Primary Objective
The statistical analysis of the Full Analysis Set derived from a total of 140 randomized subjects, randomized to receive active K.O.S-treatment, or sham-treatment, reached the Primary Endpoint goal by demonstrating a significantly reduced number of monthly headache days (MHD) with moderate to severe intensity from baseline.

Secondary Objectives
Response Rate data defined as ≥30% reduction in MHD with moderate to severe intensity from baseline demonstrated significance. Other Secondary endpoints demonstrated significant or favorable results.
The study data contains no treatment related serious adverse events.
The final study data will be communicated by Chordate in detail once the first scientific article manuscript has been accepted for publication.
“The value for us as a company to have the final data confirming this level of success, and added to our strategic scientific evidence base, is simply immense. By this we can deliver in full on the hypothesis that K.O.S, a non-drug medical device solution for preventive treatment of chronic migraine, is a valid treatment option, that can change the lives of many patients to the better. As we are cautious about preserving the scientific news-value in the coming publication of one or more articles, we will have to await approval-for-publication before we communicate the results in detail”, says Anders Weilandt, CEO of Chordate.

About the PM007 trial
This randomized, sham-controlled, double-blind, multicenter study was conducted at five neurology clinics in Germany and four in Finland. The study randomized 140 subjects and was designed to evaluate the efficacy and safety of the K.O.S-treatment. Primary endpoint was to detect mean change from baseline (4-week screening period, 4-week follow-up period) in monthly headache days with moderate to severe intensity, following weekly treatments for six weeks. Fifty percent of the subjects received active K.O.S-treatment from the S211 investigative device, and fifty percent received a validated sham/placebo treatment from the same equipment.

The study enrolled subjects with diagnosed chronic migraine (≥15 days/month of headache, whereof >8 days with migraine) and saw the last subject leaving the study at the beginning of August 2022.

The poster reveals that the subgroup analysis of the 46 German subjects receiving active K.O.S-treatment demonstrated a significantly reduced number of monthly headache days (MHD) with moderate to severe intensity from baseline, when compared to the 46 subjects receiving the sham treatment. The difference shown by the least square means (LSQ) of the ANCOVA model between the 4-week baseline period and treatment weeks 3-6 was -2.52 MHD (CI95%=[-4.52; -0.52], p=0.0140 and by non-parametric, stratified van Elteren test p=0.0092). The 4-week follow-up period results – after ending six weeks of stimulation – showed a reduction in LSQ of -2.70 MHD (CI95%=[-4.73;-0.68], p=0.093; van Elteren test p=0.0151), demonstrating a sustained improvement during the observation period.

Response defined as ≥30% reduction in MHD with moderate to severe intensity from baseline was achieved in 41.4% of the subjects receiving active K.O.S vs. 14.9% in the group receiving sham treatment. The treatment was also reported as well-tolerated without severe adverse events.

The authors concludes that this trial thus far indicates that K.O.S is an effective and safe option for the preventive treatment of chronic migraine. And further that as the K.O.S is a non-pharma alternative it would constitute a valuable expansion of the current therapeutic arsenal, without the significant risk of unwanted side effects commonly seen with other preventive treatment alternatives.

“It is remarkable to learn about such stunning effect from the German part of the PM007 study. The demonstrated level of response with K.O.S is also remarkable. This will indeed be a great support for our marketing and sales ambitions. The opportunity to make this subgroup analysis presented itself as the German clinics completed their work early. Our near-term task is now to compile the data from the completed study, and to get it published in its entirety”, says Anders Weilandt, CEO of Chordate.

About the PM007 trial

This randomized, sham-controlled, double-blind, multicenter study was conducted at five neurology clinics in Germany and four in Finland. The study enrolled 132 subjects and was designed to evaluate the efficacy and safety of the K.O.S-treatment. Primary endpoint was to detect mean change from baseline (4-week screening period, 4-week follow-up period) in monthly headache days with moderate to severe intensity, following weekly treatments for six weeks. Fifty percent of the subjects received active K.O.S-treatment from the S211 investigative device, and fifty percent received a validated sham/placebo treatment from the same equipment. The study enrolled subjects with diagnosed chronic migraine (≥15 days/month of headache, whereof >8 days with migraine) and saw the last subject leaving the study at the beginning of August 2022.