FDA grants breakthrough designation to device invented by Indian scientist

A device invented by Indian scientist Dr Rajah Vijay Kumar has been granted Breakthrough Device Designation by FDA for Treatment of Breast, Liver, and Pancreatic Cancers. The device helps in tissue engineering of cancer cells to modify how specific proteins are regulated to stop multiplying and spreading of the cancer cells. Cytotron was invented by Dr Kumar at the Centre for Advanced Research and Development (CARD)after around 30 years of research in understanding cellular pathways and interactions with specifically modulated fast radio bursts. The research details of the device have been published in the Journal of Clinical & Experimental Oncology.

The Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA) has granted 'Breakthrough Device Designation' for the CYTOTRON® - a CE marked, whole-body therapeutic medical device.

Dr. Rajah Vijay Kumar D.Sc., Inventor of the Cytotron® and Shreis' technology partner, at Scalene Cybernetics Ltd (SCL), and the Scalene Center for Advanced Research & Development (S-CARD), located in Bengaluru, India, said, "The clinical trial with this non-invasive, tissue engineering platform technology called Quantum Magnetic Resonance Therapy (QMRT®) could eventually help to establish the Cytotron® as an integral adjunct to existing standards of care in the cancer armamentarium."(Cytotron® Publication, 2016)

"We are confident that the FDA will continue to interact with Shreis under the premises of the recent guidance (Breakthrough Devices Program), to enable the marketing submission, with the clinical datasets needed to support it," said Prof. Meena Augustus, Co-Founder CEO & CSO of Shreis. The company's designation request stated that "The Cytotron® is intended to be used to cause degeneration of uncontrolled growth of tissues. It is indicated for treating protein-linked, abnormally regenerating disorders such as neoplastic disease, by selectively targeting and enabling tissue apoptosis, allowing extended progression-free survival, with pain relief, palliation, improved quality and dignity of life. It is indicated for the treatment of solid tumours of the breast, liver, and pancreas."

"We are very encouraged by the breakthrough designation that will expedite the review of an Investigational Device Exemption and future marketing application by the FDA, " said Rayol John Augustus Ph.D., Founder-President and COO of SSS-LLC. The diligent support of Dr R.V. Kumar D.Sc., the dedicated efforts of Emergo by UL based in Austin, Texas, the Shreis' regulatory team, the staff of SCL and S-CARD, helped ensure a favourable decision by the FDA.

Series, while actively pursuing collaborations for clinical trials in the currently proposed indications for use, intends to also submit a request for Breakthrough designation in other solid tumours such as adult and pediatric brain tumours, lung cancer, and other life-limiting diseases.

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