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
SS Innovations International, Inc. (OTC: SSII) has provided an update on its progress towards FDA approval for the SSi Mantra Surgical Robotic System. The company completed its first interactive pre-submission meeting with the FDA earlier this year and received valuable feedback. Based on this, SSII will proceed with a de novo pathway for pre-market submission for numerous indications in parallel.
SSII plans to submit an investigational device exemption (IDE) application in Q1 2025 to initiate clinical trials for various indications including abdominal, pelvis, thoracic, and cardiac procedures. The company expects to secure pre-market approvals by the end of 2025. SSII believes it can meet clinical trial requirements quickly due to the SSi Mantra's demonstrated safety and efficacy in India, where it has already performed all types of surgical procedures for which approval is being sought.
SS Innovations International, Inc. (OTC: SSII) ha fornito un aggiornamento sui progressi verso l'approvazione della FDA per il SSi Mantra Surgical Robotic System. L'azienda ha completato il suo primo incontro interattivo di pre-sottomissione con la FDA all'inizio di quest'anno, ricevendo feedback preziosi. Sulla base di ciò, SSII procederà con un percorso de novo per la sottomissione pre-mercato per numerose indicazioni in parallelo.
SSII prevede di presentare una domanda per l'esenzione da dispositivo investigativo (IDE) nel primo trimestre del 2025 per avviare prove cliniche per varie indicazioni, tra cui procedure addominali, pelviche, toraciche e cardiache. L'azienda si aspetta di ottenere approvazioni pre-mercato entro la fine del 2025. SSII crede di poter soddisfare rapidamente i requisiti per le prove cliniche grazie alla dimostrata sicurezza ed efficacia del SSi Mantra in India, dove ha già eseguito tutti i tipi di procedure chirurgiche per le quali è stata richiesta l'approvazione.
SS Innovations International, Inc. (OTC: SSII) ha proporcionado una actualización sobre su progreso hacia la aprobación de la FDA para el SSi Mantra Surgical Robotic System. La compañía completó su primera reunión interactiva de pre-sumisión con la FDA a principios de este año y recibió comentarios valiosos. Con base en esto, SSII procederá con un camino de novo para la presentación pre-mercado para numerosas indicaciones en paralelo.
SSII planea presentar una solicitud de exención de dispositivo investigacional (IDE) en el primer trimestre de 2025 para iniciar ensayos clínicos para varias indicaciones, que incluyen procedimientos abdominales, pélvicos, torácicos y cardíacos. La compañía espera obtener aprobaciones pre-mercado para la final de 2025. SSII cree que podrá cumplir rápidamente con los requisitos de ensayos clínicos gracias a la seguridad y eficacia demostradas del SSi Mantra en India, donde ya se han realizado todo tipo de procedimientos quirúrgicos para los cuales se está solicitando la aprobación.
SS Innovations International, Inc. (OTC: SSII)는 SSi Mantra Surgical Robotic System의 FDA 승인 진행 상황을 업데이트했습니다. 회사는 올해 초 FDA와의 첫 번째 인터랙티브 사전 제출 회의를 완료하고 귀중한 피드백을 받았습니다. 이를 바탕으로 SSII는 여러 적응증에 대한 사전 시장 제출을 위해 de novo 경로를 진행할 것입니다.
SSII는 2025년 1분기에 조사 장치 면제(IDE) 신청서를 제출하여 복부, 골반, 흉부 및 심장 수술을 포함한 다양한 적응증에 대한 임상 시험을 시작할 계획입니다. 회사는 2025년 말까지 사전 시장 승인을 확보할 것으로 기대하고 있습니다. SSII는 SSi Mantra가 인도에서 입증된 안전성 및 효능 덕분에 임상 시험 요건을 신속하게 충족할 수 있을 것으로 믿고 있으며, 여기서 승인이 요청된 모든 유형의 수술을 이미 수행했습니다.
SS Innovations International, Inc. (OTC: SSII) a fourni une mise à jour sur ses progrès vers l'approbation de la FDA pour le SSi Mantra Surgical Robotic System. La société a terminé sa première réunion interactive de pré-soumission avec la FDA plus tôt cette année et a reçu des retours précieux. Sur cette base, SSII procédera avec un parcours de novo pour la soumission sur le marché préalable pour de nombreuses indications en parallèle.
SSII prévoit de soumettre une demande d'exemption pour dispositif d'investigation (IDE) au premier trimestre 2025 pour initier des essais cliniques pour diverses indications, y compris des procédures abdominales, pelviennes, thoraciques et cardiaques. La société s'attend à obtenir des approbations pré-commerciales d'ici la fin 2025. SSII estime pouvoir rapidement répondre aux exigences des essais cliniques grâce à la sécurité et à l'efficacité démontrées du SSi Mantra en Inde, où tous les types de procédures chirurgicales pour lesquelles l'approbation est demandée ont déjà été effectués.
SS Innovations International, Inc. (OTC: SSII) hat ein Update zu den Fortschritten bei der FDA-Zulassung für das SSi Mantra Surgical Robotic System gegeben. Das Unternehmen hat zu Beginn dieses Jahres sein erstes interaktives Prä-Submission-Meeting mit der FDA abgeschlossen und wertvolles Feedback erhalten. Basierend darauf wird SSII mit einem de novo Verfahren für die Marktvoranmeldung für zahlreiche Indikationen parallel fortfahren.
SSII plant, im 1. Quartal 2025 einen Antrag auf investigational device exemption (IDE) einzureichen, um klinische Studien für verschiedene Indikationen, einschließlich abdominaler, pelvischer, thorakaler und kardialer Eingriffe, zu starten. Das Unternehmen erwartet, bis zum Ende 2025 vorab Marktgenehmigungen zu sichern. SSII ist der Ansicht, dass es aufgrund der nachgewiesenen Sicherheit und Wirksamkeit des SSi Mantra in Indien, wo bereits alle Arten von chirurgischen Verfahren durchgeführt wurden, für die eine Genehmigung beantragt wird, schnell die Anforderungen an klinische Studien erfüllen kann.
- Completed first interactive pre-submission meeting with FDA
- Proceeding with de novo pathway for pre-market submission
- Plans to submit IDE application in Q1 2025
- Expects to secure pre-market approvals by end of 2025
- SSi Mantra already demonstrated safety and efficacy in India
- Potential for faster clinical trial completion due to existing data from India
- FDA approval process still in early stages
- Clinical trials yet to begin
- Potential for unanticipated developments in the approval process
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.
About SS Innovations International, Inc.:
SS Innovations International, Inc. (OTC: SSII) is a developer of innovative surgical robotic technologies with a vision to make the benefits of robotic surgery affordable and accessible to a larger part of the global population. SS Innovation’s product range includes its proprietary “SSi Mantra” surgical robotic system, and “SSi Mudra” its wide range of surgical instruments capable of supporting a variety of surgical procedures including robotic cardiac surgery. SS Innovations’ business operations are headquartered in India and the Company has plans to expand the distribution of its technologically advanced, user-friendly, and cost-effective surgical robotic solutions, globally. For more information, visit SS Innovation’s website at ssinnovations.com or LinkedIn for updates.
About SSi Mantra:
Supporting advanced, affordable, and accessible robotic surgery, the SSi Mantra Surgical Robotic System provides the capabilities for multi-specialty usage including cardiothoracic, head and neck, gynecology, urology, general surgery and more. With its modular arm configuration, 3D 4K vision open-console design and superior ergonomics, the system engages with the surgeon and surgical teams to improve safety and efficiency during procedures. The SSi Mantra system has received Indian Medical Device regulatory approval (CDSCO) and is clinically validated in India in more than 80 different types of surgical procedures. SS Innovations has commenced the regulatory approval process in the United States and the European Union and anticipates receiving FDA approval to market and CE Mark approval in the latter half of 2025.
Forward-Looking Statements:
This press release may contain statements that are not historical facts and are considered forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. The words “anticipate,” “assume,” “believe,” “estimate,” “expect,” “will,” “intend,” “may,” “plan,” “project,” “should,” “could,” “seek,” “designed,” “potential,” “forecast,” “target,” “objective,” “goal,” or the negatives of such terms or other similar expressions to identify such forward-looking statements. These statements relate to future events or SS Innovations’ future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance, or achievements to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements.
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FAQ
When does SS Innovations (SSII) expect to receive FDA approval for the SSi Mantra Surgical Robotic System?
What is the current status of SS Innovations' (SSII) FDA approval process for the SSi Mantra?
Which surgical indications will SS Innovations (SSII) seek FDA approval for with the SSi Mantra system?
How does SS Innovations (SSII) plan to expedite the clinical trial process for the SSi Mantra system?
