$SSII SS Innovations Conducts Interactive Meeting with the Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) and Updates its Expected FDA Approval Timeline
https://www.globenewswire.com/en/news-release...val-T.html
FORT LAUDERDALE, Fla., Sept. 11, 2024 (GLOBE NEWSWIRE) -- SS Innovations International, Inc. (the “Company” or “SS Innovations”) (OTC: SSII), developer of innovative surgical robotic technologies dedicated to making world-class robotic surgery affordable and accessible to a global population, today issued an update on its progress and timeline in obtaining U.S. Food and Drug Administration (“FDA”) approvals to market the SSi Mantra Surgical Robotic System (“SSi Mantra”) in the United States.
Early this year, the Company completed its first interactive pre submission meeting with the FDA for the SSi Mantra. The Company received valuable feedback from the FDA regarding its planned regulatory strategy, biocompatibility assessment, reprocessing validation, and clinical data requirements and, based on this feedback, will proceed with a de novo pathway for the pre-market submission of the SSi Mantra for numerous indications in parallel.
The Company plans to have follow-on pre-submission meetings in the upcoming months and anticipates submitting the SSi Mantra for an investigational device exemption (IDE) application in the first quarter of 2025 to initiate clinical trials.
The Company is planning to simultaneously conduct clinical trials for various indications including abdominal, pelvis, thoracic and cardiac.
The Company believes that it will be able to meet the clinical trial requirements relatively quickly because (i) the SSi Mantra’s safety, efficacy, and performance has already been demonstrated in ongoing clinical use in India, where it has performed all the types of surgical procedures for which approval is being applied for; and (ii) under applicable FDA protocols, procedures performed in India can be included in the clinical trials. The Company plans to also conduct some of the clinical trials in the United States, particularly for Cardiac, where it has already identified potential testing sites.
The Company estimates that, barring any unanticipated developments, it should be able to secure its pre-market approvals by the end of 2025.
https://www.globenewswire.com/en/news-release...val-T.html
FORT LAUDERDALE, Fla., Sept. 11, 2024 (GLOBE NEWSWIRE) -- SS Innovations International, Inc. (the “Company” or “SS Innovations”) (OTC: SSII), developer of innovative surgical robotic technologies dedicated to making world-class robotic surgery affordable and accessible to a global population, today issued an update on its progress and timeline in obtaining U.S. Food and Drug Administration (“FDA”) approvals to market the SSi Mantra Surgical Robotic System (“SSi Mantra”) in the United States.
Early this year, the Company completed its first interactive pre submission meeting with the FDA for the SSi Mantra. The Company received valuable feedback from the FDA regarding its planned regulatory strategy, biocompatibility assessment, reprocessing validation, and clinical data requirements and, based on this feedback, will proceed with a de novo pathway for the pre-market submission of the SSi Mantra for numerous indications in parallel.
The Company plans to have follow-on pre-submission meetings in the upcoming months and anticipates submitting the SSi Mantra for an investigational device exemption (IDE) application in the first quarter of 2025 to initiate clinical trials.
The Company is planning to simultaneously conduct clinical trials for various indications including abdominal, pelvis, thoracic and cardiac.
The Company believes that it will be able to meet the clinical trial requirements relatively quickly because (i) the SSi Mantra’s safety, efficacy, and performance has already been demonstrated in ongoing clinical use in India, where it has performed all the types of surgical procedures for which approval is being applied for; and (ii) under applicable FDA protocols, procedures performed in India can be included in the clinical trials. The Company plans to also conduct some of the clinical trials in the United States, particularly for Cardiac, where it has already identified potential testing sites.
The Company estimates that, barring any unanticipated developments, it should be able to secure its pre-market approvals by the end of 2025.
