par hasard suis tombé sur ça sur forum yahoo:
"(MARKET CAP 24 M$ / CASH 16 M$ / SHARES OUT 11 M ) = A ONCE IN A LIFETIME OPPORTUNITY .PLEASE DO YOUR OWN RESEARCH .GLTA
US APPROVAL WILL PUSH THIS STOCK TO 7$+ EASILY .EDAP HAS A PROSTATE CANCER TREATMENT APPROVED IN EUROPE AND IS IN FINAL PHASE 3 IN USA .SEE BELOW .
EDAP TMS ( NASDAQ: EDAP )
Market Cap : 27 Million$
Cash : 15,8 Million$
Price : 2,40 $
Shares Out : 11,1 M
Press Release Source: EDAP TMS SA On Thursday August 19, 2010, 9:15 am EDT
Marc Oczachowski, EDAP's Chief Executive Officer, commented, "We are actively moving forward in obtaining approval in major lithotripsy markets for our recently developed, innovative Sonolith i-move lithotripter. Our recent 510(k) application to the FDA is a clear milestone for EDAP's expansion in this field. In addition to our high-range fully integrated Sonolith I-sys lithotripter that received 510(k) marketing clearance a year ago, our compact multi-configurations Sonolith i-move device offers a wide range of urinary stones treatment options to mid-size clinics and hospitals, hence covering all lithotripsy market segments. We look forward to working with the FDA in view of approval of our Sonolith i-move, hence providing U.S. patients and physicians with the most versatile advanced treatment option."
510(k) Status Program
Submitters may request information on their 510(k) review status 90 days after the initial log-in date of the 510(k).
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. Approved in Europe as a treatment for prostate cancer, Ablatherm-HIFU (High Intensity Focused Ultrasound) is currently undergoing evaluation in a multicenter U.S. Phase II/III clinical trial under an Investigational Device Exemption granted by the FDA, the ENLIGHT U.S. clinical study.
LOAD UP THE TRUCK WHILE ITS VERY VERY CHEAP "
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méchant spam , mais en y regardant de plus près il s'agit d'une société française sur le
Nasdaq
http://investor.edap-tms.com/releases.cfm
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http://www.lesechos.fr/economie-politique/france/d ossier/020729514137-edap-tms-a-la-pointe-des-ultrasons-therapeutiques.htm
18/ 08/10
Edap TMS à la pointe des ultrasons thérapeutiques
Le fabricant, qui a repris en 1994 les actifs de son rival Technomed, est champion du monde dans son domaine. Il commercialise deux familles d'appareils, le Sonolith et l'Ablatherm, conçus pour traiter respectivement les calculs rénaux et le cancer de la prostate.
DE NOTRE CORRESPONDANTE À LYON, MARIE-ANNICK DEPAGNEUX
Numéro un mondial des ultrasons thérapeutiques, Edap TMS évolue dans le champ des traitements non invasifs et donc moins traumatisants que la chirurgie classique. Cette entreprise est issue du rapprochement en 1994 entre deux rivaux : le parisien Edap s'est alors emparé du lyonnais Technomed Medical Systems (TMS) dont il a adopté la région en quittant Marne-la-Vallée (Seine-et-Marne) pour Vaulx-en-Velin (Rhône). Autre spécificité : l'entreprise est cotée depuis 1997 au Nasdaq de New York qui, le 17 décembre 2007, a invité Marc Oczachowski, le directeur général, à célébrer dix ans de cotation. En qualité d'hôte d'honneur de la Bell Ceremony, le quadragénaire a sonné, du balcon dominant Times Square, la cloche marquant la fin de la séance du jour.
Pour revenir à la genèse, Edap a été créé en 1979 par une équipe de chercheurs de la Compagnie Générale de Radiologie (CGR), une filiale de Thomson. TMS est né en 1985 à partir des travaux de recherche du professeur Jean-Michel Dubernard, chirurgien et transplanteur en urologie à l'hôpital Edouard-Herriot de Lyon, et de son équipe dans le cadre de l'unité Inserm alors dirigée par Claude Fourcade. « Pour industrialiser leur lithotriteur [machine à fragmenter les calculs rénaux par ondes de choc, NDLR], ils se sont alors tournés vers des investisseurs
Et ils ont vu pas moins de 69 financiers dont le dernier fut le bon. La société pouvait alors être portée sur les fonts baptismaux », avant de déposer le bilan en 1993, raconte l'actuel dirigeant.
La lithotritie continue à assurer un peu plus de la moitié des ventes consolidées (24,9 millions d'euros en 2009, dont 80 % à l'exportation) d'Edap TMS qui annonce un parc installé dans le monde de quelque 550 lithotriteurs Sonolith, dont la société assure aussi la maintenance. Toutefois, ce marché est mature dans la mesure où il s'agit désormais surtout de pourvoir au remplacement des machines de première génération. Afin de s'assurer un relais de croissance, l'entreprise, qui compte 150 collaborateurs dont 50 à l'étranger, a exploité le filon de la technologie Hifu (ultrasons à haute intensité appartenant à la même famille que les ondes de choc) en ciblant, dans un premier temps, les cancers localisés de la prostate. « Nous avons déjà déposé 61 brevets. Sur le même modèle de collaboration qui a prévalu pour le lithotriteur, nous nous sommes appuyés à la fois sur les cliniciens du service du professeur Dubernard et les chercheurs du laboratoire Inserm U556 », indique Marc Oczachowski.
Ce nouvel appareil, l'Ablatherm, qui a obtenu en 2000 le marquage CE, a été commercialisé en 90 exemplaires et 23.000 patients ont été traités dans différents pays. L'acte est remboursé en Allemagne, en Italie, en Grande-Bretagne (au cas par cas) ou encore en Hollande pour les échecs de la radiothérapie. En France, « nous avons saisi pour la deuxième fois, en 2008, la Haute Autorité de la santé. Nous attendons une réponse d'ici à la fin de l'année. L'intérêt que l'Association française d'urologie porte à l'Ablatherm nous rend optimistes », se rassure le patron. Aux Etats-Unis, le fabricant a engagé les essais cliniques en vue d'obtenir l'agrément de la FDA (Food and Drug Administration) fin 2012, voire début 2013. Cette démarche est financée grâce aux 20 millions de dollars levés sur le Nasdaq en 2007. Outre la prostate, l'entreprise mène des études sur le cancer du foie avec le centre hospitalier lyonnais Léon-Bérard. Preuve supplémentaire s'il en était besoin que la société est déterminée à conserver son leadership alors que tous les grands du secteur (Siemens, General Electric, etc.) ont mis le pied à l'étrier du Hifu.
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EDAP Reports Second Quarter 2010 Financial Results
Outlines Strategic Initiatives to Counter Weak Global Economic Environment
LYON, France, Aug 24, 2010 (GlobeNewswire via COMTEX News Network) --
-- Maintained robust cash position of EUR 11.4 million (USD 14.0 million)
at June 30, 2010
-- Raised visibility for positive long-term European experience of
Ablatherm(R)-HIFU with four abstracts presented at American Urological
Association (AUA)
-- Entering patient follow-up phase after completing enrollment in U.S.
ENLIGHT Ablatherm-HIFU clinical trial
-- Increasing global sales opportunities with receipt of European approval
for Sonolith i-move and Japanese approval for Sonolith i-sys
-- Enhancing U.S. lithotripsy market potential with submission of 510(k)
marketing clearance application to U.S. FDA for Sonolith i-move
-- Strengthening third quarter lithotripsy machine backlog with nine
machines in pipeline to date
-- Entered exclusive agreement with Lumenis to distribute state-of-the-art
urological lasers in France
LYON, France, Aug. 24, 2010 (GLOBE NEWSWIRE) -- EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic ultrasound, announced today financial results for the second quarter ended June 30, 2010. The Company outlines strategic initiatives to counter the continuing weak global economic climate.
Marc Oczachowski, EDAP's Chief Executive Officer, commented, "Our second quarter results reflected the overall weak global economic environment and the resulting slowdown in hospital capital expenditures. In the face of these trends, we are undertaking several initiatives to broaden the market opportunities for our medical device portfolio. We are actively pursuing efforts for the clinical recognition of Ablatherm-HIFU for the treatment of localized prostate cancer. During the second quarter, four abstracts that outlined the long-term positive European experience were presented at the American Urological Association (AUA) 2010 Annual Meeting. The data confirmed that EDAP's lifestyle preserving Ablatherm treatment is on par with other more invasive treatment options, such as surgery or radiotherapy. Simultaneously, we are undertaking marketing initiatives to position HIFU as an alternative treatment for prostate cancer patients that did not respond to radiation treatments."
Mr. Oczachowski continued, "Prostate cancer treatment is currently going through a re-definition as the treatment approach transitions from a radical approach to a focal therapy approach that features focused treatment at the identified prostate cancer location. Due to its precision, accuracy and repeatability, EDAP's Ablatherm-HIFU is most advantageously positioned to address the focal therapy approach as it is being defined by the International Urology Community. We believe that the focal therapy approach represents a unique opportunity for Ablatherm HIFU to become the gold standard of treatment for prostate cancer. We at EDAP want to seize this tipping point opportunity and are now putting in place actions and plans to achieve this goal."
Mr. Oczachowski concluded, "Turning to our established lithotripsy franchise, EDAP continues to move forward with the rollout of its expanded product portfolio. In April 2010 at the European Associate Urology Congress, EDAP launched the Sonolith i-move, a compact, stand-alone lithotripter with a revolutionary infrared stereo-vision system for real-time, three-dimensional ultrasound localization of urinary stones. Following European approval, we sold two Sonolith i-move devices during the quarter. Our high-end Sonolith i-Sys lithotripsy device received Japanese approval in March 2010. We received our first sale in Japan in the weeks following approval and continue to cultivate positive sales leads that we should be able to convert in the coming months. Since the end of the second quarter 2010, the Company has built a strong promising backlog of nine lithotripsy systems, including four recently launched Sonolith i-move systems."
Other Recent Developments
In June 2010, EDAP entered an exclusive agreement with Lumenis to distribute its high-technology urological lasers in France. Lumenis markets leading lasers that enable precise minimally invasive treatment for a wide array of urologic conditions such as benign prostatic hyperplasia (BPH) and bladder, urethral and kidney stones. These products are a natural, synergistic expansion of EDAP's product portfolio.
In July 2010, patient enrollment was completed in the Company's U.S. ENLIGHT Ablatherm-HIFU clinical trial, a multi-center Phase II/III clinical trial under an Investigational Device Exemption granted by the FDA, and the Company entered the required two-year follow-up phase. In aggregate, 134 patients participated in the U.S. study.
In August 2010, EDAP filed its application for 510(k) marketing clearance with the U.S. FDA for its compact, multi-configurations Sonolith i-move lithotripsy device. Following receipt of FDA marketing clearance, EDAP should be well positioned to address all segments of the U.S. lithotripsy market offering the widest product range spanning compact to fully integrated devices.
Quarterly Results
Revenue for the second quarter 2010 was EUR 6.0 million (USD 7.6 million), compared to EUR 6.8 million (USD 9.4 million) for the second quarter 2009.
Total revenue for the HIFU division was EUR 1.9 million (USD 2.4 million) for the second quarter 2010, compared to EUR 2.2 million (USD 3.0 million) for the same period last year. Results for the second quarter 2010 reflected the sale of one Ablatherm-HIFU machine.
For the three months ended June 30, 2010, total revenue for the lithotripsy division was EUR 4.1 million (USD 5.2 million), compared to EUR 4.6 million (USD 6.4 million) during the year ago period. During the second quarter 2010, the Company recorded sales of nine lithotripsy machines, including four Sonolith i-sys devices and two Sonolith i-move devices.
Gross profit for the second quarter 2010 was EUR 2.5 million (USD 3.1 million), compared to EUR 3.2 million (USD 4.4 million) for the year ago period. Gross profit margin was 41.5% in the second quarter 2010, compared to 46.6% in the year ago period.
Operating expenses were EUR 3.8 million (USD 4.7 million) for the second quarter 2010, compared to EUR 3.7 million (USD 5.1 million) for the same period 2009. Second quarter 2010 operating expenses included EUR 0.7 million related to the U.S. FDA ENLIGHT clinical trial for Ablatherm-HIFU.
Operating loss was EUR 1.3 million (USD 1.6 million) for the second quarter 2010, compared to EUR 0.5 million (USD 0.7 million) for the year ago period. Excluding U.S. FDA trial expenses, second quarter 2010 operating loss was EUR 0.6 million.
Net loss for the second quarter 2010 was EUR 1.0 million (USD 1.3 million), or EUR 0.09 per diluted share, compared to a net loss of EUR 0.5 million (USD 0.7 million), or EUR 0.05 per diluted share, in the year ago period. The second quarter 2010 net loss included a non-cash interest income of EUR 0.6 million (USD 0.8 million) to adjust the Company's convertible debt and outstanding warrants to fair value, compared to a EUR 0.7 million (USD 0.9 million) non-cash income during the prior year period.
At June 30, 2010, cash and cash equivalents, including short-term treasury investments, were EUR 11.4 million (USD 14.0 million). With its current cash position, the Company continues to be well funded to pursue its strategic development projects, both in the U.S. and Europe.
