Device developed in India granted Breakthrough Device certification from the US FDA.
A path-breaking cancer-treating device, developed in India, by an Indian scientist at the Bengaluru-based R&D facility of an American company, has just received approval from the US Food and Drugs Administration’s (FDA) Center for Devices and Radiological Health, under the Breakthrough Device Program. The machine provides non-invasive tissue engineering that can help treat solid tumours of the breast, liver and pancreas, and is also useful in pain relief and palliative care. Research by Dr Rajah Vijay Kumar, at the Bengaluru-based Scalene Center for Advanced Research and Development, led to the invention of the Cytotron, a device that is based on quantum magnetic resonance therapy (QMRT). The body’s tumour suppression mechanism is reactivated non-invasively by QMRT by targeting calibrated doses of radio- or sub-radio frequency, non-ionising, non-thermal electromagnetic waves at the tumour site. This triggers the production of new tumour suppressing nucleoproteins that lead to apopstosis (programmed cell death).
Cytotron is likely to be of immense benefit in other solid tumours such as adult and pediatric brain tumours, lung cancer and many other life-limiting diseases—the fact that it is lined up for application for Breakthrough Device designation for these cancer types suggests this. The US FDA’s Breakthrough Device Program was intended to expedite access to new, life-saving medical devices for patients with life-threatening diseases. Under the programme, the US FDA guides the development of a product to the extent that it eases pre-market approval while meeting all the norms, and the product is accorded priority in the approval process. Cytotron has been demonstrated to be a unique, non-invasive cancer-treatment device that can target both primary and metastatic cancers simultaneously—thereby meeting a key criterion for being designated as a “Breakthrough Device”. Indeed, Cytotron got the CE mark (the certification required for marketing of such products in the European Economic Area) in 2012 for the whole-body nine axes system that is used in tissue regeneration in osteoarthritis and other musculoskeletal disorders. Apart from this, Cytotron’s technology is also indicated for regrowing cartilage, and treatment of spinal dysplasia and sports injuries.
The invention could mean a new lease of life or vastly improved quality of living at the end-stage for millions of cancer patients around the world. As per the International Agency for Research on Cancer, in 2018, nearly 2.1 million cases of breast cancer, half a million cases of pancreatic cancer and over 800,000 liver cancer cases were detected. The ramifications of the technology are significant for India too—of every two women newly diagnosed with breast cancer, one dies of the disease. With cancer being a major cause of morbidity and mortality in India—the burden has more than doubled over the past two-and-half decades—innovative solutions like Cytotron could prove a manna. The India connection underscores the R&D potential, with the right capital support, that country can tap into.