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Global Health Solutions Announces Filing of FDA 510(k) Application for Antimicrobial Saturated Petrolatum Gauze

Global Health Solutions
Posted on: 07 Sep 17
Global Health Solutions Announces Filing of FDA 510(k) Application for Antimicrobial Saturated Petrolatum Gauze

PR Newswire

LOS ANGELES, Sept. 7, 2017

LOS ANGELES, Sept. 7, 2017 /PRNewswire/ -- Global Health Solutions, a leader in innovative solutions for advanced wound care and dermatology, has announced filing of its 510(k) application for an antimicrobial advancement upon traditional petroleum saturated gauze. Global Health Solutions' petrolatum-based wound formula, Hexagen™ Wound Dressing, is used every day in leading clinics and institutions to care for even the most challenging acute and chronic wounds. This petrolatum-based formula has been successfully impregnated into a synthetic, non-woven gauze and pouched for single use. This 510(k) filing is consistent with the company's key corporate directive to leverage its proprietary PermaFusion™ delivery technology and formulas into additional medical arenas. PermaFusion™ permanently fuses liquid ingredients, such as antimicrobials, with petrolatum without an emulsifier. This first of its kind technology enables the creation of formulas that produce extremely powerful clinical effects, yet employ low ingredient loads by weight, minimizing insult to fragile tissue.

Global Health Solutions founder and CEO, Bradley Burnam, states: "It is projected that this will be a highly disruptive product. Millions of pieces of petroleum soaked gauze are used each year to care for surgical wounds, as well as acute and chronic wounds. A non-sensitizing, non-cytotoxic, antimicrobial option stands to potentially change the entire standard of care." Global Health Solutions' Chief Medical Officer, Neil Ghodadra, MD, also states: "Petroleum saturated Gauze has been a mainstay of medicine for over half a century. In this healthcare economy, Global Health Solutions' preventative innovation upon such a simple standard of care stands to change global wound care patterns. As a surgeon, I am excited and expect rapid adoption by many of my colleagues."

Global Health Solutions, LLC, is a concept-to-approval research, development, and commercialization entity focused on novel, best in class products for infection control, skin, and wound care. The company's proprietary technologies are used every day by world-leading healthcare institutions to care for a variety of skin and wound conditions. For more information, visit

Global Health Solutions, LLC

Forward Looking Statements Disclaimer: The statements contained herein may include prospects, statements of future expectations, and other forward-looking statements that are based on management's current views and assumptions and involve known and unknown risks and uncertainties. Actual results, performance, or events may differ materially from those expressed or implied in such forward-looking statements.

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SOURCE Global Health Solutions

PR Newswire

Last updated on: 07/09/2017

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