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    Breaking News

    Bioventus Enters into New Agreement for DUROLANE

    The company plans to file PMA application and bring the product to the U.S.

    Bioventus Enters into New Agreement for DUROLANE
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    Bioventus12.14.16
    Bioventus, a developer of orthobiologic solutions, today announced it has a new agreement with Galderma for DUROLANE, a single-injection, hyaluronic acid (HA) product used for joint lubrication in the treatment of pain associated with knee osteoarthritis. Financial terms of the transaction were not disclosed.

    Bioventus plans to file a premarket approval application with the FDA in early 2017 to bring DUROLANE to the U.S. market in the near future. It owns the international rights to the product and has commercialized it outside of the United States for nearly 15 years. Bioventus currently markets and sells it in more than 25 countries including Canada, Mexico, Australia and much of Europe. Galderma manufactures DUROLANE and other HA products.

    “Bringing DUROLANE to the US is the next step in our strategy to offer osteoarthritis patients more choices for pain relief,” said Tony Bihl, CEO of Bioventus. “As a single-injection HA, it has improved the lives of more than one million people worldwide and we are pleased to work with Galderma to complete the process of introducing this solution to US patients.”

    The addition of DUROLANE to the US portfolio for Bioventus will complement its newly launched three-injection HA GELSYN-3 and its popular five-injection HA SUPARTZ FX, giving the company an unmatched offering of options for patients, physicians and payers.
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    Related Breaking News

    • Spine/Neurology
      InVivo Therapeutics Attains 25 Percent Enrollment in Spinal Cord Injury Study

      InVivo Therapeutics Attains 25 Percent Enrollment in Spinal Cord Injury Study

      Fourteen sites currently are open for patient enrollment.
      Business Wire 12.09.19

    • BioPrax Biofilm Disruption Device Granted FDA Breakthrough Device Designation

      BioPrax Biofilm Disruption Device Granted FDA Breakthrough Device Designation

      Product is designed to help eliminate biofilm infections on prosthetic knee implants during early intervention procedures.
      PR Newswire 12.09.19

    • Spine/Neurology
      Orthofix Appoints New Spine Business Leader

      Orthofix Appoints New Spine Business Leader

      Kevin Kenny was previously VP of U.S. sales for Spine and Biologics at Medtronic.
      Business Wire 12.05.19


    • Packaging & Sterilization
      Viant to Halt EtO Sterilization at Michigan Plant by End of Year

      Viant to Halt EtO Sterilization at Michigan Plant by End of Year

      EGLE had been investigating over the past year and issued Viant several violations for inadequate capture and control of ethylene oxide emissions.
      Michigan Department of Environment, Great Lakes, and Energy (EGLE) 12.04.19

    • Spine/Neurology
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      Business Wire 12.04.19

    • 3-D Printing/Additive Mfg. | Biologics | Materials
      3D-Printed Graftless Bone Transplants Go to Clinical Trials

      3D-Printed Graftless Bone Transplants Go to Clinical Trials

      ADAM is piloting the use of ceramics and polymer in 3D-printed bone implants, able to be produced at commodity prices.
      PR Newswire 12.04.19


    • Extremities
      CrossRoads Extremity Systems Acquires Implant Systems from Surgical Frontiers

      CrossRoads Extremity Systems Acquires Implant Systems from Surgical Frontiers

      The add-on acquisition furthers CrossRoads' strategy to build a market-leading company in the high-growth orthopedic extremities sector.
      PR Newswire 12.04.19

    • Spine/Neurology
      Micro Spine Implant Could Restore Standing and Walking

      Micro Spine Implant Could Restore Standing and Walking

      Hair-like electrical wires send electrical signals to trigger networks that already know how to do the hard work.
      University of Alberta Faculty of Medicine & Dentistry 12.03.19

    • Spine/Neurology
      RTI Surgical Appoints New Division Leaders

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      Terry Rich, experienced spine leader, named president, Global Spine; Olivier Visa elevated to president, Global OEM.
      GlobeNewswire 12.03.19


    • KCI Introduces Solution for Challenging Surgical Locations

      KCI Introduces Solution for Challenging Surgical Locations

      Company's latest technology targets post-operative incisions and surrounding soft tissue.
      Business Wire 12.03.19

    • EOS Imaging Receives FDA 510(k) Clearance for Next-Gen Imaging System

      EOS Imaging Receives FDA 510(k) Clearance for Next-Gen Imaging System

      EOSedge will be unveiled at the RSNA Annual Meeting.
      Business Wire 12.02.19

    • Large Joint
      mediCAD is Now Officially a Medical Device in Japan

      mediCAD is Now Officially a Medical Device in Japan

      The product is an orthopedic planning solution for hip, knee, shoulder, hand, leg, or spine surgery.
      mediCAD Hectec GmbH 12.02.19

    • Imaging
      New Generation Imaging System Launched in Europe and Canada

      New Generation Imaging System Launched in Europe and Canada

      EOS Imaging will unveil its EOSedge at the upcoming Radiological Society of North America (RSNA) 2019 Annual Meeting.
      Business Wire 11.26.19

    • Software & Quality
      Survey Identifies Challenges to Improving Product Development Processes

      Survey Identifies Challenges to Improving Product Development Processes

      81% of medical device companies are not using tools designed for the medical device industry in their quality management processes.
      PRWeb 11.26.19

    • Extremities
      Arthrosurface Introduces the SpiralUp TCL Allograft System

      Arthrosurface Introduces the SpiralUp TCL Allograft System

      Joint-preserving allograft addresses ankle instability and benefits the entire musculoskeletal system.
      Arthrosurface Inc. 11.26.19


    Breaking News
    • InVivo Therapeutics Attains 25 Percent Enrollment in Spinal Cord Injury Study
    • BioPrax Biofilm Disruption Device Granted FDA Breakthrough Device Designation
    • 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
    View Breaking News >
    CURRENT ISSUE

    November/December 2019

    • From Nitinol to Nanotubes: A Materials Science Roundtable
    • In Good Repair: Trauma Technologies Under Review
    • Anxious Undertones: A Review of 2019
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