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SS Innovations International, Inc. Announces First Mantra Surgical Robotic System Sale in South America

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SS Innovations International, Inc. (OTC: SSII) has announced its first sale of the SSi Mantra Surgical Robotic System in South America, specifically in Ecuador. The company received regulatory approval for clinical use in Ecuador in May 2024 and partnered with Ingemedica Del Ecuador S.A. for distribution. The first system will be installed at Interhospital in Guayaquil City, Ecuador.

The SSi Mantra system aims to make robotic surgery affordable and accessible globally. It has been used in over 1,900 cases across 80+ surgical procedures and has received regulatory approvals in India, Indonesia, Nepal, Guatemala, and now Ecuador. SS Innovations is also seeking approvals in the US and EU, expected in the second half of 2025.

SS Innovations International, Inc. (OTC: SSII) ha annunciato la sua prima vendita del SSi Mantra Surgical Robotic System in Sud America, specificamente in Ecuador. L'azienda ha ricevuto l'approvazione normativa per l'uso clinico in Ecuador nel maggio 2024 e ha stretto una partnership con Ingemedica Del Ecuador S.A. per la distribuzione. Il primo sistema sarà installato presso l'Interhospital nella città di Guayaquil, Ecuador.

Il sistema SSi Mantra mira a rendere la chirurgia robotica accessibile e conveniente a livello globale. È stato utilizzato in oltre 1.900 casi in più di 80 procedure chirurgiche e ha ricevuto approvazioni normative in India, Indonesia, Nepal, Guatemala e ora Ecuador. SS Innovations sta anche cercando approvazioni negli Stati Uniti e nell'UE, previste per la seconda metà del 2025.

SS Innovations International, Inc. (OTC: SSII) ha anunciado su primera venta del SSi Mantra Surgical Robotic System en Sudamérica, específicamente en Ecuador. La compañía recibió aprobación regulatoria para uso clínico en Ecuador en mayo de 2024 y se asoció con Ingemedica Del Ecuador S.A. para su distribución. El primer sistema se instalará en Interhospital en la ciudad de Guayaquil, Ecuador.

El sistema SSi Mantra tiene como objetivo hacer que la cirugía robótica sea asequible y accesible a nivel mundial. Se ha utilizado en más de 1,900 casos en más de 80 procedimientos quirúrgicos y ha recibido aprobaciones regulatorias en India, Indonesia, Nepal, Guatemala y ahora en Ecuador. SS Innovations también está buscando aprobaciones en EE.UU. y la UE, que se espera en la segunda mitad de 2025.

SS 이노베이션즈 인터내셔널, Inc. (OTC: SSII)는 남미, 특히 에콰도르에서 SSi Mantra 수술 로봇 시스템의 첫 판매를 발표했습니다. 이 회사는 2024년 5월 에콰도르에서 임상 사용을 위한 규제 승인을 받았으며 Ingemedica Del Ecuador S.A.와 배급 파트너십을 체결했습니다. 첫 번째 시스템은 에콰도르 기에 있는 과야킬시의 인터병원에 설치될 예정입니다.

SSi Mantra 시스템은 전 세계적으로 로봇 수술을 저렴하고 접근 가능하게 만드는 것을 목표로 합니다. 이 시스템은 80개 이상의 수술 절차에서 1,900건 이상의 사례에 사용되었으며 인도, 인도네시아, 네팔, 과테말라 및 현재 에콰도르에서 규제 승인을 받았습니다. SS Innovations는 미국 및 EU의 승인을 요청하고 있으며, 이는 2025년 하반기에 예상됩니다.

SS Innovations International, Inc. (OTC: SSII) a annoncé sa première vente du SSi Mantra Surgical Robotic System en Amérique du Sud, spécifiquement en Équateur. La société a reçu l'approbation réglementaire pour une utilisation clinique en Équateur en mai 2024 et a établi un partenariat avec Ingemedica Del Ecuador S.A. pour la distribution. Le premier système sera installé à l'Interhospital dans la ville de Guayaquil, Équateur.

Le système SSi Mantra vise à rendre la chirurgie robotique abordable et accessible à l'échelle mondiale. Il a été utilisé dans plus de 1 900 cas au cours de plus de 80 procédures chirurgicales et a obtenu des approbations réglementaires en Inde, en Indonésie, au Népal, au Guatemala et maintenant en Équateur. SS Innovations cherche également des approbations aux États-Unis et dans l'UE, prévues pour la deuxième moitié de 2025.

SS Innovations International, Inc. (OTC: SSII) hat seinen ersten Verkauf des SSi Mantra Surgical Robotic Systems in Südamerika, insbesondere in Ecuador, bekannt gegeben. Das Unternehmen erhielt im Mai 2024 die behördliche Genehmigung zur klinischen Anwendung in Ecuador und ging eine Partnerschaft mit Ingemedica Del Ecuador S.A. für die Distribution ein. Das erste System wird im Interhospital in der Stadt Guayaquil, Ecuador, installiert.

Das SSi Mantra-System zielt darauf ab, robotergestützte Chirurgie weltweit erschwinglich und zugänglich zu machen. Es wurde in über 1.900 Fällen in mehr als 80 chirurgischen Eingriffen eingesetzt und hat Genehmigungen in Indien, Indonesien, Nepal, Guatemala und nun auch in Ecuador erhalten. SS Innovations strebt zudem Genehmigungen in den USA und der EU an, die für die zweite Hälfte des Jahres 2025 erwartet werden.

Positive
  • First sale of SSi Mantra Surgical Robotic System in South America (Ecuador)
  • Received regulatory approval for clinical use in Ecuador
  • Partnership with Ingemedica Del Ecuador S.A. for distribution
  • System has been used in over 1,900 cases across 80+ surgical procedures
  • Regulatory approvals obtained in India, Indonesia, Nepal, Guatemala, and Ecuador
  • US FDA and EU CE Mark approvals anticipated in second half of 2025
Negative
  • None.

SS Innovations receives Regulatory Approval for Clinical Use in Ecuador

SS Innovations Partners with Medical Device Firm Ingemedica S.A. for Distribution in Ecuador

The first SSi Mantra Surgical Robotic System to be installed at Interhospital, Guayaquil City, Ecuador

FORT LAUDERDALE, Fla. , Sept. 03, 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, announced that it has completed the first sale of its SSi Mantra Surgical Robotic System in Ecuador as it begins its sales efforts in Central and South America.

SS Innovations successfully received the Ecuadorian regulatory approvals for clinical use in May 2024. Following the approvals, ongoing efforts to bring the Company’s affordable surgical robotic system to Ecuador began to solidify. Through SS Innovation’s partnership with Ingemedica Del Ecuador S.A., the Company’s distribution partner in Ecuador, the first purchase order was placed in August 2024 by Interhospital, a large multispecialty hospital in Guayaquil City, Ecuador.

Juan Pablo Rovayo, Sales and Project Manager for Ingemedica Del Ecuador S.A., commented, “The acquisition of the SSi Mantra Robotical Surgical System by Interhospital represents a significant advancement for the healthcare system in Ecuador. The SSi Mantra, designed with the philosophy of making high-tech surgery affordable for everyone, not only places Ecuador at the forefront of modern medicine but also reinforces Interhospital's commitment to accessibility and quality in healthcare. The SSi Mantra offers numerous advantages, such as advanced surgical precision that reduces recovery times and minimizes postoperative complications. This not only improves the experience and outcomes for patients but also optimizes hospital resources by reducing prolonged stays and the need for additional interventions.”

Mr. Rovayo further added, “The incorporation of this technology can make complex surgeries more accessible, eliminating the economic barriers that traditionally limit many patients. By making these surgeries more affordable, Interhospital not only elevates its level of service but also contributes to the overall well-being of the population, aligning with its mission to offer excellent healthcare to all Ecuadorians.”

SS Innovations’ President and COO, Dr. Vishwa Srivastava, said, “We are very excited to announce that we have completed our first SSi Mantra Surgical Robotic System sale in South America. We are very excited for the opportunity to extend our Company’s vision beyond borders and across continents. I am confident that the surgeons at Interhospital in Ecuador will be able to utilize our technology to best serve the patients in their community, offering the highest level of surgical care at an affordable cost, making our innovative technology accessible to all in Ecuador. As we are launching in South America, representing another part of the world that has tremendous inequity of healthcare access amongst its population, this expansion serves as a potent reminder and validation of our vision and mission to address the global need for affordable and accessible world-class robotic surgery. It is this same reminder that drives us forward at SS Innovations as a digital healthcare company in order to democratize global access to the latest technologies.”

The SSi Mantra Surgical Robotic System has received regulatory approvals in India, Indonesia, Nepal, Guatemala and now, Ecuador. It has been clinically utilized in over 1,900 cases in more than 80 different surgical procedures. SS Innovations has initiated the regulatory approval process in the United States and the EU, with approvals to market anticipated in the second half 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. SSII’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. SSII’s business operations are headquartered in India and SSII has plans to expand the presence of its technologically advanced, user-friendly, and cost-effective surgical robotic solutions, globally. For more information, visit SSII’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 second 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 International, Inc.’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 is the recent milestone for SS Innovations International (SSII) in South America?

SS Innovations International (SSII) has completed its first sale of the SSi Mantra Surgical Robotic System in Ecuador, marking its entry into the South American market.

When did SS Innovations (SSII) receive regulatory approval for the SSi Mantra system in Ecuador?

SS Innovations (SSII) received regulatory approval for clinical use of the SSi Mantra Surgical Robotic System in Ecuador in May 2024.

Which hospital in Ecuador will install the first SSi Mantra Surgical Robotic System?

The first SSi Mantra Surgical Robotic System in Ecuador will be installed at Interhospital, a large multispecialty hospital in Guayaquil City.

How many cases has the SSi Mantra Surgical Robotic System been used in globally?

The SSi Mantra Surgical Robotic System has been clinically utilized in over 1,900 cases across more than 80 different surgical procedures globally.

When does SS Innovations (SSII) expect to receive FDA and CE Mark approvals for the SSi Mantra system?

SS Innovations (SSII) anticipates receiving FDA approval to market and CE Mark approval for the SSi Mantra system in the second half of 2025.

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