(By Balaseshan) NovaBay Pharmaceuticals Inc. (NYSEAMEX:NBY) said it has received additional 510(k) clearance from the U.S. regulatory authorities for NeutroPhase wound cleanser.
The Food and Drug Administration (FDA) granted the company 510(k) clearance to market NeutroPhase(R) Skin and Wound Cleanser under widened indications including the moistening and debriding of graft and donor sites. Concurrently, the FDA cleared NeutroPhase to be administered through a new convenient spray pump.
NeutroPhase Skin and Wound Cleanser, first cleared in 2007, is intended for use under the supervision of healthcare professionals for the cleansing and removal of foreign material including microorganisms and debris from wounds and for moistening absorbent wound dressings and cleaning minor cuts, minor burns, superficial abrasions and minor irritations of the skin.
It is also intended for moistening and debriding acute and chronic dermal lesions, such as Stage I-IV pressure ulcers, stasis ulcers, leg ulcers, diabetic foot ulcers, post-surgical wounds, first and second degree burns, grafted and donor sites.
NovaBay is currently seeking appropriate potential partners to out-license rights to NeutroPhase in North America and Europe.
"This new FDA clearance is a major milestone in the recognition of NeutroPhase as an effective wound cleanser and significantly strengthens and enhances its use throughout the surgical community. We believe surgeons will be attracted to the flexibility it offers in the grafting and donor arena and its availability in a new easy-to-use spray pump," said Ron Najafi, Chief Executive of NovaBay.
The company believes that NeutroPhase is the only patented pure hypochlorous acid solution available and has the potential to be best suited to treat the 6 million patients in the U.S. who suffer from chronic non-healing wounds, such as pressure, venous stasis and diabetic ulcers.
NBY is trading down 3.23% at $1.20 on Monday. The stock has been trading between $0.79 and $1.72 for the past 52 weeks.