SS Innovations Surpasses Milestone of 100 Installations of the SSi Mantra Surgical Robotic System
SS Innovations (NASDAQ:SSII) has achieved a significant milestone by installing over 100 SSi Mantra surgical robotic systems across India and six other countries. The company reported that more than 5,000 surgical procedures have been completed using the system, including 240 cardiac surgeries and 32 telesurgeries, showing substantial growth from the 2,759 total procedures reported as of December 31, 2024.
The company plans to submit a De Novo application to the FDA by July 2025 for multiple indications and is pursuing European Union CE marking certification, expected by late 2025. SS Innovations aims to democratize robotic surgery access by expanding both in existing markets and new geographies.
SS Innovations (NASDAQ:SSII) ha raggiunto un traguardo importante installando oltre 100 sistemi chirurgici robotici SSi Mantra in India e in altri sei paesi. L'azienda ha comunicato che sono state eseguite più di 5.000 procedure chirurgiche utilizzando il sistema, incluse 240 chirurgie cardiache e 32 telesurgery, evidenziando una crescita significativa rispetto alle 2.759 procedure totali riportate al 31 dicembre 2024.
La società prevede di presentare una domanda De Novo alla FDA entro luglio 2025 per diverse indicazioni e sta perseguendo la certificazione CE dell'Unione Europea, attesa entro la fine del 2025. SS Innovations punta a rendere accessibile la chirurgia robotica ampliando la sua presenza sia nei mercati attuali che in nuove aree geografiche.
SS Innovations (NASDAQ:SSII) ha alcanzado un hito importante al instalar más de 100 sistemas quirúrgicos robóticos SSi Mantra en India y otros seis países. La compañía informó que se han realizado más de 5,000 procedimientos quirúrgicos utilizando el sistema, incluyendo 240 cirugías cardíacas y 32 telesurgerías, mostrando un crecimiento significativo respecto a los 2,759 procedimientos totales reportados al 31 de diciembre de 2024.
La empresa planea presentar una solicitud De Novo a la FDA para julio de 2025 para múltiples indicaciones y está en proceso de obtener la certificación CE de la Unión Europea, esperada para finales de 2025. SS Innovations busca democratizar el acceso a la cirugía robótica expandiéndose tanto en mercados existentes como en nuevas geografías.
SS Innovations (NASDAQ:SSII)는 인도 및 6개국에 걸쳐 100대 이상의 SSi Mantra 수술용 로봇 시스템을 설치하며 중요한 이정표를 달성했습니다. 회사는 이 시스템을 사용하여 5,000건 이상의 수술 절차이 완료되었으며, 그 중 240건의 심장 수술과 32건의 원격 수술이 포함되어 2024년 12월 31일 기준 2,759건에서 크게 성장했다고 보고했습니다.
회사는 여러 적응증에 대해 2025년 7월까지 FDA에 De Novo 신청서를 제출할 계획이며, 2025년 말까지 유럽연합 CE 인증 획득을 추진 중입니다. SS Innovations는 기존 시장과 새로운 지역 모두에서 확장하여 로봇 수술 접근성을 민주화하는 것을 목표로 하고 있습니다.
SS Innovations (NASDAQ:SSII) a franchi une étape importante en installant plus de 100 systèmes chirurgicaux robotiques SSi Mantra en Inde et dans six autres pays. La société a rapporté que plus de 5 000 interventions chirurgicales ont été réalisées avec ce système, dont 240 chirurgies cardiaques et 32 téléchirurgies, montrant une croissance significative par rapport aux 2 759 procédures totales rapportées au 31 décembre 2024.
L'entreprise prévoit de soumettre une demande De Novo à la FDA d'ici juillet 2025 pour plusieurs indications et poursuit la certification CE de l'Union européenne, attendue d'ici fin 2025. SS Innovations vise à démocratiser l'accès à la chirurgie robotique en s'étendant à la fois sur les marchés existants et dans de nouvelles régions.
SS Innovations (NASDAQ:SSII) hat einen bedeutenden Meilenstein erreicht, indem es über 100 SSi Mantra chirurgische Robotersysteme in Indien und sechs weiteren Ländern installiert hat. Das Unternehmen berichtete, dass mit dem System mehr als 5.000 chirurgische Eingriffe durchgeführt wurden, darunter 240 Herzoperationen und 32 Telesurgerien, was ein erhebliches Wachstum gegenüber den 2.759 insgesamt bis zum 31. Dezember 2024 gemeldeten Eingriffen darstellt.
Das Unternehmen plant, bis Juli 2025 einen De Novo-Antrag bei der FDA für mehrere Indikationen einzureichen und strebt die CE-Zertifizierung der Europäischen Union an, die bis Ende 2025 erwartet wird. SS Innovations verfolgt das Ziel, den Zugang zur robotergestützten Chirurgie zu demokratisieren, indem es sowohl in bestehenden Märkten als auch in neuen Regionen expandiert.
- Milestone achievement of over 100 SSi Mantra system installations across 7 countries
- Significant procedure growth from 2,759 to 5,000 surgeries, including complex cardiac and telesurgeries
- Planned expansion with upcoming FDA application and EU certification pathway
- Pending regulatory approvals in major markets (US and EU) create market entry uncertainty
Continuing strong procedure growth, including an upsurge in telesurgeries
FORT LAUDERDALE, Fla., July 15, 2025 (GLOBE NEWSWIRE) -- SS Innovations International, Inc. (the “Company” or “SS Innovations”) (Nasdaq: SSII), a developer of innovative surgical robotic technologies dedicated to making robotic surgery affordable and accessible to a global population, today announced that the Company has installed more than 100 SSi Mantra surgical robotic systems in India and six other countries. To date, more than 5,000 surgical procedures have been successfully performed utilizing the SSi Mantra, including 240 cardiac surgeries and 32 telesurgeries. As of December 31, 2024, a total of 2,759 robotic surgeries had been successfully completed using the SSi Mantra, including 151 cardiac surgeries and 9 telesurgeries.
Dr. Sudhir Srivastava, Chairman of the Board and Chief Executive Officer of SS Innovations, commented, “We are thrilled to surpass the milestone of 100 installations of our SSi Mantra surgical robotic system in India and beyond. We are seeing growing demand for and acceptance of the SSi Mantra, which reflects its premium quality, innovative features, ease of use, improved patient experience, and overall cost-effectiveness. We aim to democratize access to cutting edge robotic surgery through deploying SSi Mantra in existing markets while simultaneously pursuing new geographies. In that regard, we expect to submit a De Novo application for approval to market the SSi Mantra to the U.S. Food and Drug Administration by the end of July 2025 for multiple indications and continue along the pathway towards a European Union CE marking certification as soon as late 2025.”
About SS Innovations
SS Innovations International, Inc. (Nasdaq: SSII) develops innovative surgical robotic technologies with a vision to make the benefits of robotic surgery affordable and accessible to a larger segment of the global population. The Company’s product range includes its proprietary “SSi Mantra” surgical robotic system and its comprehensive suite of “SSi Mudra” surgical instruments, which support a variety of surgical procedures including robotic cardiac surgery. An American company headquartered in India, SS Innovations plans to expand the global presence of its technologically advanced, user-friendly, and cost-effective surgical robotic solutions. Visit the Company’s website at ssinnovations.com or LinkedIn for more information and updates.
About the SSi Mantra
The SSi Mantra surgical robotic system is a user-friendly, modular, multi-arm system with many advanced technology features, including: 3 to 5 modular robotic arms, an open-faced ergonomic surgeon command center, a large 3D 4K monitor, a touch panel monitor for all patient related information display, a virtual real-time image of the robotic patient side arm carts, and the ability for superimposition of 3D models of diagnostic imaging. A vision cart provides the table-side team with the same magnified 3D 4K view as the surgeon to provide better safety and efficiency. The SSi Mantra utilizes over 40 different types of robotic endo-surgical instruments to support different specialties, including cardiac surgery. The SSi Mantra has been clinically validated in India in more than 100 different types of surgical procedures.
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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