Paris, November 29, 2011 - Theraclion is an innovative start-up developing the TH-One system for the non-invasive ablation of small tumors (thyroid nodules, parathyroid gland pathologies and breast fibroadenomas). It today announced the first ever successful treatments of two breast fibroadenoma patients (in Bulgaria) using its high-intensity, focused ultrasounds (HIFU) technology. A second study on the treatment of breast fibroadenoma (this time in France) has just been launched.
With six months' hindsight, it is clear that the treatment of the first patients included in the Bulgarian clinical trial (initiated in spring 2011) has been a success. The fibroadenomas have shrunk in volume by 64%. The lump has become softer on palpation and the patients are totally satisfied with the outcomes.
"In view of the excellent results already obtained in Bulgaria in this first study in patients with breast fibroadenomas, we have decided to launch a new clinical trial in France. This will enable us to gather more data and accelerate the adoption of our technology and the TH-One treatment system. Our solution is a true alternative for women keen to avoid surgery for the treatment of their benign tumors", stated Theraclion's Marketing Director David Del Bourgo.
"When my physician suggested ultrasound treatment, I decided to try it because as a young woman, I did not want to risk having a scar on my breast. Six months after the ultrasound treatment, the lump is much smaller - I can hardly feel it and I am totally satisfied", emphasized 27-year-old Marina (treated in May 2011 in the Bulgarian study).
"I have always been very scared of surgery - particularly the general anesthesia and the risk of having a scar on the breast. Six months after the treatment, I am very pleased with the result because the lump is much smaller and doesn't bother me anymore", commented 22-year-old Roza (treated in May 2011 in the Bulgarian study).
"The results obtained here are very promising. I saw a remarkable difference in the size of the fibroadenomas, both clinically and in an ultrasound examination. They can barely be felt by palpation and the two patients are very satisfied", commented Professor Roussanka Kovatcheva (Sofia University Medical Center), who performed the HIFU treatments in May of this year.
A second prospective, multicenter study has just been launched in France. It plans to include 20 patients over a 6-month period and will be performed at two prestigious investigating centers in Paris and Lille. The trial's objective is to confirm the efficiency of HIFU use in the treatment of breast fibroadenomas. This will be demonstrated by a reduction in the fibroadenoma's size and (for some patients) by histological analysis. Positive study results would prove the potential for ablating a fibroadenoma without having to resort to surgery - thus avoiding general anesthesia and the trauma of scarring. HIFU treatments are performed in a single session under sedation and on an outpatient basis. They last for about 30 to 40 minutes, depending on the size of the fibroadenoma.
"Theraclion's technology meets needs in fibroadenoma treatment and constitutes an innovative, relevant alternative for patients seeking relief from their fibroadenoma without having to undergo surgery", commented Professor Michel Cosson, Professor of Gynecology and Obstetrics at Jeanne de Flandres Hospital (Lille University Medical Center).