APR obtains the European Class III CE Mark approval for Nexodyn AcidOxidizing Solution (AOS)™

APR has successfully accomplished the certification of Nexodyn AcidOxidizing (AOS)™ as Medical Device Class III according to the European regulation.

The certification has been conducted by the Notified Body BSI (British Standards Institution), one of the largest and most experienced certification bodies in the Medical Device arena and the UK Medicines and Healthcare Products Regulatory Agency (MHRA), whose consultancy granted a positive opinion during the certification process.

Nexodyn AcidOxidizing Solution (AOS)™ has been developed based on APR’s proprietary technology TEHCLO®, enabling the production of an acidic and super-oxidizing solution containing free chlorine species, of which > 95% as stabilized hypochlorous acid.

Nexodyn AcidOxidizing Solution (AOS)™ is intended for use in the debridement, irrigation, cleansing and moistening of acute and chronic wounds (e.g. diabetic foot ulcers, pressure ulcers, lower leg ulcers, vascular ulcers), post-surgical wounds, cuts, abrasions, burns and other lesions. As it contains hypochlorous acid as a preservative, Nexodyn AcidOxidizing Solution (AOS)™ can effectively prevent wound contamination by exerting a local antimicrobial effect on the wound surface.

Thanks to its physico-chemical characteristics, Nexodyn AcidOxidizing Solution (AOS)™ spray is able to control local microbial burden and concomitantly contributes to create a wound microenvironment conducive to physiological healing, representing an advanced option to support the management of chronic wounds across the healing continuum.

2015-10-22T12:24:22+00:00 Applied Pharma Research (APR)