AXIM® Biotechnologies Develops First Non-Invasive, Rapid, Point-of-Care, Diagnostic Test for Parkinson’s Disease

AXIM’s New Assay Uses a Single Tear Drop to Measure abnormal alpha-synuclein, known as the “Parkinson’s Protein” Biomarker, with Results in 8 minutes

SAN DIEGO,--(BUSINESS WIRE)--AXIM Biotechnologies, Inc. (OTCQB: AXIM) (“AXIM Biotech,” “AXIM” or “the Company”), an international healthcare diagnostic solutions development company, announced today that it has successfully developed the world’s first rapid, point-of-care, non-invasive diagnostic assay for the detection of abnormal alpha-synuclein, a known biomarker for Parkinson’s Disease (PD).

A new study released in April of 2023 by the Michael J. Fox Foundation shows that the presence of abnormal alpha-synuclein was detected in an astonishing 93% of people with Parkinson’s who participated in the study.

Furthermore, emerging evidence shows that α-synuclein assays have the potential to differentiate people with PD from healthy controls, enabling the potential for early identification of at-risk groups. These findings suggest a crucial role for α-synuclein in therapeutic development, both in identifying pathologically defined subgroups of people with Parkinson's disease and establishing biomarker-defined at-risk cohorts.

Additional studies have already proven that α-synuclein in its aggregated form can be detected in tears; however, these previous studies collected tears using an outdated Schirmer Strip collection method, immediately freezing the samples at 80 below Celsius. The samples were then sent to a lab where a subsequent centrifugation occurs for 30 min. Total tear protein content is first quantified using a bicinchoninic acid assay followed by alpha-Synuclein using a bulky plate reader. This outdated process is neither fast, easy, nor inexpensive. (Sources 1.1, 1.2)

The revolutionary nature of AXIM’s new test is that it is non-invasive, inexpensive and it can be performed at a Point-of-Care. It does not require a lumbar puncture, freezing, or sending samples to a lab. AXIM’s assay uses a tiny tear drop versus a spinal tap to collect the fluid sample and the test can be run at a doctor’s office with quantitative results delivered from a reader in less than 10 minutes.

Additionally, studies have shown that total lactoferrin content is reduced in patients with PD. AXIM is already marketing a lactoferrin assay, which may be used in conjunction with the newly developed novel Synuclein test.

“Our proven expertise in developing tear-based diagnostic tests has led to the development of this test in record speed and I’m extremely proud of our scientific team for their ability to expand our science to focus on such an important focus area as Parkinson’s,” said John Huemoeller II, CEO of AXIM Biotechnologies. “With this new assay, AXIM has immediately become a stakeholder in the Parkinson’s Disease community and through this breakthrough, we are making possible new paradigms for better clinical care, including earlier screening and diagnosis, targeted treatments, and faster, cheaper drug development. This is just the beginning for AXIM in this arena, but I am convinced when pharmaceutical companies, foundations and neurologists see how our solution can better help diagnose Parkinson’s Disease in such an expedited and affordable way, we will be at the forefront of PD research, enabling both researchers and clinicians a brand-new tool in the fight against PD.”

According to The Parkinson’s Foundation, nearly one million people in the U.S. are living with PD. This number is expected to rise to 1.2 million by 2030. Parkinson's is the second-most common neurodegenerative disease after Alzheimer's disease. Nearly 90,000 people in the U.S. are diagnosed with PD each year. More than 10 million people worldwide are living with PD. There are currently 219 PD trials going at various Phase I, II and III stages, according to Global Data’s Clinical Trial Database supported by a variety of organizations, from institutions to pharmaceutical companies.

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 Parkinson’s Disease and ophthalmological conditions such as Dry Eye Disease (DED) through rapid tear based 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.

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, 2023, 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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