Shreis Compiles 510K Market Clearance Application for the SHYCOCAN® Device That Disables Coronaviruses
GAITHERSBURG, Md., April 19, 2021 /PRNewswire/ -- 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. "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.
About Shreis Scalene Group of LLCs - Shreis Scalene Therapeutics LLC prioritized the SHYCOCAN® device project to meet emergent needs during the COVID-19 Public Health Emergency. The Shreis Scalene Group of Therapeutic and Diagnostic medical device companies is head-quartered in Montgomery County, MD. Together with the Inventor and Technology partner, Dr. Rajah Vijay Kumar, the Shreis Scalene Group is bringing novel, non-invasive, engineering solutions to human health problems. These include the CYTOTRON® with US-FDA Breakthrough Designation granted for solid tumors of the Breast, Liver and Pancreas (among other solid tumors clinically validated in off-shore clinical studies); tissue regeneration (in musculoskeletal disorders, degenerative respiratory disorders, wound healing etc.); the CELLFORN® for safe, non-invasive cancer drug delivery, and the HAEMOSEIS-256® - a diagnostic cardiovascular disease detection device; for North and South American markets, including Mexico and the Caribbean. Shreis' mission is to introduce leading-edge platform technologies that will impact the survivorship experience with quality of life, and continue to offer global solutions for safe, patient-centric, affordable healthcare.
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SOURCE Shreis Scalene Therapeutics LLC