(Sponsored Content) SS Innovations International (SSII), based in Fort Lauderdale, Florida, is a commercial-stage medical device and services company focused on the development, manufacturing, sale, and support of medical and surgical robotic systems. The company is at the early stages of a commercialization strategy through which it aims to make robotic surgery accessible to a larger part of the global population, supported by cost-effectiveness and product differentiation, writes Steve Silver, analyst at Argus Research.
In our view, the company is well positioned to benefit from the global trend of aging populations coupled with the need to deliver healthcare more effectively and efficiently. Its robotic product suite holds the promise of improving function, thus lowering morbidity and improving overall outcomes, as smaller incisions associated with the product result in lower infection rates.
Since the initial commercial introduction of medical robotic technology more than 20 years ago, robotic assisted surgery has successfully reduced the risk of pain and infection, and also shortened recovery times. Recently, miniaturization and adaptability became the focus of the industry. We think its flagship “Mantra” surgical system is well positioned to capitalize on these trends.
To date, Mantra has completed two successful clinical trials encompassing more than 380 surgeries, and over 100 surgeons have been trained on the system. The platform has been validated in India to perform more than 40 different types of surgical procedures, including cardiac surgery.
In addition to distinct product features that represent key product differentiation to current market leaders, we see the product further enhanced by proprietary software that is able to take any diagnostic imaging (CT, MRI) and on the fly, configure a 3D model that has been reconstructed specifically to the anatomy of the patient. This allows surgeons to know exactly where all of the structures are at the outset, thus helping them to navigate a much more efficient and safer procedure.
SS Innovations has also developed solutions to complement Mantra in providing a full-service solution to surgeons and their treatment centers. The company developed the Mudra line of surgical instruments, which currently features more than 35 instruments, and Maya, which offers robotics-based virtual training platforms. The company’s mission is to provide these technologies and services to vast global populations that lack access to this advanced surgical care.
The SSi Mantra system has been cleared by India’s Central Drugs Standard Control Organization (CDSCO), India’s equivalent of the US FDA, and is already clinically validated in India in more than 40 different surgical procedures. Moreover, CDSCO clearance is viewed as a proxy for acceptance by up to 50 other countries.
An additional 79 countries would require registration for clinical use while 16 countries have their own regulatory process independent of both US FDA and European CE Mark. Importantly, once the Mantra system has received regulatory clearance in many global jurisdictions including India, all surgical uses are authorized, rather than requiring approval or completing individually conducted clinical trials. However, procedures may need to be approved for specific indications by the US FDA.
To read the complete Argus Research report on SSII, click HERE.
Disclosure: This is a Company-Sponsored Report from Argus Research. SSII is a paid advertiser of MoneyShow.