Halifax, Nova Scotia – (December 2, 2021) – Sixth Wave Innovations Inc. (CSE:SIXW) (OTCQB:SIXWF) (FSE:AHUH) (“Sixth Wave”, “SIXW” or the “Company”) is pleased to announce the commencement of LIVE VIRUS testing in saliva samples using its patent-pending Accelerated Molecularly Imprinted Polymer (“AMIPs™”) technology relative to SARS-CoV-2 and variants of concern.
The Company along with researchers at the La Ki Shing Institute of Virology are currently testing with AMIPs™ using saliva samples spiked with live SARS-CoV-2 virus by using a protocol similar to an ELISA clinical test. Confirmation studies, as well as additional advanced manufacturing techniques to increase sensitivity levels, are ongoing. These new techniques will simplify test analysis and should lead to further improvements in sensitivity and rejection of interferent molecules that are present in complex saliva samples and other sample collection methods. This phase of the development is expected to be completed later this month.
AMIPs – Next Steps
Viral selectivity screening is the next and final stage of laboratory-based development and will involve testing against a standardized panel of respiratory viruses to confirm that there is no cross-reactivity. Completion of the cross-reactivity testing is the last scientific development step required to produce specificity data before the Company can begin the process of applying for regulatory approval from government agencies such as the FDA and Health Canada. The Company is positioning itself to begin production of product prototypes in the first half of 2022 pending completion of this step.
The Company expects to complete the current phase of testing in the coming weeks, with a successful outcome leading to validation testing by 3rd party laboratories. This testing will continue during the cross-reactivity testing and ultimately will progress to clinical trials with the pre-production prototypes as the Company moves toward submission of AMIPs™ and testing data to regulatory bodies for use authorization. Regulatory approval can be a time-intensive process but the Company believes that AMIPs™ represents a paradigm shift in testing. To date, AMIPs™ have proven very robust in the detection of variants and by design should continue to be relatively unaffected by mutations. AMIPs™ is completely synthetic eliminating major bottlenecks in raw materials, supply chain difficulties, handling limitations, nasal swabs, and waste products. Nothing about the design or manufacturing requirements identified to date suggests that AMIPs™ tests can’t be produced at or below the costs of similar ELISA or antigen tests.
The Company is not making any express or implied claims that its current AMIPs™ product has the ability to eliminate, cure, contain, or detect, at a commercial level, COVID-19 (or SARS-2 coronavirus) at this time.
For more information on the AMIPs™ and associated molecular imprinting technology, please visit: https://www.amips.com
About Sixth Wave
Sixth Wave is a nanotechnology company with patented technologies that focus on extraction and detection of target substances at the molecular level using highly specialized Molecularly Imprinted Polymers (MIPs). The Company is in the process of a commercial rollout of its Affinity™ cannabinoid purification system, as well as, IXOS®, a line of extraction polymers for the gold mining industry. The Company is in the development stages of a rapid diagnostic test for viruses under the Accelerated MIPs (AMIPs™) label.
Sixth Wave can design, develop and commercialize MIP solutions across a broad spectrum of industries. The company is focused on nanotechnology architectures that are highly relevant for the detection and separation of viruses, biogenic amines, and other pathogens, for which the Company has products at various stages of development.
For more information about Sixth Wave, please visit our website at: www.sixthwave.com
ON BEHALF OF THE BOARD OF DIRECTORS
Jonathan Gluckman, Ph.D., President & CEO
For information, please contact the Company:
Phone: (801) 582-0559
This press release includes certain statements that may be deemed “forward-looking statements” including statements regarding the planned use of proceeds and performance of the AMIPs™ technologies. All statements in this release, other than statements of historical facts, that address future events or developments that the Company expects, are forward-looking statements. Although the Company believes the expectations expressed in such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of future performance, and actual events or developments may differ materially from those in forward-looking statements. Such forward-looking statements necessarily involve known and unknown risks and uncertainties, which may cause the Company’s actual performance and financial results in future periods to differ materially from any projections of future performance or results expressed or implied by such forward-looking statements. In particular, successful development and commercialization of the AMIPs™ technology are subject to the risk that the AMIPs™ technology may not prove to be successful in detecting virus targets effectively or at all, the uncertainty of medical product development, the uncertainty of timing or availability of required regulatory approvals, lack of track record of developing products for medical applications and the need for additional capital to carry out product development activities. The value of any products ultimately developed could be negatively impacted if the patent is not granted. The Company has not yet completed the development of a prototype for the product that is subject of its patent application and has not yet applied for regulatory approval for the use of this product from any regulatory agency.