EDAP and Collaboration Partners Awarded EUR 1.1 Million European Grant for HIFU Triggered Drug Delivery Program

/ Source: GlobeNewswire

LYON, France, April 14, 2011 (GLOBE NEWSWIRE) -- EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic ultrasound, announced today that the European Union's Eurostars Program has awarded Euro 1.1 million to the Consortium research cooperation program comprised of project leader Epitarget AS, a Norwegian Company, French academic laboratory INSERM, and EDAP. The funds will be used to accelerate the transfer of the program's ultrasound triggered drug delivery technology from laboratory to patient.

The technology comprises a nanocarrier designed to transport drug to tumors and an ultrasound device to activate drugs after accumulation in solid tumors, thereby facilitating drug delivery. In the current project, a clinical ultrasound prototype will be developed and further safety and efficacy studies will be conducted with the nanocarrier in animal models. The prototype nanocarrier is a sonosensitive liposome containing a cancer drug currently in use for treatment of breast cancer and the liposome will allow encapsulation of other type of drugs addressing a variety of pathologies.

Emmanuel Blanc, EDAP's VP and Research Director, commented, "Ultrasound triggered drug delivery is drawing growing interest among the medical community as it approaches the clinical development phase. Each partner's complementary expertise in its specific field and their experience in monitoring clinical environment are essential to successfully implementing this project."

Esben A. Nilssen PhD, CEO of Epitarget, remarked, "We are excited to start on the path leading to human proof-of-concept with such an excellent team. The project is the spearhead of Epitarget and we hope that it not only will prove the clinical benefit of sonosensitive liposomal doxorubicin, but that this technology will provide a universal delivery platform for improving drug safety and efficacy."

Professor Charles Dumontet, MD PhD, and Cyril Lafon PhD, principal investigators at INSERM units U590 and U1032, respectively, stated, "Ultrasound therapy is a potent means for local tumour control. This non-invasive approach, which has already demonstrated its efficacy in prostate cancer, will allow enhanced anti-tumor efficacy of chemotherapy at the level of the tumor, while reducing systemic exposure and side effects of treatment."

Marc Oczachowski, EDAP's Chief Executive Officer, concluded, "We are pleased to bring EDAP's strong expertise in HIFU as we participate in this extremely important collaboration that has the potential to improve drug delivery in cancer patients. This exemplifies HIFU's broad application capabilities beyond prostate cancer and EDAP's sound expertise in HIFU technologies."


EDAP TMS SA develops and markets Ablatherm, the most advanced and clinically proven choice for high-intensity focused ultrasound (HIFU) treatment of localized prostate cancer. HIFU treatment is shown to be a minimally invasive and effective treatment option with a low occurrence of side effects. Ablatherm-HIFU is generally recommended for patients with localized prostate cancer (stages T1-T2) who are not candidates for surgery or who prefer an alternative option, or for patients who failed radiotherapy treatment. Approved in Europe as a treatment for prostate cancer, Ablatherm-HIFU (High Intensity Focused Ultrasound) is currently undergoing evaluation in a multi-center U.S. Phase II/III clinical trial under an Investigational Device Exemption granted by the FDA, 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). For more information on the Company, please visit , and.

About the Consortium

Epitarget AS is a Norwegian drug delivery company dedicated to developing cancer therapies through novel targeting methods. For more information, please visit .

INSERM is the only French public organization entirely dedicated to biological, medical and public health research. The participating Unit 1032 in Lyon entirely focuses on therapeutic applications of ultrasound, while the activities of Unit 590 centres on oncogenesis and tumour progression. For more information, please visit , , and http://labtau.univ-lyon1.fr/

Forward-Looking Statements

In addition to historical information, this press release contains forward-looking statements that involve risks and uncertainties. These include statements regarding the Company's growth and expansion plans, the conclusiveness of the results of and success of its Ablatherm-HIFU clinical trials and expectations regarding the IDE submission to and approval by the FDA of the Ablatherm-HIFU device. Such statements are based on management's current expectations and are subject to a number of uncertainties, including the uncertainties of the regulatory process, and risks that could cause actual results to differ materially from those described in these forward-looking statements. Factors that may cause such a difference include, but are not limited to, those described in the Company's filings with the Securities and Exchange Commission and in particular, in the sections "Cautionary Statement on Forward-Looking Information" and "Risk Factors" in the Company's Annual Report on Form 20-F. Ablatherm-HIFU treatment is in clinical trials, but not FDA-approved or marketed in the United States.

CONTACT: Blandine Confort Investor Relations / Legal Affairs EDAP TMS SA +33 4 72 15 31 72 bconfort@edap-tms.com Investors: Stephanie Carrington The Ruth Group 646-536-7017 scarrington@theruthgroup.com