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Intestinal Management System gets Breakthrough Designation from FDA

MOWOOT’s CEO and co-founder, Dr. Markus Wilhelms, said: “The FDA’s Breakthrough Device Designation is an important milestone for our company since it confirms our opinion that our solution has considerable advantages above other approved or cleared alternatives. Our clinical results show that our technology has clear benefits for severely constipated patients, and we look forward to working with the FDA to quickly bring our technology to the US market to improve bowel management in patients with neurogenic bowel disorders, resulting in better patient outcomes and lower healthcare costs.”

Patients with intestinal transit issues, such as persistent constipation, can benefit from the MOWOOT device’s patented ‘Intermittent Colonic Exoperistalsis’ technology, which is a completely physical, non-drug, and non-invasive treatment. MOWOOT’s Breakthrough Device Designation demonstrates that it can provide significant benefits in the treatment of neurogenic bowel disorder (NBD), a severe form of chronic constipation that affects up to 80% of neurological patients with conditions like spinal cord injury, multiple sclerosis, or Parkinson’s disease.

“In our service, we see the most severe and refractory cases, so I was sceptical about this therapy,” said Dr. Yan Yiannakou, professor of neuro-gastroenterology at the County Durham and Darlington NHS Foundation Trust. “But we have now tried MOWOOT therapy in several patients who had failed all other treatments, with substantial benefit in the majority.”

MOWOOT is now gathering funds to expand in European markets and prepare for a US market debut through a crowdfunding campaign on Capital Cell, Europe’s top healthcare crowdfunding platform, which is backed by Aescuvest, EIT Health’s digital venture capital platform. With this strategy, the company is once again displaying a patient-centered approach, as a combination of crowdsourcing and professional investors in the area allows smaller investors and direct beneficiaries of the product, such as patients or medical professionals in the field, to invest.

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