"This is a Holy Grail from regulatory perspective," said Nandakumar S, co-founder and CEO of Perfint. "This gives us a leverage not only to access the U.S. market, but other global markets as well."
On the back of the FDA approval, the Indian medtech company has kick-started a fundraising process to finance the development of new products.
Maxio is an image-guided, physician-controlled stereotactic computed tomography (CT) accessory which helps physicians see, plan, treat and verify tumors during CT guided procedures like Tumor Ablation or Paincare.
"This (approval) is proof of the pudding for the investors," said Nandakumar, whose firm has raised total funding of $30 million from Norwest Venture Partners, IDG Ventures and Accel Partners.
“We have been working with some of the best physicians in the U.S.A. over the last several years during the development and validation phases of Maxio," said Guruswamy K, sales director at Perfint Healthcare. "Studies have been performed at the National Institutes of Health, Bethesda, (Md.), and Memorial Sloan Kettering Cancer Center in New York City. Obtaining the 510(K) clearance allows us to start commercial marketing of Maxio in the U.S.A. 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.”Perfint sells two robot products — Robio and Maxio in Asia Pacific, India, Middle East, China and Europe at half the price of a typical robotic system.
Founded in 2008 and headquartered in Chennai, India, with an advanced research and development center in Redmond, Wash., Perfint develops interventional oncology solutions. Its two products, Robio and Maxio, are installed at top teaching hospitals worldwide.