CE mark enables launch of the TRUFORMA® Diagnostic Platform into the European Union
ANN ARBOR, MI / ACCESSWIRE / June 25, 2024 / Zomedica Corp. (NYSE American:ZOM) ("Zomedica" or the "Company"), a veterinary health company offering point-of-care diagnostics and therapeutic products for equine and companion animals, today announced it has secured the CE mark for its proprietary point-of-care TRUFORMA Bulk Acoustic Wave (BAW) diagnostic platform. The CE mark signifies compliance with stringent European Union safety, health, and environmental standards, enabling Zomedica to introduce the TRUFORMA diagnostic platform across the European Economic Area (EEA).
"Securing the CE mark certification is a significant milestone for Zomedica," commented Larry Heaton, Zomedica's Chief Executive Officer. "Since the launch of the TRUFORMA system into the US veterinary market in 2021, we have received a growing number of requests for the platform to be available in various international markets, including the European Union. Veterinarians worldwide recognize the potential of having such a powerful diagnostic tool in a compact and easy-to-use package right at the point of care."
Mike Mockler, Senior Product Manager at Zomedica, stated, "The TRUFORMA diagnostic platform offers fully quantitative results with reference lab accuracy right at the point of care in minutes, allowing veterinarians to make treatment decisions faster and with more confidence. The TRUFORMA platform offers proprietary assays, such as our Cobalamin & Folate multiplex assay, which have never before been available at the point of care, empowering veterinarians to provide new levels of care. We are proud to bring this innovative technology to veterinary practices across the EEA."
"This is an exciting time for the TRUFORMA platform. The CE mark demonstrates Zomedica's commitment to providing better patient outcomes domestically and globally," commented Brandon Marino, Senior Director of Global Channels for Zomedica. "We believe the TRUFORMA platform will enable veterinarians worldwide the ability to make decisions sooner and treat patients faster through its one-of-a-kind diagnostic testing capabilities."
The TRUFORMA platform addresses a $1.5 billion annual recurring revenue opportunity in the US, and with CE marking secured, is now positioned to expand into the European veterinary diagnostics market, which is forecast to surpass $3.6 billion by 2028.
To learn more about the TRUFORMA diagnostic platform and its innovative use of BAW technologies, please visit Zomedica's website at zomedica.com/truforma.
About Zomedica
Based in Ann Arbor, Michigan, Zomedica (NYSE American:ZOM) is a veterinary health company creating products for horses, dogs, and cats by focusing on the unmet needs of clinical veterinarians. Zomedica's product portfolio includes innovative diagnostics and medical devices that emphasize patient health and practice health. Zomedica's mission is to provide veterinarians the opportunity to increase productivity and grow revenue while better serving the animals in their care. For more information, visit www.zomedica.com.
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Except for statements of historical fact, this news release contains certain "forward-looking information" or "forward-looking statements" (collectively, "forward-looking information") within the meaning of applicable securities law. Forward-looking information is frequently characterized by words such as "plan", "expect", "project", "intend", "believe", "anticipate", "estimate" and other similar words, or statements that certain events or conditions "may" or "will" occur and include statements relating to our expectations regarding future results. Although we believe that the expectations reflected in the forward-looking information are reasonable, there can be no assurance that such expectations will prove to be correct. We cannot guarantee future results, performance, or achievements. Consequently, there is no representation that the actual results achieved will be the same, in whole or in part, as those set out in the forward-looking information.
Forward-looking information is based on the opinions and estimates of management at the date the statements are made, including assumptions with respect to economic growth, demand for the Company's products, the Company's ability to produce and sell its products, sufficiency of our budgeted capital and operating expenditures, the satisfaction by our strategic partners of their obligations under our commercial agreements, our ability to realize upon our business plans and cost control efforts and the impact of COVID-19 on our business, results and financial condition.
Our forward-looking information is subject to a variety of risks and uncertainties and other factors that could cause actual events or results to differ materially from those anticipated in the forward-looking information. Some of the risks and other factors that could cause the results to differ materially from those expressed in the forward-looking information include, but are not limited to: the outcome of clinical studies, the application of generally accepted accounting principles, which are highly complex and involve many subjective assumptions, estimates, and judgments, uncertainty as to whether our strategies and business plans will yield the expected benefits; uncertainty as to the timing and results of development work and verification and validation studies; uncertainty as to the timing and results of commercialization efforts, as well as the cost of commercialization efforts, including the cost to develop an internal sales force and manage our growth; uncertainty as to our ability to successfully integrate acquisitions; uncertainty as to our ability to supply products in response to customer demand; uncertainty as to the likelihood and timing of any required regulatory approvals, and the availability and cost of capital; the ability to identify and develop and achieve commercial success for new products and technologies; veterinary acceptance of our products, including the acceptance of the TRUFORMA system by European veterinarians; competition from related products; the level of expenditures necessary to maintain and improve the quality of products and services; changes in technology and changes in laws and regulations; our ability to secure and maintain strategic relationships; performance by our strategic partners of their obligations under our commercial agreements, including product manufacturing obligations; risks pertaining to permits and licensing, intellectual property infringement risks, risks relating to any required clinical trials and regulatory approvals, risks relating to the safety and efficacy of our products, the use of our products, intellectual property protection, risks related to the COVID-19 pandemic and its impact upon our business operations generally, including our ability to develop and commercialize our products, and the other risk factors disclosed in our filings with the SEC and under our profile on SEDAR+ at www.sedarplus.com. Readers are cautioned that this list of risk factors should not be construed as exhaustive.
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Investor Relations Contact:
Zomedica Investor Relations
investors@zomedica.com
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SOURCE: Zomedica Corp.
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