USFDA designates Indian invention a ‘breakthrough device’ for cancer

BENGALURU: The Centre for Devices and Radiological Health (CDRH) of the US Food and Drug Administration (USFDA) has designated Cytotron—a device invented in India by a Bengaluru scientist—as a “Breakthrough Device” in the treatment of liver, pancreas and breast cancers.

Cytotron aids in tissue engineering of cancer cells to alter or modify how specific proteins are regulated to cause cancer cells to stop multiplying and spreading.

Cytotron was invented in India by Rajah Vijay Kumar at the Centre for Advanced Research and Development (CARD) after nearly 30 years of research in understanding cellular pathways and interactions with specifically modulated fast radio bursts.

“It is been a great feeling that after so many years of hard work against all odds, a prestigious institution like the USFDA is designating our work as a “breakthrough” in the treatment of three notorious cancers,” Kumar said in a statement.

He told TOI that the recognition—which comes his way because there haven’t been any new technologies in cancer treatment—is more valuable because it is unheard of that an Indian device gets a ‘breakthrough’ status assigned to it by the US.

UAE, Malaysia & other countries

“The devices will all be made in India given that there are hardly any imported components. And our partner in the US will take the device to there for the benefit of the American people. Cytotron is already an approved medical device and is in use in countries like the UAE, Mexico, Malaysia, and even in Hong Kong, among others,” Kumar told TOI.

A communique from CDHR said that 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, and allowing extended progression free survival, with pain relief, palliation, improved quality and dignity of life. It is indicated for the treatment of solid tumors of breast, liver and pancreas – We are pleased to inform you that your device and proposed indication for use meet the criteria and have been granted designation as a Breakthrough Device,” CDHR said in a letter to Shreis Scalene Sciences, the firm that has taken the device to the US.

How it works

Generically known as rotational field quantum magnetic resonance, Cytotron uses Fast Radio Bursts (FRB)—a high energy and powerful short radio bursts—in which both electric and magnetic components of the electromagnetic signals are “circularly” polarized.

FRBs are produced when a radio signal is travelling through a powerful instantaneous magnetic field on its path to the target.

“FRBs can be used to communicate with the cellular command and control, to up or down regulate a specific protein or gene. In cancer cells, Cytotron does two things:First, it alters the protein pathways of a pro-apoptosis protein called p53 via p21 inducing programmed cell death in the cancer cells, and secondly, exposure to Cytotron stops metastasis by inhibiting the Epithelial Mesenchymal Transition cells, responsible for spread of cancer; 90% cancer patients die due to metastasis,” the statement reads.

Source:https://health.economictimes.indiatimes.com/news/medical-devices/usfda-designates-indian-invention-a-breakthrough-device-for-cancer/72007663

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