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Otivio extends exploratory clinical trial

Otivio medical device

The Norwegian healthtech company Otivio has extended an exploratory clinical trial with Neuro-SysMed to confirm the potential of its FlowOx medical device to alleviate multiple sclerosis symptoms.

The trial follows a recent case series of 7 people with MS (pwMS) conducted by neurologist Dr Gabriela Fortes where FlowOx significantly alleviated MS related spasticity and pain, states the company in a press release.

The MS application

FlowOx was originally developed for improving blood flow to the legs of patients with peripheral arterial disease (PAD) by applying a negative oscillating pressure. Comfortable and easy to use, the sleeve is regulated as a Class IIa Medical Device and can transiently increase blood flow by approx. 60% in the small arteries and more than 100% in the capillaries.

“One of our investors managed to get her neurologist to apply for off-label use to treat her relapsing-remitting multiple sclerosis for which leg cramping, especially at night, is one of the main symptoms. She called the office a few days later and reported that she, for the first time in years, had slept through the night without any problems and that she finally had found a solution to her problems.”

“The MS application came about completely by chance. One of our investors managed to get her neurologist to apply for off-label use to treat her relapsing-remitting multiple sclerosis for which leg cramping, especially at night, is one of the main symptoms,” says Otivio’s CEO Andreas Mollatt. “She called the office a few days later and reported that she, for the first time in years, had slept through the night without any problems and that she finally had found a solution to her problems.”

Dr Flores was then engaged to interview pwMS with similar symptoms and the results were the same she says.

“A total of 7 pwMS were interviewed and they all but one reported a clear impact on their shared and individual symptoms such as pain (4 out of 4), cramps (2 out of 3), and spasticity (4 out of 6). We concluded that using intermittent negative pressure therapy for about 60 minutes daily results in clinically meaningful reduction in spasticity, pain and cramping. The effect lasting for more than 24 hours.”

Investigate the discovery further

“Encouraged by our own observations and Dr. Flores’ report, we then contacted Neuro-SysMed at Haukeland University Hospital in Bergen. Neuro-SysMed is a National Center for Clinical Treatment Research in Neurological Research including multiple sclerosis, and we asked them to investigate the discovery further as a leading independent expert institution,” says Mollatt.

Neuro-SysMed has enrolled 10 individuals so far. Due to the interesting observations, it has been decided to extend the study to reach a total number of 15 pwMS in the exploratory trial and expect to report results and their conclusion before summer 2022, the company states.

Photo: Otivio