Biomerica Signs Exclusive Distribution Agreement in Canada for its New and Proprietary Helicobacter Pylori (H. pylori) Test, ...
June 24 2021 - 08:19AM
Biomerica Inc. (NASDAQ: BMRA) today announced that it has signed an
exclusive five-year distribution agreement with a Canadian partner
for the distribution and marketing of Biomerica’s new and
proprietary Helicobacter pylori test, called hp+detect™. The
hp+detect™ product has been developed for the identification and
monitoring of H. pylori infection, the leading cause of duodenal
and gastric ulcers, and a contributing risk factor associated with
gastric cancer. Physicians and medical centers can use hp+detect™
to diagnose the presence of H. pylori and to monitor the efficacy
of treatment.
In order to sell the product in Canada, Biomerica’s distribution
partner will now seek Health Canada clearance using the clinical
data recently generated by Biomerica using the hp+detect™ product.
The Company also intends to seek a CE Mark for the product to be
sold in the European Union and FDA clearance in the USA.
Biomerica’s test is designed to increase the sensitivity and
specificity of H. pylori testing as compared to certain other
products currently in the market.
According to the U.S. Centers for Disease Control and
Prevention, “The prevalence of Helicobacter
pylori infection worldwide is approximately 50%, and as high
as 80%–90% in developing countries, and ≈35%–40% in the United
States. Approximately 20% of persons infected with H.
pylori develop related gastroduodenal disorders during their
lifetime.”1
“H. pylori infection can cause serious health conditions, so
early detection of the disease in symptomatic patients is important
for those infected with these bacteria. Our hp+detect™ product
identifies the presence of H. pylori antigen, enabling doctors to
diagnose patients, as well as monitor treatment efficacy. Because
of the rise of antibiotic resistance in H. pylori treatment, and
the long-term cancer risk associated with proton-pump inhibitor
ulcer medication use, it is important to monitor the eradication of
infection,” said Zack Irani, Chairman and Chief Executive Officer
of Biomerica. “We’re pleased to enter into this relationship with a
well-established medical distributor in Canada. This partnership
will be our first step to launching the hp+detect™ test in markets
around the world to assist gastroenterologists and other medical
professionals who are dedicated to preventing ulcers and gastric
cancer in the patients they treat.”
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 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,
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, 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. 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® 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.
1. Duck WM, Sobel J, Pruckler JM, et al.
Antimicrobial Resistance Incidence and Risk Factors among
Helicobacter pylori–Infected Persons, United States. Emerging
Infectious Diseases. 2004;10(6):1088-1094.
doi:10.3201/eid1006.030744.
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 H. pylori and
other tests, FDA clearance of the Company’s products including the
hp-detect product, Health Canada and CE Mark clearance of these
products, the rapidity of testing results, uniqueness of the
Company’s products, test result accuracy of 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 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, InFoods tests and
other products; regulatory approvals necessary prior to
commercialization 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
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; regulations 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:
John Nesbett /Jennifer BelodeauIMS Investor
Relations203.972.9200jnesbett@institutionalms.com
Source: Biomerica, Inc.
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