Leading Dry Eye Disease Diagnostic Healthcare Company’s Assays to be Performed in Over 40 Initial Clinics Across US
SAN DIEGO, CA, May 24, 2023 (GLOBE NEWSWIRE) — via NewMediaWire – AXIM Biotechnologies, Inc. (OTCQB: AXIM) (“AXIM Biotech,” “AXIM” or “the Company”), an international healthcare diagnostic solutions development company, announced today that through its distribution partner Verseá Ophthalmics it has received commitments from over 40 clinics across the United States for implementation of both of its FDA-cleared Dry Eye Disease (DED) diagnostic assays. The milestone marks the initial step in its nationwide roll out of the platform and the Company expects new clinics to continue to commit over the coming months with the goal of doubling the amount by Q4 2023.
As part of the onboarding process for clinics, each of the 40 clinics either currently have their CLIA moderate complexity license or are in the application process. Once they have their CLIA license the Company will send its clinic partners a validation kit, along with a reader that is used to interpret results, and the clinics will run the required amount of validation test assays in anticipation of full-scale implementation. Once initial validation testing is done, the Company anticipates clinics on average will begin monthly reordering of approximately 200-300 tests. Each of the 40 clinics are committed to introducing the diagnostic platform and will receive a combination of IgE and Lactoferrin diagnostic assays. Additionally, AXIM’s commercialization partner Verseá Ophthalmics continues to meet with and educate clinics on the diagnostic assay platform, with the goal of garnering additional commitments.
While currently all clinics working with the assays must be CLIA-moderate complexity certified before they can run tests, the Company is currently in the process of preparing the appropriate research trial and paperwork for submission to the appropriate regulatory body seeking a CLIA-waiver, which once accomplished, will exponentially increase the market opportunity for introduction of the tests.
“We are so pleased to share this update with our investors and the medical community as a whole,” said John Huemoeller II, CEO of AXIM Biotechnologies. “Since launching our diagnostic platform, we have looked forward to the day where our solutions would officially begin to improve the lives of thousands of patients a week, and today we can share that dream is a reality. Verseá has been showcasing our platform at industry trade shows and to clinics across the country and the initial response has been tremendous. I could not be more excited about the opportunity before us and every day we continue to scale manufacturing to be able to meet the growing demand. Also – I would like to personally thank the Verseá team who has played an integral part in achieving this milestone – they continue to prove their professionalism and passion for our mutual success, which are great qualities to look for in a partner.”
According to the American Academy of Ophthalmology, approximately 344 million people worldwide suffer from DED while clinicians struggle to properly diagnose and treat the disease. AXIM’s solutions seek to address this unmet medical need through further introduction of its diagnostic platform. Each of its tests are designed to be administered at the point-of-care, render results in less than nine minutes, and offer a qualitative assessment of biomarkers and enzymes in the body whose variances provide indications on DED plausibility. Additionally, beyond initial diagnosis, consistent testing is required to evaluate the efficacy of treatment for DED, creating a recurring need for AXIM’s solutions at the point-of-care.
For more information on AXIM’s diagnostic solutions or to speak with someone at AXIM’s commercialization partner Verséa about adding these innovative solutions to your clinic, please visit: https://www.versea.com/divisions/ophthalmics/.
About AXIM® Biotechnologies
Founded in 2014, AXIM® Biotechnologies, Inc. (AXIM) is a vertically integrated research and development company focused on improving the landscape for the diagnosis of ophthalmological conditions such as Dry Eye Disease (DED) through rapid diagnostic tests. The Company owns two of the only five FDA Cleared Diagnostic tests for Dye Eye Disease. For more information, please visit www.AXIMBiotech.com.
The statements made by Axim Biotechnologies Inc., in this press release may be “forward-looking” in nature within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. Forward-looking statements describe Axim’s future plans, projections, strategies and expectations, and are based on assumptions and involve a number of risks and uncertainties, many of which are beyond the control of Axim Biotechnologies, Inc. Actual results could differ materially from those projected due to there being no assurance that our diagnostic candidate will ever be approved for use by the U.S. FDA or any equivalent foreign regulatory agency. Further, Axim’s eye care diagnostic products that are FDA cleared may not be manufactured in large enough quantities or that third parties with established eye care physicians will enter into agreements or purchase from the Company, and even if the Company’s diagnostic candidates are successful, they may generate only limited revenue and profits for the Company. Various other factors are detailed from time to time in Axim’s SEC reports and filings, including our Annual Report on Form 10-K filed on April 15, 2022, and other reports we file with the SEC, which are available at www.sec.gov. Axim Biotechnologies, Inc., undertakes no obligation to update publicly any forward-looking statements to reflect new information, events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, unless otherwise required by law.
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