MDR Certification Granted to TOOsonix’s Dermatological Therapy Device

TOOsonix A/S has been awarded EU Medical Device Regulation (MDR) CE certification for its image-guided dermatologic therapy solution, System ONE-M.

The certification allows TOOsonix to sell its flagship product throughout the European Economic Area. Treatment of skin cancer and skin diseases can now be conducted in ways never before possible, providing more patient-friendly treatment than traditional procedures, the company claims.

“Our device presents oncologists and dermatologists with a new and versatile tool that can remove the need for an array of lasers, RF-devices, and other expensive specialized tools. With System ONE-M, a typical session may encompass the primary treatment of e.g. 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 Managing Director Torsten Bove said.

Unlike conventional dermatological therapy, everything can now be accomplished within a single straightforward session using the same device. The clinician can assess the target lesion area in microscopic resolution before treatment using System ONE-M’s integrated imaging capability, and proceed directly to an image-guided treatment with extreme accuracy.

“The treatment allows patients to depart virtually unaffected and without requiring downtime. Our objective has been to provide the most patient friendly treatment. TOOsonix System ONE-M is the next level device for treatment of the skin,” TOOsonix Co-Managing Director Tomasz Zawada stated.

The approved treatments span several subcategories within dermatology. In oncology, interventions cover the treatment of basal cell carcinoma, the most prevalent cancer worldwide, and actinic keratosis, the most common pre-cancerous condition. Additionally, the system offers a pioneering non-invasive treatment of cutaneous neurofibromas in patients with the rare disease Neurofibromatosis Type 1, the most widespread genetic disorder. Finally, a wide range of benign skin tumors and neoplasms within general dermatology are approved. Treatments of these encompass several tens of millions conducted in hospitals and private practice every year, utilizing lasers, light therapies, RF-therapy, cryotherapy, and a range of topical and systemic pharmaceutical products.

Clinical data for all treatments demonstrate safe, swift, and efficient therapies, now providing patients with a non-invasive option that have minimal discomfort and no downtime following treatments, and no side effects from pharmaceutical agents or harmful radiation. In many cases, a single treatment session taking less than 90 seconds suffices to achieve the desired therapeutic outcome.

“Introducing a safe, swift, and effective system to the market for both medical and aesthetic dermatological therapy holds immense potential,” TOOsonix Chairman and Consolidated Holdings A/S CEO Lone Schøtt Kunøe commente. “I view the CE mark as the initial realization of TOOsonix’s breakthrough in the market, and I am enthusiastic about the prospects for the future”.

Copenhagen, Denmark-based TOOsonix develops ultrasound technology. Collaborating with clinicians and healthcare experts throughout Europe and the United States, the firm offers improved clinical options for dermatological therapy. Its clinically approved treatments address some of the most prevalent cancerous, pre-cancerous, genetic, and benign skin conditions.