TONISITY CONFIRMS THE EFFICACY OF TONISITY Px® AGAINST PORCINE EPIDEMIC DIARRHEA VIRUS IN A PEER-REVIEWED ARTICLE

Tonisity’s Isotonic Product Proven Effective in Reducing Mortality and Adverse Impacts of Deadly Virus on Swine

Tonisity International Limited (“Tonisity”), an animal health and nutrition company based in Ireland, is pleased to announce that its flagship product, Tonisity Px, has been the subject of a peer-reviewed article[1] in the Veterinary Immunology and Immunopathology journal, a leading international journal of comparative immunology. This article outlined the efficacy of Tonisity Px against Porcine Epidemic Diarrhea Virus (“PEDV”).

The Peer-Reviewed Article

This article is the first report to show a beneficial impact on PEDV using a commercially available swine feed product – Tonisity Px – that is already registered for use throughout Asia, Europe, South America, North America, Australia and Africa. Tonisity Px is unique in that it is delivered as a supplementary liquid drink that is consumed voluntarily, in a manner somewhat similar to milk replacer. This means that it can be used even in neonatal pigs who are still primarily dependent upon suckling the sow’s milk. Piglets of this age are the ones most commonly affected by PEDV, with mortality rates of 50-80%[2].

Overall, results indicate that Tonisity Px supplementation is a viable intervention to support the intestine and to aid tissue recovery in response to PEDV in piglets. The results of this study also serve to clarify the behavior of key intestinal health biomarkers in live pigs with PEDV infection, based upon the immunologic work performed independently by our co-authors from the Dnipro State Agrarian and Economic University in Ukraine.

The study examined the effects of administering Tonisity Px via the drinking water to 14-day-old PEDV-infected piglets. Outcomes were measured on indicators of intestinal integrity, immune response, tissue repair and virus shedding. Piglets were followed for 21 days, with samples taken at 1, 5, 14 and 21 days after infection.

The piglets who consumed Tonisity Px shed less PED virus on days 5 and 14 post-infection and had cleared the virus by day 21 post-infection. This outcome was in contrast with the control group which had detectable virus excretion up to the end of the study (day 21 post-infection).

At the intestinal level, the Tonisity Px piglets had a more intense immune response and faster tissue repair than control piglets. This study is the first report of this panel of biomarkers in the face of live pigs with PEDV infection, which also makes the study important on an immunological level.

[1] Dmytro M. Masiuk, Andrii V. Kokariev, Stefan G. Buzoianu, Ava M. Firth and Victor S. Nedzvetsky, “An Isotonic Protein Solution Favorably Modulated the Porcine Intestinal Immune Response and Cellular Adhesion Markers and Reduced PEDV Shedding In Vivo.” Veterinary Immunology and Immunopathology 271 (2024) 110753 (the “Peer Reviewed Article”). https://doi.org/10.1016/j.vetimm.2024.110753

[1] Zimmerman, J.J. Diseases of Swine; Wiley-Blackwell, 2012; ISBN 9780813822679

Dr. Ava Firth, Director of Research and Development for Tonisity, and one of the original developers of Tonisity Px, along with Dr. Stefan Buzoianu, Senior Scientist of Tonisity, noted, “This study affirms the sound science and physiology that is the foundation of all Tonisity products. The significance of these findings cannot be overstated as no other product in the world is effective in combating this deadly disease. Tonisity Px and our other products have been successful globally, with over 65 million animals having consumed them in a variety of situations. Our entire team is working hard to accelerate market penetration so that more animals, producers and related businesses can benefit from the positive health, environmental and economic outcomes that our products create.”

About PEDV

PEDV is a contagious coronavirus that attacks the intestine of pigs. PEDV is especially lethal to young piglets, with outbreaks leading to 50-80% mortality rates in this age group. The virus was first recognized in Europe in the 1970s and has since spread globally. The prevention of PEDV infection relies mainly on biosecurity measures. Despite the application of attenuated vaccines, highly virulent PEDV strains are still present and are causing significant economic losses to swine producers in many countries.[3]

Quantifying the exact financial losses caused by PEDV over the last decade in various countries can be challenging due to varying reporting standards and economic impacts. However, significant outbreaks in major pork-producing countries have led to considerable economic losses:

  • United States: The outbreak that began in 2013 caused widespread devastation, particularly in 2014. The total losses attributed to PEDV in the U.S. were estimated to be in the hundreds of millions of dollars, considering the death of an estimated 7 million piglets and the resultant increase in pork prices[4],[5].
  • China: As the world’s largest pork producer and consumer, China has experienced severe impacts from PEDV, particularly during the outbreaks in the early 2010s. The virus has been endemic in the country, and while specific financial figures are harder to come by, the economic impact is significant in terms of lost production and increased costs for biosecurity and control measures[6].
  • South Korea: In South Korea, an outbreak in 2013-2014 led to the culling of thousands of pigs and substantial economic losses. The government and industry spent considerable resources on control measures and vaccine development[7],[8].

Economic impacts generally include direct costs such as animal deaths, reduced growth rates, and increased veterinary care, as well as indirect costs like enhanced biosecurity measures, disruptions to trade, and losses in export markets. The cumulative global impact over the last decade likely runs into billions of dollars[9].

About Tonisity’s Swine Products

Tonisity Px is a patented isotonic protein drink that directly feeds the intestinal cells of livestock, such as piglets, thus improving nutrient absorption. Tonisity Px is administered to piglets in the first week of life and around weaning and is voluntarily consumed even by newborn piglets. The result is higher weight gain, lower mortality and less need for medications for these animals – all producing a high return on investment for producers.

Tonisity is dedicated to research and has completed over 235 swine trials throughout the world. In an overview of 91 commercial and R&D studies examining pre-weaning mortality, Tonisity Px was shown to consistently reduce pre-weaning mortality by 22%. This amounts to an extra pig for every three litters. Administration of Tonisity Px also results in higher weaning weights and 3 kg extra weight at finisher stage, with an improved feed conversion rate. This technology results in a reliable 3:1 return on investment (5:5-1 in a recent China study[10]) at weaning and 5-6:1 at finishing.[11]

Tonisity PxW™ contains the same key bioactives aimed at nourishing the intestine and is delivered through waterlines to newly-weaned pigs, with no extra labour required. The weaning period and the first 2-3 weeks after weaning are a major danger period for pigs. Often, newly-weaned pigs struggle to maintain sufficient water intake. Reduced water intake correlates to reduced feed intake, which creates a growth lag and contributes to morbidity and mortality.[12],[13]

Tonisity PxW™ improves water intake by up to two times in the first few days after weaning. Pigs given Tonisity PxW™ for five days post-weaning had a 36% reduction in post-weaning mortality and a 18% decrease in post-weaning morbidity. Tonisity PxW™ has also been shown to improve end-Nursery weights by 300 grams when compared to a competitor product[14]. Trials indicate that the return on investment on Tonisity PxW™ is a minimum of 4.5:1.

Tonisity’s swine products can also be given to pigs of any age at other stress points in production, such as weaning, before and after transport, and for sows, at farrowing or during lactation. While both products have been demonstrated to improve the performance of healthy pigs, trial data also shows that they are particularly useful in support of dehydration and recovery from illnesses such as Porcine Reproductive and Respiratory Syndrome[15] and PEDV[16].

Tonisity’s swine products are patented in all key markets and are currently being sold in Europe, Africa, Asia, North America, South America and Australia. The swine products are manufactured in Ireland.

For More Information on Tonisity

Tonisity is an animal health and nutrition company based in Ireland that is currently focusing its patented technology in three specific markets: (1) isotonic products for the enhancement of swine production; and (2) novel companion animal nutrition products; and (3) isotonic products for the enhancement of ruminant production. Tonisity is focused on creating positive physiological changes by addressing the issue of intestinal health of young animals, thus improving their overall health, leading to better lifetime performance. With respect to novel companion animal products, Tonisity is poised to become the first mover and market leader in a targeted nutrition approach for pets – which is a rapidly growing market across the globe. For more information on Tonisity’s livestock business, visit www.tonisity.com. For more information on Tonisity’s companion animal business, visit www.doggyrade.com.

ON BEHALF OF THE BOARD

“Mathieu Cortyl”

Mathieu Cortyl
Commercial Director
Email: mathieu@tonisity.com

Forward-Looking Statements

This press release contains forward-looking statements and information that are based on the beliefs of management and reflect Tonisity’s current expectations. When used in this press release, the words “estimate”, “project”, “belief”, “anticipate”, “intend”, “expect”, “plan”, “predict”, “may” or “should” and the negative of these words or such variations thereon or comparable terminology are intended to identify forward-looking statements and information.

The forward-looking statements and information in this press release include information relating to the business plans of Tonisity, including the development of new product lines in both the swine and companion animal product lines.

Such statements and information reflect the current views of Tonisity. By their nature, forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements, or other future events, to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Such factors include, among others, the following risks: Tonisity’s ability to raise capital to maintain its growth and business objectives, Tonisity’s ability to negotiate and enter into binding agreements with counterparties in geographic markets that are part of its expansion plans, changes in laws and regulations that could adversely affect Tonisity’s business, growth or results of operations, Tonisity’s ability to attract and retain customers and consumers and impacts of the COVID-19 pandemic.

There are a number of important factors that could cause Tonisity’s actual results to differ materially from those indicated or implied by forward-looking statements and information. Such factors include, among others: limited business history of Tonisity; risks related to Tonisity’s corporate strategy including that previous and future acquisitions do not meet expectations; disruptions or changes in the credit or security markets; results of operation activities; unanticipated costs and expenses, fluctuations in commodity prices, and general market and industry conditions; protection of Tonisity’s intellectual property; disruption at any of Tonisity’s facilities including as a result of the current COVID-19 pandemic; effect of public health crises, including the current COVID-19 pandemic; Tonisity’s supply chain management; availability of suppliers of raw materials; limited or disrupted supply of key ingredients; the availability of key ingredients for Tonisity’s products; failure to expand production capacity; effect of product innovation; failure to retain current customers and/or recruit new customers potential volatility of share price; no assurance of active market for shares; dividends; global financial conditions; the effect of product labelling requirements; price of raw materials; consumer trends; publication of inaccurate or unfavourable research and reports; management and conflicts of interest.

Tonisity cautions that the foregoing list of material factors is not exhaustive. When relying on Tonisity’s forward-looking statements and information to make decisions, readers should carefully consider the foregoing factors and other uncertainties and potential events. Tonisity has assumed that the material factors referred to in the previous paragraph will not cause such forward-looking statements and information to differ materially from actual results or events. However, the list of these factors is not exhaustive and is subject to change and there can be no assurance that such assumptions will reflect the actual outcome of such items or factors.

The forward-looking information contained in this press release represents the expectations of Tonisity as of the date of this press release and, accordingly, is subject to change after such date. Readers should not place undue importance on forward-looking information and should not rely upon this information as of any other date. While Tonisity may elect to, it does not undertake to update this information at any particular time, except as required by applicable laws.

[1] Dmytro M. Masiuk, Andrii V. Kokariev, Stefan G. Buzoianu, Ava M. Firth and Victor S. Nedzvetsky, “An Isotonic Protein Solution Favorably Modulated the Porcine Intestinal Immune Response and Cellular Adhesion Markers and Reduced PEDV Shedding In Vivo.” Veterinary Immunology and Immunopathology 271 (2024) 110753 (the “Peer Reviewed Article”). https://doi.org/10.1016/j.vetimm.2024.110753

[2] Zimmerman, J.J. Diseases of Swine; Wiley-Blackwell, 2012; ISBN 9780813822679

[3] Jung, K., Saif, L.J., 2015. Porcine epidemic diarrhea virus infection: Etiology, epidemiology, pathogenesis and immunoprophylaxis. Vet. J. 204, 134–143. https://doi.org/10.1016/j.tvjl.2015.02.017 .

[4] Alvarez, J., Sarradell, J., Morrison, R., & Perez, A. (2015). Impact of Porcine Epidemic Diarrhea on Performance of Growing Pigs. PLoS One, 10(3): e0120532. doi:10.1371/journal.pone.0120532

[5] Schulz, L. L., & Tonsor, G. T. (2015). Assessment of the economic impacts of porcine epidemic diarrhea virus in the United States. Journal of Animal Science, 93(11), 5111–5118. doi:10.2527/jas.2015-9136

[6] Wang, D., Fang, L., & Xia, S. (2016). Porcine epidemic diarrhea in China. Virus Research, 226, 7–13. doi: 10.1016/j.virusres.2016.05.026. PMCID: PMC7114554. PMID: 27261169.

[7] Kim, S.-H., Lee, J.-M., Jung, J., Kim, I.-J., Hyun, B.-H., Kim, H.-I., Park, C.-K., Oem, J.-K., Kim, Y.-H., Lee, M.-H., & Lee, K.-K. (2015). Genetic characterization of porcine epidemic diarrhea virus in Korea from 1998 to 2013. Archives of Virology, 160(4), 1055–1064. doi: 10.1007/s00705-015-2353-y. PMCID: PMC7086719. PMID: 25666198.

[8] Park, J.-E., Kang, K.-J., Ryu, J.-H., Park, J.-Y., Jang, H., Sung, D.-J., Kang, J.-G., & Shin, H.-J. (2018). Porcine epidemic diarrhea vaccine evaluation using a newly isolated strain from Korea. Veterinary Microbiology, 221, 19-26. doi: 10.1016/j.vetmic.2018.06.007.

[9] What’s PEDV really costing pork producers? National Hog Farmer. https://www.nationalhogfarmer.com/livestock-management/what-s-pedv-really-costing-pork-producers-

[10] China study 21-024-P-P

[11] USA Study 18-014-P-P (PWM -22.8% & final weight +3.2 %): ROI = 3.2:1 at weaning and 5.9:1 at finishing;

UK Study 20-002-P-P (PWM -21% & final weight +2.5 %): ROI = 3.3:1 at weaning and 8.6:1 at finishing.

USA Study 17-061-P-P in disease situation (PRRS): ROI = 7.05:1

[12] Pluske J, Le Dividich J, Verstegen M. Weaning the Pig – Concepts and Consequences. Weaning pig Wageningen Academic Publishers, 2003.

[13] Kruse S, Traulsen I, Krieter J. Analysis of water, feed intake and performance of lactating sows. Livest Sci 2011;135:177–183.

[14] US Study 20-047-P-P

[15] Trials 17-061-P-P USA, 20-038-P-P USA

[16] Peer-Reviewed Article, note 1.