{"success":true,"data":{"pressRelease":{"id":"167560","rtpr_id":"nGNX8YHGx1-20261013","ticker":"SSII","exchange":"NASDAQ","all_tickers":["SSII"],"title":"SS Innovations Submits Response to FDA Request for Additional Information Regarding the Company’s 510(k) Submission for the SSi Mantra","author":"Globe Newswire","published_at":"2026-10-13T12:30:00.496Z","article_body":"FORT LAUDERDALE, Fla., Oct. 13, 2026 (GLOBE NEWSWIRE) -- via IBN -- SS\nInnovations International, Inc.\n(https://www.globenewswire.com/Tracker?data=Hhkoiszmd5UmbwbxwRXwuSXHRY0TJwEdoZrMd2kDbUGVx_NBZNKY-VsWdY2xG2gOB8kw6wzFBwzyy493q7AWWWtDACvqILncZHHFUUHl9fZfOtYp-0uvaYJ4kPfByOOR)\n(the “Company” or “SS Innovations”) (NASDAQ: SSII), a developer of\ninnovative surgical robotic technologies dedicated to making robotic surgery\naffordable and accessible to a global population, today announced that, on\nOctober 5, 2026, the Company submitted its response to a request for\nadditional information letter (the “AINN”) received from the United States\nFood and Drug Administration (the “FDA”) with regard to the Company’s\n510(k) submission for its SSi Mantra surgical robotic system (the “SSi\nMantra”). \n\nThe Company’s response to the AINN includes final data from an expanded\nhuman clinical and human factors validation study (the “Study”) for the\nSSi Mantra.  The completion of the Study was designed to provide essential\nevidence that the SSi Mantra meets the FDA’s requirements for safety,\nefficacy and feasibility, and is an important part of the Company’s 510(k)\npremarket notification.\n\nThe Company’s response to the AINN also includes final data from a bridging\nstudy (the “Bridging Study”), which the Company completed in August 2026\nat Hospital Internacional de Colombia, a member of the Mayo Clinic Care\nNetwork located in Bucaramanga, Colombia.\n\nThe Company anticipates that the FDA will complete its review of the\nCompany’s AINN response and the Company’s 510(k) submission for the SSi\nMantra in the first quarter of 2027.     \n\nThe Company engaged Daniel & Daniel Consulting, LLC to assist with the AINN\nresponse, the Study, the Bridging Study, and the 510(k) submission, which\ncovers the initial indication of cholecystectomy (gallbladder removal).\n\nDr. Sudhir Srivastava, Chairman of the Board and Chief Executive Officer of SS\nInnovations, commented, “In response to the FDA’s request for additional\ninformation, we completed an expanded human clinical and human factors\nvalidation study for our SSi Mantra surgical robotic system.   Our response\nto the FDA’s AINN brings us closer to our goal of introducing our advanced,\ncost-efficient SSi Mantra surgical robotic system to the U.S. market.”\n\nAbout SS Innovations \nSS Innovations International, Inc. (Nasdaq: SSII) develops innovative surgical\nrobotic technologies with a vision to make the benefits of robotic surgery\naffordable and accessible to a larger segment of the global population. The\nCompany’s product range includes its proprietary “SSi Mantra” surgical\nrobotic system and its comprehensive suite of “SSi Mudra” surgical\ninstruments, which support a variety of surgical robotic procedures including\ncardiac surgery.  Headquartered in India, SS Innovations is a U.S. company\nfocused on expanding the global presence of its technologically advanced,\nuser-friendly, and cost-effective surgical robotic solutions.  Visit the\nCompany’s website at ssinnovations.com\n(https://www.globenewswire.com/Tracker?data=zd1FR9fXJ7ez354UkznjiD8d-yzRFf8iJ-cQCYdVBFlqYudBEeU3aHxrnjMNVMFA_JDigidnJYs_6-0dlz10c1Jqf88BkDg6dZWpiiTm2ws=)\nor LinkedIn\n(https://www.globenewswire.com/Tracker?data=Hv7FVq0xi_MCIjCFx2b_7QOJXAZDtPAqdaJC1xwf3XGvtMza9w4EHh4J2phGm8yd-l2FRETapYK6Qk7DlA_DcIrHx1R3ieD3GrZ2VdUzMnpmlpWxBHiAiWcvcnI1zGAY)\nfor more information and updates.\n\nAbout the SSi Mantra\nThe SSi Mantra surgical robotic system is a modular, multi-arm system with\nadvanced technology features, including: 3 to 5 modular robotic arms, an\nopen-faced ergonomic surgeon command center, a large 3D 4K monitor, a touch\npanel monitor for all patient related information display, a virtual real-time\nimage of the robotic patient side arm carts, and the ability for\nsuperimposition of 3D models of diagnostic imaging. The optional SSi\nMantrAsana tele-surgeon console is a portable, compact alternative to the SSi\nMantra’s standard surgeon command center that is intended to provide\nequivalent control functionality while enabling enhanced portability,\nergonomic flexibility, and telesurgery capability. The SSi Mantra utilizes\nover 40 different types of robotic endo-surgical instruments to support\ndifferent specialties, including cardiac surgery, and 5mm instruments for the\npediatric population and ENT surgeries. A vision cart is designed to provide\nthe table-side team with the same magnified 3D 4K view as the surgeon to\nprovide better safety and efficiency. The SSi Mantra has been clinically\nvalidated in India in more than 190 different types of surgical procedures.\n\nForward Looking Statements\nThis press release may contain statements that are not historical facts and\nare considered forward-looking within the meaning of the Private Securities\nLitigation Reform Act of 1995. The words “anticipate,” “assume,”\n“believe,” “estimate,” “expect,” “will,” “intend,”\n“may,” “plan,” “project,” “should,” “could,” “seek,”\n“designed,” “potential,” “forecast,” “target,”\n“objective,” “goal,” or the negatives of such terms or other similar\nexpressions to identify such forward-looking statements. These statements\nrelate to future events or SS Innovations’ future financial performance and\ninvolve known and unknown risks, uncertainties and other factors that may\ncause our actual results, levels of activity, performance, or achievements to\nbe materially different from any future results, levels of activity,\nperformance or achievements expressed or implied by these forward-looking\nstatements.\n\nInvestor Contact:\nThe Equity Group        \nKalle Ahl, CFA              \nT: (303) 953-9878        \nkalle.ahl@theequitygroup.com\n\nDevin Sullivan, Managing Director \nT: (212) 836-9608\ndevin.sullivan@theequitygroup.com\n\nMedia Contact:\nRooneyPartners LLC\nKate Barrette\nT: (212) 223-0561\nkbarrette@rooneypartners.com\n\nCorporate Communications:\n\nIBN\nAustin, Texas\nIBN.Ai\n(https://www.globenewswire.com/Tracker?data=WwyjIe75DIDNvNvs_R9zs14SyT-zPHqnc_dDQRoOEyYTzd-avYrqnRTm9ewQSTfd232tv1qHE262IyTU-sfq22-o7q56I2Zg_JgcCg684PLTmwIYyG-uvPYqzbrNx3kI23li9Ob9C7ihq08EtZprga0UdPqUc_85qS93fezOg_xFEAwXcr_nduIoS64tDW-eRX-mnWD6SSiXsHeNcHfupQYNPvfbiu4xfLtMsllifv8=)\n512.354.7000 Office\nEditor@IBN.Ai\n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/cb88a52f-54aa-46d4-8af4-c86d42df8a7e)\n\n\n\nGlobeNewswire, Inc. 2026","article_body_html":"","raw_payload":{"data":{"id":"nGNX8YHGx1-20261013","title":"SS Innovations Submits Response to FDA Request for Additional Information Regarding the Company’s 510(k) Submission for the SSi Mantra","author":"Globe Newswire","ticker":"SSII","created":"2026-10-13T12:30:00.496Z","tickers":["SSII"],"exchange":"NASDAQ","article_body":"FORT LAUDERDALE, Fla., Oct. 13, 2026 (GLOBE NEWSWIRE) -- via IBN -- SS\nInnovations International, Inc.\n(https://www.globenewswire.com/Tracker?data=Hhkoiszmd5UmbwbxwRXwuSXHRY0TJwEdoZrMd2kDbUGVx_NBZNKY-VsWdY2xG2gOB8kw6wzFBwzyy493q7AWWWtDACvqILncZHHFUUHl9fZfOtYp-0uvaYJ4kPfByOOR)\n(the “Company” or “SS Innovations”) (NASDAQ: SSII), a developer of\ninnovative surgical robotic technologies dedicated to making robotic surgery\naffordable and accessible to a global population, today announced that, on\nOctober 5, 2026, the Company submitted its response to a request for\nadditional information letter (the “AINN”) received from the United States\nFood and Drug Administration (the “FDA”) with regard to the Company’s\n510(k) submission for its SSi Mantra surgical robotic system (the “SSi\nMantra”). \n\nThe Company’s response to the AINN includes final data from an expanded\nhuman clinical and human factors validation study (the “Study”) for the\nSSi Mantra.  The completion of the Study was designed to provide essential\nevidence that the SSi Mantra meets the FDA’s requirements for safety,\nefficacy and feasibility, and is an important part of the Company’s 510(k)\npremarket notification.\n\nThe Company’s response to the AINN also includes final data from a bridging\nstudy (the “Bridging Study”), which the Company completed in August 2026\nat Hospital Internacional de Colombia, a member of the Mayo Clinic Care\nNetwork located in Bucaramanga, Colombia.\n\nThe Company anticipates that the FDA will complete its review of the\nCompany’s AINN response and the Company’s 510(k) submission for the SSi\nMantra in the first quarter of 2027.     \n\nThe Company engaged Daniel & Daniel Consulting, LLC to assist with the AINN\nresponse, the Study, the Bridging Study, and the 510(k) submission, which\ncovers the initial indication of cholecystectomy (gallbladder removal).\n\nDr. Sudhir Srivastava, Chairman of the Board and Chief Executive Officer of SS\nInnovations, commented, “In response to the FDA’s request for additional\ninformation, we completed an expanded human clinical and human factors\nvalidation study for our SSi Mantra surgical robotic system.   Our response\nto the FDA’s AINN brings us closer to our goal of introducing our advanced,\ncost-efficient SSi Mantra surgical robotic system to the U.S. market.”\n\nAbout SS Innovations \nSS Innovations International, Inc. (Nasdaq: SSII) develops innovative surgical\nrobotic technologies with a vision to make the benefits of robotic surgery\naffordable and accessible to a larger segment of the global population. The\nCompany’s product range includes its proprietary “SSi Mantra” surgical\nrobotic system and its comprehensive suite of “SSi Mudra” surgical\ninstruments, which support a variety of surgical robotic procedures including\ncardiac surgery.  Headquartered in India, SS Innovations is a U.S. company\nfocused on expanding the global presence of its technologically advanced,\nuser-friendly, and cost-effective surgical robotic solutions.  Visit the\nCompany’s website at ssinnovations.com\n(https://www.globenewswire.com/Tracker?data=zd1FR9fXJ7ez354UkznjiD8d-yzRFf8iJ-cQCYdVBFlqYudBEeU3aHxrnjMNVMFA_JDigidnJYs_6-0dlz10c1Jqf88BkDg6dZWpiiTm2ws=)\nor LinkedIn\n(https://www.globenewswire.com/Tracker?data=Hv7FVq0xi_MCIjCFx2b_7QOJXAZDtPAqdaJC1xwf3XGvtMza9w4EHh4J2phGm8yd-l2FRETapYK6Qk7DlA_DcIrHx1R3ieD3GrZ2VdUzMnpmlpWxBHiAiWcvcnI1zGAY)\nfor more information and updates.\n\nAbout the SSi Mantra\nThe SSi Mantra surgical robotic system is a modular, multi-arm system with\nadvanced technology features, including: 3 to 5 modular robotic arms, an\nopen-faced ergonomic surgeon command center, a large 3D 4K monitor, a touch\npanel monitor for all patient related information display, a virtual real-time\nimage of the robotic patient side arm carts, and the ability for\nsuperimposition of 3D models of diagnostic imaging. The optional SSi\nMantrAsana tele-surgeon console is a portable, compact alternative to the SSi\nMantra’s standard surgeon command center that is intended to provide\nequivalent control functionality while enabling enhanced portability,\nergonomic flexibility, and telesurgery capability. The SSi Mantra utilizes\nover 40 different types of robotic endo-surgical instruments to support\ndifferent specialties, including cardiac surgery, and 5mm instruments for the\npediatric population and ENT surgeries. A vision cart is designed to provide\nthe table-side team with the same magnified 3D 4K view as the surgeon to\nprovide better safety and efficiency. The SSi Mantra has been clinically\nvalidated in India in more than 190 different types of surgical procedures.\n\nForward Looking Statements\nThis press release may contain statements that are not historical facts and\nare considered forward-looking within the meaning of the Private Securities\nLitigation Reform Act of 1995. The words “anticipate,” “assume,”\n“believe,” “estimate,” “expect,” “will,” “intend,”\n“may,” “plan,” “project,” “should,” “could,” “seek,”\n“designed,” “potential,” “forecast,” “target,”\n“objective,” “goal,” or the negatives of such terms or other similar\nexpressions to identify such forward-looking statements. These statements\nrelate to future events or SS Innovations’ future financial performance and\ninvolve known and unknown risks, uncertainties and other factors that may\ncause our actual results, levels of activity, performance, or achievements to\nbe materially different from any future results, levels of activity,\nperformance or achievements expressed or implied by these forward-looking\nstatements.\n\nInvestor Contact:\nThe Equity Group        \nKalle Ahl, CFA              \nT: (303) 953-9878        \nkalle.ahl@theequitygroup.com\n\nDevin Sullivan, Managing Director \nT: (212) 836-9608\ndevin.sullivan@theequitygroup.com\n\nMedia Contact:\nRooneyPartners LLC\nKate Barrette\nT: (212) 223-0561\nkbarrette@rooneypartners.com\n\nCorporate Communications:\n\nIBN\nAustin, Texas\nIBN.Ai\n(https://www.globenewswire.com/Tracker?data=WwyjIe75DIDNvNvs_R9zs14SyT-zPHqnc_dDQRoOEyYTzd-avYrqnRTm9ewQSTfd232tv1qHE262IyTU-sfq22-o7q56I2Zg_JgcCg684PLTmwIYyG-uvPYqzbrNx3kI23li9Ob9C7ihq08EtZprga0UdPqUc_85qS93fezOg_xFEAwXcr_nduIoS64tDW-eRX-mnWD6SSiXsHeNcHfupQYNPvfbiu4xfLtMsllifv8=)\n512.354.7000 Office\nEditor@IBN.Ai\n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/cb88a52f-54aa-46d4-8af4-c86d42df8a7e)\n\n\n\nGlobeNewswire, Inc. 2026"},"type":"article","timestamp":"2026-10-13T12:30:00.55303174Z","server_sent_at_ms":1791894600553},"received_at":"2026-10-13T12:30:00.605Z","source_url":null},"analysis":null,"durationMs":null,"modelName":null}}