Under the Symbol:
Zomedica Inc. Prepares to Launch Veterinarian Diagnostic Device, TRUFORMA(TM); Has Potential to Change Diagnostic Landscape in Animal Health (NYSE American: ZOM)
Tuesday, August 13, 2019 8:00 AM
MIAMI BEACH, FL / ACCESSWIRE / August 13, 2019 / As dogs and cats continue to integrate into more families across the globe, new, interesting business opportunities arise. And, while most pet owners hope that their furry friends remain healthy and vibrant, proper attention to health is an essential part of a dog or cat’s life. And, since our companions aren’t able to tell us how they’re feeling verbally, veterinarians and pet owners, alike, are turning to companies like Zomedica (NYSE American:ZOM) to bring innovative tools that assist veterinarians in diagnosing and treating illness and disease to market. And, their focus on Zomedica is well placed.
Zomedica is making tremendous strides to launch its first companion pet diagnostics device, TRUFORMA™, to a market that has both demand and lucrative opportunities. After all, with current estimates suggesting that over 60 million Americans own a dog, making up 44% of all households nationwide, it represents just a part of a market that brings with it a more than $19 billion veterinary care opportunity. And, for Zomedica, a Michigan-based company that is blazing a trail to become a leader in companion animal diagnostic and therapeutic treatments, they can earn a sizable slice of that market potential by capitalizing on the improvements being made in the human medical field, which they can adapt and implement for veterinary practice.
TRUFORMA™ is the company's innovative diagnostic tool that aims to replace old-fashioned methods of diagnosis that require patient samples to be sent to an outside lab for testing before therapeutic or prescription treatments can be offered. And, as most already know, that diagnostic turnaround time can take days or even weeks, which can not only delay urgent treatment but can also lead to additional medical complications. Now, with modern innovations coming to market by companies like Zomedica, a fast, accurate point-of-care diagnosis can be provided right at the clinic. In doing so, Zomedica can help to streamline the vet care industry.
Zomedica is for the Modern Veterinarian
Zomedica is an animal health company, creating diagnostics and therapeutics for cats and dogs, with a focus on developing systems that can improve and expedite the standard of care in the veterinary industry. The company’s flagship candidate is TRUFORMA™, a clinical point of care diagnostic system designed to test thyroid and adrenal disorders in companion pets. Beyond TRUFORMA™, Zomedica has a growing pipeline of therapeutic products (drugs) that are progressing through testing and analysis phases - all of which have already been approved for human use. Those prior approvals are important and will help Zomedica expedite regulatory processes that provide accelerated pathways that allow for already approved human drugs to be used for treatment in companion animals. As noted above, Zomedica is effectively working to bring to market a platform of novel drug formulations, in addition to its diagnostic platforms, explicitly tailored to animals. And, with the approval channels more receptive to already approved medications for use in companion animals, Zomedica is well-positioned to expand its revenue-generating product base in the coming quarters.
On the drug front, four therapeutics within the company’s pipeline are targeting treatment opportunities for some of the most common disorders in pets and include two formulations of metronidazole for diarrhea, methimazole for hyperthyroidism, and transdermal fluoxetine for behavioral problems. Each drug market can bring to Zomedica an independent and substantial prescription drug opportunity.
To replace the prescription of human medications to animals, Zomedica can capitalize on a significant market opportunity by replacing the drugs that are often prescribed to animals in inaccurate doses based on ambiguous dosing guidelines and subjective reasoning. However, prescribing drugs for animals can become even more complicated. If a treating veterinarian decides against allowing a pet owner to administer a human dose to the animal inaccurately, or if they are hesitant to prescribe human drugs based on regulatory oversight, then they are forced to use the next best alternative by calling the prescription into a local compound pharmacy, who then must specially prepare a pet-friendly dose. Not only is the medication more expensive in that instance, but compound pharmacies are not as popular as they were two decades ago, and finding one is no easy task in some communities. Thus, the inefficiencies in the prescription drug market demonstrate just how vital the mission at Zomedica can be to the industry by helping to streamline companion animal drug costs, potency, and regulatory compliance.
Probably most important at this stage of Zomedica's growth story is that the company is expecting to launch its first of several planned products by the first quarter of next year. It's a plan that will take them from development stage to revenue-generating, which in and of itself can perpetuate other opportunities. In fact, behind the expected market launch of TRUFORMA™, the company is also positioning itself to drive revenues even higher by capitalizing on the TRUFORMA™ design that will allow follow-up assays to be quickly integrated into the platform. And, banking on the innovative and totality of services that the device can offer, Zomedica can inevitably provide veterinarians with the tools and resources to benefit from multiple new revenue streams by giving them the ability to diagnose, treat, and sell medications immediately and in-house. That's good news.
For all involved, it's a win-win situation. Also, demand for the services won't be hard to find, especially when the Zomedica pipeline goes a long way to satisfy the consumer, the veterinarian, the patient, the pet owner, and even pet-insurance providers.
TRUFORMA Prepares To Make Market Debut
Zomedica is not only seizing upon opportunities generated from the innovations within the broad medical treatments sector, but they can also take advantage of already approved drugs that can expedite regulatory approvals. For instance, as the company began development of the TRUFORMA™ biosensor diagnostic platform, they likely took into account that the companion animal diagnostic and treatment sector could provide relatively swift returns as the direct regulatory hurdles are far less restrictive when compared to human approvals from the FDA or USDA.
And, with compelling data that shows its broad utility to providers, Zomedica is getting close to capitalizing from the TRUFORMA™ launch that can generate formidable revenue streams from its scalable platform that can quickly integrate new assays to diagnose disease or illness in companion animals.
TRUFORMA Uses Radio Frequency, BAW Technology
In addition to speed and accuracy, when compared to the optical diagnostic readers commonly used by reference labs, TRUFORMA™ has shown superiority from its ability to substantially reduce costs and to significantly shorten the time needed to generate test results. A contributing factor to these potentially market-changing advantages is coming from the use of radio frequency solutions and BAW technology that can isolate a target bandwidth and detect a potential immunological reaction.
Investigational testing of the platform is showing that if an immunological reaction takes place, the mass of the combined particle is increased which triggers a response in the sensor located in the cartridge to note a change in the oscillation frequency, indicating a positive test. Comparative results against commonly used optical sensors show that the acoustic approach is substantially more precise and may become the eventual gold standard in point-of-care diagnostics, providing users with results that were once only available in the reference lab.
A Novel Diagnostic Pipeline
Alongside TRUFORMA™, the company is preparing to bring two other point-of-care diagnostic platforms to the market, each bringing unique and specific detection capabilities straight to the veterinary clinic. For example, Zomedica's point-of-care pathogen detection platform is a second diagnostic platform that makes use of the company's razor/razorblade business model. Designed for minimal sample preparation, clinicians can insert an animal's fecal or urine sample into the device’s disposable cuvette, which the machine can analyze and then return an analysis of identified pathogens within minutes. Because it can detect the pathogen rather than merely the antigen antibody response, veterinarians can quickly and precisely determine the treatment required. Other platforms, such as Zomedica's canine cancer liquid biopsy platform, offer assays including osteosarcoma, hemangiosarcoma, and lymphoma, which are in development. With this technology, veterinarians can perform a simple blood test and send samples to a reference lab for results. These assays will also benefit Zomedica by utilizing the razor/razorblade model.
Zomedica is Taking Advantage of a Sizable Opportunity
Combining TRUFORMA™ with its other emerging product candidates, Zomedica has positioned themselves to seize a massive opportunity in a thriving industry. Within the $19 billion veterinary care industry, animal health diagnostic services account for about $2.6 billion in revenues, which is where the company is currently focusing its resources. And, to penetrate that market, Zomedica is hiring executive talent to seize upon the opportunity, adding Bruk Herbst in 2017 to serve as the Chief Commercial Officer at Zomedica. Mr. Herbst brings over 20 years of industry experience and was formerly the head of US Sales at IDEXX.
Also, as noted above, TRUFORMA™ revenues will come though the razor/razorblade business model that generates income from the sale of its disposable test cartridges, creating an indefinite sales lifecycle from the clinics that use the TRUFORMA™ platform. Also, the platform has been designed from the ground-up to be adaptable to specific and new applications, creating the organic potential for future streams of revenue to be added to the platform’s consumable lifecycle, with future assays expected to diagnose gastrointestinal disorders.
More than just being a diagnostic equipment and pet-specific drug company, though, Zomedica's pipeline will not only help themselves, but it can also benefit veterinarians. Zomedica's suite of products are being designed to allow a service provider to manage complete control of an all-inclusive point-of-sale service, and to provide them with the means to diagnose, treat, prescribe, and sell medications prior to the patient leaving the clinic. ZOM can transform veterinary clinics into one-stop-shops for services and treatment.
Expedited Regulatory Approvals, Insider Stakes Drive Innovation At Zomedica
From an investment perspective, Zomedica is expected to benefit substantially from the shorter regulatory review timeline for veterinary device and drug approvals. In fact, Zomedica is already planning to launch pivotal safety studies for all of their candidates by H2 of 2019. The funding for these development initiatives comes in part from the recent completion of a $12 million royalty financing through an accredited investor. That deal is expected to cover research and development costs as well as to provide cash for planned and near-term milestone payments under existing license agreements. It's also noteworthy to mention that ZOM insiders also have significant investment stakes in the company. Moreover, filings indicate that recent share purchases did not come with preferred shares, convertible shares, or cheap warrant options.
Showing his vote of confidence, Zomedica President and CEO Gerald Solensky Jr. has invested $600,000 at $1.50 per share into the company's stock during a recent financing. The investment increases his stake in the company to more than 35.7% of the outstanding shares. It's worth a second mention that neither of the recent fundings included convertible shares or cheap warrants that can create an overhang to the stock and capital structure. At its core, the investment is a testament to the confidence in the science and shows support of the team that is directing Zomedica toward a leadership position in the veterinary diagnostic and therapeutic sectors.
Taking Zomedica To The Next Level Of Opportunity
As the company continues to build a potentially lucrative product portfolio, Zomedica has not lost sight of its urgency to deliver a product to market. And, as a means to accelerate its progress, Zomedica is leveraging its existing relationships with key veterinary opinion leaders that are assisting in an upcoming beta launch of the TRUFORMA™ platform planned for several top academic institutions and endocrinology centers. The company has also established working relationships with over 3000 high-diagnostic revenue clinics in the U.S.
Additionally, to emphasize the innovation and promise of its diagnostic platform, the research team at Zomedica is focused on earning publications from peer-reviewed scientific journal publications, references, and provider testimonials. Winning that recognition from established and respected researchers can go a long way to validate the diagnostic, convenient, innovative capabilities of TRUFORMA™.
Emerging Popularity Enhances Opportunity For TRUFORMA™
Zomedica may just now be emerging in popularity, but behind its development is an experienced team with the industry knowledge, relationships, and resources to achieve their goal of modernizing and simplifying the veterinary diagnostic experience. And, as the company works to change the landscape by replacing an antiquated system of diagnostic practice, Zomedica's TRUFORMA may be the device that ushers in the change to allow clinics the ability to quickly diagnose and treat its patients with a tool that is specifically designed to provide quick, accurate, and convenient point-of-service results.
As technology changes, it's the companies that embrace those opportunities that will prosper. For Zomedica, the TRUFORMA™ platform is not only timely, but it can also become one of the most revolutionary veterinary clinical devices to hit the markets in decades. The TRUFORMA™ platform may be able to secure its client base for multiple generations of the device.
Although pivotal testing is just beginning for Zomedica's therapeutics, the significantly quicker pathway to market compared to human pharmaceuticals should allow the company to complete most pivotal efficacy studies by late 2019. Thus, a value proposition is exposed. Additionally, Zomedica can also benefit from market exclusivity after approval that can range from three to seven years based on the application submitted and patent protection allowances of its therapeutics.
And, although pets have always been man's best friend, if Zomedica continues to execute on its strategy to develop and quickly bring to market novel devices that can theoretically change the landscape of how veterinarians can treat their patients, Zomedica may likely become a best friend as well... to its investor base.
Dolphin Analytics, LLC
SOURCE: Zomedica Pharmaceuticals