TOOsonix A/S, a Danish dermatology company specializing in high-intensity focused ultrasound (HIFU) technology, has announced the introduction of their TOOsonix System ONE-M for the treatment of color-independent tattoo removal, spider veins, lentigines, telangiectasia, angiomas and various other aesthetic conditions.
The CE-marked medical device uses HIFU ultrasound technology at 20 MHz, which generates thermal lesion focal points in the upper dermis and epidermis of the skin. The temperature within the focal point will increases to 50-60°C, thus inducing acute cell necrosis and promoting the replacement of affected cells with new, healthy cells.
Additionally, the device is able to penetrate lesions within the dermal interface, as well as fat and abnormal vessels in the outer subcutis, while leaving no scars or wounds.
“The CE marking of our first medical device is pioneering the field of HIFU used for the human skin. It is the first important step in TOOsonix’ vision to make new and advanced HIFU systems available for dermatological use all over the globe. The new system is ready for a range of new applications,” says Torsten Bove and Tomasz Zawada, co-founders of TOOsonix. “We initially intend to offer this device to first-mover dermatologists within the European Union and look forward to the resulting physician feedback and market data that can guide our addition of more medical indications in the future.”
The device release is supported by positive results from two clinical trials conducted at Bispebjerg University Hospital in Copenhagen, Denmark.
“High frequency HIFU has a significant potential for future use in dermatological clinics, particularly in the laser/IPL clinics, as a new and specialized member of the family of advanced devices. Tattoo removal has been studied in detail. In our experimental work we have furthermore demonstrated that the device used for actinic keratosis has important advantages over photodynamic therapy (PDT), practically, resource-wise, and with respect to efficacy,” says Jørgen Serup, M.D., lead investigator of the two TOOsonix System ONE-M clinical trials.
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“Noteworthy is the reduced pain-level during treatment,” continued Dr. Serup. “HIFU can be applied to multiple sites of the body in one short session and, obviously, has the potential to replace PDT in the future. Experimental use indicates the device can be used for dedicated ablative treatment of skin cancers, particularly basal cell carcinoma, and for a range of different premalignant conditions as well as a multitude of benign skin tumors. The method is an entirely new treatment modality in dermatology, with a large potential.”
The company plans on expanding the device’s treatment indications with actinic keratosis and basal cell carcinoma pending current regulatory activities.
DERMATOLOGY HIFU PRODUCT RELEASE. https://news.cision.com/toosonix-a-s/r/dermatology-hifu-product-release,c3141245. Published June 29, 2020. Accessed August 10, 2020.