Theraclion has chosen EDAP TMS SA to be the exclusive distributor of its Echopulse system in France, as part of a new agreement between the two companies.
The noninvasive ablation solution for breast fibroadenomas and benign thyroid nodules is now available to customers with a new option that allows the system to operate as a mobile pay-per-use solution.
“We just had approval from the French health care system to actually reimburse our benign breast tumor noninvasive solution,” David Caumartin, CEO of Theraclion, told HCB News. “We wanted to partner with someone who already had a pay-per-use business unit, which was the case with EDAP and therefore, it was natural combination for us to work with them to be able to make an echotherapy standard of care for benign breast tumors.”
The Echopulse system uses EDAP’s proprietary HIFU technology to treat breast fibroadenomas and benign thyroid nodules. Treatment with the system can take between 15 and 45 minutes.
The agreement allows EDAP France to expand the use of HIFU technology outside the field of urology. Through the reimbursement, Theraclion gains ten new sites in France.
The mobile pay-per-use solution will assist in the quick implementation of the Forfait Innovation cost-effectiveness study, which compares Echopulse echotherapy to surgery in the treatment of breast fibroadenoma, and will enable quick access among patients to thyroid echotherapy.
“Theraclion is the only one that can propose noninvasive ablation for benign thyroid and benign breast tumors,” he said. “We are proposing this in an outpatient fashion, without general anesthetic, just local. We basically destroy soft tissue lesions in 15, 30, 45 minutes of treatment time in a single session.”
Theraclion’s echotherapy procedure
was recently was listed on the website of the British National Institute for Health and Clinical Excellence with guidance on its interventional procedures program (IPP) for the noninvasive treatment of breast fibroadenoma, and also received regulatory approval from the Russian Ministry of Health.
The system has been CE marked since 2012 and is available in Europe and Asia with key markets in Germany and Hong Kong. It is currently undergoing two clinical trials at four sites in the U.S.