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MiMedx Group, Inc. announced recently that in light of the media attention and in the wake of concerns related to the Zika virus, the Company is reiterating its long standing processing safety standards for the terminal sterilization of MiMedx amniotic allografts. The MiMedx flagship amniotic allografts have always been terminally sterilized, and the Company’s proprietary PURION® Process has continually used terminal sterilization as an essential part of the process. In anticipation of questions related to the Zika virus, MiMedx is reconfirming the rigorous product safety methods and practices followed by the Company in the processing of its amniotic allografts as well as restating its precise standards for screening of placenta donors.
Bill Taylor, President and COO, commented, “With the emergence and propagation of the Zika virus, we anticipated that questions would soon arise, and we decided that, in advance of any questions, we would reconfirm our established safety processes to reassure patients and physicians of the exacting terminal sterilization methodology and the standards we employ to assure the sterility of our amniotic allografts for potential microbiological and viral transmissions. With the heightened concerns related to the Zika virus, we expect that the detailed steps taken by all other tissue processors of placenta-based products will be reviewed to ensure their product safety and the processes utilized do adequately reduce the potential for microbiological and viral transmissions. MiMedx has continuously made assessments and implemented modifications to our original processes in both the donor screening and the processing functions of our business to maximize product safety. We have recently introduced our new lyophilized version of OrthoFlo which is also terminally sterilized to the same standards as our other amniotic allografts.”
It should be noted that aseptic processes, which many tissue products utilize, are usually validated to claim a less than 1 in 1,000 probability of a non-sterile unit per FDA Guidance and ISO standards. The probability of an occurrence of a non-sterile unit in products produced by MiMedx is significantly lower, however. Specifically, MiMedx’s process and terminal sterilization validations provide a less than 1 in 1 million probability of a non-sterile unit, which is at least a 1,000 times higher safety margin than typical aseptically processed tissue products.
The FDA and the American Association of Tissue Banks (“AATB”) have issued guidance on donor eligibility and screening recommendations to reduce the risk of transmission of Zika virus via human tissues. MiMedx has been processing its amniotic allografts based on those recommendations since they were published.
For Further Information
More on the soft tissue reinforcement and regeneration device market in the U.S. can be found in a report suite published by iData Research entitled U.S. Market for Soft Tissue Reinforcement and Regeneration.