AXIM® Biotechnologies Commences Commercial Manufacturing of FDA-Cleared Proprietary Ocular Diagnostic Assays
Leading Diagnostic Healthcare Company Begins Manufacturing of Ocular Immunoglobulin (IgE), Lactoferrin Tests to Fulfill Orders From Commercialization Partner
SAN DIEGO, CA, April 11, 2023 (GLOBE NEWSWIRE) -- via -- . () (“AXIM Biotech,” “AXIM” or “the Company”), an international healthcare diagnostic solutions development company, announced today the start of manufacturing of both its proprietary Ocular Immunoglobulin E (IgE) and Lactoferrin diagnostic assays to fulfill the orders placed by its commercialization partner. As is a standard manufacturing practice, AXIM has begun manufacturing three separate lots of each assay that will be used for an internal reproducibility study with the third lot available to ship to customers. AXIM’s current manufacturing capacity is up to 25,000 units per month.
Both tests were designed to be administered at the point-of-care, and measure respective biomarker levels in patients, rendering results in just eight minutes. Unlike other clinically available assays, AXIM’s tests are quantitative and measures actual levels of both IgE and Lactoferrin allowing doctors to monitor targeted therapeutics.
Lactoferrin is a protein that exhibits a unique combination of antimicrobial, antiviral and anti-inflammatory properties. It is one of the eye’s important immunological defense mechanisms and also is a biomarker used to assess the secretory function of the lacrimal gland. Measuring Lactoferrin levels in patients enables clinicians to directly correlate low levels to dry eye disease caused by aqueous deficiency and the severity of DED can be determined by the Lactoferrin level. Low Lactoferrin levels indicate DED and depressed ocular immunity, which may represent an increased surgical risk and of contact lens intolerance. IgE is a key biomarker primarily associated with non-specific, allergic conjunctivitis, which often mimics Dry Eye Disease (DED), enabling clinicians to differentiate between the underlying causes of a patient’s eye condition and prescribe treatment accordingly and instantly at the point-of-care.
“Our research team has been working tirelessly and we’re ready to scale our production to meet the large demand for our tests – and this was a key milestone toward that goal,” said John Huemoeller II, CEO of AXIM Biotechnologies. “While many development companies merely design new technologies and outsource their production, AXIM was able to adjust our existing facilities to enable production of our own assays – a significant advantage in both quality control and profit margins. This has been a long time coming and we couldn’t be more excited to reach such an important milestone as an organization.”
AXIM has been working closely with its commercialization partner to further prepare them with all of the materials and information necessary to garner clinician interest in the tests in recent months, while simultaneously optimizing production. With these first three lots in production, AXIM will be able to follow a similar process for its other tests – enabling a more rapid go-to-market strategy in the future.
Approximately 344 million people worldwide have Dry Eye Disease, according to the American Academy of Ophthalmology, and the patient population continues to grow. Given the current landscape of diagnostic tools, clinicians struggle to properly diagnose and treat DED. Additionally, according to the , as of July 2017, a study reported an estimated six million people have experienced Dry Eye Disease symptoms but have never been diagnosed.
AXIM aims to address this discrepancy with its ocular diagnostic solution portfolio, beginning with both its IgE and Lactoferrin assays. 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: .
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 .
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 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 . 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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