Periodic Reporting for period 2 - PAREMA (PArtial REbreathing for Migraine with Aura)
Berichtszeitraum: 2024-11-01 bis 2025-10-31
We have developed a unique, highly innovative migraine treatment device, aborting attacks by raising the inspired CO2 level while ensuring a normal oxygen saturation in the body, in turn markedly increasing the brain’s oxygen/energy supply and washout rate of pain-causing molecules, as well as decreasing the pain sensitivity of the nervous system.
Our treatment disrupts the market and uniquely stands out with a number of clear competitive advantages:
• Drug-free and safe: can be used as an alternative or add-on to pharmaceuticals, and in at-risk groups
• Effective: our pilot study showed a pain relief as high or higher than current acute treatments
• Small and lightweight device that can be carried by the patient at all times.
• Affordable
The project’s work packages are tailored to achieve the central aim of a successful, gold-standard clinical validation of the Rehaler treatment, followed by preparations for commercially leveraging these results.
This validation is the crucial step required for subsequent global roll-out and exponential commercial scaling.
Our treatment disrupts the market and uniquely stands out with a number of clear competitive advantages:
• Drug-free and safe: can be used as an alternative or add-on to pharmaceuticals, and in at-risk groups
• Effective: our pilot study showed a pain relief as high or higher than current acute treatments
• Small and lightweight device that can be carried by the patient at all times.
• Affordable
The project’s work packages are tailored to achieve the central aim of a successful, gold-standard clinical validation of the Rehaler treatment, followed by preparations for commercially leveraging these results.
This validation is the crucial step required for subsequent global roll-out and exponential commercial scaling.
FINAL REPORT:
The proposed large-scale randomized clinical trial was carried up to the time point of the interim analysis, at which point 142 patients had been enrolled.
The interim analysis unfortunately showed that the study device was not superior to placebo, and that the chance of obtaining a positive result in the final analysis was almost non-existent. For that reason, the clinical study was stopped and the EIC project was terminated early.
However, the study also showed that the developed medical device is safe, as there were minimal side effects in the study and no Serious Adverse Events. This means that the innovation may potentially be used in other applications where the mechanism of action is relevant, including stroke and epilepsy.
The proposed large-scale randomized clinical trial was carried up to the time point of the interim analysis, at which point 142 patients had been enrolled.
The interim analysis unfortunately showed that the study device was not superior to placebo, and that the chance of obtaining a positive result in the final analysis was almost non-existent. For that reason, the clinical study was stopped and the EIC project was terminated early.
However, the study also showed that the developed medical device is safe, as there were minimal side effects in the study and no Serious Adverse Events. This means that the innovation may potentially be used in other applications where the mechanism of action is relevant, including stroke and epilepsy.
FINAL REPORT:
The clinical study showed that the medical device was not superior to placebo but was very safe (no serious adverse events occured)
The clinical study showed that the medical device was not superior to placebo but was very safe (no serious adverse events occured)