(EDAP) MKap $56M //Heilung für Prostatakrebs nahe US-Zulassung (Seite 110)
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ISIN: US2683111072 · WKN: 908548 · Symbol: EDA
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Werte aus der Branche Dienstleistungen
| Wertpapier | Kurs | Perf. % |
|---|---|---|
| 1,0000 | +66,67 | |
| 1,0100 | +60,32 | |
| 7,8200 | +13,99 | |
| 14.900,00 | +13,74 | |
| 0,7900 | +11,27 |
| Wertpapier | Kurs | Perf. % |
|---|---|---|
| 1.600,00 | -12,09 | |
| 10,100 | -12,17 | |
| 3,5000 | -12,50 | |
| 25,40 | -15,33 | |
| 62,01 | -20,75 |
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EDAP wird mit US-Zulassung endgültig tief in die Gewinnzone wandern bisher ist man immer knapp dran geschrammt . Nach den letzten Zahlen in Mai war EDAP profitabel auch dank höherer HIFU verkäufe die jetzt anscheinend mehr beachtung bekommen .
Trotzdem bin ich hier nur wegen ADCOM sollte die Aktie schon vor dem 30.Juli gut laufen bin ich weg .Mein erstes Verkausziel ist zwischen $4.50-5
Marktkap: $81 M
Cash: $18 M
Shares Out: 24.8 M
Jahresumsatz: knapp $40 M tendenz steigend
http://finance.yahoo.com/news/edap-reports-first-quarter-201…
Marc Oczachowski, EDAP's Chief Executive Officer, stated, "We are very enthusiastic about the Company's all time record results for the first quarter driven by a growing demand for our HIFU devices. This reflects the strong market momentum for our new Focal One HIFU technology that was introduced in Europe last summer. It is very exciting to see the growing adoption of our products among the urology community as we now have a complete and unique HIFU offering including Focal One and Ablatherm to cover most market needs. As we advance through the second quarter, we have a strong sales backlog featuring ten lithotripters and two HIFU devices and remain focused on driving product sales."
Mr. Oczachowski continued, "Our HIFU technology has now gained a new status among the international urology community and health authorities. Just last month, France's Ministry of Health granted national reimbursement for prostate cancer treatment procedures using HIFU and the European Association of Urology updated its guidelines to recommend HIFU as primary and salvage prostate cancer therapy. In the US, we have now moved to the next phase with our PMA application which is panel preparation, the team is currently in the interactive review process with FDA."
Trotzdem bin ich hier nur wegen ADCOM sollte die Aktie schon vor dem 30.Juli gut laufen bin ich weg .Mein erstes Verkausziel ist zwischen $4.50-5
Marktkap: $81 M
Cash: $18 M
Shares Out: 24.8 M
Jahresumsatz: knapp $40 M tendenz steigend
http://finance.yahoo.com/news/edap-reports-first-quarter-201…
Marc Oczachowski, EDAP's Chief Executive Officer, stated, "We are very enthusiastic about the Company's all time record results for the first quarter driven by a growing demand for our HIFU devices. This reflects the strong market momentum for our new Focal One HIFU technology that was introduced in Europe last summer. It is very exciting to see the growing adoption of our products among the urology community as we now have a complete and unique HIFU offering including Focal One and Ablatherm to cover most market needs. As we advance through the second quarter, we have a strong sales backlog featuring ten lithotripters and two HIFU devices and remain focused on driving product sales."
Mr. Oczachowski continued, "Our HIFU technology has now gained a new status among the international urology community and health authorities. Just last month, France's Ministry of Health granted national reimbursement for prostate cancer treatment procedures using HIFU and the European Association of Urology updated its guidelines to recommend HIFU as primary and salvage prostate cancer therapy. In the US, we have now moved to the next phase with our PMA application which is panel preparation, the team is currently in the interactive review process with FDA."
EDAP's Ablatherm-HIFU FDA Panel Meeting Confirmed for July 30, 2014
EDAP TMS SA, today announced that the U.S. Food and Drug Administration (FDA) Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee will review the Pre-Market Approval ("PMA") application for EDAP's Ablatherm-HIFU device for the treatment of localized prostate cancer on July 30, 2014.
Marc Oczachowski, EDAP's Chief Executive Officer, said, "Confirmation of this important milestone is great news for the Company and its PMA application. The FDA provided us with a worksheet that details the deadlines and documents to be prepared and sent to the panel members for review ahead of the advisory committee meeting on July 30, 2014. We are very excited to now have a much clearer path toward FDA approval and the entire team at EDAP is diligently preparing for this major event in the PMA application process."
EDAP TMS SA, today announced that the U.S. Food and Drug Administration (FDA) Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee will review the Pre-Market Approval ("PMA") application for EDAP's Ablatherm-HIFU device for the treatment of localized prostate cancer on July 30, 2014.
Marc Oczachowski, EDAP's Chief Executive Officer, said, "Confirmation of this important milestone is great news for the Company and its PMA application. The FDA provided us with a worksheet that details the deadlines and documents to be prepared and sent to the panel members for review ahead of the advisory committee meeting on July 30, 2014. We are very excited to now have a much clearer path toward FDA approval and the entire team at EDAP is diligently preparing for this major event in the PMA application process."
"As calculated in accordance with Rule 13d-3 of the Securities Exchange
Act of 1934, as amended, (i) Sabby Healthcare Volatility Master Fund,
Ltd. and Sabby Volatility Master Fund, Ltd. beneficially own 1,500,000
and 500,000 shares of the Issuer's ordinary shares (ordinary shares),
respectively, representing approximately 6.05% and 2.02% of the Common
Stock, respectively, and (ii) Sabby Management, LLC and Hal Mintz each
beneficially own 2,000,000 shares of the ordinary shares,
representing approximately 8.07% of the ordinary shares. Sabby Management,
LLC and Hal Mintz do not directly own any shares of ordinary shares, but
each indirectly owns 2,000,000 shares of ordinary shares. Sabby Management,
LLC, a Delaware limited liability company, indirectly owns
2,000,000 shares of ordinary shares because it serves as the investment
manager of Sabby Healthcare Volatility Master Fund, Ltd. and Sabby
Volatility Warrant Master Fund, Ltd., Cayman Islands companies. Mr.
Mintz indirectly owns 2,000,000 shares of ordinary shares in his capacity
as manager of Sabby Management, LLC."
Act of 1934, as amended, (i) Sabby Healthcare Volatility Master Fund,
Ltd. and Sabby Volatility Master Fund, Ltd. beneficially own 1,500,000
and 500,000 shares of the Issuer's ordinary shares (ordinary shares),
respectively, representing approximately 6.05% and 2.02% of the Common
Stock, respectively, and (ii) Sabby Management, LLC and Hal Mintz each
beneficially own 2,000,000 shares of the ordinary shares,
representing approximately 8.07% of the ordinary shares. Sabby Management,
LLC and Hal Mintz do not directly own any shares of ordinary shares, but
each indirectly owns 2,000,000 shares of ordinary shares. Sabby Management,
LLC, a Delaware limited liability company, indirectly owns
2,000,000 shares of ordinary shares because it serves as the investment
manager of Sabby Healthcare Volatility Master Fund, Ltd. and Sabby
Volatility Warrant Master Fund, Ltd., Cayman Islands companies. Mr.
Mintz indirectly owns 2,000,000 shares of ordinary shares in his capacity
as manager of Sabby Management, LLC."
EDAP Closes $9.3 Million Registered Direct Offering
2014-06-03 08:30 ET - News Release
LYON, France, June 3, 2014 (GLOBE NEWSWIRE) -- EDAP TMS SA (Nasdaq:EDAP), a global leader in therapeutic ultrasound, today announced the closing on June 2, 2014 of a $9.3 million registered direct offering of ordinary shares in the form of American Depositary Shares ("ADSs"), at a price of $3.11 per share, with no warrants. The Company intends to use a portion of the net proceeds to advance preparatory activities in connection with the Ablatherm-HIFU PMA process and the upcoming U.S. Food and Drug Administration (FDA) Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee scheduled for July 30, 2014. The Company also intends to utilize the net proceeds to invest significantly in the expansion of its U.S. operations in preparation for the potential approval of its Ablatherm-HIFU.
Marc Oczachowski, Chief Executive Officer, commented, "This offering provides EDAP with the necessary capital to effectively prepare for the recently confirmed panel meeting on July 30, 2014. In addition, it positions EDAP to continue developing and adapting its operations in the U.S. to execute on our long-term growth strategy."
H.C. Wainwright & Co., LLC, acted as the exclusive placement agent for the transaction and Northland Capital Markets acted as Financial Advisor.
2014-06-03 08:30 ET - News Release
LYON, France, June 3, 2014 (GLOBE NEWSWIRE) -- EDAP TMS SA (Nasdaq:EDAP), a global leader in therapeutic ultrasound, today announced the closing on June 2, 2014 of a $9.3 million registered direct offering of ordinary shares in the form of American Depositary Shares ("ADSs"), at a price of $3.11 per share, with no warrants. The Company intends to use a portion of the net proceeds to advance preparatory activities in connection with the Ablatherm-HIFU PMA process and the upcoming U.S. Food and Drug Administration (FDA) Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee scheduled for July 30, 2014. The Company also intends to utilize the net proceeds to invest significantly in the expansion of its U.S. operations in preparation for the potential approval of its Ablatherm-HIFU.
Marc Oczachowski, Chief Executive Officer, commented, "This offering provides EDAP with the necessary capital to effectively prepare for the recently confirmed panel meeting on July 30, 2014. In addition, it positions EDAP to continue developing and adapting its operations in the U.S. to execute on our long-term growth strategy."
H.C. Wainwright & Co., LLC, acted as the exclusive placement agent for the transaction and Northland Capital Markets acted as Financial Advisor.
Trading Spotlight
Wenn die Zulassung erteilt werden sollte,mit welchem Marktanteil könnte gerechnet werden?
EDAP Outlines Key Events Scheduled in the Ablatherm-HIFU PMA Process
EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic ultrasound, today provided additional details on key events scheduled as part of the U.S. Food and Drug Administration (FDA) Pre-Market Approval ("PMA") process for its Ablatherm-HIFU device for the treatment of localized prostate cancer. In addition to the previously announced panel of experts that is scheduled to review the Ablatherm-HIFU device and provide a recommendation based on the clinical data submitted to the FDA, the Company has additional milestones to achieve as part of the PMA application process. The first relates to an engineering, manufacturing and quality assessment of EDAP's factory, which consists of a routine inspection by the FDA. This has now been confirmed and scheduled to take place June 23 to June 26, 2014. In parallel there is a clinical data validation process, which includes an FDA audit of the investigation sites. The Company has received confirmation and scheduling of the "foreign" site's audit which will be conducted in the course of July 2014.
Marc Oczachowski, EDAP's Chief Executive Officer, said, "Having dates confirmed for these additional milestones is further great news for EDAP, as it demonstrates how quickly the FDA process is moving for our Ablatherm-HIFU PMA application. We are very enthusiastic to see the progression of events since our last complete submission in March of this year and consider this to be a very exciting time in the Company's history. Our experienced team is fully committed to preparing for these upcoming events so that we can execute these optimally. EDAP has successfully met the requirements of all of our previous FDA inspections and audits and is professionally organized in compliance with major quality assurance systems."
About EDAP TMS SA
EDAP TMS SA markets today Ablatherm® for high-intensity focused ultrasound (HIFU) treatment of localized prostate cancer. HIFU treatment is shown to be a minimally invasive and effective treatment option 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 and commercialized in Europe as a treatment for prostate cancer and is currently under regulatory review in the U.S. following submission of the Pre-Market Approval Application in February 2013 after the completion of a multi-center U.S. Phase II/III clinical trial under an Investigational Device Exemption (IDE) granted by the FDA. In February 2013, the Company introduced a new innovative 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 commercializes medical equipment (the Sonolith® range) for treatment of urinary tract stones using extra-corporeal shockwave lithotripsy (ESWL). For more information on the Company, please visit http://www.edap-tms.com, and http://www.hifu-planet.com.Bingl dabei
EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic ultrasound, today provided additional details on key events scheduled as part of the U.S. Food and Drug Administration (FDA) Pre-Market Approval ("PMA") process for its Ablatherm-HIFU device for the treatment of localized prostate cancer. In addition to the previously announced panel of experts that is scheduled to review the Ablatherm-HIFU device and provide a recommendation based on the clinical data submitted to the FDA, the Company has additional milestones to achieve as part of the PMA application process. The first relates to an engineering, manufacturing and quality assessment of EDAP's factory, which consists of a routine inspection by the FDA. This has now been confirmed and scheduled to take place June 23 to June 26, 2014. In parallel there is a clinical data validation process, which includes an FDA audit of the investigation sites. The Company has received confirmation and scheduling of the "foreign" site's audit which will be conducted in the course of July 2014.
Marc Oczachowski, EDAP's Chief Executive Officer, said, "Having dates confirmed for these additional milestones is further great news for EDAP, as it demonstrates how quickly the FDA process is moving for our Ablatherm-HIFU PMA application. We are very enthusiastic to see the progression of events since our last complete submission in March of this year and consider this to be a very exciting time in the Company's history. Our experienced team is fully committed to preparing for these upcoming events so that we can execute these optimally. EDAP has successfully met the requirements of all of our previous FDA inspections and audits and is professionally organized in compliance with major quality assurance systems."
About EDAP TMS SA
EDAP TMS SA markets today Ablatherm® for high-intensity focused ultrasound (HIFU) treatment of localized prostate cancer. HIFU treatment is shown to be a minimally invasive and effective treatment option 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 and commercialized in Europe as a treatment for prostate cancer and is currently under regulatory review in the U.S. following submission of the Pre-Market Approval Application in February 2013 after the completion of a multi-center U.S. Phase II/III clinical trial under an Investigational Device Exemption (IDE) granted by the FDA. In February 2013, the Company introduced a new innovative 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 commercializes medical equipment (the Sonolith® range) for treatment of urinary tract stones using extra-corporeal shockwave lithotripsy (ESWL). For more information on the Company, please visit http://www.edap-tms.com, and http://www.hifu-planet.com.Bingl dabei
Hallo,
Hab mir vorhin in Stuttgart mal eine erste kleine Position zugelegt bin auch von dem Teil überzeugt. Vielen Dank nochmal für die tollen Beiträge.
Gruss an alle investierten.
Hab mir vorhin in Stuttgart mal eine erste kleine Position zugelegt bin auch von dem Teil überzeugt. Vielen Dank nochmal für die tollen Beiträge.
Gruss an alle investierten.
http://www.cancerfactorfiction.com/prostate-cancer/hifu-succ…
http://www.hifu.ca HIFU has high success rates with the 700 patients treated at the Maple Leaf HIFU clinic. Over 300,000 patients have been treated worldwide by HIFU, with 10 years of documented success for treating prostate cancer with Ablatherm HIFU – High Intensity Focused Ultrasound.
http://www.hifu.ca HIFU has high success rates with the 700 patients treated at the Maple Leaf HIFU clinic. Over 300,000 patients have been treated worldwide by HIFU, with 10 years of documented success for treating prostate cancer with Ablatherm HIFU – High Intensity Focused Ultrasound.
ADCOM steht fest für den 30. Juli heißt man sollte langsam ein paar einsammeln bevor die Spekuherde EDAP auf ihre liste nimmt . 100-200% Kurspotential sollten drin sein und eventuell höher bei positivem ausgang .
EDAP's Ablatherm-HIFU FDA Panel Meeting Confirmed for July 30, 2014
http://finance.yahoo.com/news/edaps-ablatherm-hifu-fda-panel…
EDAP's Ablatherm-HIFU FDA Panel Meeting Confirmed for July 30, 2014
http://finance.yahoo.com/news/edaps-ablatherm-hifu-fda-panel…
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