Biomerica InFoods® IBS Data Presented at the 2022 American College of Gastroenterology (ACG) Annual Scientific Meeting
November 02 2022 - 08:19AM
Biomerica, Inc. (Nasdaq: BMRA) (the “Company”) announced that data
derived from a clinical study of InFoods® IBS was presented at the
2022 American College of Gastroenterology (ACG) Annual Scientific
Meeting in a poster titled “IgG-based Elimination Diets for
Patients with IBS: Results From a Prospective, Multi-Center,
Double-Blind, Placebo-Controlled Trial.” The poster was selected by
ACG as a “Presidential Poster.” Fewer than 5% of accepted ACG
abstracts each year receive this distinction, which is awarded for
high quality, novel and potentially industry disruptive research.
The outcomes of this prospective, multi-center, double-blinded,
placebo-controlled clinical trial presented at ACG showed that IBS
patients who used the InFoods® IBS test to guide the elimination of
specific foods from their diets for eight weeks (“treatment diet
arm”) led to a material improvement of symptoms over placebo in
several IBS measures including: abdominal pain intensity, bloating,
Subject Global Assessment of Relief (SGA) and the Global
Improvement Scale (GIS). People with IBS-Constipation and IBS-Mixed
who participated in the study showed the greatest decrease in
symptoms. No significant adverse events were reported.
In the data presented at the ACG annual meeting, for the
Abdominal Pain Intensity (API) responder endpoint of >30%
improvement in pain, patients with IBS Constipation and IBS Mixed
in the treatment diet arm had a statistically significant
improvement over patients in the placebo diet arm (p-value of
0.0246). The improvement for patients in the treatment versus the
placebo is considered clinically significant and is similar and, in
some cases, better than the current drugs in the market.
Anthony Lembo, MD, FACG, Beth Israel Deaconess Medical Center
and Harvard Medical School said, “The standard self-directed IBS
elimination diets can be challenging to adhere to, require a
significant time commitment and ultimately do not necessarily
provide positive outcomes. These data show that this novel,
proprietary IgG based test may help guide the elimination of
specific foods resulting in benefit to some patients with IBS.”
These clinical study results presented at the ACG meeting were
also featured in an article published by Medscape titled “IgG-Based
Elimination Diet Beneficial for IBS Symptoms: Study” and in an
additional article published by Gastroenterology Advisor titled
“IgG-Based Elimination Diets Reduce IBS Abdominal Pain,
Bloating.”
Zack Irani, Chief Executive Officer of Biomerica, said, “We are
highly encouraged by the data validations and this award-winning
medical research that reinforces the potential efficacy of our
revolutionary InFoods® IBS diagnostic-guided therapy. We believe
that InFoods IBS can play an important role in the treatment of
people who have IBS.”
About InFoods®The Biomerica InFoods® IBS
product is designed to allow physicians to identify
patient-specific foods (e.g., eggs, broccoli, wheat, potatoes,
pork, etc.), that when removed from the diet, may alleviate or
improve an individual's IBS symptoms including, but not limited to,
constipation, diarrhea, bloating, cramping, 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 version of the 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 40 million people in America currently suffer from IBS
making it a leading cause for patient doctor visits1.
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 in 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’s primary focus is on gastrointestinal and
inflammatory diseases where the Company has multiple diagnostic and
therapeutic products in development.
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 or other written statements made or to be made by
Biomerica) contains statements that are forward-looking, such as
statements relating to the efficacy of the Company’s InFoods IBS
test and other tests, breadth and accuracy of results derived from
clinical trials on the InFoods IBS test and other tests, future FDA
clearance of the Company’s products and tests, possible
international regulatory clearance of the companies tests and
products, the rapidity and/or accuracy of the InFoods IBS test
results and the Company’s other products and tests, uniqueness of
the Company’s products, pricing of the Company’s test kits, demand
for domestic or international orders, potential revenues from the
sale of current or future products, availability of the Company’s
InFoods IBS test and other test kits, and patent protection on any
of the Company’s products or 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 tests and other products; regulatory approvals necessary
prior to commercialization any of the Company’s products;
availability of the Company’s test kits and other products;
capacity, resource and other constraints on our suppliers;
dependence on our third party component manufacturers; dependence
on international shipping carriers; governmental import/export
regulations; demand for our various tests and other products;
competition from other similar products and from competitors that
have significantly more financial and other resources available to
them; governmental virus control regulations that make it difficult
or impossible for the company to maintain current operations; the
Company’s ability to comply with current and future regulations in
the countries where our products are made and sold and the
Company’s ability to obtain patent protection on any aspects of its
rapid test 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 will be competing, 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.
Corporate Contact:Zack Irani949-645-2111zirani@biomerica.com
Source: Biomerica
1. Canavan et al. The epidemiology of irritable bowel
syndrome Clin Epidemiol. 2014; 6: 71–80. doi:
10.2147/CLEP.S40245
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