Shreis Scalene Therapeutics LLC (SSTx), a MD-USA-based medical device company will fast-track the manufacture and distribution of the CE-marked (EU-Class 1) Scalene Hypercharge Corona Canon (SHYCOCAN) under US FDA ‘Enforcement Policy for Sterilizers, Disinfectant Devices, and Air Purifiers During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.”
“Although the pandemic continues to rage globally, plans are afoot to reopen schools, places of worship and restaurants among other workplaces, raising wide-spread concerns. We are confident that our unique approach to disable the air and surface-borne spread of CoVs, will meet an emergent need,” said Prof. Meena Augustus, Founder-President, CEO & CSO of SSTx. The SHYCOCAN device inventor, Dr. Rajah Vijay Kumar – Chairman and Chief Scientific Officer of the Organization de Scalene and Scalene Cybernetics Ltd. in Bengaluru, India, and long-standing technology partner of the Shreis Scalene Group of US Companies, said, “This innovative technology is intended to ‘physically attenuate’ the homing mechanism on the virus and prevent infectivity.” The device is designed to release a very high concentration of environmentally safe electrons using proprietary Photon-Mediated Electron Emitters (PMEEs) made with a superalloy developed by Scalene, applying well-known principles of physics, to emit and excite photons with the required kinetic energy. As the photons bombard bulk surfaces and suspended particles in confined environments, the emanated electron cloud actively ‘disarms’ air and surface transmission of the Corona family of viruses. The SHYCOCAN does not use any chemicals nor does it produce ozone, or ionize the air to produce reactive oxygen species, oxides of nitrogen or other harmful compounds. The device can be safely deployed in all environments inhabited by people, be it very large or small enclosed spaces.
The attachment of the SARS-CoV-2 to the host cell receptor is mediated by the spike protein (S-protein). The hypercharge electrons flooding exposed areas are ‘attracted’ to the virus’ S-protein, thereby disabling infectivity. Data from lab studies have indicated significant viricidal impact with a 3.435 Log10 reduction demonstrated in an EPA-approved phylogenetic surrogate, resulting in 99.9% reduction in infectivity. There is also emerging evidence for the significant disabling of the Influenza B viral capsid (a strain within the corona virus family), by the SHYCOCAN. The device can also possibly be deployed in pig and chicken farms to prevent the transmission of the G4-EA-H1N1 virus, described as being highly adapted to infect humans.
“An important feature of this technology is that only the Corona family of viruses is targeted, while bacteria, fungi or other eco-friendly micro-organisms are not, allowing for 24/7, safe deployment,” clarified Dr. Kumar.
Initiatives surrounding the R&D on the device prototype began in April 2019, to stem the decline in work force productivity due to the common cold and seasonal Influenza in Scalene’s facilities. Over the last 6 months, Dr. Kumar and his team have worked tirelessly and successfully completed extensive EU-CE – mandated safety testing undertaken by the Underwriters Laboratories (UL). Scalene has since obtained the CE Mark with Class I designation, enabling the expedited manufacture, distribution, and sales in all CE-compliant countries/markets, including India.
“The phased deployment of the SHYCOCAN is being discussed with a top tier global manufacturing company for mass production and distribution,” said Rayol John Augustus Ph.D., Co-Founder and COO of SSTx and the Founder President of the Shreis Group of Medical Device companies. “As a humanitarian project, Shreis has reached out to several key opinion leaders and decision makers, with the intent of prioritizing deployment of SHYCOCAN devices in all high-risk and essential service environments,” said Mr. David E. Garnett, Chief Strategist for SSTx, and Founder-President of iAM Solutions LLC., in VA.
“Physically attenuating and disabling active viral transmission with a design-registered device using patent-protected PMEEs, the SHYCOCAN will help create ‘safer zones’ in homes, health care facilities, grocery chains, eateries, schools, daycares, places of worship, and residential, corporate, industrial and sporting environments, to fill unmet needs,” according to Dr. Augustus. “The low-cost, plug and play device, that can be safely installed in a large variety of indoor settings, makes it a very practical and complimentary solution – along with the use of personal protective equipment (PPE), where necessary – to reduce burdens of indefinite social distancing.”
The overarching support of Emergo (by UL), during US-FDA’s pre-EUA interactive review of the SHYCOCAN device, enabling SSTx’ expeditious manufacture, marketing, and distribution under the Enforcement Discretion guidance, is acknowledged.
Source: Company Press Release
