H.C. Wainwright Remains Positive On EDAP Following FDA’s Guidance


In a research report issued today, H.C. Wainwright analyst Swayampakula Ramakanth reaffirmed a Buy rating on EDAP TMS S.A. (NASDAQ:EDAP) with a price target of $4.50, as the company announced that the FDA, while not approving Ablatherm device for the primary treatment of low-risk, localized prostate cancer that the company asked for, provided guidance to make the Pre-Markeing Approval (PMA) application approvable.

Ramakanth wrote, “If management decides to amend the current PMA, the FDA requires this additional information by April 29, 2015. On successful submission of the amended PMA by the said date, the regulatory clock is expected to continue for a 180-day review period. We believe Ablatherm could come to market, if successful, by 2016. We believe management could potentially decide to amend the PMA, as it provides a chance to enter the US market; the US market is still considered large with nearly 230,000 new cases of prostate cancer diagnosed every year. On July 31, we removed all Ablatherm-related US revenues from our model based on the negative advisory committee panel recommendations. Management plans to discuss their registration strategy during the scheduled 3Q14 earnings call on November 20. With no clarity on the strategy, we are not making any changes to our current financial model.”

According to TipRanks.com, which measures analysts’ and bloggers’ success rate based on how their calls perform, analyst Swayampakula Ramakanth has a total average return of -16.1% and a 40.0% success rate. Ramakanth has a -39.9% average return when recommending EDAP, and is ranked #3208 out of 3363 analysts.