AXIM Biotech Announces New Milestones in Preparation of Dry Eye Disease Diagnostics Launch
- AXIM is driven to positively transform the state of Dry Eye Disease (DED) testing and diagnosis
- The company will deploy industry leader IUL’s state-of-the-art iPeak readers
- Company Adds Veteran Lab Testing Exec Barry Craig
- AXIM develops and files for a patent for Novel Tear Collector System
SAN DIEGO, Feb. 15, 2022 (GLOBE NEWSWIRE) — AXIM Biotechnologies, Inc (OTCQB: AXIM) (“AXIM Biotech,” “AXIM” or “the Company”), an international healthcare solutions company targeting dry eye disease (DED), today announced two key milestones in preparation of the launch of its DED diagnostics testing initiative.
AXIM has signed a supply agreement with Barcelona-based IUL SA (“IUL”) for its iPeak DED readers which will be deployed for diagnostic testing with a focus on lactoferrin levels. This state-of-the-art portable reader is a colorimetric lateral flow reader designed to hold different cassette sizes and can read cassettes of up to five strips and seven lines per strip at a time.
iPeak is equipped with “Flash Eye” technology based on the principles of machine vision illumination. Its camera captures the image of the test illuminated from LED lights situated in the most studied geometry to achieve a precise and uniform illumination and enhance the colors of any lateral flow test. The iPeak technology also allows for more sensitivity, which is the main success of its application.
AXIM evaluated the iPeak readers in the lab against six other comparable products before deciding on IUL’s state-of-the-art products. The new readers will be calibrated with the new test strips and distributed to the Company’s Medical Advisory Board (MAB) of renowned DED experts for non-clinical field testing on their patients, which includes studying the accuracy and ease of use. These tests are expected to run for a few weeks and the MAB will provide management with data and feedback regarding the test results and any other research findings.
The Company’s diagnostic testing process for DED, and specifically for lactoferrin levels as a primary indicator, will include the use of reagent strip samples. These strips will have the patients’ tear sample obtained and applied and then an ophthalmologist or optometrist will run the strips through an iPeak reader to determine lactoferrin levels and incidence and severity of DED.
To manage and navigate the readers, lab testing, compliance, and field-testing process, AXIM has retained veteran laboratory testing executive Barry Craig as a consultant. In this role, he will manage the Company’s DED lab testing initiative. He has more than 25 years of experience in the clinical laboratory as a Generalist, QA Coordinator, and Microbiology Supervisor. He also served as Lab Coordinator for the Children’s Hospital of Alabama for 12 years. Craig has deep-seated experience in regulatory compliance as the owner of Laboratory Consulting, LLC, and has served as the Regulatory Compliance Consultant for CLIA, the Commission on Office Laboratory Accreditation (COLA), and the College of American Pathologists (CAP). He has successfully established more than 200 moderate and high complexity laboratories, and is a contributor for several trade publications such as MLO magazine, ADVANCE for Administrators of the Laboratory Magazine, and Physician Office Resource Magazine.
“After extensive due diligence, we fully expect our supply agreement with IUL will enable us to transform the DED diagnostic testing market with the highest quality readers available and an approach that is light years ahead of industry competitors,” said John Huemoeller, CEO of AXIM Biotech. “We have the only FDA-cleared quantitative test for Dry Eye Disease and believe that it has tremendous accuracy and convenient ease of use for ophthalmologists as well as frontline optometrists. Barry will be instrumental in assisting us to navigate our field study and regulatory approval process.”
About IUL SA
Headquartered in Barcelona, Spain and founded in 1987, IUL has been designing, producing, and marketing automation solutions for microbiology laboratories. The company seeks to provide more comfortable, safer, and reliable microbiological control for the industry and to deliver devices for in-vitro diagnostics in the field of human and animal health. IUL’s new iPeak portable reader is a colorimetric off-the-shelf lateral flow reader designed to hold different cassette sizes. This state-of-the-art portable reader is equipped with connectivity, and it can read cassettes of up to five strips and seven lines per strip at a time. iPeak is equipped with “Flash Eye” technology based on the principles of machine vision illumination. The iPeak reader “flash Eye” camera captures the image of the test illuminated from LED lights situated in the most studied geometry to achieve a precise and uniform illumination and enhance the colors of any lateral flow test, he iPeak technology allows for more sensitivity, which is the main success of its application. https://iul-instruments.com
Tear Collection System
Tear fluid analysis contributes to the greater understanding of various ocular and systemic diseases. However, obtaining adequate samples for tear analysis requires an effective collection method. Most tear sample collectors on the market use capillary designs which are often intimidating to a patient, difficult to use by untrained personnel, and are expensive to manufacture. AXIM developed and patented a novel tear sample collector system that is extremely cost-effective to produce on mass scale, features an indicator that appears on the strip when enough tear fluid has been absorbed making it easy to use by untrained personnel, soft and non-intimidating to user and patient alike.
About AXIM® Biotechnologies
Founded in 2014, AXIM® Biotechnologies, Inc. (AXIM) is a vertically integrated research and development company focused on improving the landscape for diagnosis of ophthalmological conditions such as Dry Eye Disease (DED) through rapid diagnostic tests. Additionally, it owns IP and has conducted research on SARS-CoV-2 (COVID-19) rapid neutralizing antibody tests to detect levels of functional neutralizing antibodies that are believed to prevent SARS-CoV-2 from entering the host cells, as well as for oncological indications. For more information, please visit www.AXIMBiotech.com.
Forward-Looking Statements
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 be successfully shown to detect SARS-CoV-2 neutralizing antibodies, that the diagnostic candidate will be approved for use by the U.S. FDA or any equivalent foreign regulatory agency, that the diagnostic candidate can be manufactured in large quantities or that third parties with an established presence in blood collection clinics, vaccine development, employer or individual use will enter into agreements or purchase from the Company, and even if the Company’s diagnostic candidate is successful, it may generate only limited revenue and profits for the Company, including whether any of Axim’s diagnostic products will receive clearance from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies to sell its products and whether and when, if at all, they will receive final approval from the U.S. FDA or equivalent foreign regulatory agencies, the fact that there has never been a commercial diagnostic test utilizing neutralizing antibodies approved for use and various other factors detailed from time to time in Axim’s SEC reports and filings, including our Annual Report on Form 10-K filed on April 15, 2021 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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