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SS Innovations International, Inc (SSII) was founded by a seasoned leadership team with vast experience in medical research, innovation, and development in the medical robotics sector. The company aims to meet the rising demand for practical medical robotic devices by creating a platform-independent precision guidance system, initially focusing on skin resurfacing.
The flagship SSi Mantra surgical device has been utilized in over 1000 procedures, showcasing the company's commitment to advancing robotic surgery. Dr. Sudhir Srivastava, the Chairman and CEO of SS Innovations, highlights the Mantra's fifth arm capability, enabling complex cardiac surgeries with minimal invasiveness, reduced blood loss, quicker recovery times, and superior outcomes.
The global market for cardiac surgery devices and surgical robotics is growing rapidly, presenting significant opportunities for SS Innovations. The Company's innovative approach and unique value proposition position it well for future success and market expansion.
SS Innovations International (OTC: SSII) has achieved a historic milestone in global healthcare by successfully performing the world's first robotic cardiac telesurgeries using its SSi Mantra 3 Surgical Robotic System. The procedures, including a robotic-assisted Internal Mammary Artery Harvesting and a Robotic Beating Heart Totally Endoscopic Coronary Artery Bypass (TECAB), were conducted remotely between Gurugram and Jaipur, India, spanning 286 kilometers with a latency of only 40 milliseconds.
This breakthrough was made possible due to the recent approval from the Central Drugs Standard Control Organization (CDSCO), India's regulatory authority, making SS Innovations the first in India to receive such approval for telesurgery and teleproctoring capabilities. The SSi Mantra 3 system has been clinically validated in over 80 different types of surgical procedures in India and is awaiting FDA and CE Mark approvals by the second half of 2025.
The success of these telesurgeries underscores the potential of advanced surgical technology in overcoming geographical barriers, enabling timely and precise medical care. It also marks a significant step forward in making high-quality healthcare accessible to underserved communities, particularly in rural areas.
SS Innovations International (SSII) announced the completion of BDO India LLP's re-audit of its 2022-2023 financial statements, following the termination of its previous auditor BF Borgers CPA PC. The re-audit revealed material errors in prior statements, leading to restated financials showing improved metrics: shareholders' equity increased by $5.42 Million to $19.72 Million, and working capital surplus rose by $3.85 Million to $12.96 Million.
The company has withdrawn its Form S-1 Registration Statement and plans to uplist to NASDAQ without completing the previously contemplated offering. SSII reports over 2,500 completed robotic surgical procedures using its SSi Mantra Surgical Robotic System, with systems now installed in 5 countries, including recent expansion to Indonesia where it completed the country's first robotic cardiac surgery.
SS Innovations International (OTC: SSII) has achieved a significant milestone by becoming the first company in India to receive CDSCO regulatory approval for Telesurgery and Teleproctoring capabilities of its SSi Mantra surgical robotic system. This breakthrough enables remote surgical procedures and training, particularly benefiting patients in rural areas with access to specialized medical care.
The SSi Mantra system features advanced capabilities including 3-5 robotic arms, a 3D 4K monitor, and over 40 different types of robotic endo-surgical instruments. The system has been clinically validated in India across more than 80 different surgical procedures. The company is currently seeking FDA and CE Mark approvals, anticipated in the second half of 2025.
SS Innovations International (OTC: SSII) has achieved a significant milestone by completing Indonesia's first robotic cardiac surgery using its SSi Mantra Surgical Robotic System at Harapan Kita National Cardiac Hospital in Jakarta. Dr. Sudhir Srivastava, the company's Founder and CEO, performed the first Beating Heart Totally Endoscopic Coronary Artery Bypass (TECAB), followed by 7-8 additional robotic-assisted procedures. The procedures included bilateral IMA CABG, ASD Repair, and TECAB surgeries. This achievement marks a significant advancement for Indonesia's healthcare sector, with its population of over 284 million and nearly 3,000 hospitals.
SS Innovations International, Inc. (OTC: SSII) has announced the addition of Tim Adams to its Board of Directors as an Independent Director. Mr. Adams, a healthcare executive with over 40 years of experience, currently serves as a Regional Operating Officer at Ascension, overseeing high-growth Horizontal Business Units. His extensive background includes leadership roles at major healthcare providers such as Tenet Healthcare , Community Health Systems, and HCA.
Dr. Sudhir Srivastava, SS Innovations Chairman and CEO, expressed enthusiasm about Mr. Adams joining during a phase of global growth. The company recently launched the SSI Mantra 3, an advanced surgical robotic system designed for multi-specialty usage. SS Innovations is currently seeking FDA approval and anticipates receiving marketing approval in the second half of 2025.
SS Innovations International, Inc. (OTC: SSII) has announced a significant milestone: over 2,000 successful robotic surgeries performed using its SSi Mantra Surgical Robotic System, primarily in India. This achievement underscores the company's commitment to making advanced surgical technologies accessible globally.
The SSi Mantra system has been praised for its ergonomic design and precise controls, facilitating minimally invasive procedures and improving patient outcomes. It has been installed in numerous Tier 2 and Tier 3 cities across India, as well as in Nepal, marking the country's first surgical robot.
Of the 2,000 surgeries, 123 were cardiac cases, demonstrating the system's versatility. The company's focus on 'democratizing access' and 'decentralizing excellence' in healthcare is evident in its efforts to make world-class robotic surgery affordable and accessible to a larger global population.
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 (OTC: SSII) has announced the addition of Dr. Fredric Moll to its Board of Directors as Vice Chairman. Dr. Moll, known as the 'father of surgical robotics', brings extensive industry experience as the founder of Intuitive Surgical and developer of the da Vinci surgical robotic system. He recently served as Chief Development Officer for Johnson & Johnson Medical Devices Companies and was co-founder and CEO of Auris Health.
SS Innovations recently launched the SSI Mantra 3, an advanced surgical robotic system designed for multi-specialty usage. The company is currently seeking FDA approval, expected in late 2025. Dr. Moll's appointment comes at a time of global growth for SS Innovations, with the company aiming to make robotic surgery more affordable and accessible worldwide.
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 (OTC: SSII), a developer of surgical robotic technologies, has issued an update on its audit process and trading status. The company's previous auditor, BF Borgers CPA PC, was barred by the SEC, leading to the appointment of BDO India as the new auditor. SSII is undergoing a reaudit of its financial statements for 2022 and 2023, along with an internal review of accounting policies and controls.
Due to delayed filings, SSII's stock has been moved to the Expert Market Tier with liquidity. The company is working to complete the reaudit and become current with SEC reporting to restore its OTC Pink Tier status. Despite these challenges, SSII's operations and growth remain unaffected. The company recently added two experienced independent directors to its board and continues to develop its SSi Mantra surgical robotic system.
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