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NuGen Medical Commences Feasibility Study, Validation and Testing for Semaglutide - "Ozempic(R)"
Toronto, Ontario--(Newsfile Corp. - April 10, 2023) - NuGen Medical Devices Inc. (TSXV: NGMD) (th...
About this update from Nugen Medical Devices Inc
[{"type":"text","content":"NuGen Medical Commences Feasibility Study, Validation and Testing for Semaglutide - \"Ozempic(R)\"Toronto, Ontario--(Newsfile Corp. - April 10, 2023) - NuGen Medical Devices Inc. (TSXV: NGMD) (the \"Company\" or \"NuGen\") announces it has engaged Basic Pharma Technologies, a pharmaceutical company located in the Netherlands, to perform an assessment and feasibility study, which will include validation testing of semaglutide if administered using NuGen's needle free injection device, InsuJet™.Semaglutide is the drug known as Ozempic® and it is currently administered by a pen-needle method.Integrity testing of semaglutide being administered via InsuJet™ will be conducted over a seven-to-eight-month period comprising of three phases:Phase 1 will comprise of regulatory compliance and literature search, method development literature search, and reference standard research and sourcing.Phase 2 will comprise of feasibility study method and development.Phase 3 will comprise of QC method and writing and composing and validating, method and validation protocol writing review and effectiveness, method validation study execution and data review, method validation report writing and effectiveness and sample measurement and reporting of sample measurement.Conclusion of Phase 3, estimated at four-to-five-months, will determine a Go/No-Go outcome which will be reported to shareholders. \"The goal of integrity testing is to demonstrate that the molecules of the drug are not impacted by the high pressure that occurs during the needle-free injection. Previously, integrity testing with various insulins formed important groundwork for clearing the regulatory pathway for using the needle-free injector owned and developed by NuGen for insulin application.\" Commented Nicky Canton, COO \"Semaglutide (Ozempic®) and it's role in blood glucose control and possible weight loss would be a great addition to further expand the applications of the InsuJet™ platform in the field of diabetes management.\"Efficacy of InsuJet™Efficacy of InsuJet™ shows improved insulin uptake of upwards of 40%. Clinical studies, certificates, or InsuJet™ reports are found at: https://www.insujet.com/pages/partners. About Semaglutide / Ozempic®Semaglutide is a GLP-1 receptor agonist, meaning that it mimics the action of huma...