3% to -10%) for montelukast.Conclusions: In an indirect comparison, grass pollen SLIT tablets had a greater mean relative clinical impact than second-generation antihistamines and montelukast and much the same mean relative clinical impact as nasal corticosteroids. This result was obtained despite the presence of methodological factors that mask the clinical efficacy of SLIT for the treatment of seasonal allergic rhinitis. © 2014 Devillier et al.; licensee BioMed Central Ltd.


Pierot L.,University of Reims | Portefaix C.,University of Reims | Portefaix C.,Signal Sciences | Gauvrit J.-Y.,University of Rennes 1 | Boulin A.,Foch Hospital
American Journal of Neuroradiology | Year: 2012

BACKGROUND AND PURPOSE: Our aim was to compare 3D TOF-MRA sequences at 3T and 1.5T in the follow-up of coiled aneurysms. The follow-up of coiled intracranial aneurysms is mandatory to depict potential recanalization. 3D-TOF MRA is an appropriate tool for this purpose. MATERIALS AND METHODS: DSA and 3D TOF-MRA at 1.5T and 3T were performed in a prospective series of 126 aneurysms in 96 patients (58 women, 38 men; age, 25-75 years; mean, 51.3 ± 11.3 years). DSA was the reference standard to which the accuracy of 3D TOF-MRA was compared. The quality of aneurysm occlusion was assessed independently and anonymously by a core lab by using a 3-grade scale (total occlusion, neck remnant, and aneurysm remnant). Adequate occlusion was defined as total occlusion or neck remnant and used in a 2-grade scale: adequate occlusion/aneurysm remnant. RESULTS: With DSA, total occlusion was depicted in 58 aneurysms (46.0%); neck remnant, in 33 aneurysms (26.2%); and aneurysm remnant, in 35 aneurysms (27.8%). Adequate occlusion was seen in 91 cases (72.2%). A remnant (aneurysm or neck) was depicted in 68 cases (54.0%). For the 3 imaging techniques and regardless of scale used, the interobserver agreement was always greater at 3T than at 1.5T. SE and NPV for the prediction of aneurysm remnant versus adequate occlusion were higher at 3T than at 1.5T (SE 3T, 0.74; SE 1.5T, 0.54; NPV 3T, 0.90; NPV 1.5T, 0.85). CONCLUSIONS: In this large prospective series of patients, 3D TOF-MRA was superior at 3T to 1.5T for the evaluation of coiled intracranial aneurysms.


HOUSTON--(BUSINESS WIRE)--Penumbra, Inc. (NYSE: PEN), a global interventional therapies company, today announced the presentation of the results of the ASTER Trial, the first independent, prospective, randomized trial comparing the use of Penumbra’s aspiration system to stent retriever, in the opening plenary session at the International Stroke Conference in Houston, Texas. The ASTER Trial provides additional evidence of Penumbra’s aspiration system as an effective frontline thrombectomy approach for acute ischemic stroke as part of the ADAPT (A Direct Aspiration, First Pass Technique) technique. “The ASTER study provides evidence that starting with Penumbra aspiration first as part of the ADAPT technique is similar to the stent retriever technique,” said Michel Piotin, MD, principal investigator and interventional neuroradiologist at Rothschild Fondation Hospital in Paris. “The ADAPT technique offers the possibility to easily add a stent retriever following Penumbra aspiration if needed, leading to time savings.” The data showed that the ADAPT technique compared favorably: 85.4 percent of patients treated with Penumbra’s aspiration system achieved the primary endpoint of TICI 2b/3 at the end of the procedure compared with 83.1 percent of patients treated with stent retrievers (p=0.53). Moreover, 63.0 percent of patients treated with Penumbra’s aspiration system achieved the secondary endpoint of TICI 2b/3 after frontline treatment compared to 67.7 percent with stent retrievers (p=0.33). “The ASTER Trial shows no significant difference in revascularization rate and safety using either thrombectomy technique – Penumbra aspiration and stent retrievers – for acute ischemic stroke patients with large vessel occlusions,” said Bertrand Lapergue, MD, PhD, Division of Neurology, Stroke Center, Foch Hospital, University Versailles Saint-Quentin en Yvelines (France) and scientific coordinator for the study. “The broad eligibility criteria achieved in the ASTER Trial make the results generalizable to the majority of stroke patients with large vessel occlusions.” Secondary safety endpoints presented, including embolization in new territory (ENT) and symptomatic intracranial hemorrhage (sICH), were not statistically different between the two arms. “The ASTER Trial builds on the results of the 3D Trial, providing additional evidence supporting the use of Penumbra System direct aspiration devices as a first-line treatment for acute ischemic stroke patients,” said Adam Elsesser, chairman, chief executive officer and president of Penumbra. “The ADAPT technique with the Penumbra System as a frontline approach together with complementary adjunctive devices when needed offers a cost-effective solution for treating stroke patients, which is critical as patient access to mechanical thrombectomy is further expanded.” The ASTER (Adapt versus StEnt Retriever) Trial is a prospective, randomized controlled study that compared the safety and efficacy of the Penumbra aspiration system used frontline as part of the ADAPT technique versus stent retrievers. The primary endpoint was end of procedure revascularization (TICI 2b/3). The study enrolled 381 patients at eight centers in France over 12 months beginning in October 2015. Penumbra provided an institutional grant to support the ASTER Trial. The Penumbra System consists of large diameter, highly flexible, and reliably trackable reperfusion catheters that utilize the full aspiration power of the Penumbra Pump MAX™ through its Hi-Flow Aspiration Tubing. The Penumbra System enables physicians to use aspiration, which acts like a minimally invasive “vacuum” inside the artery, to remove stroke-causing blood clots from the brain safely and effectively. The Penumbra System is the only FDA cleared integrated aspiration system for the revascularization of ischemic stroke patients. Penumbra, Inc., headquartered in Alameda, California, is a global interventional therapies company that designs, develops, manufactures and markets innovative medical devices. The company has a broad portfolio of products that address challenging medical conditions and significant clinical needs across two major markets, neuro and peripheral vascular. Penumbra sells its products to hospitals primarily through its direct sales organization in the U.S., most of Europe, Canada and Australia, and through distributors in select international markets. Penumbra, the Penumbra logo, ACE, and Pump MAX are trademarks of Penumbra, Inc. Other trademarks are the property of their respective owners. Except for historical information, certain statements in this press release are forward-looking in nature and are subject to risks, uncertainties and assumptions about us. Our business and operations are subject to a variety of risks and uncertainties and, consequently, actual results may differ materially from those projected by any forward-looking statements. Factors that could cause actual results to differ from those projected include, but are not limited to: failure to sustain or grow profitability or generate positive cash flows; failure to effectively introduce and market new products; delays in product introductions; significant competition; inability to further penetrate our current customer base, expand our user base and increase the frequency of use of our products by our customers; inability to achieve or maintain satisfactory pricing and margins; manufacturing difficulties; permanent write-downs or write-offs of our inventory; product defects or failures; unfavorable outcomes in clinical trials; inability to maintain our culture as we grow; fluctuations in foreign currency exchange rates; and potential adverse regulatory actions. These risks and uncertainties, as well as others, are discussed in greater detail in our filings with the Securities and Exchange Commission, including our Quarterly Reports on Form 10-Q and our Annual Report on Form 10-K for the year ended December 31, 2015. There may be additional risks of which we are not presently aware or that we currently believe are immaterial which could have an adverse impact on our business. Any forward-looking statements are based on our current expectations, estimates and assumptions regarding future events and are applicable only as of the dates of such statements. We make no commitment to revise or update any forward-looking statements in order to reflect events or circumstances that may change.


HOUSTON - Feb. 22, 2017 - Penumbra, Inc. (NYSE: PEN), a global interventional therapies company, today announced the presentation of the results of the ASTER Trial, the first independent, prospective, randomized trial comparing the use of Penumbra's aspiration system to stent retriever, in the opening plenary session at the International Stroke Conference in Houston, Texas. The ASTER Trial provides additional evidence of Penumbra's aspiration system as an effective frontline thrombectomy approach for acute ischemic stroke as part of the ADAPT (A Direct Aspiration, First Pass Technique) technique. "The ASTER study provides evidence that starting with Penumbra aspiration first as part of the ADAPT technique is similar to the stent retriever technique," said Michel Piotin, MD, principal investigator and interventional neuroradiologist at Rothschild Fondation Hospital in Paris. "The ADAPT technique offers the possibility to easily add a stent retriever following Penumbra aspiration if needed, leading to time savings." The data showed that the ADAPT technique compared favorably: 85.4 percent of patients treated with Penumbra's aspiration system achieved the primary endpoint of TICI 2b/3 at the end of the procedure compared with 83.1 percent of patients treated with stent retrievers (p=0.53). Moreover, 63.0 percent of patients treated with Penumbra's aspiration system achieved the secondary endpoint of TICI 2b/3 after frontline treatment compared to 67.7 percent with stent retrievers (p=0.33). "The ASTER Trial shows no significant difference in revascularization rate and safety using either thrombectomy technique - Penumbra aspiration and stent retrievers - for acute ischemic stroke patients with large vessel occlusions," said Bertrand Lapergue, MD, PhD, Division of Neurology, Stroke Center, Foch Hospital, University Versailles Saint-Quentin en Yvelines (France) and scientific coordinator for the study. "The broad eligibility criteria achieved in the ASTER Trial make the results generalizable to the majority of stroke patients with large vessel occlusions." Secondary safety endpoints presented, including embolization in new territory (ENT) and symptomatic intracranial hemorrhage (sICH), were not statistically different between the two arms. "The ASTER Trial builds on the results of the 3D Trial, providing additional evidence supporting the use of Penumbra System direct aspiration devices as a first-line treatment for acute ischemic stroke patients," said Adam Elsesser, chairman, chief executive officer and president of Penumbra. "The ADAPT technique with the Penumbra System as a frontline approach together with complementary adjunctive devices when needed offers a cost-effective solution for treating stroke patients, which is critical as patient access to mechanical thrombectomy is further expanded." The ASTER (Adapt versus StEnt Retriever) Trial is a prospective, randomized controlled study that compared the safety and efficacy of the Penumbra aspiration system used frontline as part of the ADAPT technique versus stent retrievers. The primary endpoint was end of procedure revascularization (TICI 2b/3). The study enrolled 381 patients at eight centers in France over 12 months beginning in October 2015. Penumbra provided an institutional grant to support the ASTER Trial. The Penumbra System consists of large diameter, highly flexible, and reliably trackable reperfusion catheters that utilize the full aspiration power of the Penumbra Pump MAX™ through its Hi-Flow Aspiration Tubing. The Penumbra System enables physicians to use aspiration, which acts like a minimally invasive "vacuum" inside the artery, to remove stroke-causing blood clots from the brain safely and effectively. The Penumbra System is the only FDA cleared integrated aspiration system for the revascularization of ischemic stroke patients. Penumbra, Inc., headquartered in Alameda, California, is a global interventional therapies company that designs, develops, manufactures and markets innovative medical devices. The company has a broad portfolio of products that address challenging medical conditions and significant clinical needs across two major markets, neuro and peripheral vascular. Penumbra sells its products to hospitals primarily through its direct sales organization in the U.S., most of Europe, Canada and Australia, and through distributors in select international markets. Penumbra, the Penumbra logo, ACE, and Pump MAX are trademarks of Penumbra, Inc. Other trademarks are the property of their respective owners. Except for historical information, certain statements in this press release are forward-looking in nature and are subject to risks, uncertainties and assumptions about us. Our business and operations are subject to a variety of risks and uncertainties and, consequently, actual results may differ materially from those projected by any forward-looking statement s. Factors that could cause actual results to differ from those projected include, but are not limited to: failure to sustain or grow profitability or generate positive cash flows; failure to effectively introduce and market new products; delays in product introductions; significant competition; inability to further penetrate our current customer base, expand our user base and increase the frequency of use of our products by our customers; inability to achieve or maintain satisfactory pricing and margins; manufacturing difficulties; permanent write-downs or write-offs of our inventory; product defects or failures; unfavorable outcomes in clinical trials; inability to maintain our culture as we grow; fluctuations in foreign currency exchange rates; and potential adverse regulatory actions. These risks and uncertainties, as well as others, are discussed in greater detail in our filings with the Securities and Exchange Commission, including our Quarterly Reports on Form 10-Q and our Annual Report on Form 10-K for the year ended December 31, 2015. There may be additional risks of which we are not presently aware or that we currently believe are immaterial which could have an adverse impact on our business. Any forward-looking statements are based on our current expectations, estimates and assumptions regarding future events and are applicable only as of the dates of such statements. We make no commitment to revise or update any forward-looking statements in order to reflect events or circumstances that may change.


News Article | December 14, 2016
Site: globenewswire.com

LYON, France, Dec. 14, 2016 (GLOBE NEWSWIRE) -- EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic ultrasound, today announced the sale of a Focal One® system to Foch Hospital, Paris, one of the largest private hospitals in the Paris Area. Pr. Thierry Lebret, Head of Urology and Kidney Transplantation Department at Foch Hospital and recently appointed President of the French Urology Association, commented: "Our team is enthusiastic about the acquisition of Focal One HIFU as it responds to a growing demand for more non-invasive prostate cancer treatments. This innovative system adds to our portfolio of solutions offered to prostate cancer patients. Focal One combines state-of-the-art IRM and real-time ultrasound imaging capabilities with targeted HIFU technology to allow precise ablation of prostatic tissue, with reduced side effects." Pierre Reboul, EDAP TMS France Business Unit Director, added: "We are very pleased with this Focal One acquisition by the prominent Foch Hospital under the leadership of Pr. Lebret. This investment confirms the growing adoption of HIFU for the management of prostate cancer in France as demonstrated during the recent French Urology Association Congress held in Paris last November. Our HIFU Club, organized during this event, gathered more than 50 French Focal One users who shared their experience and appetite for the technology’s capabilities. We look forward to continued expansion of HIFU access to more prestigious centers in France." Marc Oczachowski, EDAP's Chief Executive Officer, concluded: "Interest in our innovative HIFU technologies is clearly growing as we continue to open and train new state-of-the-art and academic centers in France and internationally. In addition, it supports our belief that Focal One has the potential to become a primary therapeutic option in modern prostate cancer management." EDAP TMS SA markets today Ablatherm® for high-intensity focused ultrasound (HIFU) for prostate tissue ablation in the U.S. and for treatment of localized prostate cancer in the rest of the world. HIFU treatment is shown to be a minimally invasive and effective option for prostatic tissue ablation with a low occurrence of side effects. Ablatherm-HIFU is generally recommended for patients with localized prostate cancer (stages T1-T2) who are not candidates for surgery or who prefer an alternative option, or for patients who failed radiotherapy treatment. Ablatherm-HIFU is approved for commercial distribution in Europe and some other countries including Mexico and Canada, and has received 510(k) clearance by the U.S. FDA. The Company also markets an innovative robot-assisted HIFU device, the Focal One®, dedicated to focal therapy of prostate cancer. Focal One® is CE marked but is not FDA approved. The Company also develops its HIFU technology for the potential treatment of certain other types of tumors. EDAP TMS SA also produces and distributes medical equipment (the Sonolith® lithotripters’ range) for the treatment of urinary tract stones using extra-corporeal shockwave lithotripsy (ESWL) in most countries including Canada and the U.S. For more information on the Company, please visit http://www.edap-tms.com, and http://www.hifu-planet.com. In addition to historical information, this press release may contain forward-looking statements. Such statements are based on management’s current expectations and are subject to a number of risks and uncertainties, including matters not yet known to us or not currently considered material by us, and there can be no assurance that anticipated events will occur or that the objectives set out will actually be achieved. Important factors that could cause actual results to differ materially from the results anticipated in the forward-looking statements include, among others, the clinical status and market acceptance of our HIFU devices and the continued market potential for our lithotripsy device. Factors that may cause such a difference also may include, but are not limited to, those described in the Company’s filings with the Securities and Exchange Commission and in particular, in the sections "Cautionary Statement on Forward-Looking Information" and "Risk Factors" in the Company’s Annual Report on Form 20-F.

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