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Global Health Solutions Announces Filing of 510(k) Application for FDA Clearance of Non-Steroidal Eczema Formula

Wednesday, May 3, 2017 Drug News
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LOS ANGELES, May 2, 2017 /PRNewswire/ -- Global Health Solutions, a leader in innovative solutions for acute and chronic wound care, has announced filing of its first 510(k) application for dermatologic indications. Global Health Solutions' signature petrolatum-based wound formula, used every day in leading clinics and institutions, has shown incredible promise in managing the symptoms of irritant, atopic, and radiation dermatoses, conditions that affect more than 10% of the world's population. This 510(k) filing is consistent with the company's key corporate directive to leverage its patented PermaFusion™ delivery technology into additional medical arenas. PermaFusion™ permanently binds liquid ingredients 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 active ingredient loads by weight, minimizing insult to fragile tissue.
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Global Health Solutions founder and CEO, Bradley Burnam, states: "As a company, we take our cues from practitioners, who have provided consistent feedback regarding the technology's ability to manage or eliminate symptoms of these dermatoses. Patients who wish to avoid the side-effects of steroidal products will soon have an option that not only soothes symptoms without irritating, but addresses the lack of natural antimicrobials known to plague the skin of eczema sufferers. We are extremely excited to work with FDA on this important filing and hope for an expeditious process. As we continue to gather data, additional filings in post-surgical care, onychomycosis, and infection control will follow in rapid succession."
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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, including contact forms, visit www.globalhealthrx.com.

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/global-health-solutions-announces-filing-of-510k-application-for-fda-clearance-of-non-steroidal-eczema-formula-300449817.html

SOURCE Global Health Solutions

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