Peer Reviewed Study Demonstrates MIMEDX Dehydrated Human Amnion Chorion Membrane (dHACM) Outperforms Standard of Care in Select Mohs Defect Reconstructions
MIMEDX PURION® Processed Placental Allografts Proved Safer Than Autologous Tissue, Reducing Infection, Scarring and Reoperation Rates
MARIETTA, Ga., Nov. 17, 2021 (GLOBE NEWSWIRE) -- MiMedx Group, Inc. (Nasdaq: MDXG) (“MIMEDX” or the “Company”), an industry leader in utilizing amniotic tissue as a platform for regenerative medicine, today announced publication of a peer-reviewed study in Facial Plastic Surgery & Aesthetic Medicine investigating the safety and utility of the Company’s PURION® processed dHACM (EPIFIX®) for use in Mohs micrographic surgeries (MMS).
The retrospective propensity score-matched case-control study demonstrated that PURION® processed dHACM placental allografts were associated with a statistically significant lower risk for infection, poor scar cosmesis, scar revision, and additional operation at the index site, when compared to traditional methods of incisional repair. The findings indicate that placental allografts may be a viable alternative to autologous tissue-based reconstruction, including flaps and full-thickness skin grafts (FTSG), particularly in an aging population undergoing numerous Mohs procedures in moderate to high-risk areas of the face, head, neck, and dorsal hand.
“The impressive results of this study show the utility and good patient outcomes when using MIMEDX’s EPIFIX® in patients where a more invasive surgical alternative is not a viable option,” said Julia Toman, MD, Assistant Professor, Division of Facial Plastics and Reconstructive Surgery, University of South Florida. “As patients live longer and have more skin cancers in cosmetically critical areas, having another tool in the toolbox to address these complex cases is a great step forward. This study adds to the growing evidence that dHACM is a great option for the management of skin cancer defects.”
Mohs micrographic surgery is considered the most effective technique for treating many basal and squamous cell carcinomas, the two most common types of non-melanoma skin cancer (NMSC). With the incidence of NMSC increasing rapidly in people over 65, Mohs has become a common procedure to remove these cutaneous malignancies. In some cases, lesions occur multiple times in a localized region and repeat surgery to remove them impacts quality and availability of nearby autologous tissue, thereby impacting the aesthetic and functional success of graft or flap procedures. To complicate matters, tumors among the elderly are often more invasive, and obtaining cancer-free margins can result in significant tissue loss, which further increases the need to consider alternative tissue sources.
“When there are limited options for surgical reconstruction due to unavoidable patient or defect location considerations, patients may experience longer recovery times, unpredictable scarring, and emotional distress,” said Oliver J. Wisco, DO, FAAD, FACMS. “Placental allografts have shown great potential as a non-surgical alternative or reconstruction adjunct to help provide functional and cosmetically satisfactory patient outcomes.”
The retrospective, case-controlled study patient population (n = 286) included 143 propensity score-matched pairs undergoing MMS for a basal or squamous cell carcinoma on the face, head, neck, or dorsal hands with same-day reconstruction using either autologous tissue or dHACM placental allograft, between January 2014 and December 2018. The size, location, and reconstructive complexity of defects repaired by both approaches were equivalent. The study compared a variety of post-surgical medical complications, such as infection, bleeding, dehiscence, additional operation and development of a non-healing wound, as well as cosmetic outcome measures, including suboptimal scarring and scar revision or treatment.
Patients who received placental allografts were 12 times less likely to have a post-surgical infection or require additional surgery, and 19 times less likely to have unacceptable scarring. A significantly greater proportion of patients in the placental allograft group (97.9%) experienced zero postoperative complications compared to patients undergoing autologous tissue-based repairs (71.3%). Placental allograft cases developed less infection than their flap and FTSG counterparts, and no instances of bleeding, dehiscence, non-healing wounds, scar revision, additional operation at the index site, or poor scar cosmesis were observed.
These findings support the potential for use of the Company’s PURION® processed dHACM placental allografts as an alternative to existing methods for reconstructive repair in Mohs procedures, particularly in older patients with moderate to high-risk defects.
MIMEDX is an industry leader in utilizing amniotic tissue as a platform for regenerative medicine, developing and distributing placental tissue allografts with patent-protected, proprietary processes for multiple sectors of healthcare. As a pioneer in placental biologics, we have both a base business, focused on addressing the needs of patients with acute and chronic non-healing wounds, and a promising late-stage pipeline targeted at decreasing pain and improving function for patients with degenerative musculoskeletal conditions. We derive our products from human placental tissues and process these tissues using our proprietary methods, including the PURION® process. We employ Current Good Tissue Practices, Current Good Manufacturing Practices, and terminal sterilization to produce our allografts. MIMEDX has supplied over two million allografts, through both direct and consignment shipments. For additional information, please visit www.mimedx.com.
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