{"success":true,"data":{"pressRelease":{"id":"102245","rtpr_id":"nGNXbQxnSS","ticker":"SN","exchange":"LSE","all_tickers":["SN"],"title":"Smith+Nephew’s TESSA™ Spatial Surgery System granted De Novo classification by the FDA sparking a generational leap in Sports Medicine for personalized planning and procedural innovation","author":"Globe Newswire","published_at":"2026-07-29T14:00:00.379Z","article_body":"Smith+Nephew (LSE:SN, NYSE:SNN), the global medical technology company, today\nannounces it has been granted De Novo classification by the U.S. Food & Drug\nAdministration (FDA) for its TESSA Spatial Surgery System. Utilizing\ncutting-edge accelerated computing and AI technology, the TESSA (Tracking\nEnabled Spatial Surgery Assistant) System brings personalized planning,\naugmented reality, advanced imaging, navigation, and real-time tracking to\nhelp transform arthroscopic procedures, leveraging technology originally\ndeveloped by Perceive3D S.A., a spin-off from the University of Coimbra that\nbecame part of Smith+Nephew through acquisition.\n\nThe TESSA System uses preoperative MR or CT scans with cloud-based\ndeep-learning neural net algorithms running on Amazon Web Services (AWS) to\ngenerate patient-specific 3D anatomical models. Powered by NVIDIA AI\ninfrastructure, the TESSA System overlays this patient-specific 3D bone model\nonto live 4K arthroscopic video, providing real-time video-based navigation to\nhelp surgeons visualize anatomy with greater accuracy during surgery.*(1)\n\nThe first indication for use for the TESSA System is femoral anterior cruciate\nligament reconstruction (ACLR) surgery of the knee, where femoral malposition\n(29%) and tibial malposition (11%) are among the most common reasons for ACLR\nfailure.(2) The TESSA System will assist a surgeon in placement and navigation\nof the femoral tunnel – helping mitigate these challenges using augmented\nreality technology.\n\n(https://www.globenewswire.com/Tracker?data=0Ayc20-0gYJQrt3W7k7zRAjXQY7ViYeHJspJu3ZWjiuiUPFDTrUGdl0rFa7vGIT2XwyuW6mY5-JhTmTv0z9Q0v4efI-WMU9R2Z-vxqrI5Gg5XZCm_i-uNrqQHVLiVvfXDUYhvc-NNkcR87Oh_ZrXb-WVqJtZW7lxu28bvfiV6V5u2gjo36b0UT8DZ3jjFbvTYQCLxgmgkoz5t2YaDj9CDQ==)\n\n“Musculoskeletal innovation is entering a new era, where enabling\ntechnologies matter just as much as implants,” said Dr. Jorge Chahla,\nOrthopedic Surgeon and Assistant Professor of Orthopedic Surgery at Rush\nUniversity Medical Center. “Starting with ACL reconstruction, spatial\nsurgery technology is designed to support surgeon planning and execution, not\nto replace clinical decision making.”\n\nWith De Novo classification, the TESSA System serves as the first device in a\nnew FDA category for intra-articular orthopedic stereotaxic navigation\ninstruments - establishing a regulatory reference point for future innovations\nand reinforcing Smith+Nephew's leadership in personalized, data-enabled,\ndigital Sports Medicine.\n\n”The TESSA Spatial Surgery System is going to change the game for Sports\nMedicine surgeons – bringing procedural innovation and patient\npersonalization to an entirely new level,” said Scott Schaffner, President\nof Global Sports Medicine at Smith+Nephew. “Over time, we anticipate the\nTESSA System will support applications across a broad spectrum of arthroscopic\nprocedures, starting with ACL reconstruction, where tunnel placement and\ntrajectory remain significant clinical challenges.”\n\n“The TESSA System is modernizing ACL surgery by solving an unmet need,”\nsaid Dr. Anil Ranawat, Chief of the Hip and Knee Division of Sports Medicine\nat Hospital for Special Surgery in New York. “It uses computer mapping to\nhelp give us accurate tunnel placement – a major problem with current ACL\nsurgery solutions.”\n\nThe TESSA Spatial Surgery System will be commercially introduced during Q3\n2026 focusing on early customer adoption and will see increased deployment in\n2027. Anyone wishing to learn more about Smith+Nephew’s category defining\nspatial surgery solutions for Sports Medicine are encouraged to visit:\nhttps://spatialsurgery.com.\n\n- ends –\n\nMedia Enquiries \nDave Snyder                +1 (978) 749-1440 \nSmith+Nephew        david.snyder@smith-nephew.com\n\n\n\n* Comparison to published data on standard ACL reconstruction techniques\n\n\n\nReferences\n1. Smith+Nephew. 2025. Internal Report. 10153865\n2. Li X, Yan L, Li D, et al. Failure modes after anterior cruciate ligament\nreconstruction: a systematic review and meta-analysis. Int Orthop.\n2023;47(3):719–734.\n\n\nAbout Smith+Nephew\nSmith+Nephew is a portfolio medical technology business focused on the repair,\nregeneration and replacement of soft and hard tissue. We exist to restore\npeople’s bodies and their self-belief by using technology to take the limits\noff living. We call this purpose ‘Life Unlimited’. Our 17,000 employees\ndeliver this mission every day, making a difference to patients’ lives\nthrough the excellence of our product portfolio, and the invention and\napplication of new technologies across our three global business units of\nOrthopaedics, Sports Medicine & ENT and Advanced Wound Management.\n\nFounded in Hull, UK, in 1856, we now operate in around 100 countries, and\ngenerated annual sales of $6.2 billion in 2025. Smith+Nephew is a constituent\nof the FTSE100 (LSE:SN, NYSE:SNN). The terms ‘Group’ and\n‘Smith+Nephew’ are used to refer to Smith & Nephew plc and its\nconsolidated subsidiaries, unless the context requires otherwise.\n\nFor more information about Smith+Nephew, please visit www.smith-nephew.com and\nfollow us on X\n(https://www.globenewswire.com/Tracker?data=rdG8zdOcOJ6agkRP1VhTONljJ0gBKzNZ91BxKtvZ_HTU21gPoh4Qx5ROFHWuR-uMzgwyWtIi13Eap9bkFbTKBVmknmarqXXL3JOflDy9-t8tgH9X4nc7wcf2GqClZ1BMCuxhjMLsatDJ9vPIZUMZNB4FDz37fth0g_gkizdNAsrDakfh-YpXMCsR9uQAbkIIPoBmVoRozXGSEwiciDvcMJQMdOYlbKiTezivag_wY7N7ew1gqZltuoLrUR5bNQwZkGvgZpH1zeNc28j_DiKD1m4XaF-msaQh7q_VCsGme4Q1Z9j0_kiIjNFwgdkJNuHmfuFxszBTjDsTI-aSHFIASqehCY35CUJ6VPdbp7NdUEPVTWEN08Uce3Xzrc6mlEgoG_wrLxsRjhb2ROhY6qMNu6MZgUqt9FuXRphUVdm0y6-6YyvCFGMPHvBoZjCGoCHHtgBCs0lqe1R9OGcGxlYoIwNAgk689f2GRUWOPlj7SdjlJxEqnsPvD2_eeF5F8iWQJAJgTR9S3FQDz-vxMAP6wl_GY7HUlt1ijybl9srUtYTvRmA252eMexhap2sZKFSHzd-bmioeYwD8I4NfzxPjIUlJi9gaA9pKHO7PY8jwXwUo3VFJ0jD91FOu4GrllHbP),\nLinkedIn\n(https://www.globenewswire.com/Tracker?data=k5Hpyk9mCzWkK47ApkS-MlaHEuQPbrsmzYrK7P9AP5ZMXp1Sf9sns7lmo7iz0K2xfblQmhtNZMN2jYpbOiL9J8UBUl1iRd7Mv9i5fBZiXyDL4dhrnrqK0MlZgoimoS00FpM2FfgihQ5eprlRCIsz8_B8VsHkQo7REXeGMchOftmzgQRXgdZ-yHqgYD41SLuOc3PIi09VTyPJJah_Dsgn1SMdgeK5gzGA73P0wqp6eSCT4l0K1mfmhPczoYYIbT3qg40Q12kOfO6mL4U13XKyUoSl7_E9QFJnpeT2xMr08iaMEDHn3qWpHSPk0pFyZ6ox2joox_6mbtC-olCpwtJILP3j4MKFZm_f0ACPC6YJDghrihOCFURhEQC_IGKnippZhJCYIRBrsI8rK53hJ0ki52GaEqDMN-5SYTO1HtpO9fcqVt4FAc44yGqSiySMrSO3ueXJw9sibVMppXkTK-udjmiJbiGZST1rfkfc2T6LjgXWpYdmSvO7lJuJLOCai4cqHKe5jsmkdh_43C-vI-x0vdPmYdZeZGWodfFKN0p7IMPwwfFOBVK4y_39LXwkcR4SdtcaqKYxt2XRhMX9Ld8W6KP2_2IFgGjUPjVMavyygH12yAITVjrbAWXJx6KCbdIe4aaOlY97m50XaWjfXRJR-K9gL8w1rO2wRbh8fmR852c=),\nInstagram\n(https://www.globenewswire.com/Tracker?data=XOBxLcbfuA91RWRBEkqIEI1nRE3F-BEAfGBxxWRXBbKI8pqpyneUT-iGSwfg2nOHVRZ0uviV1SdWUDjJlrYgiOBFq50w5kfLLktptb3OOViB0OJs3suvupVnL6XKYB-dBhFRpF5YAGbPESEHpHwcYmJ5VmKSjkWbsuefc9NjKkUgzLtffoNB-hNQbCvXzafE_e9ce8FpTwxpmjt83V0jWZcaE1LZIQIG7r4snJGV5B3wk_35xM-tDpZpj9vq6xCLmoxe7kBuT0B_9vTFilhEDM7PYOqYUlOp-sWGBq-VPaA7WeY8W2trpP8YdnTOFP0eb_W8hSrf6LBHKovNnWO7vtJSOXNFspshMR6_rwBLdfrJtM5vpScCgELzUqkxZWXkkm1i7QslYHD-QA6URhMB-D1DK8kHYY_tMdlzEaLiEXVQefzdu_vJQOpew-TwKuFxpD-jL3OVYvtIqXOwqeyKarX6gmCZdfPa_bMioKk6db2kyIeLEw0cH6dqJRjBvFwMMByA_O8KvCKaSwNOsjNiwyIzZbFFHF-3sKC8QWV1zM2_tbv9hgqBvU9Y3in_64gInMx--FEl7xkGJC_iKSWYB-ww5JInWranXAVZyuGikQLZUgDzw8AszEM8OxmOO2za3VJh6eTgcaa9qvT0PmawnA==)\nor Facebook\n(https://www.globenewswire.com/Tracker?data=UCdm-YZhV8bVEKTV66N4wxyn_U44nfY0tCNo4f-im2PkIseKSqHPo4n-duzSHw6bGOl5WuZ1IWPObBy9E152gjIv0d4G3x7j4Ojq8Aksot4EUwTlVKpXaUwf8i8KzczkRXFy9gAV2qO-dogZJ8vsd0TsTZx3F6k5A7OoSFlR0sVmaesbPfjw-9CBy_CFjpsvseAuhtPKAe68IormxsjGvAZiMpZzdNH1q_XQW3vCKkw0fYaBiYejw6FEBHCo25kU4tRmRwkR5K6gugy3KDqFsyOZfpkBlhJ0y2n2Z9PKBrOgKF110o5Ox-8Wt9ShAVofDFnYHxs2c34iyi9Zcyjw584Gwp51TTmvkyTpkjt_JagRfUWkQEKPkoaJlcEv8oj89y73zu-AN3gpJ68qwCc1m41wTyha8Eoe6v2h8DlbtbYUPohJPCj8VrxQUf9WTb3tiKYjV72Jtak16RBYhp-rehLITyQNXL_KissLvsJolK8xF8dfCsnoXhvS57zjbN_tmonSJqGncNGO0RYXMcLf1yhJheLQX1pBSo0KgbA8sBZV16xSeCkTQeZ1zjrOHYUyQF1Cf4m7vipdCkBB3WMlLwXZiqG159sDONctdTK1n_WHGOJQAg96IZSVlkZKk-Wd).\n\n\n\nForward-looking Statements\n\nThis document may contain forward-looking statements that may or may not prove\naccurate. For example, statements regarding expected revenue growth and\ntrading profit margins, market trends and our product pipeline are\nforward-looking statements. Phrases such as \"aim\", \"plan\", \"intend\",\n\"anticipate\", \"well-placed\", \"believe\", \"estimate\", \"expect\", \"target\",\n\"consider\" and similar expressions are generally intended to identify\nforward-looking statements. Forward-looking statements involve known and\nunknown risks, uncertainties and other important factors that could cause\nactual results to differ materially from what is expressed or implied by the\nstatements. For Smith+Nephew, these factors include: conflicts in Europe and\nthe Middle East, economic and financial conditions in the markets we serve,\nespecially those affecting healthcare providers, payers and customers; price\nlevels for established and innovative medical devices; developments in medical\ntechnology; regulatory approvals, reimbursement decisions or other government\nactions; product defects or recalls or other problems with quality management\nsystems or failure to comply with related regulations; litigation relating to\npatent or other claims; legal and financial compliance risks and related\ninvestigative, remedial or enforcement actions; disruption to our supply chain\nor operations or those of our suppliers; competition for qualified personnel;\nstrategic actions, including acquisitions and disposals, our success in\nperforming due diligence, valuing and integrating acquired businesses;\ndisruption that may result from transactions or other changes we make in our\nbusiness plans or organisation to adapt to market developments; relationships\nwith healthcare professionals; reliance on information technology and\ncybersecurity; disruptions due to natural disasters, weather and climate\nchange related events; changes in customer and other stakeholder\nsustainability expectations; changes in taxation regulations; effects of\nforeign exchange volatility; and numerous other matters that affect us or our\nmarkets, including those of a political, economic, business, competitive or\nreputational nature. Please refer to the documents that Smith+Nephew has filed\nwith the U.S. Securities and Exchange Commission under the U.S. Securities\nExchange Act of 1934, as amended, including Smith+Nephew's most recent annual\nreport on Form 20-F, which is available on the SEC’s website at www.\nsec.gov, for a discussion of certain of these factors. Any forward-looking\nstatement is based on information available to Smith+Nephew as of the date of\nthe statement. All written or oral forward-looking statements attributable to\nSmith+Nephew are qualified by this caution. Smith+Nephew does not undertake\nany obligation to update or revise any forward-looking statement to reflect\nany change in circumstances or in Smith+Nephew's expectations.\n\n(◊ )Trademark of Smith+Nephew. Certain marks registered in US Patent and\nTrademark Office.\n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/8512c693-36e3-49c5-9341-0e33875d614d)\n\n\n\nGlobeNewswire, Inc. 2026","article_body_html":"","raw_payload":{"data":{"id":"nGNXbQxnSS","title":"Smith+Nephew’s TESSA™ Spatial Surgery System granted De Novo classification by the FDA sparking a generational leap in Sports Medicine for personalized planning and procedural innovation","author":"Globe Newswire","ticker":"SN","created":"2026-07-29T14:00:00.379Z","tickers":["SN"],"exchange":"LSE","article_body":"Smith+Nephew (LSE:SN, NYSE:SNN), the global medical technology company, today\nannounces it has been granted De Novo classification by the U.S. Food & Drug\nAdministration (FDA) for its TESSA Spatial Surgery System. Utilizing\ncutting-edge accelerated computing and AI technology, the TESSA (Tracking\nEnabled Spatial Surgery Assistant) System brings personalized planning,\naugmented reality, advanced imaging, navigation, and real-time tracking to\nhelp transform arthroscopic procedures, leveraging technology originally\ndeveloped by Perceive3D S.A., a spin-off from the University of Coimbra that\nbecame part of Smith+Nephew through acquisition.\n\nThe TESSA System uses preoperative MR or CT scans with cloud-based\ndeep-learning neural net algorithms running on Amazon Web Services (AWS) to\ngenerate patient-specific 3D anatomical models. Powered by NVIDIA AI\ninfrastructure, the TESSA System overlays this patient-specific 3D bone model\nonto live 4K arthroscopic video, providing real-time video-based navigation to\nhelp surgeons visualize anatomy with greater accuracy during surgery.*(1)\n\nThe first indication for use for the TESSA System is femoral anterior cruciate\nligament reconstruction (ACLR) surgery of the knee, where femoral malposition\n(29%) and tibial malposition (11%) are among the most common reasons for ACLR\nfailure.(2) The TESSA System will assist a surgeon in placement and navigation\nof the femoral tunnel – helping mitigate these challenges using augmented\nreality technology.\n\n(https://www.globenewswire.com/Tracker?data=0Ayc20-0gYJQrt3W7k7zRAjXQY7ViYeHJspJu3ZWjiuiUPFDTrUGdl0rFa7vGIT2XwyuW6mY5-JhTmTv0z9Q0v4efI-WMU9R2Z-vxqrI5Gg5XZCm_i-uNrqQHVLiVvfXDUYhvc-NNkcR87Oh_ZrXb-WVqJtZW7lxu28bvfiV6V5u2gjo36b0UT8DZ3jjFbvTYQCLxgmgkoz5t2YaDj9CDQ==)\n\n“Musculoskeletal innovation is entering a new era, where enabling\ntechnologies matter just as much as implants,” said Dr. Jorge Chahla,\nOrthopedic Surgeon and Assistant Professor of Orthopedic Surgery at Rush\nUniversity Medical Center. “Starting with ACL reconstruction, spatial\nsurgery technology is designed to support surgeon planning and execution, not\nto replace clinical decision making.”\n\nWith De Novo classification, the TESSA System serves as the first device in a\nnew FDA category for intra-articular orthopedic stereotaxic navigation\ninstruments - establishing a regulatory reference point for future innovations\nand reinforcing Smith+Nephew's leadership in personalized, data-enabled,\ndigital Sports Medicine.\n\n”The TESSA Spatial Surgery System is going to change the game for Sports\nMedicine surgeons – bringing procedural innovation and patient\npersonalization to an entirely new level,” said Scott Schaffner, President\nof Global Sports Medicine at Smith+Nephew. “Over time, we anticipate the\nTESSA System will support applications across a broad spectrum of arthroscopic\nprocedures, starting with ACL reconstruction, where tunnel placement and\ntrajectory remain significant clinical challenges.”\n\n“The TESSA System is modernizing ACL surgery by solving an unmet need,”\nsaid Dr. Anil Ranawat, Chief of the Hip and Knee Division of Sports Medicine\nat Hospital for Special Surgery in New York. “It uses computer mapping to\nhelp give us accurate tunnel placement – a major problem with current ACL\nsurgery solutions.”\n\nThe TESSA Spatial Surgery System will be commercially introduced during Q3\n2026 focusing on early customer adoption and will see increased deployment in\n2027. Anyone wishing to learn more about Smith+Nephew’s category defining\nspatial surgery solutions for Sports Medicine are encouraged to visit:\nhttps://spatialsurgery.com.\n\n- ends –\n\nMedia Enquiries \nDave Snyder                +1 (978) 749-1440 \nSmith+Nephew        david.snyder@smith-nephew.com\n\n\n\n* Comparison to published data on standard ACL reconstruction techniques\n\n\n\nReferences\n1. Smith+Nephew. 2025. Internal Report. 10153865\n2. Li X, Yan L, Li D, et al. Failure modes after anterior cruciate ligament\nreconstruction: a systematic review and meta-analysis. Int Orthop.\n2023;47(3):719–734.\n\n\nAbout Smith+Nephew\nSmith+Nephew is a portfolio medical technology business focused on the repair,\nregeneration and replacement of soft and hard tissue. We exist to restore\npeople’s bodies and their self-belief by using technology to take the limits\noff living. We call this purpose ‘Life Unlimited’. Our 17,000 employees\ndeliver this mission every day, making a difference to patients’ lives\nthrough the excellence of our product portfolio, and the invention and\napplication of new technologies across our three global business units of\nOrthopaedics, Sports Medicine & ENT and Advanced Wound Management.\n\nFounded in Hull, UK, in 1856, we now operate in around 100 countries, and\ngenerated annual sales of $6.2 billion in 2025. Smith+Nephew is a constituent\nof the FTSE100 (LSE:SN, NYSE:SNN). The terms ‘Group’ and\n‘Smith+Nephew’ are used to refer to Smith & Nephew plc and its\nconsolidated subsidiaries, unless the context requires otherwise.\n\nFor more information about Smith+Nephew, please visit www.smith-nephew.com and\nfollow us on X\n(https://www.globenewswire.com/Tracker?data=rdG8zdOcOJ6agkRP1VhTONljJ0gBKzNZ91BxKtvZ_HTU21gPoh4Qx5ROFHWuR-uMzgwyWtIi13Eap9bkFbTKBVmknmarqXXL3JOflDy9-t8tgH9X4nc7wcf2GqClZ1BMCuxhjMLsatDJ9vPIZUMZNB4FDz37fth0g_gkizdNAsrDakfh-YpXMCsR9uQAbkIIPoBmVoRozXGSEwiciDvcMJQMdOYlbKiTezivag_wY7N7ew1gqZltuoLrUR5bNQwZkGvgZpH1zeNc28j_DiKD1m4XaF-msaQh7q_VCsGme4Q1Z9j0_kiIjNFwgdkJNuHmfuFxszBTjDsTI-aSHFIASqehCY35CUJ6VPdbp7NdUEPVTWEN08Uce3Xzrc6mlEgoG_wrLxsRjhb2ROhY6qMNu6MZgUqt9FuXRphUVdm0y6-6YyvCFGMPHvBoZjCGoCHHtgBCs0lqe1R9OGcGxlYoIwNAgk689f2GRUWOPlj7SdjlJxEqnsPvD2_eeF5F8iWQJAJgTR9S3FQDz-vxMAP6wl_GY7HUlt1ijybl9srUtYTvRmA252eMexhap2sZKFSHzd-bmioeYwD8I4NfzxPjIUlJi9gaA9pKHO7PY8jwXwUo3VFJ0jD91FOu4GrllHbP),\nLinkedIn\n(https://www.globenewswire.com/Tracker?data=k5Hpyk9mCzWkK47ApkS-MlaHEuQPbrsmzYrK7P9AP5ZMXp1Sf9sns7lmo7iz0K2xfblQmhtNZMN2jYpbOiL9J8UBUl1iRd7Mv9i5fBZiXyDL4dhrnrqK0MlZgoimoS00FpM2FfgihQ5eprlRCIsz8_B8VsHkQo7REXeGMchOftmzgQRXgdZ-yHqgYD41SLuOc3PIi09VTyPJJah_Dsgn1SMdgeK5gzGA73P0wqp6eSCT4l0K1mfmhPczoYYIbT3qg40Q12kOfO6mL4U13XKyUoSl7_E9QFJnpeT2xMr08iaMEDHn3qWpHSPk0pFyZ6ox2joox_6mbtC-olCpwtJILP3j4MKFZm_f0ACPC6YJDghrihOCFURhEQC_IGKnippZhJCYIRBrsI8rK53hJ0ki52GaEqDMN-5SYTO1HtpO9fcqVt4FAc44yGqSiySMrSO3ueXJw9sibVMppXkTK-udjmiJbiGZST1rfkfc2T6LjgXWpYdmSvO7lJuJLOCai4cqHKe5jsmkdh_43C-vI-x0vdPmYdZeZGWodfFKN0p7IMPwwfFOBVK4y_39LXwkcR4SdtcaqKYxt2XRhMX9Ld8W6KP2_2IFgGjUPjVMavyygH12yAITVjrbAWXJx6KCbdIe4aaOlY97m50XaWjfXRJR-K9gL8w1rO2wRbh8fmR852c=),\nInstagram\n(https://www.globenewswire.com/Tracker?data=XOBxLcbfuA91RWRBEkqIEI1nRE3F-BEAfGBxxWRXBbKI8pqpyneUT-iGSwfg2nOHVRZ0uviV1SdWUDjJlrYgiOBFq50w5kfLLktptb3OOViB0OJs3suvupVnL6XKYB-dBhFRpF5YAGbPESEHpHwcYmJ5VmKSjkWbsuefc9NjKkUgzLtffoNB-hNQbCvXzafE_e9ce8FpTwxpmjt83V0jWZcaE1LZIQIG7r4snJGV5B3wk_35xM-tDpZpj9vq6xCLmoxe7kBuT0B_9vTFilhEDM7PYOqYUlOp-sWGBq-VPaA7WeY8W2trpP8YdnTOFP0eb_W8hSrf6LBHKovNnWO7vtJSOXNFspshMR6_rwBLdfrJtM5vpScCgELzUqkxZWXkkm1i7QslYHD-QA6URhMB-D1DK8kHYY_tMdlzEaLiEXVQefzdu_vJQOpew-TwKuFxpD-jL3OVYvtIqXOwqeyKarX6gmCZdfPa_bMioKk6db2kyIeLEw0cH6dqJRjBvFwMMByA_O8KvCKaSwNOsjNiwyIzZbFFHF-3sKC8QWV1zM2_tbv9hgqBvU9Y3in_64gInMx--FEl7xkGJC_iKSWYB-ww5JInWranXAVZyuGikQLZUgDzw8AszEM8OxmOO2za3VJh6eTgcaa9qvT0PmawnA==)\nor Facebook\n(https://www.globenewswire.com/Tracker?data=UCdm-YZhV8bVEKTV66N4wxyn_U44nfY0tCNo4f-im2PkIseKSqHPo4n-duzSHw6bGOl5WuZ1IWPObBy9E152gjIv0d4G3x7j4Ojq8Aksot4EUwTlVKpXaUwf8i8KzczkRXFy9gAV2qO-dogZJ8vsd0TsTZx3F6k5A7OoSFlR0sVmaesbPfjw-9CBy_CFjpsvseAuhtPKAe68IormxsjGvAZiMpZzdNH1q_XQW3vCKkw0fYaBiYejw6FEBHCo25kU4tRmRwkR5K6gugy3KDqFsyOZfpkBlhJ0y2n2Z9PKBrOgKF110o5Ox-8Wt9ShAVofDFnYHxs2c34iyi9Zcyjw584Gwp51TTmvkyTpkjt_JagRfUWkQEKPkoaJlcEv8oj89y73zu-AN3gpJ68qwCc1m41wTyha8Eoe6v2h8DlbtbYUPohJPCj8VrxQUf9WTb3tiKYjV72Jtak16RBYhp-rehLITyQNXL_KissLvsJolK8xF8dfCsnoXhvS57zjbN_tmonSJqGncNGO0RYXMcLf1yhJheLQX1pBSo0KgbA8sBZV16xSeCkTQeZ1zjrOHYUyQF1Cf4m7vipdCkBB3WMlLwXZiqG159sDONctdTK1n_WHGOJQAg96IZSVlkZKk-Wd).\n\n\n\nForward-looking Statements\n\nThis document may contain forward-looking statements that may or may not prove\naccurate. For example, statements regarding expected revenue growth and\ntrading profit margins, market trends and our product pipeline are\nforward-looking statements. Phrases such as \"aim\", \"plan\", \"intend\",\n\"anticipate\", \"well-placed\", \"believe\", \"estimate\", \"expect\", \"target\",\n\"consider\" and similar expressions are generally intended to identify\nforward-looking statements. Forward-looking statements involve known and\nunknown risks, uncertainties and other important factors that could cause\nactual results to differ materially from what is expressed or implied by the\nstatements. For Smith+Nephew, these factors include: conflicts in Europe and\nthe Middle East, economic and financial conditions in the markets we serve,\nespecially those affecting healthcare providers, payers and customers; price\nlevels for established and innovative medical devices; developments in medical\ntechnology; regulatory approvals, reimbursement decisions or other government\nactions; product defects or recalls or other problems with quality management\nsystems or failure to comply with related regulations; litigation relating to\npatent or other claims; legal and financial compliance risks and related\ninvestigative, remedial or enforcement actions; disruption to our supply chain\nor operations or those of our suppliers; competition for qualified personnel;\nstrategic actions, including acquisitions and disposals, our success in\nperforming due diligence, valuing and integrating acquired businesses;\ndisruption that may result from transactions or other changes we make in our\nbusiness plans or organisation to adapt to market developments; relationships\nwith healthcare professionals; reliance on information technology and\ncybersecurity; disruptions due to natural disasters, weather and climate\nchange related events; changes in customer and other stakeholder\nsustainability expectations; changes in taxation regulations; effects of\nforeign exchange volatility; and numerous other matters that affect us or our\nmarkets, including those of a political, economic, business, competitive or\nreputational nature. Please refer to the documents that Smith+Nephew has filed\nwith the U.S. Securities and Exchange Commission under the U.S. Securities\nExchange Act of 1934, as amended, including Smith+Nephew's most recent annual\nreport on Form 20-F, which is available on the SEC’s website at www.\nsec.gov, for a discussion of certain of these factors. Any forward-looking\nstatement is based on information available to Smith+Nephew as of the date of\nthe statement. All written or oral forward-looking statements attributable to\nSmith+Nephew are qualified by this caution. Smith+Nephew does not undertake\nany obligation to update or revise any forward-looking statement to reflect\nany change in circumstances or in Smith+Nephew's expectations.\n\n(◊ )Trademark of Smith+Nephew. Certain marks registered in US Patent and\nTrademark Office.\n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/8512c693-36e3-49c5-9341-0e33875d614d)\n\n\n\nGlobeNewswire, Inc. 2026"},"type":"article","timestamp":"2026-07-29T14:00:00.419007406Z","server_sent_at_ms":1785333600419},"received_at":"2026-07-29T14:00:00.469Z","source_url":"https://www.globenewswire.com/news-release/2026/07/29/3335378/0/en/smith-nephew-s-tessa-spatial-surgery-system-granted-de-novo-classification-by-the-fda-sparking-a-generational-leap-in-sports-medicine-for-personalized-planning-and-procedural-innov.html"},"analysis":{"id":"91271","press_release_id":"102245","analysis_json":{"industry":{"label":"Health Care Equipment & Supplies","sector":"Health Care"},"redFlags":[],"eventType":"fda_approval","narrative":"Smith+Nephew received FDA De Novo classification for the TESSA Spatial Surgery System, establishing a new regulatory category for intra-articular orthopedic stereotaxic navigation instruments.\n\nThe system leverages AI and augmented reality to create patient-specific 3D models, initially targeting ACL reconstruction to address common malposition issues.\n\nA commercial launch is planned for Q3 2026, with the company anticipating future applications across a broader spectrum of arthroscopic procedures.","sentiment":"bullish","agentHooks":{"shouldPost":true,"suggestedAngle":"First-in-category De Novo win creates a new standard in AI-powered sports surgery."},"keyFigures":{"drugName":"TESSA Spatial Surgery System","customDimensions":{"annual_sales_2025":"$6.2 billion","tibial_malposition_rate":"11%","femoral_malposition_rate":"29%"}},"quotedText":"The TESSA Spatial Surgery System is going to change the game for Sports Medicine surgeons – bringing procedural innovation and patient personalization to an entirely new level","namedEntities":{"people":[{"name":"Dr. Jorge Chahla","role":"Orthopedic Surgeon and Assistant Professor at Rush University Medical Center"},{"name":"Scott Schaffner","role":"President of Global Sports Medicine at Smith+Nephew"},{"name":"Dr. Anil Ranawat","role":"Chief of the Hip and Knee Division of Sports Medicine at Hospital for Special Surgery"}],"products":["TESSA Spatial Surgery System"],"companies":[{"name":"Smith+Nephew","ticker":"SN"},{"name":"Perceive3D S.A.","relationship":"acquired technology origin"},{"name":"Amazon Web Services","relationship":"infrastructure partner"},{"name":"NVIDIA","relationship":"infrastructure partner"}],"dollarAmounts":[{"amount":"$6.2 billion","context":"annual sales in 2025"}]},"materialImpact":{"score":5,"reasoning":"FDA De Novo classification is a binary regulatory event authorizing the first device in a new category for intra-articular orthopedic stereotaxic navigation. This clears the path for commercial launch of a novel, AI-driven surgical platform."},"tickerRelevance":{"others":[{"ticker":"SNN","relevance":"listing"}],"primary":"SN"},"globalImportance":55,"audienceRelevance":45,"eventTypeSecondary":["product_launch"],"importanceComponents":{"tickerTier":"large-cap","eventGravity":"fda_binary_event","sectorWeight":"health_care"}},"event_type":"fda_approval","event_type_secondary":["product_launch"],"sentiment":"bullish","material_impact_score":5,"narrative":"Smith+Nephew received FDA De Novo classification for the TESSA Spatial Surgery System, establishing a new regulatory category for intra-articular orthopedic stereotaxic navigation instruments.\n\nThe system leverages AI and augmented reality to create patient-specific 3D models, initially targeting ACL reconstruction to address common malposition issues.\n\nA commercial launch is planned for Q3 2026, with the company anticipating future applications across a broader spectrum of arthroscopic procedures.","key_figures":{"drugName":"TESSA Spatial Surgery System","customDimensions":{"annual_sales_2025":"$6.2 billion","tibial_malposition_rate":"11%","femoral_malposition_rate":"29%"}},"named_entities":{"people":[{"name":"Dr. Jorge Chahla","role":"Orthopedic Surgeon and Assistant Professor at Rush University Medical Center"},{"name":"Scott Schaffner","role":"President of Global Sports Medicine at Smith+Nephew"},{"name":"Dr. Anil Ranawat","role":"Chief of the Hip and Knee Division of Sports Medicine at Hospital for Special Surgery"}],"products":["TESSA Spatial Surgery System"],"companies":[{"name":"Smith+Nephew","ticker":"SN"},{"name":"Perceive3D S.A.","relationship":"acquired technology origin"},{"name":"Amazon Web Services","relationship":"infrastructure partner"},{"name":"NVIDIA","relationship":"infrastructure partner"}],"dollarAmounts":[{"amount":"$6.2 billion","context":"annual sales in 2025"}]},"model_name":"glm-4.7","prompt_hash":"sha256:727b4b9429a443af","schema_hash":"sha256:05005c02d9cffac9","created_at":"2026-07-29T19:29:49.537Z","global_importance":55,"audience_relevance":45,"importance_components":{"tickerTier":"large-cap","eventGravity":"fda_binary_event","sectorWeight":"health_care"}},"durationMs":229850,"modelName":"glm-4.7"}}