EDAP Signs Exclusive Agreement with Theraclion to Distribute Echopulse® HIFU Product in France

Planet edap Inc.
Oct 09,2017

EDAP Signs Exclusive Agreement with Theraclion to Distribute Echopulse® HIFU Product in France

EDAP to Market Echotherapy for ablation of breast fibroadenomas and benign thyroid nodules

LYON, France, October 9, 2017 -- EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic ultrasound, today announced the signature of an Agreement with French HIFU Company Theraclion, to exclusively distribute the Echopulse® system in France. Echopulse is using EDAP's proprietary HIFU technology to address breast fibroadenomas and benign thyroid nodules.

The long-lasting relationship between EDAP and Theraclion is now expanding towards product commercialization. The companies have worked closely for years, EDAP previously licensed patents to Theraclion and will now provide significant expertise with successful market penetration through various business models in France.

Pierre Reboul, France Business Unit Director of EDAP, commented: "We are very excited about this exclusive agreement. During the past years, we built EDAP's business in France as a unique global Urology company by adding other systems such as Holmium lasers to complement our HIFU and ESWL technologies, addressing most urology pathologies. We are pleased to see EDAP TMS France evolve to offer various HIFU platforms addressing multiple indications using different approaches."

David Caumartin, Chief Executive Officer of Theraclion, added: "In France, EDAP has developed a mature sales and logistics organization utilizing business models which enable rapid market penetration where access to reimbursement is slow. Offering a pay-per-use with a mobile solution will be very beneficial in a market like France. The demand for such a model is high and this partnership allows us to continue focusing our direct distribution efforts in key markets such as Germany and Asia."

Marc Oczachowski, Chief Executive Officer of EDAP TMS, concluded: "Our Sales and Marketing team in France has done a tremendous job in the last few years generating major revenue growth in urology while developing a unique set of offerings with Holmium, HIFU and ESWL products. We plan to continue this growth momentum by expanding our portfolio with new HIFU applications such as breast fibroadenomas and benign thyroid nodules, confirming our HIFU leadership in France."


EDAP TMS SA markets today Ablatherm® for high-intensity focused ultrasound (HIFU) for prostate tissue ablation in the U.S. and for treatment of localized prostate cancer in the rest of the world. HIFU treatment is shown to be a minimally invasive and effective option for prostatic tissue ablation 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. Ablatherm-HIFU is approved for commercial distribution in Europe and some other countries including Mexico and Canada, and has received 510(k) clearance by the U.S.FDA. Ablatherm Fusion is FDA cleared. The Company also markets an innovative robot-assisted HIFU device, the Focal One®, dedicated to focal therapy of prostate cancer. Focal One® is CE marked but is not FDA cleared. The Company also develops its HIFU technology for the potential treatment of certain other types of tumors. EDAP TMS SA also produces and distributes medical equipment (the Sonolith® lithotripters' range) for the treatment of urinary tract stones using extra-corporeal shockwave lithotripsy (ESWL) in most countries including Canada and the U.S. For more information on the Company, please visit http://www.edap-tms.com , and http://www.hifu-prostate.com.

About Theraclion

Theraclion is a French company specializing in high-tech medical equipment using therapeutic ultrasound. Drawing on leading-edge technologies, Theraclion has designed and manufactured an innovative solution for echotherapy, the Echopulse®, allowing non-invasive tumor treatment through ultrasound-guided high-intensity focused ultrasound. Theraclion is ISO 13485 certified and has received the CE mark for non-invasive ablation of breast fibroadenomas and thyroid nodules. Based in Malakoff, near Paris, France Theraclion has brought together a team of 35 people, 50% of whom are dedicated to R&D and clinical trials. For more information, please visit Theraclion's website: www.theraclion.com

Forward-Looking Statements

In addition to historical information, this press release may contain forward-looking statements. Such statements are based on management's current expectations and are subject to a number of risks and uncertainties, including matters not yet known to us or not currently considered material by us, and there can be no assurance that anticipated events will occur or that the objectives set out will actually be achieved. Important factors that could cause actual results to differ materially from the results anticipated in the forward-looking statements include, among others, the clinical status and market acceptance of our HIFU devices and the continued market potential for our lithotripsy device. Factors that may cause such a difference also may 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.

Investor Contact

Rich Cockrell

Company Contact
Blandine Confort
Investor Relations / Legal Affairs EDAP TMS SA
+33 4 72 15 31 50

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