One of the studies was the 1st direct comparison of echotherapy to surgery. The study, which was published in the International Journal of Hyperthermia, compared 43 patients who were treated with Theraclion’s Echopulse, an ultrasound-guided high-intensity focused ultrasound system, to 103 patients who underwent hemithyroidectomy.
Patients who were treated with the French company’s system experienced significantly lower incidence of subclinical hypothyroidism, better symptoms improvement scores, shorter length of hospital stay and better voice quality after 1 month.
The 2nd study, published in Radiology, compared patients with symptomatic benign thyroid nodules who were treated with Echopulse to an observational cohort. A comparison of 12-month follow-up results showed that patients in the echotherapy group had a significantly better volume reduction, better symptoms reduction and experienced significant improvement in their quality of life score compared to the control group.
The 3rd study, published in the International Journal of Hyperthermia, demonstrated that the underlying thryoid function was preserved after ablation with Echopulse in a series of 83 consecutive patients, according to the company. After 3 and 6 months, none of the patients developed hyperthyroidism and only 1 patient with a past history lobectomy developing hypothyroidism.
“These studies demonstrate that HIFU treatment is not only effective in terms of volume reduction of symptomatic benign thyroid nodules but also in relief of symptoms, while being safe,” Dr. Michel Nuta, chief medical officer, said in prepared remarks. “In addition, these results demonstrate a very feasible alternative to conventional thyroid surgery, with significant reduction in nodule volume.”
“These 3 critical studies will help us accelerate further clinical adoption of echotherapy as the first-line treatment option for thyroid nodules. This marks the 1st time that echotherapy has been directly compared to surgery, and the results showed patients having shorter hospital stays, less subclinical hypothyroidism, lower cost and better symptom improvement,” CEO David Caumartin added. “Collectively, these studies will also specifically support accelerated adoption in China, following the joint-venture in China with our shareholder Inner Mongolia Furui Medical Science Co, Ltd.”