MiMedx Announces U.S. Pharmacopeia Monograph For dHACM Allografts Has Published
MIMEDX'S PURION PROCESSED dHACM ALLOGRAFTS REPRESENT YEARS OF SCIENTIFICRIGOR THAT CONFORM TO THE NEW USP–NF MONOGRAPH
Marietta, Georgia , November 3, 2016, (PR Newswire) ‐‐ MiMedx Group, Inc. (NASDAQ: MDXG), the leading regenerative medicine company utilizing human amniotic tissue and patent‐protected processes to develop and market advanced products and therapies for the Wound Care, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic, and Dental sectors of healthcare, announced today that with the online publication of U.S. Pharmacopeia 40 – National Formulary 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 pharmacopeiastandards 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 infrequent 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 very 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.
MiMedx® is an integrated developer, processor and marketer of patent protected and proprietary regenerative biomaterial products and bioimplants processed from human amniotic membrane and other human birth tissues, such as amniotic fluid, umbilical cord and placental collagen, and human skin and bone. "Innovations in Regenerative Biomaterials" is the framework behind our mission to give physicians products and tissues to help the body heal itself. We process the human amniotic membrane utilizing our proprietary PURION® Process, to produce a safe and effective implant. MiMedx proprietary processing methodology employs aseptic processing techniques in addition to terminal sterilization. MiMedx is the leading supplier of amniotic tissue, having supplied over 700,000 allografts to date for application in the Wound Care, Burn, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic and Dental sectors of healthcare.
Safe Harbor Statement
This press release includes statements that look forward in time or that express management's beliefs, expectations or hopes. Such statements are forward‐looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to the Company's belief that 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, and that the publication of the Monograph has clearly established another standard by which the Company's dHACM allografts are unmatched in the industry. Among the risks and uncertainties that could cause actual results to differ materially from those indicated by such forward‐looking statements include that market acceptance for the Company's products are always subject to change; the effects of competition; external factors may affect usage of products regardless of their safety and efficacy; and the risk factors detailed from time to time in the Company's periodic Securities and Exchange Commission filings, including, without limitation, its 10‐K filing for the fiscal year ended December 31, 2015 and its most recent 10Q filing. By making these forward‐looking statements, the Company does not undertake to update them in any manner except as may be required by the Company's disclosure obligations in filings it makes with the Securities and Exchange Commission under the federal securities laws.