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NuGen Medical Commences Feasibility Study, Validation and Testing for Semaglutide - "Ozempic(R)"

Newsfile Corp.
Updated ·3 min read

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:

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  1. Phase 1 will comprise of regulatory compliance and literature search, method development literature search, and reference standard research and sourcing.

  1. Phase 2 will comprise of feasibility study method and development.

  1. 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 human incretin glucagon-like peptide-1 (GLP-1). This improves insulin secretion and glycemic control, and reduces appetite and calorie intake. It was developed by Novo Nordisk in 2012 as a longer-acting alternative to liraglutide, an insulin for type 2 diabetics but also for administration to obese patients and marketed under the trade name " Ozempic®". Ozempic® has recently come into the public eye, with numerous celebrities and influencers claiming to have lost weight with the drug. The result was product shortages[1], so that the levy was regulated in many places[2].

About Basic Pharma Technologies

Basic Pharma is an advanced, independent pharmaceutical company primarily engaged in the development, licensing, manufacture and commercialisation of pharmaceutical and biopharmaceutical products. Basic Pharma is a full-service package to the Pharmaceutical, Biotech and Medical Device industry.

For more information, visit www.basicpharma.nl

About NuGen Medical Devices

NuGen is an emerging specialty medical device company developing the next generation of needle-free technologies and other innovative medical delivery products. The company's products, which include the InsuJet™ and PetJet™ needle-free injection systems, are designed to improve the lives of millions of people and animals. NuGen continues to receive approval in numerous countries, including Canada. NuGen's products are designed for use in several important fields including, but not limited to, diabetes, veterinary medicine, and vaccines.

For further information, please visit:

Websites: www.insujet.com and www.nugenmd.com

Instagram: @NuGenMD

Twitter: @NuGenMD

LinkedIn: https://www.linkedin.com/company/nugenmd/

For further information, please contact:

Tony Di Benedetto
Executive Chairman
(416) 791-9399
tony@nugenmd.com

Richard Buzbuzian
President & CEO
(647) 501-3290
richard@nugenmd.com

To arrange a media interview with Nugen Medical Devices, please contact:

Nelson Hudes
Hudes Communications International
(905) 660-9155
nelson@hudescommunications.com

Notice Regarding Forward-Looking Information:

Neither TSXV nor its Regulation Services Provider (as that term is defined in policies of the TSXV) accept responsibility for the adequacy or accuracy of this release.

This news release contains "forward-looking information" and "forward-looking statements" (collectively, "forward-looking statements") within the meaning of the applicable Canadian securities legislation. All statements, other than statements of historical fact, are forward-looking statements and are based on expectations, estimates and projections as at the date of this news release. Any statement that involves discussions with respect to predictions, expectations, beliefs, plans, projections, objectives, assumptions, future events or performance (often but not always using phrases such as "expects", or "does not expect", "is expected", "anticipates" or "does not anticipate", "plans", "budget", "scheduled", "forecasts", "estimates", "believes" or "intends" or variations of such words and phrases or stating that certain actions, events or results "may" or "could", "would", "might" or "will" be taken to occur or be achieved) are not statements of historical fact and may be forward-looking statements. 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.

[1] https://www.reuters.com/business/healthcare-pharmaceuticals/novo-nordisks-diabetes-drug-ozempic-back-supply-after-months-shortage-2023-03-17/

[2] https://www.cbc.ca/news/canada/british-columbia/ozempic-canada-british-columbia-1.6793114

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/161814