This study showed the safety and the effectiveness of Echopulse® in the treatment of benign hot and cold thyroid nodules assessed by thyroid function:
• Procedure preserving the thyroid function
• Effectiveness proved by thyroglobulin levels increase correlated to the emitted energy
• Well tolerated, simple and non-invasive ambulatory procedure
Malakoff - FRANCE, October 15th, 2014 - THERACLION (Alternext, FR0010120402 - ALTHE, PEA PME eligible), a company specialized in avant-garde medical equipment for echotherapy, announces today the results published on October 14th, 2014 in the « International Journal of Hyperthermia » on the early assessment by thyroid function of benign thyroid nodules treatment by Echopulse®, entitled: Local thyroid tissue ablation by High-Intensity Focused Ultrasound: Effects on thyroid function and first human feasibility study with hot and cold thyroid nodules is available online:
http://informahealthcare.com/eprint/BfkRtButzJrpVvudRSCU/full
This study on 4 hot and 6 cold benign thyroid nodules was performed and assessed by Korkusuz Huedayi, MD (Nuclear Medicine Department, Goethe University Clinic, Frankfurt am Main, Germany).
Ten patients with one thyroid nodule each, examined 24 hours after the procedure, were assessed by hormone levels measurements before and after the treatment performed by Echopulse®.
The article published in the journal specialized in new thermic methods reviews, demonstrates that the superior Echopulse® postoperative results are confirmed by the hormone levels assessment. The patients treated with Echopulse® showed:
• that the procedure did not affect the thyroid function, with stable hormones levels (p<0.05). • a significant (p<0.05) increase of thyroglobulin levels correlated with the emitted total energy by HIFU (p<0.1), witnessing the extent of the ablation. • the absence of induced immune reaction, similar in hot and cold nodules. • an easy to perform ambulatory procedure, under local anesthesia or without anesthesia at all.
In terms of safety, no serious side effect related to the procedure was reported and only one treatment session per patient treatment was necessary.
Huedayi Korkusuz MD, principal investigator, comments in his article: “HIFU represents the next logical step to a non-invasive, well-tolerated and efficient method with the lowest side effect possible rate and without any risk of infection. Based on the results of this study with Theraclion’s Echopulse® there is no evidence that HIFU either interferes with the function of the thyroid gland, induces thyrotoxicosis or serious immune reactions. Thus, in the future HIFU constitutes an interesting alternative to surgery.”
Michel Nuta MD, Theraclion Chief Medical Officer, concludes: “These robust results are encouraging us to pursue the improvements of our procedure in order to decrease the treatment time and thus target all benign nodules, irrespective of their size, as for surgery, but in preserving the thyroid function and the patients’ quality of life.”
About Theraclion
Based in Malakoff, near Paris, Theraclion is a French company specialized in cutting-edge medical devices for echotherapy. Theraclion designs, develops and markets a medical device (Echopulse®) that combines advanced ultrasound imaging and HIFU therapy. Theraclion is ISO 13485 certified and has received the CE mark for non-invasive ablation of breast fibroadenomas and thyroid nodules. A full 65% of its 23-strong team are dedicated to R&D and clinical trials. For more information, visit http://www.theraclion.com.
Theraclion
David Caumartin
CEO
Tel.: +33 (0)1 55 48 90 70
david.caumartin@theraclion.com
NewCap.
Financial Communications & Investors relations
Emmanuel Huynh / Sophie Boulila
Tel.: +33 (0)1 44 71 94 91
theraclion@newcap.fr
ALIZE RP
Press Relations
Caroline Carmagnol / Valentine Boivin
Tel.: + 33 (0)1 70 22 53 92
theraclion@alizerp.com
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