Chordate Medical Holding AB (publ) ("Chordate") (Nasdaq FirstNorth Stockholm: CMH), a specialty medtech company that focuses on developing neuromodulating systems for treating chronic migraine, today announces that final data analysis confirms the statistically significant results from the subgroup analysis presented as a poster early September at the Migraine Trust International Symposium 2022, London.
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.
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.