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    Breaking News

    Stimwave Awarded U.S. Government DAPA Contract

    First agreement for spinal cord stimulators by U.S. government agency.

    Stimwave Awarded U.S. Government DAPA Contract
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    Business Wire04.24.17
    Stimwave LLC, a medical device manufacturer and independent research institute headquartered in South Florida, announced it has been awarded a Distribution and Pricing Agreement (DAPA) by the Defense Logistics Agency. Stimwave, which distributes the Stimwave Freedom Spinal Cord Stimulation (SCS) System and StimQ Peripheral Nerve Stimulator (PNS) System, received a five-year contract, negotiated by TAMM Net Inc., which is the first global agreement for spinal cord stimulators by a U.S. government agency.
     
    “We are extremely pleased Stimwave received a DAPA. The successful product validation process now allows Stimwave products to be accessed and used by doctors at all military treatment facilities across the globe,” said Laura Perryman, CEO and president of Stimwave. “Multiple facilities have been pleased to hear they can now acquire our products through their purchasing vehicles.”
     
    Stimwave’s devices use Wireless Pain Relief technology and are 95 percent smaller than any other neuromodulation device on the market. Stimwave’s wireless device delivers small pulses of energy to specific nerves, triggering a reaction that enables the brain to remap pain pathways, thus providing pain relief. The device is fixed in place by an anchor, so it stays “in line” with the body’s nerves, allowing a freedom of motion that is impossible with bulkier implanted devices.
     
    Stimwave launched its FDA-cleared devices for the relief of chronic back and leg pain to a limited number of patients throughout 2015. In March 2016, Stimwave was granted FDA 510(k) for the relief of peripheral nervous system (PNS) pain, becoming the only neuromodulation device manufacturer cleared by the FDA to help reduce chronic neuropathic pain at most locations throughout the body, from back and leg pain addressed by spinal cord stimulation to PNS treatment for shoulder pain, wrist and elbow pain, knee pain, hip pain and more.
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      Receipt of closeout letter signals the completion of a 24-month initiative to expand and enhance quality management systems.
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    • Extremities
      FDA OKs Shoulder Innovations

      FDA OKs Shoulder Innovations' Augmented Glenoids for Total Shoulder System

      The new InSet Plus glenoids feature an angled articular surface.
      PR Newswire 12.10.19

    • Trauma/Sports
      OrthoGrid Systems Receives FDA 510(k) Clearance for New PhantomMSK Trauma Application

      OrthoGrid Systems Receives FDA 510(k) Clearance for New PhantomMSK Trauma Application

      Trauma application added to universal PhantomMSK platform; one platform with use across a variety of procedures.
      OrthoGrid 12.10.19


    • Tyber Medical Opens $8M Office and Manufacturing Facility

      Tyber Medical Opens $8M Office and Manufacturing Facility

      Creates about 30 additional jobs for Lehigh Valley's second-fastest growing company.
      PR Newswire 12.10.19

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      PR Newswire 12.10.19

    • Spine/Neurology
      Clinical Study of Cell Therapy for Disc Degeneration Clears Final Planned Safety Review

      Clinical Study of Cell Therapy for Disc Degeneration Clears Final Planned Safety Review

      Patient enrollment in this U.S. study will now continue through completion of 60 total subjects.
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    • Spine/Neurology
      InVivo Therapeutics Attains 25 Percent Enrollment in Spinal Cord Injury Study

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      Business Wire 12.09.19

    • BioPrax Biofilm Disruption Device Granted FDA Breakthrough Device Designation

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    • Spine/Neurology
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      Kevin Kenny was previously VP of U.S. sales for Spine and Biologics at Medtronic.
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    • 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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      Synaptive Medical's Modus V Expands Into Spine Market

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    • 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.
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      Micro Spine Implant Could Restore Standing and Walking

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      RTI Surgical Appoints New Division Leaders

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    Breaking News
    • TriMed Closes Out FDA Warning Letter
    • FDA OKs Shoulder Innovations' Augmented Glenoids for Total Shoulder System
    • OrthoGrid Systems Receives FDA 510(k) Clearance for New PhantomMSK Trauma Application
    • Tyber Medical Opens $8M Office and Manufacturing Facility
    • FDA OKs Shoulder Surgery 3D Planner & Positioner
    View Breaking News >
    CURRENT ISSUE

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    • Anxious Undertones: A Review of 2019
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