Theraclion Announces Exclusive Distribution Agreement with EDAP TMS France

Regulatory News:

THERACLION (Paris:ALTHE) (Alternext, FR0010120402 – ALTHE), a company specialized in leading-edge medical equipment for echotherapy, today announced the signature of an Agreement with EDAP TMS SA, to exclusively distribute Theraclion’s Echopulse® system in France.

Originated as a spin-off from EDAP, the global leader in therapeutic ultrasound specialized in urology, Theraclion has developed echotherapy in the use of two indications, fibroadenoma of the breast and benign thyroid nodules and successfully expanded its commercialization efforts in Europe and Asia with key markets being Germany and Hong-Kong. The companies have partnered closely for years and their commercial teams address the same clinics and hospitals.

David Caumartin, CEO of Theraclion, said: "In France, EDAP has put in place a mature sales and logistics organization with business models allowing to quickly penetrate a market 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 the collaboration allows us to continue focusing our direct distribution efforts in other key markets such as Germany and Asia.”

"The mobile pay-per-use solution will in particular help to put quickly and smoothly in place the implementation of Theraclion’s Forfait Innovation cost-effectiveness study in breast fibroadenoma and enable a fast patient access to thyroid echotherapy,” added Anja Kleber, VP Marketing & Market Access of Theraclion.

"Forfait Innovation” is a reimbursement mechanism for innovative medical devices designed to accelerate market adoption of novel technologies. It will be effective in a multicenter, randomized study comparing breast fibroadenoma treatment with Echopulse® to reference treatment by surgery.

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 to new HIFU applications such as breast fibroadenomas and benign thyroid nodules, confirming our HIFU leadership in France.”

About EDAP TMS SA

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 not FDA cleared yet. 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

Theraclion is listed on Alternext Paris
PEA-PME eligible
Mnemonic: ALTHE - ISIN Code: FR0010120402

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