April 19, 2021
Shreis Scalene Therapeutics LLC (SSTx), a MD-USA-based medical device company has fast-tracked the marketing and distribution of the CE-marked (EU-Class 1) Scalene Hypercharge Corona Canon (SHYCOCAN®), that is currently market-enabled under “US FDA’s ‘Enforcement Policy for Sterilizers, Disinfectant Devices, and Air Purifiers During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency.”
To enable uninterrupted marketability, SSTx is now compiling a 510K market clearance application for the US FDA, with regulatory support provided by EMERGO (by UL).
“Significant strides have been made by SSTx in collaboration with technology partner Scalene Cybernetics Limited, Bengaluru, India, to facilitate the submission of technical and biological validation dossiers to the regulatory bodies in neighboring countries, through its collaborative marketing and distribution partners, leading to additional marketing authorizations from Mexico’s COFEPRIS as a Class I device, Health Canada’s Class I device classification for marketing under an MDEL in Canada, and other US FDA and CE compliant countries in neighboring Latin America and Caribbean countries” said Prof. Meena Augustus Ph.D., Founder-President, CEO & CSO of SSTx.
Prof. Augustus added, “This device has been safety-certified to be deployed 24/7 in almost all enclosed indoor environments. No ultraviolet light, filter-systems, hazardous ozone, or other harmful chemical emission occurs with the SHYCOCAN®. A salient feature of this technology that has also been biologically validated, is that while viruses are targeted, beneficial bacteria, fungi or other micro-organisms, human and mammalian epithelial cells are not, making it eco-, people, and pet friendly.”
“The SHYCOCAN® with its innovative technology that delivers photoelectrons in real-time, is currently being marketed in other global regions of the world by Dr. Rajah Vijay Kumar D.Sc., in Bengaluru, India, while SSTx gears up to meet the growing demand from within N. & S. America. To continue to mass produce and market the product, SSTx is in the process of identifying internationally reputed, domestic contract manufacturing collaborations,” said Rayol John Augustus Ph.D., Co-Founder and COO of SSTx and the Founder President of the Shreis Group of Medical Device companies.