New FDA 510(k) Clearance Expands Anika's Sports Medicine Soft Tissue Portfolio

  • Anika Therapeutics Inc ANIK has received FDA 510(k) clearance for the X-Twist Knotless Fixation System, a platform of suture anchors designed to be mechanically robust, easy to use, and support healing for critical repairs such as rotator cuff repair. 
  • According to SmartTRAK, nearly 670,000 rotator cuff procedures were performed in 2021, mainly in the ambulatory surgery center.
  • "The clearance of the X-Twist Knotless Fixation System is another step forward in establishing Anika as a preferred partner within the ASC," said Kevin Stone, Vice President and General Manager, Sports Medicine. 
  • The design includes venting, intended to support cellular infiltration through the anchor, a double helix thread allowing fast & easy deployment, supports the surgeon's preferred combination of multiple sliding sutures or tape configurations, and X-Spline drive technology for more torque transfer for easy anchor insertion. 
  • In addition to the shoulder, X-Twist has direct applications in various procedures, including the foot and ankle, and will initially be available in PEEK-Optima.  
  • Anika expects to begin commercializing the X-Twist Knotless Fixation System in the second half of 2022 in the U.S.
  • Price Action: ANIK shares are down 3.93% at $21.03 during the market session on the last check Friday.
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