Kinetic Oscillation Stimulation, Ozilia™ Migraine., was originally developed to treat chronic rhinitis – what is commonly called nasal congestion. During the years that Ozilia™ Migraine. was tested and studied, several patients reported that their migraine symptoms ceased or subsided after being treated for rhinitis. This is now the subject of a study which is expected to be completed during 2022.
The treatment is performed by inserting a balloon catheter into one nostril at a time, inflating the balloon and making it vibrate at a specific frequency. This goes on for ten minutes per nostril.
The clinical benefit of using Ozilia™ Migraine to treat chronic rhinitis is proven and well-supported in research. The treatment is in use in several countries, and the number of clinics using Ozilia™ Migraine. is increasing. A comprehensive study is currently being conducted at 13 clinics and with approximately 300 patients. An interim analysis of the rhinitis study was performed, during the fall of 2020, which indicated a too low probability to reach a conclusive result. Hence, the inclusion of further patients was halted for ethical and cost reasons. Howver, the study contiues with follow-up for 12 months of the patients already enrolled.
In 2020, the University of Amsterdam published a study which analyzed data from an older study, carried out in 2013-2014, and which concluded that Ozilia™ Migraine. treatment has a significantly better effect on patients than placebo treatment. This confirms our view that the rhinitis market for Ozilia™ Migraine. has great potential.
When it comes to migraine, the research situation is very promising. The patient study PM007, on the Ozilia™ against chronic migraine, that started in 2018 was completed in August 2022. On September 8, 2022, a scientific poster was presented at the Migraine Trust International Symposium 2022 in London, which reported a statistically significant reduction in the number of headache days. On November 3, 2022, it was reported that the final analysis of the entire study confirmed statistical significance. Chordate’s Ozilia™ Migraine treatment is thus clinically proven to be as good or better than drug-based alternatives against migraines.
In june, 2023, the study results was presented at the American Headache Society Scientific Meeting, by the coordinating principal investigator, Dr. Jan Hoffmann. The abstract said “The findings of the clinical trial show that intranasal K.O.S (Ozilia®) is an effective and safe option for the preventive treatment of chronic migraine. The non-pharmacological nature of the treatment option positions the treatment as a valuable addition to the current therapeutic portfolio for the management of chronic migraine as beyond having a solid and sustained treatment effect, it stands out from other preventive treatments by its favorable side effect profile”.
In August, 2023, the complete study results was submitted as a manuscript for publication in one of the three most prominent journals within the migraine field.
Final study data will be communicated in detail by Chordate once the first scientific article has been approved for publication.
The results from the study serve as sales support to develop the market, both within and outside the EU.
Ozilia™ Migraine. is completely pain free and can easily be performed by a nurse or doctor after a medical examination. The patient may experience some discomfort during the first few minutes, mostly due to the unusual feeling of having something inserted into the nose – but no pain.
The effect of the rhinitis treatment is felt within a few hours. The effect also increases and is usually fully felt one to two days after treatment. Normally, two initial treatments are performed at one-month intervals, after which one to two treatments per year is usually sufficient for patients with chronic rhinitis to experience noticeable improvement.
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