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New Clinical Evidence And A Landmark VLU Study To Be Presented At SAWC Fall Meeting


MiMedx Regenerative Wound Care Products Highlighted in Presentations and Eight Poster Abstracts

MARIETTA, Ga., Oct. 18, 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 eight poster abstracts showing the clinical and cost effective healing results of the Company's EpiFix® and AmnioFix® dehydrated Human Amnion/Chorion Membrane (dHACM) allografts, AmnioFill® placental collagen matrix product, and EpiCord® dehydrated human umbilical cord allograft will be presented at the 2017 Symposium on Advanced Wound Care Fall (SAWC Fall) at Caesars Palace in Las Vegas, Nevada. The SAWC, now in its 30th year, is the official meeting for members of The Association for the Advancement of Wound Care and the leading national wound healing conference.

The conference begins Friday, October 20, 2017, and concludes on Sunday, October 22, 2017. MiMedx will be exhibiting in booth #415 during all booth times throughout the three-day meeting.

The eight poster abstracts will report on the clinical and cost effectiveness of MiMedx EpiFix, AmnioFix AmnioFill and EpiCord in the healing of diabetic foot ulcers (DFUs), venous leg ulcers (VLUs), chronic diabetic lower extremity ulcerated wounds, stage IV pressure ulcers, complex wounds, non-healing wounds, post-surgical amputation wounds, and burns.

Parker H. "Pete" Petit, CEO, said, "We are grateful to the Association for the Advancement of Wound Care, the conference organizers and the physician members for conducting this very enlightening and beneficial symposium for the wound care community. We are pleased to have the opportunity to present and discuss our regenerative products, and we look forward to another outstanding SAWC symposium."

An overview of the landmark VLU study of MiMedx EpiFix, entitled, "A Multicenter Randomized Controlled Trial Evaluating the Efficacy of Dehydrated Human Amnion/Chorion Membrane (EpiFix) Allograft for the Treatment of Venous Leg Ulcers," will be presented by Christian Bianchi, MD, FACS, the principle investigator for the study. Dr. Bianchi will discuss the impressive study highlights indicating that: 1) Patients treated with EpiFix showed VLU complete healing rates of 60% within 12 weeks and 71% within 16 weeks; and 2) EpiFix showed clinical superiority over Standard of Care (SOC) in the treatment of non-healing, full thickness VLUs. Wounds treated with EpiFix were 2.26 times more likely to heal within 12 weeks than wounds treated with SOC alone. This landmark study is important when considering the existing historical published study evidence. In a separate study, Apligraf®, the other biologically active product with the next largest market share behind the EpiFix allograft, took twice as long to heal 45% of wounds at 24 weeks. In the EpiFix study, EpiFix showed the highest percentage of patients healed in 12 weeks at 60%. Additionally, in the Apligraf study, significantly smaller wounds were treated, and the study excluded patients with difficult medical conditions that were included in the EpiFix study.

Dr. Bianchi will also be one of the presenters during the Research Highlights: Hottest Topics of the Year session on Saturday, October 21st at 10:30am. MiMedx will sponsor a Breakfast Symposium entitled, "New Evidence – Further Support for the Use of PURION Processed Placental Tissue Products in the Treatment of Complex, Acute and Chronic Wounds," on Friday, October 20th from 7:30am to 9:00am. The list of faculty and their respective topics presented during the breakfast symposium include: 

  • Will Li, MD - ChairOverview of regenerative medicine, biopharmaceutical landscape and the impact of placental-based allografts in wound and surgical applications
  • Michelle Massee, Manager of Biomedical Research at MiMedx Overview of MiMedx processing and scientific data
  • Christian Bianchi, MDDetail and review the results of the recently published landmark, multicenter RCT for EpiFix in the treatment of VLUs
  • Matthew Garoufalis, DPMReview MiMedx published clinical data and present case examples on MiMedx placental-based products in wound and surgical applications

MiMedx will sponsor two educational presentations. The first event will be held on Friday, October 20th, at 7:30 pm with Naz Wahab, MD, FAAFP, FAPWCA, presenting "The Wisdom of Wounds." The second event will be held on Saturday, October 21st, at 7:00 pm, with Mazin Foteh, MD, presenting "Wound and Surgical Applications of Placental-Based Allograft Products." In-booth hands-on demonstrations will be provided by expert physicians David Kyle, DPM, and Brandon Hawkins, DPM, in the MiMedx booth #415 on October 20th from 5:00pm to 5:30pm and on October 21st from 12:30pm to 2:30pm.

The eight abstracts chronicling independent case studies and respective conclusions relative to MiMedx allografts include:

  1. Abstract: "Dehydrated Human Umbilical Cord Allograft for the Treatment of a Post-Surgical Amputation Wound of the Right Forefoot"
    Author: Brandon Hawkins, DPM
  2. Abstract: "The Use of Human Placental Connective Tissue Allograft for the Treatment of a Post-Surgical Amputation Wound" 
    Author: Brandon Hawkins, DPM
  3. Abstract: "Paraplegic Man with Non-Healing Stage IV Sacral Pressure Ulcer with Tunneling Successfully Treated with dHACM"
    Author: William Mannella, MD
  4. Abstract: "Use of Dehydrated Human Amnion/Chorion Membrane Mesh Allograft in the Treatment of a Large Thermal Burn" 
    Author: Daisy Briseno, FNP
  5. Abstract: "Use of Human Placental Connective Tissue Matrix Allograft as a Non-Surgical Option to Heal Stage IV Pressure Ulcers and Aid in Post Flap Reconstruction Healing: A Case Series"
    Author: Kevin Broder, MD
  6. Abstract: "Innovative Use of Dehydrated Human Amnion/Chorion Membrane in Conjunction with Hyperbaric Oxygen Therapy to Treat a Non-Healing Nasal Wound Subsequent to Squamous Cell Carcinoma Resection and Radiation: A Case Study" 
    Author: Jessica A. Henderson, DO
  7. Abstract: "A Retrospective Study Focusing on the Benefits of Using a Comprehensive Evidenced Based Clinical Pathway in Combination with Dehydrated Human Amnion/Chorion Membrane for the Treatment of Non-Healing Chronic Ulcers to Improve Wound Healing Outcomes"
    Author: Audrey K. Moyer-Harris, BSN RN 
  8. Abstract: "An Initial Retrospective Quality Control Analysis of Lower Extremity Ulcer Recurrence post dHACM in a High Risk Veteran Patient Population in Chicago"
    Author: Aamir Mahmood, DPM

About MiMedx 
MiMedx® is 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. "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

Important Cautionary Statement 
This press release includes forward-looking statements, including statements regarding the implications of clinical study results and the significance of case study results.  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 that other case studies and clinical studies may have different or less favorable results, and differences in case studies may not have the significance.  For more detailed information on the risks and uncertainties, 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.

Apligraf® is a registered trademark of Sandoz AG. Use of this mark in this press release does not imply any affiliation with or endorsement by the trademark holder.


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SOURCE MiMedx Group, Inc.

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