Press Release

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Vivione Biosciences Inc. receives coveted Letter of No Objection (LNO) designation from US Department of Agriculture Food Safety & Inspection Services


LITTLE ROCK, Arkansas. – Vivione Biosciences, Inc. (TSX:VBI) through its wholly owned subsidiary, Vivione Biosciences, LLC, is pleased to announced that, following a lengthy and vigorous process, the USDA FSIS (US Department of Agriculture Food Safety & Inspection Services) has issued Vivione a Letter of No Objection (“LNO”) for its RAPID-B non-O157 Shigatoxigenic group of Escherichia coli (“STEC”) Test Kit, intended for the rapid screening of beef trim and ground beef that may contain O-antigen positive Non-O157 STEC.

The Test Kit is used with Vivione’s RAPID-B platform and is designed to provide companies with a faster result than existing options. Testing is accomplished by adding RAPID-B proprietary reagents to an enriched sample and then running the sample on the RAPID-B instrument. Analysis of the sample by the instrument is accomplished in minutes. The decision to adopt a new diagnostic testing platform is a serious decision for any company and the process needs to be absolutely trustworthy. Today’s USDA FSIS designation enables companies to acquire and deploy the RAPID-B process with complete confidence that RAPID-B meets some of the world’s toughest, most demanding testing standards.. The LNO process involves the assessment of key platform parameters to ensure satisfactory performance and the ability to consistently produce accurate results.

According to the CDC (Center for Disease Control), an estimated 265,000 STEC infections occur each year in the United States. The importance of speed and sensitivity in detecting the presence of certain E. coli bacteria cannot be overestimated. E. coli contamination can have very serious economic and safety consequences to the meat industry, as well as immense public health implications. Any product containing these bacteria that inadvertently reaches the market would be subject to recall, with the likelihood of producers suffering both significant financial and reputational harm. As a result, meat producers currently hold inventory sufficiently to ensure that the product is not contaminated. The sooner a negative result is received, the faster the product can be released for shipment. The bottom line for producers is that the faster a result is received, the faster a producer can respond or ship their product to market.

“This LNO designation is an important step for us as we continue to expand in the food safety market,” said Vivione’s Chief Executive Officer Kevin Kuykendall. “The designation is highly valued in the food industry because the testing is performed by an independent laboratory and the data is reviewed by the USDA. With this validation, our customers now have the assurance that they need to move forward with the RAPID-B system. As they do, they lower their inventory risk, get their product to market faster, help contribute to the safety and security of the global food supply chain, and increase consumers’ confidence in the industry’s commitment to food safety.”

About Vivione

Vivione’s business is centered on the commercialization of the RAPID-B system, which is an integrated system of hardware, software and chemical reagents that tests bacteria in key environments. This technology could have potentially diverse applicability from food safety to clinical diagnostics, by identifying and quantifying microorganism levels more rapidly and with greater precision than currently employed techniques.

For further information please contact:

Vivione Biosciences Inc.
Kevin Kuykendall
Chief Executive Officer
Tel: (214) 886-5733

Cautionary Statements

This news release contains "forward-looking statements" within the meaning of applicable securities laws. In particular, this release contains forward-looking information relating to the approval of the option grants, the completion and timing of the Offering and the use of proceeds of the Offering. Although Vivione believes that the expectations reflected in its forward-looking statements are reasonable, such statements have been based on factors and assumptions concerning future events that may prove to be inaccurate. These factors and assumptions are based upon currently available information to Vivione. Such statements are subject to known and unknown risks, uncertainties and other factors that could influence actual results or events and cause actual results or events to differ materially from those stated, anticipated or implied in the forward-looking statements. Factors that could cause the actual results to differ materially from those in forward-looking statements include the ability of management to raise adequate proceeds from the Offering and the failure to obtain final approval of the Offering from the TSX Venture Exchange. Additionally, this press release contains forward-looking information relating to the commercialization of RAPID-B and independent third party certification of RAPID-B. Readers are cautioned to not place undue reliance on forward-looking statements.

The statements in this press release are made as of the date of this release and, except as required by applicable law, Vivione does not undertake any obligation to publicly update or to revise any of the included forward-looking statements, whether as a result of new information, future events or otherwise. Vivione undertakes no obligation to comment on analyses, expectations or statements made by third-parties in respect of Vivione, or its financial or operating results or (as applicable), their securities.



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Forward looking statements are subject to numerous risks and uncertainties, some of which are beyond the management and the Company’s control, including but not limited to, the impact of general economic conditions, industry conditions, fluctuation of foreign exchange rates, imperfection of estimates, industry competition, availability of qualified personnel and management, stock market volatility, timely and cost effective access to sufficient capital from internal and external sources, ability to integrate and realize anticipated benefits from acquisitions, ability to resell third party network communications at favorable rates, and to effectively manage growth. The Company's actual results, performance or achievement could differ materially from those expressed in or implied by, these forward looking statements and accordingly, no assurance can be given that any of the events anticipated to occur or transpire from the forward looking statements will provide any benefits to the Company. All data presented herein should be read in conjunction with the Company's regulatory filings with the appropriate securities regulatory authorities and the System for Electronic Document Analysis and Retrieval (“SEDAR”). Copies of these filings are available for review under the Company's SEDAR profile at