The medical device company USMIMA S.L. (brand name MOWOOT), a CataloniaBio &  HealthTech member, announced that its first product “MOWOOT II Intestinal Transit Management System” has been granted the breakthrough device designation by the US Food and Drug Administration (FDA). With this important recognition by the USA´s highest authority for medical devices the company joins a select list of companies to receive this designation since the program began in 2016.

"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." said Dr. Markus  Wilhelms, CEO and cofounder of MOWOOT.

The receipt of Breakthrough Device Designation demonstrates that MOWOOT can offer significant advantages over existing  alternatives for more effective and efficient management of neurogenic bowel disorder (NBD). 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 specialized in healthcare, Capital Cell, and supported by Aescuvest, EIT Health’s digital venture capital platform.

Currently, MOWOOT's most important market is Germany, representing up to 40% of Europe’s medical device market. The US market entry is planned for 2023.