MARIETTA, Ga., Aug. 22, 2016 /PRNewswire/ -- 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 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.
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 validation
s 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.
Zika Virus Background Information and Regulatory Guidance
According to the Centers for Disease Control ("CDC"), the Zika virus is an emerging mosquito-borne Flavivirus that was initially limited to sporadic cases in Africa and Asia. In 2007, it was detected in French Polynesia, and then later detected in other Pacific islands, South America and certain Caribbean Islands. Zika is continuing to spread and the first U.S. mosquito generated cases have now been reported in Florida. The latest data reported by the CDC lists more than 55 countries and territories with active local Zika virus transmissions. There is expectation for additional dispersion of the virus. The Zika virus' potential adverse effects on pregnancy are an area of greatest concern, and knowledge of the impact of Zika and its transmission is rapidly evolving. Although most Zika virus infections are characterized by mild influenza-like illness, severe manifestations have been described, including microcephaly in babies born to infected mothers. The primary way a pregnant woman (or any other individual) gets the Zika virus is through the bite of an infected Aedes species mosquito; however, the Zika virus can be sexually transmitted to a pregnant female by a man infected with the Zika virus as well.
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.
The terminal sterilization conducted by MiMedx is a validated process in conformance with the International Organization of Standardization ("ISO") standard ISO 11137 "Sterilization of Healthcare Products." Conformance with this ISO standard requires a demanding Sterility Assurance Level ("SAL") of 10-6, which is the probability of 1 in 1,000,000 units being non-sterile. To further enhance the safety of its amniotic products, the MiMedx proprietary processing methodology employs aseptic processing techniques in addition to terminal sterilization.
Not only does terminal sterilization enhance safety and prevention of infectious disease transmission, it also is a critical component in the Company's proprietary processing technology. The Company's proprietary processing technology provides the MiMedx amniotic allografts with their unique capabilities to retain the proteins and growth factors that are critical for clinical efficacy, provide ease of use by the physician and offer the capacity to be stored at ambient temperature with a five year shelf life. The Company's terminal sterilization further contributes to the differentiation of the MiMedx amniotic allografts.
Parker H. "Pete" Petit, Chairman and CEO, stated, "Neither an effective treatment nor a vaccine is currently available for the Zika virus; therefore, the public health response focuses on preventing infection, particularly in pregnant women. The regulatory response has primarily focused on screening potentially infected placenta donors. While these responses are prudent, we believe our sector of the healthcare industry and especially processors of placental tissue products, have a responsibility to take even more stringent measures to ensure the product safety of their respective allografts. We have taken those rigorous measures and safeguards into account in our proprietary processing methodology to help ensure the safety of our amniotic allografts. We hope that this degree of uncompromising insistence on product safety is demanded and practiced by all who process placenta-based products."
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."
"At a recent CDC conference, it was reported that four patients receiving amniotic tissue products contracted infections that were most likely transmitted by a common donor. MiMedx learned through contacts at the CDC that these tissue products were not terminally sterilized. Additionally, the FDA has taken action against this small Texas based manufacturer by issuing a warning letter. If any provider of amniotic and placental tissue does not currently have adequate processes in place, it is critical that all of these providers commit to implementing the adequate level of sterilization that inactivates viruses to the degree necessary to result in a sterile product. In addition, all providers of amniotic and placental tissue must further commit to a validation process which confirms that the assured degree of inactivation is met and sustained. We undertake these meticulous and laborious measures and wish that all others would take similar safety measures. There are a number of amniotic allografts currently on the market that are attempting to replicate our technologies, but these allografts are not necessarily produced on par with our processing and sterilization techniques," stated Petit.
"Adding our strict terminal sterilization processes to our proprietary processing methodology does not affect the cytokines, growth factors, regulatory proteins, chemokines and other critical factors that optimize the performance of our allografts. These factors contained in the MiMedx allografts and their inherent benefits, along with our rigorous safety standards, are the critical advantage and differentiation of our products," said Taylor.
Each MiMedx placenta donor completes a series of questions to ensure that the donor has not engaged in behaviors that place her at an increased risk for the transmission of infectious disease, and undergoes a physical examination by a healthcare professional which includes a blood draw for serology testing. Additionally, tissue cultures taken following recovery are analyzed to detect the presence of bacterial contaminants. All test results for serology, bacteriology and infectious disease are reviewed prior to the release of the donor tissue. Only tissue from donors with acceptable test results in conformance with MiMedx standards as well as the standards of all state and federal regulatory bodies is released to be processed.
"We have thoroughly reviewed the FDA Zika Guidance and have made updates to our donor eligibility process to continue to be in compliance with all requirements, and we already include all AATB recommendations on donor eligibility for Zika transmission risks in the MiMedx Quality System. We have devoted numerous resources and energy to assuring that our placenta donors are fully screened for any risk of infectious disease. Also, our amniotic allografts are specifically processed to ensure the dual goals of maximizing patient safety and retaining the native characteristics of the placental tissues and amniotic membrane," 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 birth tissues 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. The MiMedx allograft product families include our: dHACM family with AmnioFix®, EpiFix® and EpiBurn® brands; Amniotic Fluid family with OrthoFlo brand; Umbilical family with EpiCord™ and AmnioCord™ brands; Placental Collagen family with CollaFix™ brand; Bone family with Physio® brand; and Skin family with AlloBurn™ brand. AmnioFix, EpiFix, and EpiBurn are our tissue technologies processed from human amniotic membrane; OrthoFlo is an amniotic fluid derived allograft; EpiCord™ and AmnioCord™ are derived from the umbilical cord; Physio is a unique bone grafting material comprised of 100% bone tissue with no added carrier; AlloBurn is a skin product derived from human skin designed for the treatment of burns; and CollaFix, our next brand we plan to commercialize, is our collagen fiber technology, developed with our patented cross-linking polymers, designed to mimic the natural composition, structure and mechanical properties of musculoskeletal tissues in order to augment their repair.
We process the human amniotic membrane utilizing our proprietary PURION® Process, to produce a safe and effective implant. MiMedx is the leading supplier of amniotic tissue, having supplied over 600,000 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, that the Company's proprietary processing technology provides MiMedx amniotic allografts with their unique capabilities to retain proteins and growth factors that are critical for clinical efficacy, ease of use, and ability to be stored at ambient temperature with a five year shelf life; that the Company's processing techniques for amniotic allografts, which include aseptic processing and terminal sterilization, help to maximize the safety of the products . Among the risks and uncertainties that could cause actual results to differ materially from those indicated by such forward-looking statements include that as with any human tissue product, absolute safety cannot be guaranteed, even if safety is enhanced by aseptic techniques and terminal sterilization, 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.
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SOURCE MiMedx Group, Inc.