Coloplast SenSura® Mio is Extended Wear in the US

Ostomates now have access to a new option, as a recent patient survey showed that SenSura Mio reduces leakage while matching or outperforming the wear time of other extended wear products¹.

Coloplast’s SenSura® Mio ostomy system has been approved in the US for extended wear use, which represents the majority of the US ostomy barrier market².

“Although the brand was initially launched into the standard wear category, new data shows SenSura Mio is a great option for those seeking an extended wear product,” said Manu Varma, President and SVP of Chronic Care North America.

A recent survey of nearly 2,400 patients demonstrated that SenSura Mio reduces leakage while matching or outperforming the wear time of other extended wear products¹. When combined with its full-circle filter, discreet neutral-gray textile, wide outlet, and unique BodyFit Technology, SenSura Mio is now an option for ostomates seeking an extended wear solution that also addresses their concerns around leakage.

Key clinical studies have found:

• 91% of ostomates worry to some degree about leakage³ 
• 76% of ostomates experienced leakage on some level ranging from a very high degree to a low degree⁴

A secure fit to the body is important to reducing leakage, and SenSura Mio was designed to fit individual bodies. BodyFit Technology is an elastic adhesive technology that is unique to SenSura® Mio barriers, which adheres securely to the body for protection and provides a flexible fit during movement.

“Patients¹, clinicians⁵, and lab-based data⁶ confirmed what we have suspected: SenSura Mio performs very well in the extended wear market,” added Varma. “We believe in the strength of our innovative products and are proud more patients in the US now have access to our reliable extended wear solution offered with SenSura Mio.”

Coloplast is a medical device company that develops products and services designed to make life easier for people with intimate health conditions. Coloplast listens to its users to better understand their needs and responds by bringing the best ideas to market in the form of medical devices and service solutions.

_{¹Ostomy pouch user survey, 2021, n= 2,359. Dataset collected by Coloplast but includes all brands. Data on file.
²2017 Medicare data, https://www.cms.gov/Research-Statistics-Data-and-Systems/Statistics-Trends-and-Reports/Medicare-Provider-Charge-Data/Downloads/DMEPOS_National_2017.zip
³Ostomy Leak Impact tool, https://hqlo.biomedcentral.com/articles/10.1186/s12955-018-1054-0
⁴The Ostomy Life Study: The everyday challenges faced by people living with a stoma in a snapshot, n=4138, June 2015
⁵Product evaluation of SenSura Mio Convex, 2016, n=98 clinicians.
⁶Data from bench testing performed by Coloplast. Data on file.}

CONTACTS
Peter Mønster
Senior Media Relations Manager, Corporate Communications
+45 49 11 26 23
[email protected]

Ellen Bjurgert
Vice President, Investor Relations
+45 49 11 33 76
[email protected]

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• PressRelease_SenSuraMio_ExtendedWear