AXIM® Biotechnologies, Inc.
(OTCQB: AXIM) (“AXIM® Biotech,” “AXIM” or “the Company”), a leader in
the development of diagnostic testing for COVID-19 and cancer, announced
today that the Company has signed a Binding Term Sheet to acquire the
technology for the testing of Dry Eye Disease (DED), including two FDA
authorizations and approvals for the commercial sale of two ophthalmic
diagnostic lab tests.
AXIM and Advanced Tear Diagnostics, LLC, have signed a Binding Term Sheet and intend to enter into the Definitive Agreement for the transaction to close no later than October 1, 2021. However, the Binding Term Sheet will remain in full force and effect until such time as the Definitive Agreement is executed by the parties. AXIM intends to immediately implement the strategy for commercial launch of the first product projected for the beginning of 2022.
According to the American Academy of
Ophthalmology, approximately 20 million people in the United States (344
million people worldwide) have Dry Eye Disease and that number is
growing in both young and old adults, making it imperative that
clinicians figure out how best to diagnose and treat it. According to
the American Journal of Ophthalmology,
a study reported that as of July 2017 an estimated six million
people reported having experienced Dry Eye Disease symptoms but had not
been diagnosed.
The prevalence of Dry Eye Disease can
significantly impair visual acuity, workplace productivity, and quality
of life and increases with age. Dry Eye Disease is a common condition
that occurs when your tears aren't able to provide adequate lubrication
for your eyes. Tears can be inadequate and unstable for many reasons.
For example, dry eyes may occur if you don't produce enough tears or if
you produce poor-quality tears. This tear instability leads to
inflammation and damage of the eye's surface. According to Transparency Market Research, the global dry eye disease diagnostics & treatment market is on the course to reach $9.8 billion by the end of 2030.
Diagnosing
Dry Eye Disease is a challenge because it’s a multifactorial disease
with many disparate causes. It has a highly variable symptom profile at
different stages of the disease, and there’s often a discordance between
signs and symptoms. For example, a patient can have severe symptoms yet
show no sign of ocular surface damage, whereas others have advanced
ocular surface damage, yet report no symptoms. Historically, this has
been characterized by a lack of correlation between patients’ subjective
irritative ocular symptoms (as determined by, for example,
questionnaires) and the results of commonly performed objective tests,
such as corneal fluorescein staining (CFS) and tear film break up time
(TFBUT).
The tests being acquired are part of a highly
specialized point-of-care (POC) lab testing system designed specifically
to assist eye-care physicians in detecting and quantifying a variety of
biomarkers associated with external ocular disorders. The world's first
clinical lab system designed specifically for eye-care physicians is
also the first point-of-care lab testing system to receive FDA clearance
for the diagnostic testing of tears. These tests are approved for
reimbursement.
The first test is a rapid Point-of-Care
(10-minute) lateral flow diagnostic assay together with a reader that
tests for exact levels of Lactoferrin through the collection of 0.5
microliter in tears. Lactoferrin is a protein contained in tears, which
protects the ocular surface with its antimicrobial and anti-inflammatory
properties. Lower concentrations of Lactoferrin have been demonstrated
in patients with dry eye, which is associated with decreased aqueous
tear production. AXIM’s scientific team has assisted in the optimization
of the assay.
The second FDA-approved and reimbursable test is
for the measurement of Ocular Immunoglobulin E (IgE), a biomarker for
allergies and a key biomarker primarily associated with Dry Eye Disease.
The test is of high clinical utility in the confirmation of the
presence of an active ocular allergen and uses the same reader system.
AXIM’s scientific team is working on the optimization of the assay with
an expected sales launch in the first quarter of 2022.
Currently
available tests for Dry Eye Disease include Matrix metalloproteinase 9
(MMP-9) testing which has been found to identify the presence of ocular
surface inflammation in 40% of confirmed dry eye patients. However, some
findings suggest that not all patients with symptoms and signs of Dry
Eye have elevated MMP-9 levels. The other commonly used test is for
Osmolarity. Researchers have found that in a given patient, a single
tear osmolarity measurement cannot be used to distinguish patients with
dry eye from patients without dry eye. The variability among osmolarity
readings calls into question its clinical utility.
“For years,
doctors have had to rely on patient symptoms and subjective evaluation
of clinical signs to diagnose Dry Eye Disease,” said John W. Huemoeller
II, Chief Executive Officer of AXIM® Biotech. “The tools currently
available include tests for osmolarity (salt content in tears) and MMP-9
(eye inflammation). However, both are non-differential meaning they are
screening tests that require follow-up testing because positive results
could point to conditions other than Dry Eye Disease. The tests we are
acquiring are specifically differential for a diagnosis of Dry Eye
Disease and also provide a quantitative measure for the doctor to assess
the severity of the condition.”
In addition to the two
FDA-cleared tests, AXIM intends to further develop other diagnostic
tests including MMP9, ocular adenovirus, ocular osmolarity, ocular
herpes, trachoma, bacterial-viral differentiation, glucose, breast
cancer screening, and others.
Huemoeller added, “We are in the
process of building AXIM into a powerful diagnostic company. This
technology acquisition gives AXIM two finished tests that are cleared by
the FDA and we are now in the process of creating an aggressive
marketing and sales plan. With our scientific expertise in developing
lateral flow assays, this acquisition is a perfect fit and gives us a
very nice diagnostic pipeline for additional tests.”
For more information about AXIM, please visit www.AXIMbiotech.com.
About AXIM® Biotechnologies
Founded
in 2014, AXIM® Biotechnologies, Inc. (AXIM) is a vertically integrated
research and development company focused on changing diagnosis and
treatment for oncology and SARS-CoV-2 (COVID-19). AXIM’s COVID-19 rapid
neutralizing antibody test is the first rapid diagnostic test measuring
levels of functional neutralizing antibodies that are believed to
prevent SARS-CoV-2 from entering the host cells. Additionally, the
Company is developing rapid diagnostic tests for the early detection of
cancer and proprietary small molecules drugs to treat cancer and block
metastasis. For more information, please visit www.AXIMBiotech.com.
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