SS Innovations International Performs World’s First Robotic Cardiac Telesurgeries with its SSi Mantra 3
Tag: SS Innovations International
SS Innovations Engages BDO as its new Auditor
FORT LAUDERDALE, Fla., May 31, 2024 (GLOBE NEWSWIRE) — SS Innovations International, Inc. (the “Company” or “SS Innovations”) (OTC: SSII), a developer of innovative surgical robotic technologies dedicated to making world class robotic surgery affordable and accessible to a global population, today announced that it has engaged BDO India LLP (“BDO”) as its independent registered public accounting firm. The Company believes that the selection of BDO will facilitate SS Innovations’ strategy to uplist its common stock to a National Securities Exchange. In addition, the engagement of BDO reflects the Company’s commitment to transparent financial and accounting practices and regulatory compliance. SS Innovations has demonstrated significant operational success, reporting 32 successful installations of its flagship SSi Mantra Surgical Robotic System in medical facilities across India. This innovative robotic surgical system has been integral to the launch of four cardiac surgery programs, broadening the spectrum of robotic cardiac surgeries available in India. For the quarter ended March 31, 2024, SS Innovations sold 8 SSi Mantra Surgical Robotic Systems and reported revenues of approximately US $7 million, which exceeds revenues reported for the entire year ended December 31, 2023. “SS Innovations is committed to democratizing access to quality healthcare while ensuring transparency for our shareholders,” stated SS Innovations’ Founder, Chairman and Chief Executive Officer, Dr. Sudhir Srivastava. “The engagement of an audit firm of the caliber and reputation of BDO is a crucial component of this commitment, serving as a bridge to our uplisting strategy and reflecting our dedication to open and transparent financial and accounting practices. This initiative is part of our broader mission to bring advanced, precise surgical solutions to every corner of the globe and to make top-tier medical care accessible to all.” Barry Cohen, COO of the Americas for SS Innovations, added, “Engaging BDO as our auditor is a strategic move which we believe will facilitate our journey to uplist our common stock to a National Securities Exchange. Our operational achievements, demonstrated by over 1,200 operations performed using the SSi Mantra, showcase our readiness for sustained, long-term growth. This is not just a procedural step but an instrumental one, which will help prepare us for the next phase of expansion, and help solidify our market position.” Mr. Cohen further noted, “The SSi Mantra has been clinically validated in 70 types of surgical procedures, demonstrating mitigation of R&D risk. We are targeting a global market, beginning with India, which alone has a population of 1.4 billion people and about 70,000 hospitals. We have begun to capture market share in India with our 32 SSi Mantra installations. We look forward to continuing to showcase SSi Mantra’s affordability, reliability and unique capabilities in a diverse and demanding healthcare environment.” 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 has received Indian Medical Device regulatory approval (CDSCO) and is clinically validated in India in more than 60 different types of surgical procedures. The Company has initiated the regulatory approval process in the United States and the EU, with approvals anticipated in 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’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. For more information: PCG AdvisoryJeff Ramsonjramson@pcgadvisory.com
SS Innovations’ SSi Mantra Surgical Robotic System Used to Perform 100 Cardiac Surgeries, Signaling Market Expansion
• The SSi Mantra has surpassed the 100 surgery milestone for robotic cardiac surgery• SS Innovations maintains the world’s only comprehensive robotic cardiac surgery program• SSi Mantra used in more than 1000 procedures globally• Company anticipates FDA approval in early 2025 FORT LAUDERDALE, Fla., May 21, 2024 (GLOBE NEWSWIRE) — SS Innovations International, Inc. (the “Company” or “SS Innovations”) (OTC: SSII), a developer of innovative surgical robotic technologies dedicated to making world class robotic surgery affordable and accessible to a global population, today announced that 100 robotic cardiac surgery procedures have been successfully performed with the Company’s SSi Mantra Surgical Robotic System. Dr. Sudhir Srivastava, SS Innovation’s Chairman and CEO, commented, “Reaching this milestone with the SSi Mantra is another notch in SS Innovations’ strategic market expansion—transforming practices, enhancing access, and driving the widespread use of robotic surgery. The Mantra’s innovative design, featuring a fifth arm capability, uniquely enables it to perform complex cardiac surgeries—a high demand market previously without an effective robotic solution. Cardiac surgery often still requires a maximally invasive approach that involves splitting the patient’s sternum to gain access. “Our approach enables the same surgeries to be performed with minimal invasiveness, exemplifying the SSi Mantra system’s unique value proposition: precise execution, less trauma, reduced blood loss, quicker recoveries, lower cost and superior overall outcomes. We anticipate receiving FDA approval in the US and CE Mark approval in Europe in early 2025, further enhancing our market position.” In 2023, the global cardiac surgery device market was valued at $17.1 billion, according to ResearchAndMarkets, and is expected to grow at a rate of 5.5%, reaching $24.9 billion by 2030. The global surgical robotics market size was valued at $78.8 billion in 2022, and is projected to reach $188.8 billion by 2032, growing at a CAGR of 9.1% from 2023 to 2032. SS Innovations has established the world’s only comprehensive robotic cardiac surgery program, successfully executing procedures such as Totally Endoscopic Coronary Artery Bypass (TECAB), Internal Mammary Artery (IMA) Takedown, Mitral Valve Replacement, and Bilateral Internal Mammary Artery (BIMA) Takedown, all using the advanced SSI Mantra system. Dr. Srivastava further emphasized, “We see a significant opportunity to address the global need for safe, timely, and affordable cardiac care. The successful use of the SSi Mantra in cardiac surgeries is transforming practices and setting the path to boost global adoption of robotic surgery. This progress offers patients less invasive options and improved quality of life while positioning the Company to accelerate momentum and gain market share in valuable procedural territories.” Dr. Nitin Kumar Rajput, Senior Consultant in Cardiac Surgery at Narayana Institute of Cardiac Sciences in Bangalore, India, individually performed about half of the surgeries, completing 47 robotic cardiac procedures. He commented, “I have found that SS Innovations now has the most advanced system for coronary and intracardiac robotic cardiac surgeries, and we have performed bypass procedures, valve repairs and atrial septal defect closures. I believe that most robotic cardiac surgical procedures in the future will be done on the SSI Mantra Surgical Robotic System.” 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. SS Innovations has partnered with Johns Hopkins University, installing the SSi Mantra at the University’s Minimally Invasive Surgical Training and Innovation Center (MISTIC) in Baltimore, MD. This installation is actively training new surgeons and promoting the global dissemination of advancements in medical robotics. The SSi Mantra system has received Indian Medical Device regulatory approval (CDSCO) and is clinically validated in India in more than 70 different types of surgical procedures. The Company expects regulatory approvals from the US Food and Drug Administration (FDA) and CE Mark in Europe in early 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’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. For more information: PCG AdvisoryJeff Ramsonjramson@pcgadvisory.com
SS Innovations International Announces Q1 2024 Company Updates
Significant milestones achieved for SSi Mantra Made-in-India surgical robotic system FORT LAUDERDALE, Fla., April 22, 2024 (GLOBE NEWSWIRE) — SS Innovations International, Inc. (the “Company” or “SS Innovations”) (OTC: SSII), a developer of innovative surgical robotic technologies dedicated to making world class robotic surgery affordable and accessible to a global […]
SS Innovations’ SSi Mantra Surgical Robotic System used to perform Mitral Valve Replacement
The first Mitral Valve Replacement using the Made in India SSi Mantra Surgical Robotic System was successfully performed at the Narayana Institute of Cardiac Sciences in Bengaluru, IndiaFORT LAUDERDALE, Fla., March 12, 2024 (GLOBE NEWSWIRE) — SS Innovations International, Inc. (the “Company” or “SS Innovations”) (OTC: SSII), a developer of innovative surgical robotic technologies dedicated to making world class robotic surgery affordable and accessible to a global population, today announced that surgeons have successfully performed the world’s first mitral valve replacement using the Made in India, SSi Mantra Surgical Robotic System. This procedure was carried out at the Narayana Hrudayalaya Institute of Cardiac Sciences in Bengaluru, India, and represents a milestone in the treatment of heart disease using the SSi Mantra Surgical Robotic System. The mitral valve surgery was performed by Dr. Nitin Kumar Rajput from the Narayana Institute of Cardiac Sciences in Bengaluru, Karnataka, and guided by SS Innovations Founder and Chairman, Dr. Sudhir Srivastava, one of the early pioneers of robotic cardiac bypass surgery. Considering this accomplishment, Dr. Srivastava commented, “We are very proud of our team for pushing the envelope to be able to add the field of full spectrum robotic cardiac surgery to all other surgical subspecialties. 90-95% of all cardiac surgeries are still done today using large sternum splitting incisions. Since the inception of the Company, it was always our goal to address the need of offering a highly minimally invasive solution for cardiac patients. “During my practice in the US, I found that patients benefited immensely from surgical approaches which spared splitting of the sternum. Many patients would be discharged the following day and in full functional recovery in just a week to ten days later. The results were inspiring. This led me to develop more complex robotic bypass procedures that were adopted by other surgeons and would ultimately benefit more and more patients who underwent heart surgery. “We are very proud that using our Made in India, SSi Mantra Surgical Robotic System, we have performed a variety of robotic heart surgeries including, Bilateral Internal Mammary Takedowns, Totally Endoscopic Coronary Artery Bypass on a beating heart, Atrial Septal Defect Repair and now a completely robotic Mitral Valve Replacement. I am very pleased that our original goal is now being met in conjunction with the highly talented surgeons at the Narayana Institute of Cardiac Sciences.” Dr. Nitin Kumar Rajput, Consultant Cardiac Surgeon from Narayana Health, the primary surgeon on the Mitral Valve Replacement, commented following the successful completion of the procedure, “We have performed more than 60 CABGs (Heart Bypass Procedures) with the SSi Mantra Surgical Robotic System and we just did our first Robotic Mitral Valve Repair a few days back. The surgery went flawlessly, and it was wonderful operating with the Mantra System. Four ports were made for the robotic arm and a tiny 2.5 cm working port for the table side assistant. The surgery was completed quickly; the patient did well in the postoperative period and was discharged with good exercise tolerance three days post-surgery.” Dr. Srivastava said: “SS Innovations is dedicated to improving patient access and optimizing surgical outcomes with our accessible and cost-effective surgical robotic system. We recognize the immense opportunity to address the significant unmet need for safe, timely, and affordable cardiac surgical care in India and around the world.” “This milestone procedure is a testament to our commitment to advancing cardiac care. The successful operation opens new avenues for treating cardiac conditions, offering patients less invasive options, reduced recovery times, and better results.” “The SSi Mantra embodies innovation and excellence and provides unmatched precision and control in robotic-assisted surgeries. Today’s success is a proud moment for everyone at SS Innovations and our partners at Narayana Hrudayalaya,” concluded Dr. Srivastava. The mitral valve disease market size was valued at $2.5 billion in 2021 and is estimated to reach $5.7 billion by 2031, growing at a CAGR of 8.8% from 2022 to 2031. The SSi Mantra Surgical Robotic System, the first surgical robotic system to be made in India, and one of the few cost-effective global options with a wide range of surgical applications, has received regulatory approval in India, Indonesia and Guatemala, and is clinically validated for over 50 different types of surgical procedures. To date, more than 800 surgical procedures have been conducted using the system. SS Innovations has initiated the regulatory approval process in the United States and the EU, with approvals anticipated in the latter half of 2024 or 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 Narayana Institute of Cardiac Sciences Narayana Institute of Cardiac Sciences is a JCI and NABH accredited heart hospital situated in NH Health City, Bangalore. This super-specialty flagship cardiac hospital of Narayana Health is one of the largest in the world and is equipped with 16 dedicated Cardiac Operation Theatres and 6 Digital Cath Labs of which one is a Hybrid, capable of performing both interventional cardiac procedures as well as complex heart surgeries. Narayana Institute of Cardiac Sciences performs heart surgeries both on adults and children. This cardiac center has dedicated critical care beds for post-operative care and performs Cath Lab procedures routinely. It also has an 80-bed dedicated pediatric cardiac ICU, the largest in the world. Narayana Institute of Cardiac Sciences specializes in complex cardiac surgeries and other cardiac procedures such as Pulmonary Endarterectomy for chronic pulmonary embolism, Aneurysm repairs, Electrophysiology, Endovascular interventions for aneurysms and radio frequency ablations, Valve repairs and ROSS procedures, Left Ventricular remodeling / Dor’s procedure, device closure for ASD and VSD and Tetralogy of Fallot. Thrombosis Research Institute in the hospital campus is a notable unit for research and has several scientists working in collaboration with TRI, London to develop a vaccine to prevent heart attacks. For more information, visit Narayana Health’s website at https://www.narayanahealth.org. 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 50 different types of surgical procedures. The company expects to seek regulatory approvals from the US Food and Drug Administration (FDA) and CE Mark in Europe in 2024 and 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’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. For more information: PCG AdvisoryStephanie Princesprince@pcgadvisory.com (646) 863-6341
SS Innovations Announces Filing of Pre-Submission Application to the Center for Devices and Radiological Health (CDRH) of the United States Food and Drug Administration
FORT LAUDERDALE, Fla., Jan. 26, 2024 (GLOBE NEWSWIRE) — SS Innovations International, Inc. (the “Company” or “SS Innovations”) (OTC: SSII), a developer of innovative surgical robotic technologies dedicated to making robotic surgery affordable and accessible to a global population, today announced that it has filed a pre-submission application with the U.S. […]
SS Innovations Achieves Significant Milestones in 2023
Company’s award winning SSi Mantra surgical robotic system has completed over 550 surgeries and is clinically validated to perform more than 40 different types of surgical procedures Company Builds Strong Foundation for Future Growth FORT LAUDERDALE, Fla., Jan. 08, 2024 (GLOBE NEWSWIRE) — SS Innovations International, Inc. (the “Company” or […]
SS Innovations Appoints Dr. Sonia Shokeen as Head of Quality and Regulatory Affairs
Dr. Shokeen brings over 15 years of medical device experience, including time spent at Johnson & Johnson FORT LAUDERDALE, FL, Oct. 30, 2023 (GLOBE NEWSWIRE) — via NewMediaWire — SS Innovations International, Inc. (the “Company” or “SS Innovations”) (OTC: SSII), a developer of innovative surgical robotic technologies dedicated to making […]
SS Innovations Receives Regulatory Approvals from the Guatemala Ministry of Health
The Mantra Surgical Robotic System has been given the approval to be used for clinical use in Guatemala, marking the Company’s first regulatory approval in Central America FORT LAUDERDALE, FL, Oct. 10, 2023 (GLOBE NEWSWIRE) — via NewMediaWire – SS Innovations International, Inc. (the “Company” or “SS Innovations”) (OTC: SSII), […]
SS Innovations Launches Innovative Robotic Cardiac Surgery Program in India
FORT LAUDERDALE, FL, Oct. 03, 2023 (GLOBE NEWSWIRE) — via NewMediaWire – SS Innovations International, Inc. (the “Company” or “SS Innovations”) (OTC: SSII), a developer of innovative surgical robotic technologies dedicated to making robotic surgery affordable and accessible to a global population, today announces the launch of an innovative robotic cardiac surgery program […]