SpineWelding

SpineWelding AG is a Swiss medical device company headquartered in Schlieren, Switzerland, that develops implant solutions for the human spine. The company is a spin-off of WoodWelding SA and builds its product portfolio on the patent-protected BoneWelding technology platform, which uses ultrasonic energy to liquefy and extrude resorbable polymer through implant fenestrations so that the polymer solidifies in bone and creates a strong bond with surrounding tissue. SpineWelding applies this platform to load-bearing spinal implants and out-licenses related applications in cranio-maxillofacial, foot & ankle, hand & wrist and dental surgery. The company's flagship offering is the Elaris Pedicle Screw System. The Elaris I system, which uses single polymer extrusion, has received 510(k) clearance in the United States and is intended to provide immobilization and stabilization of spinal segments through posterior non-cervical pedicle fixation in skeletally mature patients as an adjunct to fusion. Indications include degenerative disc disease, trauma, tumor, spinal stenosis, spondylolisthesis, scoliosis, kyphosis, pseudarthrosis and failed previous fusion. A newer generation, Elaris II, introduces Multiple Polymer Enhancement Technology that allows extrusion of up to three polymeric pins from the screw's fenestrations, with FDA clearance pending and not for sale in the USA at the time of the source material. SpineWelding positions its technology as an alternative to bone cement for enhancing screw fixation. According to the company, surgeons can decide intraoperatively to enhance individual screws directly after placement, the process takes only a few seconds, the fixation effect is immediate, and there is no risk of uncontrolled polymer flow outside the vertebral body. Pedicle screws can also be removed as needed after polymer extrusion using an ultrasonic handpiece. The company states that its engineering team brings know-how in biocompatible materials, ultrasonic process engineering and implant design, and that it benefits from input from orthopedic key opinion leaders in the USA and Europe. SpineWelding is privately held and operates as a medical device developer and licensor rather than a broad-line orthopedic manufacturer.

SpineWelding AG is a Swiss medical device company headquartered in Schlieren, Switzerland. It is a spin-off of WoodWelding SA, a Swiss company whose BoneWelding technology platform uses ultrasonic energy to liquefy and extrude resorbable polymer through implant fenestrations; the polymer then solidifies in bone and creates a strong bond with surrounding tissue. SpineWelding was established to apply this patent-protected platform specifically to implant solutions for the human spine, while the platform's other applications — cranio-maxillofacial, foot & ankle, hand & wrist and dental surgery — are out-licensed. The company's development work has focused on the Elaris Pedicle Screw System. The Elaris I system uses single polymer extrusion and has received 510(k) clearance in the United States. Its intended use is to provide immobilization and stabilization of spinal segments through posterior non-cervical pedicle fixation in skeletally mature patients as an adjunct to fusion in the treatment of degenerative disc disease, trauma, tumor, spinal stenosis, spondylolisthesis, scoliosis, kyphosis, pseudarthrosis and failed previous fusion. The FDA clearance of the Elaris Pedicle Screw System was described by CEO Konrad Tagwerker as a significant milestone demonstrating that the technology is safe and effective. A second-generation system, Elaris II, introduces Multiple Polymer Enhancement Technology that allows the extrusion of up to three polymeric pins from the screw's fenestrations, which the company states significantly enhances pull-out and toggling resistance. At the time of the source material, FDA clearance for Elaris II was pending and the product was not for sale in the USA. The company has emphasized the clinical workflow advantages of its approach: the surgeon can decide intraoperatively to enhance single screws directly after placement, the polymer enhancement process takes only a few seconds without cumbersome preparation, the enhanced fixation effect is immediate, there is no risk of uncontrolled flow of the polymer outside the vertebral body, and the pedicle screws can be removed as needed after polymer extrusion with the help of an ultrasonic handpiece. SpineWelding states that its engineering team brings extensive know-how in biocompatible materials, ultrasonic process engineering and implant design, and that it benefits from comprehensive input from top orthopedic key opinion leaders in the USA and Europe. The company remains privately held and operates as a medical device developer and technology licensor.

• Elaris I Pedicle Screw System receives 510(k) clearance in the USA.

• Elaris II Multiple Polymer Enhancement Technology announced, allowing extrusion of up to three polymeric pins; FDA clearance pending and not for sale in the USA.

Developer of ultrasonic polymer-enhanced spinal fixation implants positioned as an alternative to bone cement, based on the BoneWelding technology platform.

• Elaris I Pedicle Screw System

  Single polymer extrusion pedicle screw system with 510(k) clearance in the USA; intended for posterior non-cervical pedicle fixation as an adjunct to fusion.

• Elaris II Pedicle Screw System

  Second-generation system with Multiple Polymer Enhancement Technology allowing extrusion of up to three polymeric pins; FDA clearance pending, not for sale in the USA.

1. 1Product - Spine Weldingspinewelding.ch
2. 2Company - Spine Weldingspinewelding.ch
3. 3SpineWelding (Switzerland) - Wikidatawikidata.org