APR Applied Pharma Research (APR) Announces the European Class III CE Mark Approval of Nexodyn AcidOxidizing Solution (AOS) TM for the Management of Acute and Chronic Wounds
14.10.2015 08:21 | Business Wire
APR Applied Pharma Research s.a. (“APR”), the Swiss, independent developer of science driven, patent protected healthcare products, is pleased to announce the grant of the Class III European CE mark approval of Nexodyn AcidOxidizing Solution (AOS)TM.
The certification process 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)TM 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)TM 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)TM can effectively prevent wound contamination by exerting a local antimicrobial effect on the wound surface.
Topical antimicrobial solutions are increasingly integrated in the standard of care benefitting of the coexisting properties of wound cleansers and agents controlling local bioburden. The regular use of such products could potentially reduce the use of local and systemic antibiotics, complying with the needs of healthcare professionals, as recently highlighted by the “Association for the Advancement of Wound Care” (*).
“Thanks to its physico-chemical characteristics, Nexodyn AcidOxidizing Solution (AOS)TM spray is able to control local microbial burden and concomitantly contributes to create a wound microenvironment conducive to physiological healing” said Giorgio Reiner, Chief Scientific Officer (CSO) and Head of Research & Development Operations, “representing an advanced option to support the management of chronic wounds across the healing continuum.”
“Nexodyn AcidOxidizing Solution (AOS)TM, - Giorgio Reiner added - is an active wound cleanser provided in a convenient and easy-to-use spray formulation suitable to meet the needs of the whole continuum of wound care in a variety of clinical settings, from hospitals to home-care management and self-medication”.
“The Class III certification is the most rigorous level of review and approval which APR sought as further evidence of its continuous focus on quality and innovation” commented Paolo Galfetti, CEO. "We strategically aim at providing our business partners with products that satisfy the highest standards and that represent a relevant addition to the armamentarium of healthcare professionals in different therapeutic areas, with the ultimate goal of bringing a benefit to patients with debilitating and persisting ulcers."
About APR Applied Pharma Research s.a.
APR is an independent Swiss company, specialized in the development of science-driven, patent-protected healthcare products. The Company identifies, develops and licenses science- driven, value-added products designed to address patient or consumer needs in selected therapeutic areas on a global basis. Specifically, APR is currently focused on 2 (two) major areas: (i) internally developed and financed (alone or with our co-development partners) proprietary, value-added products to be licensed to healthcare companies for their commercialization, and (ii) support to third-party projects, by offering value-added, R&D services under contract and fee for service arrangements. APR has a balanced pipeline of revenue-generating branded products marketed in all major markets, combined with a compelling pipeline of products at different development stages. APR has entered into licensing and partnership agreements with pharmaceutical companies in over 70 countries, with international sales on a worldwide basis. For more info, please visit: www.apr.ch.
(*)“Ostomy Wound Management”, May 2015
APR Applied Pharma Research s.a.
Paolo Galfetti; Chief Executive Officer
T: +41 91 6957020 or email to email@example.com
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