Focused Ultrasound Device Approved in Europe for Skin Cancers


Key Points

  • TOOsonix A/S’s System ONE-M has been granted the CE Mark for a wide range of non-metastasizing skin diseases.
  • With System ONE-M, patients typically only need one treatment that takes fewer than 90 seconds.
TOOsonix written in green text.

TOOsonix A/S, a focused ultrasound company based in Hørsholm, Denmark, has announced that its System ONE-M device has been granted the CE Mark for image-guided dermatologic therapy. The CE Mark is a regulatory symbol that indicates a product meets the European Union’s health and safety requirements. The ruling allows physicians in Europe to use the noninvasive device to treat a wide range of non-metastasizing skin diseases, including basal cell carcinoma (BCC), actinic keratosis (AK), and cutaneous neurofibromas, among others. 

The innovative System ONE-M device uses high-intensity focused ultrasound (HIFU) to treat skin conditions typically in a single session taking fewer than 90 seconds. Due to its high frequency, the system provides unprecedented accurate thermal lesion points confined to the very outer layer of the human dermis and epidermis. The system also provides real-time guidance from an integrated dermascope, where all targeted features in the skin are directly visible on a high-resolution color video-feed. 

“Our device presents oncologists and dermatologists with a new and versatile tool that can remove the need for an array of lasers, radiofrequency-devices, and other expensive specialized tools,” said Torsten Bove, managing Director at TOOsonix. “With System ONE-M, a typical session may encompass the primary treatment of cancerous basal cell carcinoma, pre-cancerous actinic keratosis, as well as the removal of various more benign skin conditions that may have emerged since the patient’s last visit.” 

TOOsonix was involved in a recently completed American funded clinical trial demonstrating the first non-invasive method for removal of cutaneous neurofibromas in patients with the genetic deficiency Neurofibromatosis Type 1, and support two on-going trials exploring the use of its device for treating non-nodular, or recurrent, BCC. These studies build on earlier clinical data suggesting that the HIFU treatment is effective for patients with AK, BCC, Kaposi sarcoma and a long range of other skin diseases and conditions ranging from HPV warts to tattoo removal. 

Read the Press Release 

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