Biomerica Inc. (NASDAQ: BMRA) announced today that the United
States Patent and Trademark Office has issued a Notice of Allowance
for Biomerica’s second U.S. patent pertaining to the Company’s
InFoods® technology platform that offers a revolutionary new way to
treat patients suffering from Irritable Bowel Syndrome (IBS) and
other gastrointestinal diseases. Specifically, this allowed
application #16/385,322 contains numerous claims that broadly cover
the method that enables physicians to identify patient specific
foods (e.g. pork, milk, shrimp, broccoli, chickpeas, etc.), that
when removed may alleviate or improve an individual's IBS symptoms,
such as constipation, diarrhea, bloating, severe cramping, pain and
indigestion.
The InFoods® diagnostic guided IBS therapy is in clinical
studies at Mayo Clinic, University of Texas Health Science Center
at Houston, Houston Methodist (part of Texas Medical Center, the
largest medical complex in the world), Beth Israel Deaconess
Medical Center Inc., a Harvard Medical School Teaching Hospital,
and at the University of Michigan. Since the InFoods® IBS
product is a diagnostic-guided therapy, and not a drug, it has no
drug type side effects. Several members of the ROME Foundation have
been working with the company to design and set up these
trials. Further the company expects the clinical trial sites
will be active users of the product upon clearance by the FDA.
It is estimated that over 45 million Americans suffer from IBS
and the symptoms are often triggered by consumption of specific
foods (which are unique in each sufferer). The total cost
(direct + indirect) of IBS has been estimated at $30 billion
annually in the United States. IBS is a common condition that can
substantially impair patient well-being and a person’s ability to
function both at home and in the workplace. A billable CPT code
already exists that can be used by both clinical labs and
physicians' offices upon clearance by the FDA.
Biomerica has several additional U.S. and international patent
applications in prosecution that cover other claims pertaining to
the InFoods® IBS product. Further, Biomerica has filed patents, and
is developing diagnostic guided therapies for other diseases
utilizing the InFoods® technology platform, which include:
functional dyspepsia, Crohn’s disease, ulcerative colitis,
gastroesophageal reflux disease (GERD), migraine headaches, and
others.
“This is the second allowed patent in a series of applications
to provide broad protection for a test panel and method to
determine patient specific foods that may trigger IBS symptoms, and
allows for a diagnostic guided therapy for IBS patients,” said Zack
Irani, Chairman and Chief Executive Officer of Biomerica. “The
allowance of these claims in the InFoods® patent estate clearly
validates our strategy and strengthens our efforts to enable
physicians to offer new and better therapies to
patients.”
“This patent is part of our ongoing strategy to protect the
intellectual property for our unique IBS diet guided therapy, as
well as similar products for use in other disorders such as GERD,
functional dyspepsia, IBD, migraine headaches, and osteoarthritis,”
said Elisabeth Laderman, Ph.D., VP of Development and Quality at
Biomerica. “There is a growing body of evidence that food can
exacerbate inflammation in the body, and we believe the InFoods®
technology can identify patient-specific foods that may trigger
inflammation and resulting symptoms.”
Issued patents for the InFoods® technology include: newly
allowed US patent application #16/385,322, US patent #10,309,970,
Japanese patent #6681907, and Korean patent #10-1887545 covering
compositions, devices and methods of IBS sensitivity testing.
The Company also provided an update on the
company's COVID-19 antibody tests as the COVID-19 pandemic has
substantially impacted the global healthcare delivery system.
COVID-19 Antibodies Rapid 10-minute Point of
Care tests: A newly published study in Canada reported that
Biomerica’s rapid test showed 100% sensitivity and 100% specificity
(https://www.studyfinds.org/not-all-covid-19-antibody-tests-are-created-equal-but-which-ones-are-best/)
published in Diagnostics 2020, 10, 453; July 2020. The Company’s
high-volume production version of its COVID-19 IgG/IgM and its
standard version (both of which are finger stick blood tests with
results in 10 minutes that can be performed by trained
professionals anywhere) continue to be marketed in countries
outside the US.
Unique high-volume COVID-19 IgG ELISA laboratory
test: The Company is waiting for the FDA response to its
submitted EUA. The data that was submitted to the FDA under
the EUA application for this test showed 100% specificity and zero
percent cross reactivity with many common viruses or
diseases.
The Company also plans to issue its year-end
results and SEC Form 10-K on August 31, 2020 for the fiscal year
ended May 31, 2020, and will provide further updates on it progress
with COVID tests, InFoods® and other clinical programs.
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 primarily focus is 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, pain and indigestion. This
patented, diagnostic-guided therapy is designed to allow for a
patient specific, guided dietary regimen to improve Irritable Bowel
Syndrome (IBS) outcomes. The 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 will 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 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 tests (with included but are not limited to COVID-19 and
InFoods® products), FDA clearance, EUA clearance, the rapidity of
testing results, uniqueness of a product, use and commercial
adoption of tests, pricing of the Company’s test kits, demand for
international orders, availability of the Company’s test kits, and
patent protection on the test technology. 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; regulatory approvals necessary prior to
commercialization of the Company’s tests; availability of the
Company’s test kits; capacity, resource and other constraints on
our suppliers; dependence on our third party manufacturers;
dependence on international shipping carriers; governmental
import/export regulations; demand for our tests; 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; regulations and the
Company’s ability to obtain patent protection on any aspects of its
test technology. 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.
CONTACT INFORMATION
Company Spokesperson 949-645-2111 www.biomerica.com
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