MARIETTA, Ga., Aug. 9, 2017 /PRNewswire/ — MiMedx Group, Inc. (NASDAQ: MDXG), the leading biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts with patent-protected processes for multiple sectors of healthcare, announced today that the Company has now distributed over 1,000,000 allografts to date for application in the Wound Care, Burn, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic and Dental sectors of healthcare.
Bill Taylor, President and COO, added, “We are also extremely proud of our outstanding safety record. We have extremely stringent screening and quality standards in our recovery of donated placentas, and our patented processing methodology includes both aseptic processing as well as terminal sterilization, which enhances the safety and prevention of infectious disease transmission of our allografts. Moreover, our strict sterilization processes and proprietary processing methodology does not affect the cytokines, growth factors, regulatory proteins, chemokines and other critical factors that optimize the performance of the MiMedx allografts and enable our allografts to deliver the clinical results that Pete just referenced.”
“Our dehydrated human amnion chorion membrane (dHACM) allografts are described in an official United States Pharmacopeia and The National Formulary (USP-NF) Monograph, which sets the standards for drug substances, dosage forms, excipients, compounded preparations, dietary supplements, and medical devices. A USP-NF Monograph on a human tissue product is a very rare occurrence and a recognition that allografts claiming to be dHACM allografts are only those produced in conformance with these exceptionally high standards to avoid any potential for adulteration or misbranding. We are very proud to have that distinction,” added Petit.
“The areas of care that our allografts serve are a major burden on the American health care system in both the negative impact they have on the patient’s quality of life and functionality as well as the escalating costs of care. We are pleased that we have and will continue to play an expanding role in helping the healthcare community resolve these burdens by improving outcomes and reducing costs,” noted Chris Cashman, EVP and Chief Commercialization Officer.
In recognition of this achievement, we will be make a donation to a charity recommended by the physician that utilized our one millionth allograft,” concluded Petit.
MiMedx® is a biopharmaceutical company developing and marketing regenerative biologics utilizing human placental tissue allografts with patent-protected processes for multiple sectors of healthcare. “Innovations in Regenerative Medicine” is the framework behind our mission to give physicians products and tissues to help the body heal itself. We process the human placental tissue utilizing our proprietary PURION® Process among other processes, to produce safe and effective allografts. MiMedx proprietary processing methodology employs aseptic processing techniques in addition to terminal sterilization. MiMedx is the leading supplier of placental tissue, having supplied over 1,000,000 allografts to date for application in the Wound Care, Burn, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic and Dental sectors of healthcare. For additional information, please visit www.mimedx.com.
Important Cautionary Statement
This press release includes forward-looking statements, including statements regarding the timing, results, and publication of clinical studies; and the potential safety and efficacy, and additional approved uses and markets for our products. These statements also may be identified by words such as “believe,” “except,” “may,” “plan,” “potential,” “will” and similar expressions, and are based on our current beliefs and expectations. Forward-looking statements are subject to significant risks and uncertainties, and we caution investors against placing undue reliance on such statements. Actual results may differ materially from those set forth in the forward-looking statements. Among the risks and uncertainties that could cause actual results to differ materially from those indicated by such forward-looking statements include the risk that unexpected concerns may arise from additional data or analysis from our clinical trials; regulatory submissions may take longer or be more difficult to complete than expected; and that regulatory authorities may require additional information or further studies or may fail to approve or may delay approval or grant marketing approval that is different than anticipated. For more detailed information on the risks and uncertainties associated with new product development and commercialization activities, please review the Risk Factors section of our most recent annual report or quarterly report filed with the Securities and Exchange Commission. Any forward-looking statements speak only as of the date of this press release and we assume no obligation to update any forward-looking statement.