EDAP TMS, Back on the Map (EDAP)
EDAP TMS SA (NASDAQ: EDAP) is a French company which makes medical devices for the treatment of urological diseases and the company’s stock is soaring after the company was granted marketing approval of its newly designed, high-end Sonolith I-Sys lithotripsy device by the Japanese Administration. Because this market is still under-served, we wanted to look into the news despite this not being a drug or biotech company.
The Japanese equivalent of the FDA in the US granted marketing approval of EDAP’s Sonolith I-Sys lithotripsy device. What makes this unique is that the lithotripsy market in Japan is supposed to rank as the number one market in the world in total lithotripsy sales volume and in the installed base. The company also noted that Japanese physicians have traditionally been fast adopters of products in this field.
The Sonolith I-Sys is an easy to use high-end system that the company called an effective tool to deliver benefits to both patients and physicians with integrated and robotized features. The company noted that the device successfully obtained marketing clearance by the U.S. FDA in August 2009.
EDAP TMS SA is one of those tiny companies most in the US are not familiar with. Admittedly, that includes yours truly outside of having seen the stock before on news-related share price moves. We wanted to take a look at how the company described itself. EDAP TMS makes and sells Ablatherm with approval in Europe for high-intensity focused ultrasound treatment of localized prostate cancer, which is a minimally invasive and effective treatment option with a low occurrence of side effects recommended for patients with localized prostate cancer who are not candidates for surgery or who prefer an alternative option. It is also for patients who failed radiotherapy treatment. The Ablatherm is currently undergoing evaluation in a multicenter U.S. Phase II/III clinical trial under an Investigational Device Exemption granted by the FDA called the ENLIGHT U.S. clinical study. The Company also is developing this technology for the potential treatment of certain other types of tumors. EDAP TMS SA also produces and commercializes medical equipment for treatment of urinary tract stones using extra-corporeal shockwave lithotripsy (ESWL).
Is this a game-changer for EDAP? The market believes it to be the case. Shares at almost 1:00 PM EST are up 32% at $3.30 on over 2.5 million shares. The average volume is only about 50,000 shares and the 52-week trading range is $0.96 to $5.95. As far as the market cap? That is a mere $32 million, and that is after today’s gains.
If you go back to August 2009 that is when the big jump in the stock really came along with that FDA approval. If you go back further, EDAP TMS ran from under $5 to over $20 briefly in 2006.
JON C. OGG
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