LYON, FRANCE, 22 March 2017 – EDAP TMS SA (Nasdaq: EDAP), the global leader in therapeutic ultrasound, today announced the publication of a peer-reviewed article that analyzed Ablatherm Robotic HIFU for prostate tissue ablation in patients who had previously undergone radiotherapy treatment. The article concludes that HIFU should be considered as a valuable therapeutic option for carefully selected patients who failed a previous radiotherapy treatment. The article has been published in the January 2017 edition of the prestigious peer-reviewed British Journal of Urology International.
Authored by Pr. Sébastien Crouzet, M.D., Ph.D., from Edouard Herriot Hospital, Lyon, France, and co-authored by lead urologists from nine institutions across France, Germany, UK, Italy and the USA, this retrospective analysis was designed to evaluate the outcomes of Ablatherm Robotic HIFU for the treatment of patients who had been previously treated with radiotherapy and were indicated for additional prostate tissue ablation. The results were compiled from the Ablatherm treatment registry (@-RegistryTM), a multicenter secure online database for patients who have undergone prostate HIFU with Ablatherm. Inclusion criteria for the analysis were applied to the database, resulting in 418 patients with available data. Statistical models were applied to the data, using the longest available follow-up timepoint for each outcome and patient. Based on the Kaplan Meier survivorship analysis of this data, the rates of overall survival, cancer specific survival, and metastasis free survival at 7 years were 72%, 82%, and 81%, respectively.
Pr. Sébastien Crouzet commented: "This is the largest series of salvage patients treated with HIFU and followed for data collection. The results are encouraging, and support the use of Ablatherm Robotic HIFU for these patients who are particularly fragile after the failure of their radiation treatment and are limited to minimally invasive treatment options. Patients who require additional treatment after a radiation therapy may benefit from prostate tissue ablation with HIFU."
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Marc Oczachowski, Chief Executive Officer of EDAP TMS, added: "There is a growing number of patients who failed their radiotherapy treatment and require a secondary option; this large and growing market opportunity is the result of an as-yet unmet medical need. Pr. Sébastien Crouzet's clinical publication reconfirms that EDAP's Ablatherm HIFU technology offers a valuable answer to this need and is well positioned to serve this growing population with minimal competition."