Chapter 1 │ Page 18 and has been successfully used in therapeutic settings (CE-certified as a Class IIa medical device by Neoplas med GmbH Greifswald in 2013). This certification, indicating the device’s compliance with safety and performance standards, has primarily led to NTP’s integration into standard clinical practice for non-oncological applications, most profoundly in wound healing. In this field, NTP is already incorporated into therapeutic regimens, particularly for chronic wounds. In here, Germany is one of the forerunners, with reimbursement by healthcare systems already under consideration [79, 80]. Besides its anti-microbial actions and pro-regenerative potential, one of the most appealing aspects of NTP is its excellent safety profile; no significant acute adverse e ects were reported in 25+ clinical trials, with only occasionally a transient, mild sensation of warmth or itching reported in a minority of participants [81-83]. Transitioning from wound healing to oncological applications, early case report studies have explored NTP’s anti-cancer potential, particularly in head and neck squamous cell carcinoma (HNSCC). Pioneering in this is the work by Metelmann et al., who reported on a small cohort of advanced, locally recurrent HNSCC patients treated with the kINPen® MED device. These patients, without therapeutic options, experienced a low-impact treatment that improved quality of life, reduced pain medication needs, and partial tumor remission in some cases (2 out of 6 patients) [77, 84, 85]. Although the treatment setting di ers from wound healing, a retrospective analysis in 20 HNSCC patients with palliative NTP treatment further supported the safety profile of NTP in this set-up. Reported side-e ects were absent, mild or moderate (e.g. bad taste, fatigue); but never severe nor life-threatening [76], thus suggesting it as a well-tolerated therapy for patients with high comorbidities [76, 77, 8486]. The focus on HNSCC as a model investigate NTP is not only practical but also clinically relevant. While the anti-tumoral e ects of NTP have been tested across
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