Biomerica's InFoods® Irritable Bowel Syndrome Diagnostic-Guided Therapy Clinical Trial Nears Completion of Enrollment
December 09 2020 - 8:19AM
Biomerica, Inc. (Nasdaq: BMRA), a global provider of advanced
medical products, today announced it is nearing completion of
patient enrollment in the endpoint clinical trial for its InFoods®
Irritable Bowel Syndrome (“IBS”) diagnostic-guided therapy (“DGT”).
This double-blinded, randomized, controlled clinical trial is
validating the Biomerica InFoods® IBS test to manage the
debilitating pain and suffering of patients diagnosed with IBS.
Utilizing an antibody guided blood test, the InFoods® IBS product
identifies patient-specific foods that may alleviate IBS symptoms
when eliminated from the diet.
"I am pleased our clinical endpoint trial for
InFoods® IBS remains on track to complete enrollment despite the
challenges imposed by this pandemic," stated Zack Irani, CEO of
Biomerica. "There is clearly a large unmet need in IBS patients who
seek relief but are limited to trial-and-error for foods or drugs
that treat symptoms but not the cause. Importantly, the InFoods®
IBS therapy can be used in isolation or as part of the
pharmacological drug therapy a patient would often receive, but
without adding to the side-effect burden."
Mr. Irani concluded, "The endpoint trial results
should open potential partnering opportunities with global health
sciences, pharmaceutical and medical device companies, and is
expected to pave the way to a final pivotal trial and ultimately
lead to FDA clearance. InFoods® IBS, provides a novel therapy for
patients suffering from IBS without the drug side-effects. We look
forward to providing updates on our continued progress in the
coming months as we move closer to completing this endpoint
trial."
As previously indicated, Mayo Clinic joined Beth
Israel Deaconess Medical Center, Inc., a Harvard Medical School
Teaching Hospital, Houston Methodist, University of Texas Health
Science Center at Houston and the University of Michigan as
enrollment centers for this study. Biomerica expects to complete
patient enrollment at these centers by the end of April 2021.
The clinical endpoint trial's objective is to
validate key elements and provide the selection of a proper
endpoint of a proposed larger and final FDA pivotal trial. The
design of the InFoods® IBS product clinical endpoint study has
already received a non-significant risk determination from the FDA.
The Company will not be required to submit an investigational
device exemption (“IDE”) for the InFoods® IBS product study.
Biomerica will commence the final pivotal trial
following the completion of the clinical endpoint trial.
About IBSIt is estimated that
over 45 million Americans suffer from IBS.1 IBS is a common
condition that can significantly impair the physical and mental
well-being and a person's ability to function at home and in the
workplace. The symptoms of IBS are often triggered by the
consumption of specific foods, which differ for every individual.
The total cost of IBS has been estimated at $30 billion annually in
just the United States.
About Biomerica (NASDAQ:
BMRA) Biomerica, Inc.
(www.biomerica.com) is a global, biomedical technology company that
develops, patents, manufactures, and markets advanced diagnostic
and therapeutic products used at the point-of-care (in home and
physicians' offices) and in hospital/clinical laboratories, for
detection and/or treatment of medical conditions and diseases. The
Company's products are designed to enhance the health and
well-being of people while reducing total healthcare costs.
Biomerica primarily focuses on gastrointestinal and inflammatory
diseases, where the Company has multiple diagnostic and therapeutic
products in development.
About InFoods® The Biomerica
InFoods® IBS product is designed to allow physicians to identify
patient-specific foods (e.g. eggs, broccoli, wheat, potatoes, corn,
etc.), that when removed from the diet, may alleviate or improve an
individual's IBS symptoms including, but not limited to,
constipation, diarrhea, bloating, severe pain and indigestion. This
patented, diagnostic-guided therapy is designed to allow for a
patient-specific, guided dietary regimen to improve IBS outcomes. A
point-of-care product is being developed to allow physicians to
perform the test in-office using a finger stick blood sample, while
a clinical lab version of the product is expected to be the first
for which the Company will seek regulatory approval. A billable CPT
code that can be used by both clinical labs and physicians' offices
is already available for InFoods® diagnostic products. Since the
InFoods® product is a diagnostic-guided therapy, and not a drug, it
has no drug type side effects. An estimated 45 million people in
America currently suffer from IBS making it a leading cause for
patient doctor visits.
The Private Securities Litigation Reform Act of
1995 provides a "safe harbor" for forward-looking statements.
Certain information included in this press release (as well as
information included in oral statements, written statements and
other press release issued, made or to be made by Biomerica)
contains statements that are forward-looking, such as statements
relating to the timing of the completion of clinical studies and
clinical trials, the final clinical results from clinical trials,
potential partnering opportunities, the efficacy of the Company's
COVID-19 test and other tests and products developed by the
Company, FDA clearance, EUA clearance, receipt of CE Mark, the
rapidity of testing results, uniqueness of a product, pricing of
the Company's various test kits, demand for domestic and
international orders for the Company's COVID-19 tests and other
Company products, availability of the Company's COVID-19 tests, and
patent protection on the Company's products and technologies. Such
forward-looking information involves important risks and
uncertainties that could significantly affect anticipated results
in the future, including, without limitation: results of studies
testing the efficacy of the Company's COVID-19 tests, InFoods tests
and other Company products; regulatory approvals necessary prior to
commercialization of the Company's COVID-19 tests and other Company
products; capacity, resource and other constraints on our
suppliers; dependence on our third party manufacturers; dependence
on international shipping carriers; governmental import/export
regulations; competition from products similar to those developed
or sold by the Company and from competitors that have significantly
more financial and other resources available to them; governmental
virus control regulations that could make it difficult or
impossible for the Company to maintain current operations;
regulations and the Company's ability to obtain patent protection
on any aspects of its tests and technologies. Accordingly, such
results may differ materially from those expressed in any
forward-looking statements made by or on behalf of Biomerica.
Additionally, potential risks and uncertainties include, among
others, fluctuations in the Company's operating results due to its
business model and expansion plans, downturns in international and
or national economies, the Company's ability to raise additional
capital, the competitive environment in which the Company competes,
and the Company's dependence on strategic relationships. The
Company is under no obligation to update any forward-looking
statements after the date of this release.
1Canavan et al. The epidemiology of irritable bowel syndrome
Clin Epidemiol. 2014; 6: 71–80. doi: 10.2147/CLEP.S40245
Corporate Contact: Company
Spokesperson949-645-2111
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