The first basal cell carcinoma (BCC) patients have been treated with TOOsonix A/S’s System ONE-M device.

The first basal cell carcinoma (BCC) patients have been treated with TOOsonix A/S’s System ONE-M device. 

The TOOsonix high-intensity focused ultrasound (HIFU) delivers highly accurate doses of energy to focal points in a chosen depth. It operates at 20 MHz to create a thermal focal zones in the epidermis and dermis of the human skin. Within the focal zone, the temperature rapidly increases to 50–60 °C, which causes local cell death. The body’s own healing processes will subsequently remove and replace the treated field with new and healthy tissue. It can therefore directly and selectively treat areas affected by basal cell carcinoma, typically invading the outer layer of the human skin. 

The clinical study will include 40 patients diagnosed with superficial BCC. The high-intensity focused ultrasound (HIFU) treatment will be administered as a single dosing of approximately 1-2 minutes of active focused ultrasound. The treatment does not require any local anesthetics and no special after-care. Study participants are monitored with regular follow-up visits over 12 months after treatment. An interim report with evaluation of cure rate and safety profile 3 months after treatment is planned. 

"After initial medical CE-marking of the system in June 2020, treatment data coming from selected hospitals and private clinics have been very positive, demonstrating that the system is very versatile, and can be used to treat a large range of different dermatological conditions. We have continued to support leading university hospitals with the devices and information necessary to start larger formalized clinical studies. We are therefore now very proud to see this first study on a broad range of patients suffering from the most common cancer in the world,” says Torsten Bove and Tomasz Zawada, founders of TOOsonix, in a news release.

“High frequency HIFU has a significant potential for future use in treatment of BCC and other dermatological conditions. In experimental work, it has already been indicated that the device has important practical and resource-saving advantages over photodynamic therapy (PDT), which is a leading therapy in superficial and early-stage BCC,” says Professor Joergen Serup, MD, DMSc who lead the study at Bispebjerg Hospital.Copenhagen, Denmark.  “Noteworthy is the reduced pain-level during treatment. HIFU can be applied to multiple sites of the body in one short session, and therefore has the potential to replace cumbersome and resource-demanding PDT in the future. Recurrent BCC after any previous treatment is a logic indication, taking advantage of the focused and targeted principle of the method. The method is for the same reason expected to carry low risk of post-treatment scarring and dyschromia. The method can work well in hospitals as well as private practice settings.”

The device is also being studied in actinic keratosis and Kaposi sarcoma. The new clinical data and documentation from on-going studies will be used to expand the list of indicated use in the near future.