EDAP (MCAP $28 M) FDA APPROVAL FOR PROSTATE CANCER CURE IN MID 2013 = RALLYYYYYYYYYYYYYYYYYYYYYYYYYYYYYYYYY
THIS UNDISCOVERED GOLDMINE IS FLYING UNDER RADAR . FDA APPROVAL FOR THEIR PROSTATE CANCER DEVICE EXPECTED IN MID 2013 THIS WILL PUSH THIS STOCK TO $10-15 EASILY . THIS IS A ONCE IN A LIFETIME OPPORTUNITY AT CURRENT MEGA BARGAIN LEVEL !
Edap Tms (EDAP)
Market Cap : $39 Million
Cash : $10.5 Million
Price : $2.20
Shares Out : 18 M
In early November, EDAP held a productive pre-PMA meeting with the U.S. FDA to discuss the PMA submission for the Company's Ablatherm-HIFU Phase II/III clinical trial for the indication of low risk, localized prostate cancer. Based on the guidance received in this FDA interaction, EDAP is finalizing its PMA file for submission in January 2013.
Ablatherm® HIFU: A non-invasive treatment for prostate cancer
Current surgical and radiation treatments for prostate cancer have as potential side effects erectile dysfunction and urinary incontinence, to name the most common. Today, however, a revolutionary new technology called Ablatherm HIFU offers new a treatment option for prostate cancer patients that promises lower risk of sexual side effects and incontinence.
New to the U.S., high intensity focused ultrasound (HIFU) has been in use for the treatment of prostate cancer in Europe and Canada. It has been studied as a tool for the treatment of prostate cancer (PCa) since 1989. This technology is currently undergoing clinical trials here in the U.S. which is scheduled to be completed by the end of 2012.
The Ablatherm® HIFU technology was developed by the urology department of the Hôpital Edouard Herriot in Lyons (France) and INSERM, the French National Institute for Medical Research. It has been developed on an industrial scale by EDAP.
EDAP TMS S.A. develops, produces and markets a range of high technology equipment intended for non-invasive therapy, specifically designed for the treatment of urological problems. The group also produces and markets, via its TMS S.A. subsidiary, equipment intended to destroy kidney stones (lithotripsy) using shock waves.
How it works
Ablatherm HIFU uses ultrasound waves which are focused with extreme precision and delivered through a computer controlled device onto the targeted cancerous cells in the prostate, causing a very brief rise in temperature (around 85 degrees C - 185 degrees F). The targeted tissue is then instantly and effectively destroyed, while the surrounding tissue is preserved. Operated by a specially trained urological surgeon, HIFU is a safe and effective non-surgical, non-invasive treatment for localized prostate cancer that results in fewer significant side effects.
Who are candidates for HIFU?
Ablatherm HIFU is well suited for men who cannot have or do not wish to undergo surgery because of their age or other associated health issues. It is also an excellent choice first-line salvage therapy for men whose cancer has returned following radiotherapy. In the future, in the light of long-term results, more patients will be treated with Ablatherm HIFU. One major advantage of HIFU is the ability to repeat treatment of biochemical recurrence of prostate cancer without further risk of potential side effects.
Patients receiving HIFU start on a clear liquid diet starting the day before the procedure and are usually admitted to the hospital the morning of or the night before treatment. One to two enemas are administered 2 hours prior to the procedure to cleanse the rectum. It is vitally essential that you do not move during the HIFU treatment which is why an epidural (spinal) anesthesia is administered to numb you from the waist down in preparation for the procedure. You will also be given light intravenous sedation.
A small probe is carefully inserted into the rectum under precise computer-aided control and serves two functions: ultrasound imaging of the prostate and a firing transducer for ablation of cancer cells. The prostate specialist first captures real-time images of the prostate and the surrounding area. Treatment time varies depending on the size of the prostate, but generally lasts one to three hours. Destruction of the cancerous tissue usually result in swelling of the prostate, therefore a catheter is inserted and is typically worn for 2-3 weeks to make sure that the bladder can empty properly as the body heals. Most patients are able to resume a normal diet and lifestyle almost immediately. No hospital stay is required and the entire procedure involves no incision and no scalpel.
Probable side effects
As with all prostate cancer treatments, there are some potential side effects. However, since Ablatherm HIFU is a non-surgical, non-invasive treatment there is minimal risk of infection and collateral damage to adjacent tissue and organs. Associated side effects include: urine retention following the procedure which is resolved through temporary catheterization and urinary incontinence which improves within nine-months to a year.
With regard to sexual side effects (erectile dysfunction), a study published in The Lancet Oncology reported the following findings: “At 12 months, of 35 men who had no erection problems at the start of the study, 31 (89%, 95% confidence interval 73 to 97) had erections sufficient for penetration.” There are also a number of other less common side effects so patients considering this procedure will want to be informed of these by the treatment specialist (urologist) before making a final decision.
The bottom line
At the current publication date of this article, Ablatherm HIFU treatment is not available in the United States. Patients interested in exploring HIFU treatment options outside of the United States