Novosanis obtains regulatory approval for Colli-Pee in Brazil
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Wijnegem, Belgium, July 26 2018: Novosanis announced today that Colli-Pee, a non-invasive self-sampling device suited for standardized and volumetric collection of first-void urine has been approved by the Brazilian Health Regulatory Agency, ANVISA.
First-void urine allows for improved detection of several (sexually transmitted) infections as well as early stage cancers. Recent studies have also shown the benefits of urine as a specimen to detect Zika virus infection. Colli-Pee, thereby, offers great potential in Brazil, a Zika-prone region, with an estimated 440,000 to 1,300,000 cases reported in Brazil alone in 2015.
“Regulatory approval for Colli-Pee in Brazil is yet another significant milestone for Novosanis," said Jeane Brunmark, Novosanis’ Director of Sales & Business Development for Latin America and the U.S. "Brazil is a pivotal country in South America, where new medical technologies are often first demonstrated, and we're delighted to launch Colli-Pee formally in this market during the Brazilian Congress of Clinical Pathology in Florianopolis, September 25 - 28. Following our launch in Chile earlier this year, today's announcement will certainly help drive increased adoption of Colli-Pee worldwide”.
Vanessa Vankerckhoven, Novosanis’ CEO “Thanks to the amazing efforts by our team and our regulatory agent in Brazil we now have successfully registered Colli-Pee in Brazil. The registration process of the Colli-Pee device with our proprietary UCM preservative is ongoing. We are currently running stability studies according to ANVISA guidelines and Brazil climate (temperature and humidity) specific conditions. Registration is expected early 2019. We’re really excited to further expand our presence in Latin America.”
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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 game-changing 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 and FDA listed.
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
Jeane Brunmark, Director Sales & Business Development LATAM & US
+1 858 444.5871
Jeane.brunmark@novosanis.com