Colli-Pee approved by Mexican Health Authority

Novosanis, an innovative developer and producer of medical devices, announced today that Colli-Pee, a user-friendly self-sampling device suited for standardized collection of first-void or first-catch urine has been approved by COFEPRIS, the Federal Commission for the Protection against Sanitary Risk in Mexico.

First-void urine (first 20ml of the urine flow) allows for improved detection of infectious diseases as well as early stage cancers. After gaining regulatory approval in Chile and Brazil earlier this year, Mexico is the third Latin American country where Colli-Pee has been accepted to enter the medical market.

Our Sales and Business Development Director for LATAM, Jeane Brunmark, will be working closely together with our local Mexican distributor Distribuidora Química y Hospitalaria GAP to drive adoption of the Colli-Pee device. The device is currently being launched during the XXXVI National Congress of Oncology which is taking place from November 7 to 10 in Jalisco, Mexico.

“This is yet another big milestone for our company and our team,” says Vanessa Vankerckhoven, CEO of Novosanis. “Mexico, together with Brazil is the biggest market for Medical Devices in Latin-America and we are delighted to further expand our presence globally and improving the accuracy of non-invasive urine-based diagnostics for infectious diseases and oncology,” she continues.

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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 privately held 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.

The company has two device platforms in portfolio:

VAX-ID™ is 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 and
Colli-Pee™ is a patented sampling device suited for standardized and volumetric 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, FDA listed, registered in Chile, Brazil, and Mexico.

For more information, please visit: www.novosanis.com

Trademarks

Novosanis, Colli-Pee, VAX-ID are trademarks of Novosanis NV and/or its affiliates.

For more information, please contact:

Vanessa Vankerckhoven, CEO Novosanis

+32 486761885; press@novosanis.com

Jeane Brunmark, Director Sales & Business Development LATAM & US

+1 858 444.5871; Jeane.brunmark@novosanis.com