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EDAP (buy)
EDAP TMS S.A., through its subsidiaries, develops, produces, and markets minimally invasive medical devices for the treatment of urological diseases. The company operates in two divisions: High Intensity Focused Ultrasound (HIFU), and Urology Devices and Services. The High Intensity Focused Ultrasound division develops, manufactures, and markets devices for the minimally invasive destruction of various types of localized tumors using HIFU technology. It also offers Ablatherm, a HIFU-based device for the treatment of organ-confined prostate cancer, referred to as T1-T2 stage; and Focal One device, a HIFU robotic device for the focal therapy of localized prostate cancer.
EDAP scientists claim to have come up with a unique way to treat prostate cancer -- by using sound waves to blast tumour cells.
A team at the University College London says its accuracy means the new method could well be an alternative to traditional treatment with significantly fewer side-effects, the 'Daily Express' reported.
The British study, funded by the Medical Research Council, is the first to use the experimental treatment known as HIFU (high-intensity focused ultrasound). It can even treat areas of cancer just a few millimetres in size.
In a trial, 95 per cent of patients were cancer-free after a year. The sound waves cause the tissue to vibrate and heat up, killing the cells in the target area.
Performed in hospital under general anaesthetic, most patients are back home within 24 hours. This is a less invasive procedure where only the tumour and surrounding tissue are removed.
The results show that 12 months after treatment, none of the 41 men in the trial had incontinence, a major side-effect of treatment, say the scientists.
Owen Sharp, chief executive of The Prostate Cancer Charity, said: "We welcome any prostate cancer treatment which limits side-effects such as incontinence and impotence."
Ablatherm® HIFU was the first High Intensity Focused Ultrasound device for the treatment of localized prostate cancer to receive the CE mark in 2000. In fact, the first patient was treated in 1993 with the first Ablatherm® HIFU.
LYON, France, May 22, 2014 (GLOBE NEWSWIRE) -- EDAP TMS SA (EDAP), the global leader in therapeutic ultrasound, 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.
- All Time Record High First Quarter Revenue and Positive Operating Income -
Highlights
Record revenue of EUR 7.8 million for the first quarter 2014, a 31% year-over-year increase
First quarter 2014 gross margin up nine points to 46%
Second sequential quarter with positive operating income
Ablatherm HIFU PMA moves to panel preparation phase with FDA
Reimbursement of HIFU for prostate cancer granted in France
HIFU officially recommended for prostate cancer by European Association of Urology
LYON, France, May 15, 2014 (GLOBE NEWSWIRE) -- EDAP TMS SA (EDAP), the global leader in therapeutic ultrasound, announced today financial results for the first quarter ended March 31, 2014, and provided an update on recent strategic developments.
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."
First Quarter 2014 Results
Total revenue for the first quarter 2014 was EUR 7.8 million (USD 10.6 million), a 31% year-over-year increase compared to EUR 5.9 million (USD 7.8 million) for the first quarter 2013.
Conclusion: with cap $108M, pps $4.98 and positive AdCom voting EDAP pps will easy double. Approved in USA EDAP will become a valuable acquisition target for medical device companies.