8-K
Zomedica Corp. (ZOMDF)
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 _____________________
Form 8-K _____________________
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event Reported): March 16, 2021
ZOMEDICA CORP. (Exact Name of Registrant as Specified in Charter)
| Alberta, Canada | 001-38298 | N/A |
|---|---|---|
| (State or Other Jurisdiction of Incorporation) | (Commission File Number) | (I.R.S. Employer Identification Number) |
| 100 Phoenix Drive, Suite 180, Ann Arbor, Michigan | 48108 | |
| --- | --- | |
| (Address of Principal Executive Offices) | (Zip Code) |
Registrant's telephone number, including area code: (734) 369-2555
Not Applicable (Former name or former address, if changed since last report)
| Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions: | ||
|---|---|---|
| [ ] | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) | |
| [ ] | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) | |
| [ ] | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) | |
| [ ] | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2). Emerging growth company [ X ]
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. [ X ]
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
|---|---|---|
| Common Shares, without par value | ZOM | NYSE American |
Item 8.01. Other Events.
On March 16, 2021, Zomedica Corp. issued a press release announcing that it recorded its first veterinarian sale of its TRUFORMA^®^ diagnostic platform. A copy of the press release is attached hereto as Exhibit 99.1 and incorporated herein by reference.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
| Exhibit Number | Description |
|---|---|
| 99.1 | Press Release, dated March 16, 2021 |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| ZOMEDICA CORP. | ||
|---|---|---|
| Date: March 16, 2021 | By: | /s/ Ann Marie Cotter |
| Name: Ann Marie Cotter | ||
| Title: Chief Financial Officer |
EdgarFiling
EXHIBIT 99.1
Zomedica Announces First Commercial Sale of Its Truforma® Platform
ANN ARBOR, Mich., March 16, 2021 (GLOBE NEWSWIRE) -- Zomedica Corp. (NYSE American: ZOM) (“Zomedica” or the “Company”), a veterinary health company creating point-of-care diagnostics products for dogs and cats, yesterday recorded the first veterinarian sale of TRUFORMA^®^ and officially entered commercialization.
“This is a momentous day for Zomedica, our shareholders, the veterinarians we serve, and the companion animals in their care. I would like to express my deepest gratitude to the many people at Zomedica who dedicated the past two years of their lives to achieving this critical milestone,” commented Robert Cohen, Zomedica’s Chief Executive Officer. “It is a credit to both our employees and to the stellar team with whom we have worked at our development partner, Qorvo Biotechnologies LLC, that we have created a unique and valuable diagnostic tool, and have delivered it to the veterinary market slightly ahead of our previously announced schedule.”
James Klein, president of Qorvo Biotechnologies said, “At Qorvo, we are leveraging the power of Bulk Acoustic Wave (BAW) radio frequency (RF) technology to innovate numerous products such as Wi-Fi routers, mobile phones, 5G cellular infrastructure and now veterinary diagnostics. The launch of the TRUFORMA^®^ platform is an exciting and disruptive milestone in the veterinary diagnostics testing industry that will raise the standard of point-of-care for companion animals.”
The first official purchaser of a TRUFORMA^®^ system was Jason Berg, DVM, DACVIM, founder and president of Guardian Veterinary Specialists, a 29,000-square-foot advanced emergency critical care and specialty hospital in Brewster, New York. A highly respected board-certified veterinary internist and neurologist, Dr. Berg’s dedication to advancing the field of veterinary medicine has garnered national and international recognition. He received his DVM degree from Texas A&M University and went on to complete his internship and residency training in veterinary neurology and internal medicine at The Animal Medical Center in New York City, receiving board certification in neurology in 2000 and in internal medicine in 2002. A sought-after lecturer and instructor, Dr. Berg has published numerous articles in peer-reviewed journals, including those of the American Veterinary Medical Association (AVMA), the American College of Veterinary Internal Medicine (ACVIM), and the American Animal Hospital Association (AAHA).
Dr. Berg commented that, “As a veterinary internist and business owner, I have devoted myself to advancing the practice of veterinary internal medicine and delivering care with a difference – doing more, providing more, and caring more. I am excited to be the first veterinarian to purchase TRUFORMA^®^. I will be able to go above and beyond the current standard of care to provide cutting-edge and novel testing to pet owners and veterinarians in seven surrounding counties across two states. The ability to reliably and accurately measure cortisol on-site in our emergency service at Guardian Veterinary Specialists has the potential to save lives. Offering complete thyroid testing on-site for both dogs and cats will allow our internal medicine service to provide timely answers to anxious pet owners. We dedicate ourselves to serving the needs of the broader veterinary community by offering lab services through Bloodhound laboratories, which will allow our practice partners to also advance their endocrine practice. I am most excited to use endogenous ACTH in my work as a veterinary internist to help owners make difficult decisions about medical care, including the decision to pursue complex adrenal surgery.”
With the instrument and three of five of the initial assays available for sale, the decision was made to initiate the commercial launch of TRUFORMA^®^ ahead of the previously disclosed March 30th schedule. Now available for purchase are TSH, total T4, and cortisol assays. Endogenous ACTH and free T4 are expected to be available during the coming weeks. These assays comprise testing panels for adrenal and thyroid conditions.
Having a point-of-care cortisol test available also was welcomed by Audrey Cook, BVM&S, Dip ACVIM at Texas A&M College of Veterinary Medicine and Biomedical Sciences: “Veterinarians rely on serum cortisol measurements to diagnose and manage adrenal diseases in dogs. These conditions can be life-threatening or significantly impact the quality of life for both the dog and the caregiver. Having an accurate and reliable, patient-side, cortisol assay will allow veterinarians to manage canine adrenal diseases more effectively and efficiently, and could save lives." Dr. Cook has published numerous articles and book chapters on various aspects of small-animal medicine and regularly speaks at national veterinary meetings.
Protected by approximately 70 issued and pending patents, the TRUFORMA^®^ diagnostic platform uses Bulk Acoustic Wave (“BAW”) technology, developed by Qorvo (NASDAQ: QRVO) to provide a non-optical and fluorescence-free detection system for use at the point-of-care. BAW technology, also used in cell phones and in the world’s most advanced radar and communications systems, is an extremely reliable and precise technology.
About ZomedicaBased in Ann Arbor, Michigan, Zomedica (NYSE American: ZOM) is a veterinary health company creating products for dogs and cats by focusing on the unmet needs of clinical veterinarians. Zomedica’s product portfolio will include innovative diagnostics and medical devices that emphasize patient health and practice health. It is Zomedica’s mission 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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Reader Advisory 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 American 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: 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 a distribution network and manage our growth; uncertainty as to our ability to supply equipment and assays 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; 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.sedar.com. Readers are cautioned that this list of risk factors should not be construed as exhaustive.
The forward-looking information contained in this news release is expressly qualified by this cautionary statement. We undertake no duty to update any of the forward-looking information to conform such information to actual results or to changes in our expectations except as otherwise required by applicable securities legislation. Readers are cautioned not to place undue reliance on forward-looking information.
Investor Relations Contact: PCG Advisory Kirin Smith, President [email protected] +1 646.823.8656