Faster treatment opens market
Theraclion (PA:ALTHER) has announced interim clinical results on a crucial innovation, Beamotion, to speed up EchoPulse therapy five times. The CE-marked EchoPulse device precisely focuses high-energy sound to break down benign but troublesome breast fibroadenomas and palpable thyroid nodules. EchoPulse is easy to use and leaves no scars, with no infection or surgical risks. US trials have started. In H115, Theraclion gained three new orders, had revenues of €56k, a reported loss of €3.2m and cash of €4.7m.
Breast fibroadenomas
At least 10% of women develop small hard lumps, 1-2cm, often in the upper, outer breast, which can be very painful; these often develop at a young age. EchoPulse causes fibroadenoma shrinking (average of 72.5% seen after a year) so women can be treated at low risk without surgical scarring. Confirmed fibroadenomas are benign, usually stable and up to 50% regress with time. A 20-pt study is underway at the University of Virginia and Theraclion now intends to submit a de novo 513(k) application to the FDA. Beamotion is also being trialled; no results are available yet.
Thyroid nodules – treatment time cut five-fold
These nodules form on the margins of the thyroid gland with about 5% of adults developing palpable nodules; 95% are benign (biopsy needed). Hyperfunctioning thyroid nodules will sometimes cause symptoms due to excess hormone production. Nodules can only be removed by surgery, so are usually monitored. EchoPulse allows simple therapy with 48.9% mean shrinkage. In new interim clinical data on seven patients, Beamotion cut mean treatment time from 83 to 17 minutes.
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