Breakthrough status for Intermittent Colonic Exo-peristalsis™ therapy will help provide timely access to this novel treatment for patients and providers in the US market
The medical device company USMIMA S.L. (brand name MOWOOT), with headquarter in Barcelona (Spain), announced today 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.
“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.” said Dr. Markus Wilhelms, CEO and cofounder of MOWOOT. “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 novel, 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 over existing alternatives for more 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 Parkinsons disease.
While conventional solutions were focusing on pharmacological or invasive approaches, such as laxatives, constipation drugs, trans anal irrigation systems and solutions that require surgery, which in many cases have low efficacy and several side effects for NBD patients, the approach of the MOWOOT device has demonstrated its safety as well as a high clinical responder rate, important improvements in clinical outcomes and patients’ quality of life in a recently published international clinical trial (McClurg et al. 2020).
Dr. Yan Yiannakou, Professor of Neuro-gastroenterology at the County Durham and Darlington NHS Foundation Trust (UK), stated that “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.”
Breakthrough device designation
The breakthrough device designation (BDD) is a seal of approval for medical devices that provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The following criteria must be met for such devices:
- Device provides more effective treatment or diagnosis of a life-threatening or irreversibly debilitating disease or condition
- Device represents breakthrough technologies
- No approved or cleared alternative device is currently marketed in the US
- Device offers significant advantages over existing approved or cleared alternatives
- Device availability is in the best interest of patients
The Breakthrough Devices Program was created to provide patients and providers with timely access to medical devices and offers selected companies the access to a fast-track program towards the US market entry, with priority treatment and support. Furthermore, the Centers for Medicare & Medicaid Services (CMS) are currently evaluating a special rule that would cover a breakthrough medical device for four years starting on the date of FDA authorization. This guaranteed access to public healthcare reimbursement would be a very positive signal to medical device manufacturers and investors alike.
Interest from Investors
In medical devices, investors are extra wary of the risk posed by the FDA regulatory process and want to be assured that a company’s product has value to both patients and physicians; they also want to see a return on their investment. A BDD gives investors added confidence in a company, and if the FDA has recognized a product as one that will advance public health and/or offer superior treatment, investors are more likely to take a chance on your organization.