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Global Health Solutions gets FDA 510(k) clearance for PolyPlex wound dressing

MDBR Staff Writer Published 29 November 2016

Global Health Solutions has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its PolyPlex wound dressing.

PolyPlex is a petrolatum-based topical gel developed for acute and chronic wound management.

The new wound dressing features the company's PermaFusion delivery system to provide protection against bacteria, fungi, and yeasts without irritation to fragile and healing tissue.

PermaFusion delivery system is also employed in the firm’s other wound dressing product, CurX antimicrobial gel.

The firm will offer PolyPlex wound dressing from January 2017 through McKesson Medical-Surgical.

According to the company, chronic wounds are affects around 5.7 million patients and costing an estimated $20bn per annum in the US.

Global Health Solutions CEO Bradley Burnam said: The need for innovation in acute and chronic wound care is critical, as antimicrobial resistance is at an all-time high.

“PolyPlex successfully balances potency with gentleness, eliminating frustrating tradeoffs in patient care that have plagued wound care practitioners for decades.”

Global Health Solutions executive chair Glenn Mattes said: "The approval and introduction of PolyPlex will provide practitioners with an important new wound management tool suitable for a multitude of patient types.

“We plan to aggressively market and sell PolyPlex, as well continue to develop and introduce additional products to this market."

With principal offices in Georgia, Global Health Solutions is engaged in the development of advanced wound care technologies.