LEUVEN MINDGATE

Novosanis’ medical device Colli-Pee™ approved for sales in the US


Publication date : 14/11/2016

Novosanis announced today that Colli-Pee™, a self-sampling device suited for standardized and guaranteed collection of first-void urine has been listed by the FDA and thus approved for sales in the US.

“The approval of Colli-Pee for commercial use in the US is a major milestone in Novosanis’ history. This opens new opportunities to collaborate with diagnostic companies, suppliers of diagnostic tests, laboratories and hospitals in the US. The Colli-Pee device allows for collection of standardized and guaranteed first-void urine making the sample highly suited for detection of infectious diseases, like Human Papilloma Virus and other sexually transmitted infections, but also biomarkers for detection of early stage cancer.” says Vanessa Vankerckhoven, CEO Novosanis, Belgium.

For more information, please contact:

Vanessa Vankerckhoven, CEO & co-founder, Novosanis
+32 3 485 50 16
press@novosanis.com

About Novosanis

Novosanis is an innovative developer and producer of medical devices adding value to the accuracy of diagnostics tests as well as drug delivery in the field of prevention, detection and treatment of infectious diseases and oncology.

Novosanis is a Belgian company endorsed on multiple occasions nationally and internationally for its solutions and is ISO13485 certified.

Novosanis prospers in user-friendly and clever medical devices meeting all regulatory and quality requirements for self-sampling and drug delivery solutions that improve accuracy and standardization while making handling easier, more consistent and more comfortable for the user.

Novosanis has two device platforms in portfolio: : VAX-ID™,a patented and proven platform of injection devices suited for accurate drug delivery of e.g. therapeutic, prophylactic and allergy vaccines in the dermal layer of the skin. Colli-Pee™, a patented sampling device suited for standardized and guaranteed collection of first-void urine (first 20ml of the urine flow) allowing improved detection of infectious diseases as well as early stage cancer. Colli-Pee™ is in a commercial stage. It is CE-marked and FDA listed.

More information on http://www.novosanis.com/ or contact us for all your inquiries welcome@novosanis.com

For more information on Colli-Pee™, please visit: http://www.novosanis.com/devices/colli-pee

 

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