Shreis Scalene Therapeutics (SSTx), a Md.-based medical device company has fast-tracked the marketing and distribution of the CE-marked (EU-Class 1) Scalene Hypercharge Corona Canon (SHYCOCAN), which is currently market-enabled under the U.S. 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 510(K) market clearance application for the 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 U.S. FDA and CE-compliant countries in neighboring Latin America and Caribbean countries,” says Meena Augustus PhD, founder-president, CEO and CSO of SSTx.
“This device has been safety-certified to be deployed 24/7 in almost all enclosed indoor environments,” Augustus adds. “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.”
Rayol John Augustus, PhD, co-founder and COO of SSTx, also spoke out about the product, stating: “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, DSc, in Bengaluru, India, while SSTx gears up to meet the growing demand from within North America and South America.”
Rayol John Augustus adds, “To continue to mass produce and market the product, SSTx is in the process of identifying internationally reputed, domestic contract manufacturing collaborations.”