Miami Beach, Florida--(Newsfile Corp. - October 1, 2019) - Zomedica, Inc. (NYSE American: ZOM) (TSXV: ZOM) is getting closer to commercializing its first potentially industry-changing product, TRUFORMA™, a point of care diagnostic platform with initial assays used to diagnose thyroid and adrenal disorders in dogs and cats. The device, which is on pace to launch by the end of first quarter of 2020, is expecting to earn a large share of the estimated $2.7 billion companion pet diagnostic and healthcare market expected by 2024. That's because, despite the competitive landscape for traditional diagnostic tools, Zomedica is one of the few companies intent on developing and bringing to market innovative, point-of-care animal healthcare products designed to quickly and efficiently diagnose and help treat companion animal diseases; Zomedica's products aim to support new standards around point-of-care. Zomedica is one of the only known companies that is nearing the completion of confirmatory studies that will expedite the commercialization of innovative veterinary diagnostics and pharmaceutical products; potentially securing a competitive advantage against others looking to enter the space.
Based in Ann Arbor, Michigan, Zomedica is dually traded on the NYSE American and TSX-V markets under the symbol "ZOM." As noted, Zomedica is in the final stages of its investigational studies for, TRUFORMA™, a point-of-care diagnostic platform that is proving to have substantial advantages compared to traditional options. The device, which is smaller than a desk-top printer, is used to diagnose thyroid and adrenal disorders in dogs and cats. The company's late-stage confirmatory studies are providing reliable proof-of-concept data, suggesting that TRUFORMA™ may have the capability to replace traditional methods for diagnosing thyroid and adrenal disease in dogs and cats. The product's most appealing advantage is that it eliminates the need to send patient samples to an outside lab for testing. In addition to expediting results at point-of-care, the in-office data can result in immediate and appropriate patient treatment, eliminating an often multi-day delay getting results from outside laboratory sources.
Beyond TRUFORMA™, Zomedica's pipeline of additional diagnostic and pharmaceutical products is also expected to deliver revenue-generating rewards. If the investigative studies continue as intended, Zomedica will remain on pace to deliver multiple products to market during 2020 and position the company as an integral provider of potentially industry-changing diagnostic tools. The common theme among each product is that they can meaningfully shorten the time and increase confidence around diagnosing conditions and diseases affecting dogs and cats.
TRUFORMA™ Can Become A Point-of-Care Diagnostic Game-Changer
While the potential of Zomedica's pipeline of products is earning industry attention, the company's flagship product, TRUFORMA™, is gaining wider attention as it nears commercialization. It's a point-of-care diagnostic platform that some industry experts believe can become an industry-changing tool for veterinary practices. Notably, the device is likely to get marketed as a first of its kind diagnostic tool that can provide substantial benefits to veterinarians and their teams by giving them the ability to take control of testing, diagnosing, and treating patients in a single clinic visit. Furthermore, the point-of-care TRUFORMA™ biosensor platform is not only proving its ability to deliver lab-quality testing, but study data to date for several of the initial assays also suggests that the TRUFORMA™ platform may be the only point-of-care diagnostic device capable of analyzing a serum sample and delivering accurate, reliable results in approximately fifteen minutes.
Tackling large diagnostic market opportunities first, the initial assays expected to be brought to market will target thyroid and adrenal disorders, two common conditions in companion animals. Additional assays in development are expected to broaden the TRUFORMA™ platform and include assays to test for non-infectious gastrointestinal disorders, renal disease, and diabetes. The scalable nature of TRUFORMA™ is further expected to increase and extend the revenue-generating potential of TRUFORMA™, and at the same time, open new revenue streams for users of this innovative device. Long-term revenue models are based on the company's use of the razor/razorblade business model for its diagnostic cartridges.
TRUFORMA™ Works Simply and Efficiently
From an operations perspective, the table-top TRUFORMA™ device provides quick and reliable results from only needing a small patient sample, often requiring just a small blood draw from a dog or cat. Currently, Zomedica is investigating sample preparation processes, and is showing an ability to get accurate data references from both whole blood or serum, providing an additional and significant advantage over current diagnostic processes.
Using BAW (bulk acoustic wave) technology, the tool works by detecting changes in resonant frequency. BAW technology, also used in cell phones, is an extremely reliable, precise, and well-tested technology; it is exciting that Zomedica is applying this well-established technology in a new and innovative manner.
Because of its ease of use, accuracy, and rapid delivery of results compared to competing diagnostic methods, Zomedica may be well-positioned to commercialize TRUFORMA™ as a point-of-care instrument of choice that can enhance the patient, client, and clinician standard of care, as well as increase clinic revenue. In addition to its speed and cost advantages, the device's practical superiority is creating distance from potential plagiarists because of the IP technology embedded into TRUFORMA™, which can deliver reference lab-quality testing directly to veterinarians and their teams in the clinic. That benefit allows the treatment team to have greater confidence and flexibility to diagnose, treat, and improve patient outcomes and pet owner experiences, and further streamline their own practices by eliminating the time and labor required to send samples to a reference laboratory for testing.
In simpler terms, TRUFORMA™ is on a path to become the first and only diagnostic tool that can eliminate the delays that occur with reference laboratory testing and brings the focus back to where it belongs-the patient. And, when providers control the sequence of treatment steps, their ability to focus on providing useful, timely, and quality patient care is significantly increased.
Zomedica is expected to complete validation studies for TRUFORMA™ during the fourth quarter of 2019 with a planned commercial launch before the close of first quarter of 2020. Investors have been bullish toward the stock in advance of the planned commercialization by sending shares of the company higher by more than 70% since July*. Investors may also be recognizing that although TRUFORMA™ may become the company's first product to market, they may further benefit from a growing number of assets in the company's pipeline that are also working through investigational studies. As a whole, Zomedica may be entering the next year in a position to capitalize from multiple product launches that can generate meaningful revenue streams by targeting unmet needs in the veterinarian market. (*share price percentage change calculated from July 1 - Sept 30, 2019)
Zomedica's Pipeline Targets Unmet Medical Needs
Beyond the planned launch of TRUFORMA™, Zomedica is advancing two additional diagnostic platforms toward commercialization, each bringing unique and specialized detection capabilities to the veterinary clinic.
Zomedica's pipeline for diagnostic devices is further strengthened by its canine circulating tumor cell or liquid biopsy platform (ZM-017 and ZM-022). This unique and innovative liquid biopsy platform offers assays to diagnose specific types of cancer, including canine osteosarcoma, hemangiosarcoma, and lymphoma. This device, which is moving through the investigational and development process, will be marketed to veterinarians and reference labs, and will provide them with the benefits of needing only a small patient sample that is collected by the veterinarian.
A later planned point-of-care pathogen detection diagnostic device, ZM-020, is also designed to require minimal sample preparation. This platform uses a small amount of feces or urine that is loaded into a disposable cuvette for testing by the device. The test is described as a pathogen detection device that detects fecal parasites and can help discover evidence of urinary tract disease, such as bacterial infection. Like TRUFORMA™, the device can provide accurate and reliable results in minutes. More importantly, especially to the patient, these results are provided at the point-of-care, eliminating the need to submit samples to the reference lab that can delay routine patient care.
Beyond diagnostic platforms, the company is also investigating the value of developing FDA-CVM therapeutics specifically formulated for dogs and cats. Currently, veterinarians often prescribe medicines labeled for use in humans because there is no veterinary drug equivalent. This imprecise dosing is usually based on ambiguous treatment guidelines and inconsistent and sometimes unreliable data. Zomedica is preparing to capitalize on these treatment shortfalls and seize upon a significant market opportunity by developing an approved source of animal medications designed to help veterinarians improve patient care and grow in-house pharmacy revenue. These studies are in progress and may benefit from expedited approval based on regulatory concessions related to approved human medications used for the exclusive treatment of companion animals.
2019-2020 Can Be A Transformative Period For Zomedica
Aside from the potential value from the commercialization of multiple product launches, a notable industry attraction to Zomedica may be driven by bringing potentially industry-changing products to the vet-care diagnostics market. And, with the company focused on niche markets that can exploit specialized opportunities, Zomedica may likely benefit from its compelling portfolio of intellectual property, its innovative technology and pharmaceutical platform, and from its highly experienced management team focused on bringing products to market that target unmet market needs.
The sum of the parts may equal long-term success. First, Zomedica has compelling products that are nearing commercialization and is on track to launch its first revenue-generating product early next year. Second, the company is led by a team of professionals that hold a significant ownership stake in the company. And, third, the company is drawing top-industry leadership to its board and management team. Zomedica's Chief Commercialization Officer, Bruk Herbst, and newest independent director elected to the board of directors, Johnny D. Powers, both held high-level leadership positions at industry-mammoth, IDEXX. Combined, the assets may be well-fortified to drive intrinsic value substantially higher, and like other emerging companies that are focused on making markets better, Zomedica may be on the verge of becoming a "vet-care sector" standout in 2020.
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