SS Innovations Continues its International Growth, Receiving Medical Device Regulatory Approvals for the SSi Mantra 3 Surgical Robotic System in both the Philippines and Ukraine
SS Innovations International (OTC: SSII) has secured regulatory approvals for its SSi Mantra 3 Surgical Robotic System in both the Philippines and Ukraine. The company partnered with RBGM Medical Express Sales Inc. in Manila and Loran Group in Kiev for distribution.
The Philippines market, with nearly 4,000 hospitals, represents a significant opportunity for expanding robotic surgery access. In Ukraine, despite ongoing conflict and damaged medical facilities, the Certificate of Conformity approval positions SSII to participate in the country's medical infrastructure rebuilding efforts.
The SSi Mantra 3 system features 3-5 robotic arms, 3D 4K monitoring, and over 40 different types of robotic endo-surgical instruments. It has been clinically validated in India across 80+ surgical procedures. The company anticipates receiving FDA and CE Mark approvals in the second half of 2025.
SS Innovations International (OTC: SSII) ha ottenuto le approvazioni normative per il suo SSi Mantra 3 Surgical Robotic System sia nelle Filippine che in Ucraina. L'azienda ha collaborato con RBGM Medical Express Sales Inc. a Manila e Loran Group a Kiev per la distribuzione.
Il mercato delle Filippine, con quasi 4.000 ospedali, rappresenta un'opportunità significativa per espandere l'accesso alla chirurgia robotica. In Ucraina, nonostante il conflitto in corso e le strutture mediche danneggiate, l'approvazione del Certificato di Conformità posiziona SSII per partecipare agli sforzi di ricostruzione dell'infrastruttura medica del paese.
Il sistema SSi Mantra 3 presenta 3-5 bracci robotici, monitoraggio 3D 4K e oltre 40 diversi tipi di strumenti endo-chirurgici robotici. È stato convalidato clinicamente in India in oltre 80 procedure chirurgiche. L'azienda prevede di ricevere le approvazioni FDA e CE Mark nella seconda metà del 2025.
SS Innovations International (OTC: SSII) ha obtenido las aprobaciones regulatorias para su SSi Mantra 3 Surgical Robotic System tanto en Filipinas como en Ucrania. La empresa se ha asociado con RBGM Medical Express Sales Inc. en Manila y Loran Group en Kiev para la distribución.
El mercado de Filipinas, con casi 4,000 hospitales, representa una oportunidad significativa para expandir el acceso a la cirugía robótica. En Ucrania, a pesar del conflicto en curso y las instalaciones médicas dañadas, la aprobación del Certificado de Conformidad posiciona a SSII para participar en los esfuerzos de reconstrucción de la infraestructura médica del país.
El sistema SSi Mantra 3 cuenta con 3-5 brazos robóticos, monitoreo 3D 4K y más de 40 tipos diferentes de instrumentos quirúrgicos robóticos endoscópicos. Ha sido validado clínicamente en India en más de 80 procedimientos quirúrgicos. La empresa anticipa recibir las aprobaciones de la FDA y el marcado CE en la segunda mitad de 2025.
SS Innovations International (OTC: SSII)는 필리핀과 우크라이나에서 SSi Mantra 3 Surgical Robotic System에 대한 규제 승인을 확보했습니다. 이 회사는 마닐라의 RBGM Medical Express Sales Inc.와 키예프의 Loran Group과 협력하여 유통하고 있습니다.
필리핀 시장은 거의 4,000개의 병원이 있어 로봇 수술 접근성을 확장할 수 있는 중요한 기회를 제공합니다. 우크라이나에서는 진행 중인 갈등과 손상된 의료 시설에도 불구하고, 적합성 인증 승인은 SSII가 국가의 의료 인프라 재건 노력에 참여할 수 있도록 합니다.
SSi Mantra 3 시스템은 3-5개의 로봇 팔, 3D 4K 모니터링 및 40가지 이상의 다양한 로봇 내시경 수술 도구를 특징으로 합니다. 인도에서 80개 이상의 수술 절차에 대해 임상적으로 검증되었습니다. 이 회사는 2025년 하반기에 FDA 및 CE 마크 승인을 받을 것으로 예상하고 있습니다.
SS Innovations International (OTC: SSII) a obtenu les approbations réglementaires pour son SSi Mantra 3 Surgical Robotic System tant aux Philippines qu'en Ukraine. L'entreprise s'est associée à RBGM Medical Express Sales Inc. à Manille et à Loran Group à Kiev pour la distribution.
Le marché philippin, avec près de 4 000 hôpitaux, représente une opportunité significative pour étendre l'accès à la chirurgie robotique. En Ukraine, malgré le conflit en cours et les installations médicales endommagées, l'approbation du Certificat de Conformité positionne SSII pour participer aux efforts de reconstruction de l'infrastructure médicale du pays.
Le système SSi Mantra 3 dispose de 3 à 5 bras robotiques, d'une surveillance 3D 4K et de plus de 40 types différents d'instruments chirurgicaux endoscopiques robotiques. Il a été validé cliniquement en Inde dans plus de 80 procédures chirurgicales. L'entreprise prévoit de recevoir les approbations de la FDA et le marquage CE dans la seconde moitié de 2025.
SS Innovations International (OTC: SSII) hat die behördlichen Genehmigungen für sein SSi Mantra 3 Surgical Robotic System sowohl auf den Philippinen als auch in der Ukraine erhalten. Das Unternehmen hat sich mit RBGM Medical Express Sales Inc. in Manila und der Loran Group in Kiew für den Vertrieb zusammengeschlossen.
Der philippinische Markt mit fast 4.000 Krankenhäusern stellt eine bedeutende Gelegenheit dar, den Zugang zur robotergestützten Chirurgie zu erweitern. In der Ukraine, trotz des anhaltenden Konflikts und beschädigter medizinischer Einrichtungen, positioniert die Genehmigung des Konformitätszertifikats SSII, um an den Wiederaufbaumaßnahmen der medizinischen Infrastruktur des Landes teilzunehmen.
Das System SSi Mantra 3 verfügt über 3-5 Roboterarme, 3D 4K-Überwachung und über 40 verschiedene Arten von robotergestützten endoskopischen chirurgischen Instrumenten. Es wurde klinisch in Indien in über 80 chirurgischen Eingriffen validiert. Das Unternehmen erwartet, in der zweiten Hälfte des Jahres 2025 die Genehmigungen von der FDA und das CE-Zeichen zu erhalten.
- Secured regulatory approvals in two new international markets (Philippines and Ukraine)
- Access to Philippines market with nearly 4,000 potential hospital customers
- System validated in 80+ different surgical procedures
- FDA and CE Mark approvals expected in H2 2025
- Expanding global market presence in emerging healthcare markets
- Operating in Ukraine faces challenges due to ongoing conflict and damaged medical infrastructure
- Still awaiting important FDA and CE Mark approvals for major markets
- Faces competition from established robotic surgery providers in international markets
FORT LAUDERDALE, Fla., March 28, 2025 (GLOBE NEWSWIRE) -- SS Innovations International, Inc. (OTC: SSII) (“SS Innovations” or the “Company”), a developer of innovative surgical robotic technologies dedicated to making world-class robotic surgery affordable for and accessible to a global population, has received regulatory approvals for its SSi Mantra 3 Surgical Robotic System in both the Philippines and Ukraine.
SS Innovations International along with RBGM Medical Express Sales Inc., its Manila based distribution partner in the Philippines, is proud to announce the successful registration of the SSi Mantra 3 Surgical Robotic System in the Philippines. The Company believes that this will be a significant step forward in making advanced surgical robotics accessible to Filipino healthcare professionals and institutions. The healthcare market in the Philippines has recently seen rapid growth and now has close to 4,000 hospitals.
Commenting on the receipt of regulatory approval, RBGM President Don Gabriel Oligar T. Cariño III, JD, MBA said, “SS Innovations has started to revolutionize the landscape of robotic surgery by developing cost-effective, high-quality solutions that have brought cutting-edge medical technology to India. With the introduction of the SSi Mantra 3 system to the Philippines, RBGM is committed to bringing the same level of innovation and accessibility to the local medical community.”
“We at RBGM Medical Express Sales Inc. remain steadfast in our mission to deliver state-of-the-art medical technologies that empower healthcare providers, enhance clinical outcomes, and ultimately serve the best interests of the Filipino people. Together, we are excited to embrace the future of surgery—one that is precise, efficient, affordable and accessible to all.”
In addition to receiving the regulatory approval in the Philippines, SS Innovations is also pleased to announce the successful granting of the Certificate of Conformity from the Ukrainian Government to the SSi Mantra 3 through its partnership with Loran Group based out of Kiev, Ukraine. Due to the ongoing conflict, many hospitals and medical facilities have been damaged. Despite these challenges, Ukraine has been actively working to restore its medical infrastructure, which may present a unique opportunity for SS Innovations and its partner, Loran Group, to participate in this rebuilding.
Speaking on behalf of Loran Group, Ms. Roksolana Dmytriv, Head of International Communications and Regulatory Affairs, commented, “Obtaining a certificate of conformity confirms that the equipment meets international quality standards, which is a guarantee of reliability and safety. For medical institutions and doctors, this is critically important, as it ensures that patients receive treatment using reliable and high-quality technologies. Thanks to the successful registration of the SSi Mantra 3 Surgical Robotic System in Ukraine, medical institutions will be able to purchase this high-tech and innovative system to perform complex surgeries with a high level of accuracy and safety. Loran Group is proud to partner with SS Innovations and sees great potential for the future of Ukrainian medicine, especially in the field of robotic technologies that allow doctors to achieve new levels of accuracy and efficiency in treatment.”
Ms. Dmytriv also commented, “The SSI Mantra 3 will enable Ukrainian doctors to perform complex and highly precise surgeries in urology, cardiology, general and thoracic surgery, gynecology, and head and neck surgery. The system will enable doctors to reach a level that has been unattainable for many medical institutions in the country until now. This innovative robotic surgical system will also provide patients with the best results with minimal complications and faster rehabilitation. Loran Group's partnership with SS Innovations opens up new opportunities for the development of the medical industry in Ukraine, raising the level of medical services and improving the health of patients.”
Commenting on these two milestones, SS Innovations President and COO, Dr. Vishwa Srivastava said, “We are extremely grateful for the opportunities provided to be able to offer gold standard care to countries and populations that are often overlooked. It has always been our vision and mission to deliver the latest medical technologies to parts of the world that often have limited access to cost-effective and innovative solutions. By receiving both of these regulatory approvals, we are looking forward to launching SSi Mantra 3 Surgical Robotic Programs in the Philippines and Ukraine, delivering the best possible care to their citizens.”
About SS Innovations:
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. The Company’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 plans to expand the presence of its technologically advanced, user-friendly, and cost-effective surgical robotic solutions, globally. For more information, visit our website at ssinnovations.com or LinkedIn for updates.
About the SSi Mantra:
The SSi Mantra Surgical Robotic System, by SS Innovations, is a modular multi-arm system with many advanced technology features. It allows for the use of 3-5 robotic arms, has an open-faced ergonomic Surgeon Command Centre, 32-inch large 3D 4K monitor, a 23-inch 2D 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. The Vision Cart gives the table-side team the same magnified 3D 4K view as the surgeon to provide better safety and efficiency. The modular robotic arms give flexibility in positioning and the number of arms to be used. This allows for collision-free conduct of surgical operations. There are over 40 different types of robotic endo-surgical instruments that can be used for different specialties including cardiac surgery. The learning curve for surgeons is shorter due to the SSi Mantra’s ergonomic design and user-friendly features.
The SSi Mantra has been 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 second half of 2025.
About RBGM Medical Express Sales Inc:
RBGM Medical Express Sales, Inc. has the mission to create partnerships with Multinational Medical Device firms to promote, distribute and deliver cutting edge products and reliable services to Health Care units in the Philippines.
With the philosophy of Responsible Business Growth Management, it plans to grow sustainably while maintaining its good reputation as a reliable partner to Healthcare Units, achieve goals of our principals, being a viable career for its employees and continuously striving to improve Healthcare for the Filipino people. For more information, visit the RGBM website at https://rbgm-medical.com.
About Loran Group:
Loran Group is the official importer of medical equipment in Ukraine. The company was founded in 2016 and cooperates with more than 40 leading manufacturers from around the world. The company specializes in equipment for urology, otolaryngology, neurosurgery, general surgery, gynecology and other medical fields. Loran Group pays special attention to the introduction of innovative medical technologies, in particular in the field of robotic surgery, ensuring the availability of advanced technologies for Ukrainian hospitals. For more information, visit the Loran Group website at https://loran.ua.
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.
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FAQ
What regulatory approvals did SS Innovations (SSII) receive for its SSi Mantra 3 system in March 2025?
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