MiMedx Group (MDXG) Announces Publication of USP 40 – NF 35; dHACM Now Recognized as USP-NF Monograph
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MiMedx Group, Inc. (Nasdaq: MDXG) announced that with the online publication of USP 40 – NF 35, its dehydrated human amnion/chorion membrane (dHACM) allografts will now be recognized in an official USP-NF monograph (official from May 1, 2017).
The United States Pharmacopeia (USP) and The National Formulary (NF) are the public pharmacopeia standards for drug substances, dosage forms, excipients, compounded preparations, dietary supplements, and medical devices. Historically, a USP-NF Monograph ("Monograph") sets the standard for a pharmaceutical, food ingredient, or dietary supplement product. This rare occurrence of creating a Monograph on a human tissue product is a recognition that dHACM allografts are products that should be produced in conformance with exceptionally high standards to avoid any potential for adulteration or misbranding.
The new "Tissue Human Amnion Chorion Membrane Dehydrated" USP Monograph outlines the definition of the products covered, as well as the specification, packaging, storage, and labeling requirements with which a product must conform. Validated tests, procedures for the tests, and acceptance criteria make up the specification. In general, the specification requires a stipulated strength, quality, and purity of a product to conform to the requirements of the Monograph.
Parker H. "Pete" Petit, Chairman and CEO, said, "We are pleased that the US Pharmacopeial Convention has recognized the importance of tissue products, and that dHACM allografts will now be described in an official USP-NF Monograph. The publishing of this important Monograph is the culmination of several years of work to define specifications, review, and test those specifications to ensure they truly and accurately define the dHACM product."
Bill Taylor, President and COO, commented, "This is another recognition milestone for the patented processes we have developed to produce our dHACM allografts. The dHACM outcomes for healing, modulating inflammation and reducing scar tissue formation are widely respected, and they are credited to the Company's proprietary PURION® Process and strict processing standards and validations. All products must have the stipulated strength, quality, and purity if they expect to conform to the requirements of this Monograph."
"The publication of the Monograph has clearly established another standard by which our dHACM allografts are unmatched in the industry," concluded Petit.
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