May 4, 2017 — Theraclion recently announced the presentation of data from the U.S. feasibility trial of echotherapy with Echopulse, a non-invasive treatment employing ultrasound-guided high-intensity focused ultrasound (HIFU), in women with breast fibroadenomas. Results were presented at The American Society of Breast Surgeons (ASBrS) Annual Meeting, held April 26-30 in Las Vegas.
The single-arm feasibility study was led by David Brenin, M.D., chief of breast surgery, co-director of the University of Virginia Breast Care Program, associate professor of surgery at UVA’s School of Medicine and principal investigator of the ongoing pivotal trial. The study enrolled 20 patients with 1 cm or larger palpable breast fibroadenomas to assess the safety and feasibility of a single Echopulse treatment. Fifty percent of patients reported a painful mass prior to enrollment. The study showed that echotherapy was well-tolerated. Pain and discomfort were the most commonly-reported side effects but remained minimal. Patient satisfaction after three months was 4.4 and the likelihood that they would recommend the treatment to a friend or family member was 4.7 (scale of 1-5, in which 5 indicated most satisfied). Long-term cosmetic outcome, reduction in breast fibroadenoma size and patient experience are currently under investigation.
Following this initial feasibility study, Theraclion has recently launched a U.S. pivotal trial evaluating the safety and efficacy of Echopulse. The pivotal trial is currently enrolling patients and is also being led by Brenin. The trial will enroll approximately 100 patients at four centers in the United States — University of Virginia School of Medicine, NYU Langone Bellevue, Montefiore Medical Center (NY) and New York-Presbyterian/Columbia University Medical Center — and two in Europe with Tübingen University Hospital, Germany and the University Hospital of Endocrinology in Sofia, Bulgaria.
Brenin said, “Although benign, breast fibroadenomas can cause discomfort, and the discovery of a lump in their breast can create anxiety in women. The current standard of care is surgery, which can cause significant pain and discomfort requiring medication and inevitably leads to scar formation. Echopulse is a very promising non-invasive alternative approach to treat the condition without the complications of surgery.”
Theraclion Chief Medical Officer Michel Nuta, M.D., said the results are consistent with clinical evaluations performed in Europe, where Echopulse is currently indicated with a CE Mark for this condition. Nuta said the company anticipates announcing top-line results for the U.S. clinical trial in 2019.
For more information: www.theraclion.com