SS Innovations to Submit De Novo Application to the FDA for the SSi Mantra 3 Surgical Robotic System for Multiple Indications
SS Innovations International (NASDAQ: SSII) announced plans to submit a De Novo Classification Request to the FDA for its SSi Mantra 3 surgical robotic system in July 2025. The company has demonstrated significant market traction with 80 SSi Mantra systems installed across 75 hospitals since August 2022, facilitating over 3,800 surgeries. The newer SSi Mantra 3 version, launched in June 2024, has 37 installations and has been used in more than 750 procedures, including 70 cardiac cases, with no device-related complications.
The FDA submission will seek approval for multiple surgical specialties including urology, gynecology, general surgery, and thoracic and cardiac surgery. The system is currently approved in six countries, and the company is simultaneously pursuing EU CE Mark approval.
SS Innovations International (NASDAQ: SSII) ha annunciato l'intenzione di presentare una richiesta di classificazione De Novo alla FDA per il suo sistema robotico chirurgico SSi Mantra 3 a luglio 2025. L'azienda ha ottenuto un significativo successo commerciale con 80 sistemi SSi Mantra installati in 75 ospedali dal agosto 2022, permettendo oltre 3.800 interventi chirurgici. La versione più recente, SSi Mantra 3, lanciata nel giugno 2024, conta 37 installazioni ed è stata utilizzata in più di 750 procedure, tra cui 70 casi cardiaci, senza complicazioni legate al dispositivo.
La richiesta alla FDA mira all'approvazione per diverse specialità chirurgiche, tra cui urologia, ginecologia, chirurgia generale, toracica e cardiaca. Il sistema è già approvato in sei paesi e l'azienda sta contemporaneamente lavorando per ottenere la marcatura CE nell'Unione Europea.
SS Innovations International (NASDAQ: SSII) anunció planes para presentar una Solicitud de Clasificación De Novo a la FDA para su sistema robótico quirúrgico SSi Mantra 3 en julio de 2025. La compañía ha demostrado un importante avance en el mercado con 80 sistemas SSi Mantra instalados en 75 hospitales desde agosto de 2022, facilitando más de 3,800 cirugías. La versión más reciente, SSi Mantra 3, lanzada en junio de 2024, cuenta con 37 instalaciones y se ha utilizado en más de 750 procedimientos, incluyendo 70 casos cardíacos, sin complicaciones relacionadas con el dispositivo.
La presentación a la FDA buscará la aprobación para múltiples especialidades quirúrgicas, incluyendo urología, ginecología, cirugía general, cirugía torácica y cardíaca. El sistema ya está aprobado en seis países, y la compañía está simultáneamente buscando la aprobación del marcado CE en la UE.
SS Innovations International (NASDAQ: SSII)는 2025년 7월에 SSi Mantra 3 수술 로봇 시스템에 대한 FDA De Novo 분류 요청을 제출할 계획을 발표했습니다. 회사는 2022년 8월 이후 75개 병원에 80대의 SSi Mantra 시스템을 설치하며 3,800건 이상의 수술을 지원하는 등 시장에서 큰 성과를 보였습니다. 2024년 6월에 출시된 최신 버전 SSi Mantra 3는 37대가 설치되어 750건 이상의 수술에 사용되었으며, 그중 70건은 심장 수술로 기기 관련 합병증이 없었습니다.
FDA 제출은 비뇨기과, 부인과, 일반 외과, 흉부 및 심장 수술 등 여러 외과 전문 분야에 대한 승인을 목표로 하고 있습니다. 이 시스템은 현재 6개국에서 승인되었으며, 회사는 동시에 EU CE 인증 획득도 진행 중입니다.
SS Innovations International (NASDAQ : SSII) a annoncé son intention de soumettre une demande de classification De Novo à la FDA pour son système robotique chirurgical SSi Mantra 3 en juillet 2025. L'entreprise a démontré une forte implantation sur le marché avec 80 systèmes SSi Mantra installés dans 75 hôpitaux depuis août 2022, facilitant plus de 3 800 interventions chirurgicales. La version plus récente, SSi Mantra 3, lancée en juin 2024, compte 37 installations et a été utilisée dans plus de 750 procédures, dont 70 cas cardiaques, sans complications liées à l'appareil.
La soumission à la FDA vise à obtenir l'approbation pour plusieurs spécialités chirurgicales, notamment l'urologie, la gynécologie, la chirurgie générale, ainsi que la chirurgie thoracique et cardiaque. Le système est actuellement approuvé dans six pays, et l'entreprise poursuit parallèlement l'obtention du marquage CE pour l'UE.
SS Innovations International (NASDAQ: SSII) kündigte an, im Juli 2025 einen De Novo-Klassifizierungsantrag bei der FDA für sein SSi Mantra 3 chirurgisches Robotersystem einzureichen. Das Unternehmen verzeichnete seit August 2022 eine bedeutende Marktdurchdringung mit 80 installierten SSi Mantra-Systemen in 75 Krankenhäusern, die über 3.800 Operationen ermöglichten. Die neuere Version SSi Mantra 3, die im Juni 2024 auf den Markt kam, wurde bereits 37-mal installiert und in mehr als 750 Eingriffen eingesetzt, darunter 70 Herzoperationen, ohne gerätebedingte Komplikationen.
Der FDA-Antrag zielt auf die Zulassung für mehrere chirurgische Fachgebiete ab, darunter Urologie, Gynäkologie, Allgemeinchirurgie sowie Thorax- und Herzchirurgie. Das System ist derzeit in sechs Ländern zugelassen, und das Unternehmen strebt gleichzeitig die CE-Kennzeichnung für die EU an.
- Successful track record with 80 systems installed and 3,800+ surgeries performed
- Strong safety profile with no device-related mortality, injury, or complications in 750+ procedures
- Clinical data validated by leading third-party CRO
- Already approved in 6 countries with EU approval in progress
- Multi-specialty application covering various surgical procedures
- FDA submission does not guarantee approval
- Relatively new product in market with limited track record compared to established competitors
Insights
SS Innovations' FDA submission plans represent a significant regulatory milestone toward potential U.S. market access for their cost-effective surgical robot.
The planned July 2025 De Novo Classification Request to the FDA marks a critical regulatory milestone for SS Innovations' SSi Mantra 3 surgical robotic system. This pathway is appropriate for novel medical devices without predicate devices already on the market, though as correctly noted in the release, submission does not guarantee approval.
The company presents compelling real-world evidence to support their application: 80 systems installed in 75 hospitals globally, with 3,800+ procedures performed since August 2022, including over 200 complex cardiac surgeries. Particularly noteworthy is the safety profile of the newer SSi Mantra 3 (launched June 2024), with zero device-related complications across 750+ procedures performed on 37 installed systems. The third-party CRO validation of this data adds credibility to these safety claims.
The multi-specialty approach targeting urology, gynecology, general surgery, and thoracic and cardiac applications positions the system as a comprehensive surgical platform. Including cardiac applications is particularly significant, as these represent some of the most technically challenging procedures in robotic surgery.
The positioning as a "cost-effective" robotic technology signals a strategic focus on affordability in a market where capital equipment costs and per-procedure expenses remain important considerations for healthcare providers. With existing approvals in six countries and parallel pursuit of EU CE Mark certification, the company is executing a multi-region regulatory strategy.
If approved following submission, U.S. commercialization would likely begin no earlier than 2026, considering typical De Novo review timelines. This regulatory progression represents a significant potential catalyst for the company in the expanding surgical robotics market.
All Clinical Data Validated by Leading Third-Party CRO for Safety, Feasibility and Efficacy
FORT LAUDERDALE, Fla., May 08, 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 is planning to submit a De Novo Classification Request to the U.S. Food and Drug Administration (the “FDA”) for the SSi Mantra 3 surgical robotic system (the “SSi Mantra 3”) in July 2025.
If approved by the FDA, the SSi Mantra 3 would be cleared to market in the United States. Submission of the De Novo Classification Request does not guarantee FDA approval.
Since the Company began the sale of its system in August 2022 it has installed a total of 80 SSi Mantra robotic surgical systems in 75 hospitals and over 3,800 surgeries have been performed, including over 200 robotic cardiac surgeries. The SSi Mantra 3 version was launched in June 2024, and the Company has already installed 37 systems that have been utilized to perform more than 750 multispecialty robotic surgical procedures, including 70 cardiac cases, with no device related mortality, injury or complications.
Real world clinical data, validated by a leading contract research organization (“CRO”), supports the ability of the SSi Mantra 3 to safely perform a wide variety of surgical procedures. The planned submission of the SSi Mantra 3 to the FDA will include an application for multispecialty indications including urology, gynecology, general surgery, and thoracic and cardiac surgery.
Dr. Sudhir Srivastava, Chairman of the Board and Chief Executive Officer of SS Innovations, commented, “We currently have approval to market our SSi Mantra surgical robotic system in six countries and continue to advance our global expansion. We are taking important steps, including the planned De Novo application to the FDA, to introduce our empowering, cost-effective surgical robotic technology to the U.S. market. In parallel, we are pursuing European Union CE Mark approval for our SSi Mantra surgical robotic system and look forward to our future with great confidence.”
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 International’s 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.
Investor Contact:
The Equity Group
Kalle Ahl, CFA
T: (303) 953-9878
kahl@equityny.com
Devin Sullivan, Managing Director
T: (212) 836-9608
dsullivan@equityny.com
Media Contact:
press@ssinnovations.org
T: (212) 739-0300
FAQ
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