In This Article:
State of California Department of Public Heath Food and Drug Branch Issues the Company a License for Manufacturing of its Diagnostic Assays
SAN DIEGO, CA -
(NewMediaWire) - May 29, 2024 - AXIM Biotechnologies, Inc. (OTCQB: AXIM) ("AXIM Biotech," "AXIM" or "the Company"), an international healthcare diagnostic solutions development company, today announced that it received a Medical Device Manufacturing License from State of California Department of Public Heath Food and Drug Branch. The license allows AXIM to manufacture medical devices, such as its ophthalmological diagnostic assays, for either commercial or clinical use.
The Medical Device Manufacturing License broadly allows companies to manufacture any type of medical device, further enabling AXIM the ability to develop novel diagnostic solutions for use in clinical studies as well as for commercial use, pending any additional regulatory approval requirements. AXIM currently has two FDA-cleared ocular diagnostic assays, its T-POC TOTAL IgE Immunoassay and T-POC LACTOFERRIN Immunoassay Kits. Both are being marketed through the Company's commercialization partner Versa Ophthalmics and address a critically unmet need in the areas of dry eye diagnosis and treatment planning.
"We believe this license illustrates the level of quality of both our facility and our manufacturing processes," said John Huemoeller II, CEO of AXIM Biotechnologies during the presentation. "While we remain committed to focusing on the research side of diagnostics and leveraging proven manufacturing partners in order to scale sales of our approved devices, this license allows us to forge ahead on our other diagnostic programs that are in the research stage. That said, we may need to act as a secondary party in manufacturing of our approved assays if demand required so and this license allows us to do that as well. With it, we are well prepared to meet the demand for our assays in terms of manufacturing, especially important should we receive a CLIA waiver at some point, which would essentially allow for our assays to be sold to every ophthalmological clinic in the nation."
Both of AXIM's FDA-cleared tests are groundbreaking in that they are designed to be administered at the point-of-care and render results in eight minutes, allowing clinicians to better diagnosis and treat the dry-eye-disease (DED) at the time of a patients visit. There are approximately 344 million people worldwide that suffer from DED but the indication has been historically difficult to diagnose and treat due to insufficient diagnostic tools. AXIM seeks to address this market with its tear sample test kits and associated reader which offer clinicians quantitative insights into the underlaying causes of a patient's eye condition.