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

BALERNA, Switzerland–(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

Contacts

APR Applied Pharma Research s.a.
Paolo Galfetti; Chief
Executive Officer
T: +41 91 6957020 or email to paolo.galfetti@apr.ch