Edap Tms SA (ADR) (NASDAQ:EDAP), the global leader in therapeutic ultrasound, today announced that it has received a letter from the U.S. Food and Drug Administration (“FDA”) related to its Direct De Novo 510(k) petition for Ablatherm HIFU in the United States. The “Deficiency List” (as such communications about a regulatory filing are officially termed), identifies items and topics for which the FDA has requested additional information or further clarification to continue its ongoing review. Only four (4) points were raised in the deficiency list, and the FDA requested (1) the results of EDAP’s reprocessing validation tests (which are ongoing and expected to be completed in the near future), (2) additional information regarding the Company’s physician training program, (3) additions and modifications to the draft labeling materials, and (4) additions and modifications to the draft user manual.

In accordance with the De Novo process, the FDA’s review of the Ablatherm HIFU submission is on hold until EDAP provides information to address these requests. The company is working to provide the necessary information and clarifications as expeditiously as possible.

Marc Oczachowski, Chief Executive Officer of EDAP TMS SA, commented: “We are very pleased with the FDA feedback to our De Novo 510k submission. We believe we can address each of the issues raised and we look forward to continuing to work closely with FDA to move the process forward.” (Original Source)

Shares of EDAP TMS S.A. closed yesterday at $3.49. EDAP has a 1-year high of $5.57 and a 1-year low of $1.15. The stock’s 50-day moving average is $3.42 and its 200-day moving average is $3.32.

On the ratings front, H.C. Wainwright analyst Swayampakula Ramakanth reiterated a Buy rating on EDAP, with a price target of $4.50, in a report issued on May 15. The current price target represents a potential upside of 28.9% from where the stock is currently trading. According to TipRanks.com, Ramakanth has a total average return of 19.5%, a 41.9% success rate, and is ranked #479 out of 3711 analysts.

Edap TMS SA is a holding company. The Company through its divisionsHIFU and UDS,develops, produces and markets minimally invasive medical devices for urological diseases. Its divisionsoperate in Europe, the Americas, Asia and the rest of the world.