Interim results anticipated Q2 2019
Kista, Sweden, February 22, 2019 – Chordate Medical Holding AB's (publ) ("Chordate"), a specialty medtech company that focuses on developing and commercializing neuromodulating treatment systems for treating non-allergic rhinitis and chronic migraine, today announced the decision to conduct an interim analysis of the ongoing clinical study with Chordate's investigative product Kinetic Oscillation Stimulation System S211 (K.O.S-treatment). The multicenter study conducted in Germany enrolls patients with diagnosed chronic migraine (15 days/month of headache, whereof >8 days with migraine).
"We have come to the point in the development of this study where it makes sense to – by common praxis – verify the validity of the underlying statistical calculations of needed study population, and to determine probability of its outcome. Chronic headache problems concern many patients around the world. We are continuing to explore what we believe can offer a great potential for remedy with our proprietary non-pharmaceutical preventive treatment method", said Anders Weilandt, CEO of Chordate.
The randomized, placebo-controlled, double-blind, multicenter study is being conducted at four neurology clinics in Germany. The study intends to enroll up to 140 subjects and is designed to evaluate the efficacy and safety of the K.O.S-treatment, with the primary endpoint to detect mean change from baseline (4-week screening period) in monthly headache days with moderate to severe intensity, in a 4-week performance assessment period. The fifty percent of the patients in the K.O.S arm are receiving active treatment from the S211, while the other half of the patients are receiving a validated sham/placebo treatment from the same equipment.
For more information, please contact:
Anders Weilandt, CEO
Phone: +46 (0) 733 87 42 77
This information is information that Chordate Medical Holding AB (publ) is required to disclose under the EU Market Abuse Regulation. The information was provided, through the contact person above for publication on February 22, 2019 at. 08:30 CET.
The following documents can be retrieved from beQuoted
Chordate Pressrelease 2019-02-22 English.pdf
TO THE EDITORS
Chordate Medical Holding AB (publ) is a medical technology company that during ten years has developed, patented and CE-marked a new treatment method for chronic nasal congestion through nerve stimulation. The company sells its product system including treatments through its own sales organization as well as distributors to clinics and hospitals, which in their turn treat patients. Read more at www.chordate.com. Mangold Fondkommission AB, tel. +46 8 5030 1550, is the company's mentor and liquidity guarantee at NGM Nordic MTF.