FDA grants Breakthrough Designation to intestinal management system

Medical device company USMIMA S.L. (brand name MOWOOT), with headquarters in Barcelona, has announced that its first product “MOWOOT II Intestinal Transit Management System” has been granted Breakthrough Device Designation by the US Food and Drug Administration (FDA).

Dr. Markus Wilhelms, CEO and co-founder of MOWOOT, said: "The Breakthrough Device Designation is a significant milestone for our company and validates our belief that our solution offers significant advantages over existing approved or cleared alternatives, per FDA requirements. Our clinical results show clear benefits for severely constipated patients, and we look forward to working with the FDA to introduce our technology to the US market as quickly as possible to improve bowel management in patients with neurogenic bowel disorders, for better patient outcomes and reduced healthcare expenditures."

The MOWOOT device, with its patented ‘Intermittent Colonic Exoperistalsis’ technology, offers a purely physical, non-drug and non-invasive treatment for patients with intestinal transit disorders, such as chronic constipation.

The receipt of Breakthrough Device Designation demonstrates that MOWOOT can offer significant advantages for effective and efficient management of neurogenic bowel disorder (NBD), a severe form of chronic constipation that affects up to 80% of neurological patients, such as spinal cord injury, multiple sclerosis or Parkinson’s disease.

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

MOWOOT is currently raising funds to further expand in European markets and prepare the US market entry via a crowdfunding campaign on Europe´s leading crowdfunding platform specialised in healthcare, Capital Cell, and supported by Aescuvest, EIT Health’s digital venture capital platform. With this approach the company is once again demonstrating a patient centered approach, as in addition to professional investors in the field a combination with crowdfunding offers the investment opportunity also to smaller investors and direct beneficiaries of the product, such as patients or medical professionals in the field.