NuGen M.D. Submits for FDA Emergency Use Authorization Approval for its Needle-Free Injection Systems
TORONTO, Ontario – June 15, 2022 – NuGen Medical Devices Inc. (TSXV: NGMD) (“NuGen” or the “Company”), a leader in needle-free drug delivery, in collaboration with Unifire, Inc., a wholly-owned subsidiary of Mission Ready Solutions Inc. (TSXV: MRS, OTCQX: MSNVF) submitted on June 14th, 2022, an application to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (“EUA”) of NuGen reusable needle-free jet injector (NFJI) systems. NuGen MD NFJI devices are designed for patients and/or healthcare providers for the delivery of insulin, vaccines (potentially including COVID-19 vaccines), and emergency pharmaceutical injectables.
The U.S. government released its “National Strategy for a Resilient Public Health Supply Chain“ in July 2021, which outlines the government’s plan to respond to disruptions in the supply chain that came as a result of the COVID-19 pandemic. According to the report, there remains much to be done to ensure that the public health supply chain is prepared for future disruptions.
Nugen’s needle-free injection systems can help address supply chain shortages, while eliminating risks to healthcare personnel of needle stick injuries (NSIs). NSIs have been further exacerbated by the COVID-19 pandemic, as explained by the Centers for Disease Control (CDC).
NuGen and Unifire intend this EUA application to act in response to the U.S. government’s Request for Information (RFI) released May 20, 2022, as well as current medical supply chain shortages and syringe shortages in crisis-affected areas around the world.
The Emergency Use Authorization (EUA) authority allows FDA to help strengthen the nation’s public health protections against chemical, biological, radiological, and nuclear (CBRN) threats including infectious diseases, by facilitating the availability and use of medical countermeasures (MCMs) needed during public health emergencies. Under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), when the Secretary of HHS declares that an emergency use authorization is appropriate, FDA may authorize unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by CBRN threat agents when certain criteria are met, including there are no adequate, approved, and available alternatives.
Additionally, President Biden’s remarks in his first ever State of the Union Address on the diabetes pandemic and the financial strain it puts on the healthcare system and families living with diabetes. According to the report, preparedness is the key to overcoming supply chain issues.
NuGen’s needle-free injection system addresses the public health supply chain by offering an alternative to traditional hypodermic needles, which are single-use and pose safety issues if not sanitized or used correctly.
About NuGen Medical Devices
NuGen Medical Devices’ principal business is the development and commercialization of innovative needle-free injection devices and systems for the administration of subcutaneous medication.
It is developing products using needle-free drug delivery technology in several important fields including, but not limited to, anaphylaxis, diabetes, severe migraine, erectile dysfunction, chronic anemia, neutropenia, autoimmune rheumatoid arthritis, growth and fertility hormone, psoriasis as well as DNA and conventional/pediatric vaccines.
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This news release contains forward-looking information which is subject to a variety of risks and uncertainties and other factors that could cause actual events or results to differ from those projected in the forward-looking statements. Forward looking statements in this press release include the Company’s 2022 objectives of securing additional distribution and sales agreements, making submissions for regulatory approvals and capitalizing on additional market opportunities. These forward-looking statements are subject to a variety of risks and uncertainties and other factors that could cause actual events or results to differ materially from those projected in the forward-looking information. The forward-looking information contained herein is given as of the date hereof and the Company assumes no responsibility to update or revise such information to reflect new events or circumstances, except as required by law.