27 May 2014 | Regulatory | By BioSpectrum Bureau
(From L-R) Gnanasekar V- principal product architect, Nandakumar S- chief executive officer, Dr. Roy Santhosham, MD, K Puhazhendi â€“ director, global customer support
Singapore: India based Perfint Healthcare, solution provider for image guided interventional procedures in oncology and paincare, has received USFDA approval for commercial marketing of its Maxio in United States.
Perfint's flagship product, Maxio, is an image-guided, physician-controlled stereotactic CT accessory which helps physician see, plan, treat and verify during CT guided procedures like tumor ablation or paincare.
Commenting on the FDA 510(K) clearance, Mr Nandakumar S, chief executive officer, Perfint Healthcare said, "This is a significant milestone in the history of the company. We would like to dedicate this important achievement to the millions fighting cancer and pain. Our products, Maxio and Robio, were used to perform over 2000 patient procedures around the world in the last year. This has been possible due to our focus on patient centricity and clinical excellence."
He added, "The support from the Department of Biotechnology Government of India was timely and helped us reduce cost of R&D. I would like to congratulate my team and thank our clinical advisors for their significant contribution in this milestone achievement."
Mr. Guruswamy K, director-sales, Perfint Healthcare further added, "We have been working with some of the best physicians in the USA over the last several years during the development and validation phases of MAXIO. Studies have been performed at the National Institutes of Health, Bethesda and Memorial Sloan Kettering Cancer Center, New York City. Obtaining the 510(K) clearance allows us to start commercial marketing of MAXIO in the USA. It also makes it easier to scale up in several other markets globally. We are hoping to achieve Rs 100 Crore in revenue this year."
Commenting on this important achievement, Mr. Mohan Kumar, director on board, Perfint and Partner, Norwest Venture Partners said "In 2012, about 2.5 million patients were diagnosed with liver and lung cancer. That number is only growing. Many of them are also inoperable. Maxio has been proven to be very useful in providing tumor ablation therapy for such patients. Perfint with its established user base in Europe and Asia, now with the USFDA clearance, is uniquely positioned in the minimally invasive cancer care space". Perfint is an outstanding example of Bio-Medical engineering that combines Robotics, Imaging software and Medical sciences, They are a terrific team."