Galway, Ireland , Jan 12 – AOTI Ltd., announced today that it had received FDA 510(k) marketing clearance for its Hyper-Box Homecare System for use in the treatment healing non-healing wounds , allowing for these products to be marketed in the USA
We are pleased the FDA has cleared the revolutionary therapy provided by our products which address the fundamental reasons wounds do not close, by reducing pathogenic bio-burdens and reversing the localized tissue hypoxia thereby stimulating the underlying cellular mechanisms needed for tissue to regenerate, stated Mike Griffiths, CEO and President of AOTI Ltd..
This recent FDA 510(k) marketing clearance authorizes a broad indications for use for the product, encompassing a wide range of acute and chronic wound types, including:
- Skin ulcerations due to;
- diabetes
- venous stasis
- post surgical infections
- gangrenous lesions
- decubitus/pressure ulcers
- amputations and infected stumps
- skin grafts
- burns
- frostbite
Griffiths added “As the world population continues to age, demand for advanced and clinically proven wound care products such as our TWO2 system will increase dramatically. With the clearance of this new product line, AOTI is well positioned to become major player of this growing multi-billion dollar market segment.”
About AOTI
AOTI is founded on a decade of experience in providing innovative solutions to resolve severe and chronic wounds worldwide. Our products reduce healthcare costs and improve the quality of life for patients with these debilitating illnesses. Our patented non-invasive Topical Wound Oxygen (two2) therapy is unsurpassed in fully closings Diabetic, Venous and Pressure ulcers alike. AOTI is a private company based in Galway, Ireland with offices throughout the globe. For more information, see www.aotinc.net.
