Republic of Colombia’s food and drug regulatory agency grants clearance for Biomerica’s colorectal cancer screening test ...
August 21 2019 - 8:19AM
Biomerica, Inc. (Nasdaq: BMRA) announced the Republic of Colombia
Ministry of Health and Social Protection Institute National
Surveillance of Drugs and Food (INVIMA), the equivalent of the US
FDA, has granted clearance for Biomerica’s EZ Detect™
colorectal screening test, which detects an early warning sign of
colorectal cancer, to be imported and sold in Colombia.
The EZ Detect colorectal screening test is the
simplest in-home test to detect fecal occult (hidden) blood, an
early warning sign of colorectal cancer. This in-home test does not
require handling of stool or any dietary restrictions. The EZ
Detect pad is tossed into the toilet after a bowel movement.
A change in the pad’s color to blue/green, which would appear
within two minutes, indicates the presence of blood in the stool.
The pad is then simply flushed down the toilet.
Biomerica also announced that it has added a
sales and marketing director for Europe and South America who is
headquartered in Germany. This new director joins Biomerica with 22
years of experience selling and marketing Diagnostic and Life
Science products across multiple diagnostics technologies and
disciplines. She possesses broad international business experience,
with communication skills in German, English, Spanish, French and
Portuguese, and strong scientific and technical understanding of
gastrointestinal diagnostic products. She also has active
relationships with key strategic entities in Europe, Eastern
Europe, Latin America, Canada and U.S. that could help Biomerica
add new distributors for existing products. In her previous role,
this director managed relationships that accounted for
approximately 50% of her former employer’s group sales.
About Biomerica (NASDAQ:
BMRA)
Biomerica, Inc. (www.biomerica.com) is a global biomedical
company that develops, manufactures and markets advanced diagnostic
products used at the point-of-care (in home and in physicians'
offices) and in hospital/clinical laboratories for the early
detection 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 products for Gastrointestinal Disease, Diabetes and
esoteric testing.
The Biomerica InFoods® IBS product identifies patient specific
foods that when removed may alleviate an individual's IBS symptoms.
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 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.
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 intended launch dates, sales potential,
significant benefits, market size, prospects, new products,
favorable outlook, new distributors, expansion, increases in
productivity and margins, expected orders, leading market
positions, anticipated future sales or production volume of the
Company, the launch or success of product and new product
offerings. Such forward-looking information involves important
risks and uncertainties that could significantly affect anticipated
results in the future, and accordingly, such results may differ
materially from those expressed in any forward-looking statements
made by or on behalf of Biomerica. The 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(s):
CorporateZack Irani | CEOp.
949.645.2111www.biomerica.com
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