Perfint Healthcare Secures USFDA Clearance for MAXIO

Perfint Healthcare Secures USFDA Clearance for MAXIO

Perfint Healthcare, a world leader in planning and targeting solutions for image guided interventional procedures in Oncology and Paincare, today announced that the company received the 510(K) clearance from the USFDA for commercial marketing of its MAXIO  in the United States.

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 of 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.”

Commenting on other recent achievements and plans Mr. Nandakumar S added “We were recently awarded 3 patents by the US Patent office for our technologies. We also obtained the China FDA clearance recently. We hope to ramp in the USA and China in the coming quarters. We are raising additional equity capital to fund our next product roadmap and growth in global markets. Some of that funds will also be used for international acquisitions.  We hope to achieve Rs 500 Cr in revenue in the next few years.”

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. 

Perfint has successfully raised $32.7MM through 4 rounds of venture funding with prominent investors such as IDG Ventures, Accel India Ventures, and Norwest Venture Partners participating. The company has a strong presence in India, APAC, Middle East, Europe & Australia among others and now eying lucrative markets like China and USA to further expand its global presence.