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    Breaking News

    Medicare Now Covers MiMedx's Wound Care Allograft in 49 States

    Company awaits one more Medicare administrative contractor's approval fro Florida coverage.

    02.10.14
    On a roll, MiMedx Group Inc. has received approval for its wound care allograft EpiFix from Medicare contractor Noridian Healthcare Solutions LLC.

    The coverage from Noridian becomes effective on March 1 and brings the total Medicare Administrative Contractors (MACs) covering EpiFix to seven of the eight. The Noridian jurisdictions include Washington, Oregon, Idaho, Alaska, North Dakota, South Dakota, Montana, Wyoming, Utah, Arizona, California, Nevada and Hawaii. The only remaining MAC needed to approve EpiFix coverage is First Coast Service Options (FCSO), whose jurisdiction is the state of Florida. Thus, EpiFix, now has coverage in 49 of the 50 states.

    “Noridian has approved EpiFix for both diabetic foot ulcers (DFUs) and venous leg ulcers (VLUs) that fail to respond to standard of care treatments. Two of the largest categories of chronic wounds are DFUs and VLUs,” said Parker H “Pete” Petit, chairman and CEO of MiMedx.

    In the United States, approximately 1 million patients per year are reported to be suffering from DFUs and nearly 900,000 patients each year are reported to suffer from VLUs.

    “The success of EpiFix in attaining coverage from the MACs and many of the commercial health plans and state Medicaid programs is based on our clinical study data presented to those health plans. Also included in this clinical data are the results from another recently completed randomized control trial that is expected to be published shortly,” said Bill Taylor, president and chief operating officer. “In this study, patients were enrolled following a two-week run-in period, after having been treated with four weeks of conventional therapy. Those patients exhibiting rapid healing (wound reduction of more than 50 percent) at the conclusion of ‘run-in period’ were excluded. EpiFix was either utilized weekly or bi-weekly on 40 patients. In both groups, EpiFix achieved wound closure in 70 percent of patients in 4 weeks. Furthermore, 92.5 percent of the overall population exhibited healing at 12 weeks with EpiFix. The mean time to closure for the weekly applications was 17 days, and 25 days for bi-weekly applications. Pooling this data with the previously published EpiFix data, on patients who did not heal with conventional therapy after four weeks of conventional therapy and a subsequent two week ‘run-in period’, EpiFix healed 52 of 64 (81%) of patients in 6 weeks, 58 of 64 (91 percent) of patients in 9 weeks, and 59 of 64 (92 percent) of patients in 12 weeks. The median time to closure of the 58 healed patients was 14 days.”

    A clinical study published July 24, 2013 in the Journal of the American Medical Association Dermatology, reported that the median size of a DFU is 1.35 square centimeters and the median size of a VLU is 2.32 square centimeters.

    “The legacy skin substitute products most widely approved by commercial health plans are only offered in fixed sheet sizes of approximately 40 square centimeters,” said Taylor. “This leads to a tremendous amount of wastage in treating both DFUs and VLUs. The MiMedx EpiFix allograft comes in sizes ranging from 1.5 square centimeters on up, allowing for size-appropriate grafts, particularly for these wound types.”

    “Coupling the robust clinical results with the cost effectiveness of EpiFix, we expect a continuing rapid rate of health plan and state Medicaid reimbursement coverage in the months ahead,” added Petit.

    Based in Marietta, Ga., MiMedx makes regenerative biomaterial products and bioimplants processed from human amniotic membrane.

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      Minorities were less likely to undergo TKR in high-volume hospitals.
      American Academy of Orthopaedic Surgeons (AAOS) 08.04.16

    • Clemson Scientists Awarded $1.57 Million Grant to Study Infections on Medical Implants

      Research is designed to find ways to detect implant infections early, when they are easier to cure.
      Jim Melvin, Clemson University College of Science 08.01.16

    • Studies Show Amniotic Membrane Tissue Improve Foot, Ankle Outcomes

      Trial patients reported significant reductions in foot pain.
      Businesswire 07.25.16


    • Biologics
      Stem Cells Engineered to Grow Cartilage, Fight Inflammation

      Stem Cells Engineered to Grow Cartilage, Fight Inflammation

      Technique uses 3D weaving to grow a living hip replacement.
      Washington University in St. Louis 07.18.16

    • Spine/Neurology

      Two Additional Patients Implanted With InVivo's INSPIRE Scaffold in Expanded Clinical Trial

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      Business Wire 07.07.16


    • Spine/Neurology
      Implant to Restore Bladder Function in Spinal Cord Injury Patients Receives $1 Million Prize

      Implant to Restore Bladder Function in Spinal Cord Injury Patients Receives $1 Million Prize

      The vision is for these neural devices to be as ubiquitous as pacemakers or deep brain stimulators.
      University of Washington 06.23.16

    • Spine/Neurology
      Bioactive Film Helps Implants Form Stronger Bond with Bone

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      In their new study, researchers tested three types of PEEK implants in a rabbit model.
      North Carolina State University 06.16.16

    • Extremities
      510(k) Clearance of 3D-Printed Digital Fusion Implant

      510(k) Clearance of 3D-Printed Digital Fusion Implant

      Additive Orthopaedics leverages the patient, technological, and cost benefits of additive manufacturing.
      PR Newswire 06.02.16


    • VTI Launches InterGraft Biologics

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      Product features osteoinductive and wound care scaffolds to aid in implantation.
      PR Web 05.23.16

    • Tissue Regenix Group Opens New Manufacturing Center in England

      Tissue Regenix Group Opens New Manufacturing Center in England

      Facility will produce decellurised porcine tissue for treatment of sports injuries.
      Business Wire 05.17.16

    • Using Oxygen to Sterilize Medical Implants Could Save Time and Money

      Using Oxygen to Sterilize Medical Implants Could Save Time and Money

      Researchers have demonstrated a cheap, effective, and environmentally friendly way to sterilize medical implants.
      University of Bath 05.02.16

    • TranS1 Names Brandon Arthurs, Vice President of Research & Development

      Nationally respected engineer returns to TranS1 to lead innovation and product development.
      Business Wire 04.07.16

    • Misonix Launches New Vacuum Assisted Ultrasonic Wound Debridement Technology

      Addition of vacuum assistance increases SonicOne O.R.'s ability to remove wound debris.
      PR Newswire 04.07.16

    • Fidia Introduces Hymovis at AAOS Annual Meeting

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      Fidia Farmaceutici S.p.A. 03.08.16


    Breaking News
    • Orthofix Appoints New Spine Business Leader
    • Viant to Halt EtO Sterilization at Michigan Plant by End of Year
    • Synaptive Medical's Modus V Expands Into Spine Market
    • 3D-Printed Graftless Bone Transplants Go to Clinical Trials
    • CrossRoads Extremity Systems Acquires Implant Systems from Surgical Frontiers
    View Breaking News >
    CURRENT ISSUE

    November/December 2019

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    • Anxious Undertones: A Review of 2019
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