Bengaluru Organisation Gets US FDA, EU Approval For Medical Device That Can Neutralise COVID-19

A Bengaluru-based organisation received approvals from the US Food and Drug Administration and the European Union for a device that can contain the spread of novel coronavirus. Approval for manufacturing came in last week, officials said.

The device named Shycocan- Scalene Hypercharge Corona Canon, is a small drum-like device, which can be fixed in offices, schools, malls, hotels, airports or any closed area for disinfecting surfaces. The device has been proven 99.9 per cent effective in neutralising the Spike-Protein or S-protein that are present in this virus, thus completely cutting off its transmission from one person to another.

However, it does not cure an infected person but is highly efficient in containing the spread of deadly viruses in public areas, especially indoor spaces.

"We have given a 'humanitarian' licence to a few companies in India and abroad to manufacture this," says chairman of the Bengaluru-based Organisation De Scalene Dr Rajah Vijay Kumar, whose brainchild it is.

Europe, Mexico and the US-based companies have also approached for licences and we would be giving permission to manufacturers allowing the production of the device in large numbers as the demand will spike in coming days, Kumar said in an interview with News18.

"We have done studies on how it performs -- it neutralises the Spike protein or the S protein that is basic to the novel-coronavirus' structure. So if you deploy this device everywhere, possibly there will be global



containment of the virus," Dr Kumar added.

The device was first shipped to the United States in March for its due testing. And lab tests have shown that that one device can cover about 10000 cubic metres area.

HOW DOES IT WORK?

The device floods a room or any indoor spot with many electrons - regardless of whether a tainted individual comes into such a spot, the electrons noticeable all around would kill the intensity of the infection in the pressurized canned products brought about by wheezing, hack, and so on. It further kills the infections that stick to surfaces. Subsequently radically diminishing the transmission by means of surface-or airborne transmission.

"We have got clearance from the US FDA agency under an enforcement directive for Covid-19 health emergencies. For the European Union too, we have got the Conformite' Europeene, or the certificate of conformity for which the Shycocan was put through nearly 26 tests - such as safety, efficacy, whether it has any harmful effects, whether it interferes with the working of other devices, or whether other devices deployed in any place would interfere with the performance of this device. It has been cleared through all this," Dr Kumar said.

Talking about the cost and manufacturing of the device, Dr Kumar added that the licence-holders would be fixing the cost and so far, in India, about nine companies have shown interest in manufacturing it, and three companies have already entered into a licensing agreement.