VANCOUVER, BC /ACCESSWIRE/June 15, 2022/ NuGen Medical Devices Inc. (TSXV: NGMD) (“NuGen” or the “Company”), a leader in needleless medication delivery, together with Unifire Inc., a wholly owned subsidiary of Mission Ready Solutions (TSXV: MRS , OTCQX:MSNVF) on June 14, 2022 submitted an application to the United States Food and Drug Administration (FDA) for Emergency Use Authorization (“EUA”) of injector systems NuGen Reusable Needle-Free Jet (NFJI). NuGen ® NFJI devices are intended for use by patients and/or healthcare providers for the administration 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 supply chain disruptions resulting from the COVID-19 pandemic. According to the report, much remains to be done to ensure that public health supply chain is prepared for future disruptions.
Nugen’s needle-free injection systems can help solve supply chain shortages, while eliminating the risk of needlestick injuries (NSIs) for healthcare workers. 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) issued on 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 Authority (EUA) enables the FDA to help strengthen the country’s public health protections against chemical, biological, radiological, and nuclear (CBRN) threats, including diseases infections, facilitating the availability and use of necessary medical countermeasures (MCMs) during public times. 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. The FDA may authorize the use of unapproved medical products or unapproved uses of approved medical products in emergencies to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by CBRN threat agents when certain criteria are fulfilled, including that there are no approved alternatives available.
Additionally, President Biden’s remarks in his first-ever State of the Union address on the diabetes pandemic and the financial strain it is placing on the healthcare system and families living with diabetes. According to the report, preparation is the key to overcoming supply chain issues.
NuGen’s Needle-Free Injection System addresses the public health supply chain by providing an alternative to traditional hypodermic needles, which are single-use, pose safety issues if not disinfected or used correctly, and require a strict collection and disposal protocol.
About NuGen Medical Devices
NuGen Medical Devices’ core business is the development and commercialization of innovative needle-free injection devices and systems for subcutaneous drug delivery.
It develops products using needle-free drug delivery technology in several important areas, 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 press release contains forward-looking information that 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 goals to enter into additional distribution and sales agreements, submit applications for regulatory approvals and take advantage of 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.
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