Houston Methodist (part of Texas Medical Center) to start patient enrollment for Biomerica’s InFoods® Irritable Bowel Synd...
January 07 2020 - 8:19AM
Biomerica Inc. (NASDAQ: BMRA) today announced that Houston
Methodist (part of Texas Medical Center, the largest medical
complex in the world) will start enrollment for the clinical
trial of its new InFoods® diagnostic-guided therapy (DGT) to
alleviate Irritable Bowel Syndrome (IBS) symptoms. Houston
Methodist will join Beth Israel Deaconess Medical Center Inc., a
Harvard Medical School Teaching Hospital, and the University of
Michigan as primary enrollment centers for this study.
The InFoods® endpoint trial is expected to be completed before
2020. Biomerica is now in the process of adding several new
large medical groups (including Houston Methodist) to assist with
accelerating the endpoint trial and participate in the subsequent
pivotal trial needed for final FDA clearance. Further, by
adding large world-renowned centers to its trials, Biomerica
continues to grow the number of leading gastrointestinal (GI)
physicians using the InFoods® IBS product during the trials and
once FDA clearance is received.
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 physical and mental patient well-being and a person’s
ability to function both at home and in the workplace.
The patented Biomerica InFoods® IBS product is designed to allow
physicians to identify patient specific foods (e.g. pork, milk,
shrimp, broccoli, chickpeas, etc.), that when removed from the
diet, may alleviate or improve an individual's IBS symptoms
including constipation, diarrhea, bloating, abdominal cramps, pain
and indigestion. The InFoods® IBS point-of-care product is being
developed to allow physicians to perform the test in-office using a
finger stick blood sample. A clinical lab version of the
product is being used in this clinical trial. A billable CPT
code that can be used by both clinical labs and physicians' offices
is already available for InFoods® IBS products. Market research
conducted by a leading independent pharmaceutical marketing
research firm determined that seventy percent (70 %) of physicians
surveyed would use the InFoods® DGT without reimbursement and 90%
would use it with reimbursement.
Importantly, the InFoods® DGT can be used without or in
conjunction with current pharmacotherapy to potentially improve
patient outcomes. Since the InFoods® product is a diagnostic guided
therapy and not a drug, it has no drug type side
effects.
The clinical trials are randomized, double-blinded, and
placebo-controlled. Beth Israel Deaconess Medical Center Inc., a
Harvard Medical School Teaching Hospital, has completed its
enrollment of patients for this endpoint study but will continue to
participate in the final pivotal trial once that commences. The
University of Michigan will continue to enroll patients in this
endpoint trial along with Houston Methodist and others.
This clinical endpoint trial is expected to be completed in
approximately 9 months. If all goes as expected, Biomerica is
looking to commence the final pivotal trial a few months
thereafter, which is needed for submission to the FDA for final
clearance. The endpoint trial stratifies enrollment by the
three main IBS subclasses (IBS-Constipation, IBS-Diarrhea and
IBS-Mixed). There is currently no FDA cleared therapy for
IBS-Mixed. The study design has already received a non-significant
risk determination from FDA.
Zackary Irani, Chief Executive Officer of Biomerica, commented:
“We are thrilled to have Huston Methodist commence patient
enrollment for the InFoods® IBS trial. As part of the Texas Medical
Center, the world’s largest medical complex, we expect Houston
Methodist to significantly accelerate the completion of this
endpoint trial and play a significant role in the final FDA InFoods
trial. IBS patients who desperately seek symptom relief will be the
beneficiaries of this revolutionary disruptive technology. We are
also very pleased to be working with leading experts in functional
GI disorders that have been the primary investigators in clinical
studies for many of the leading drug therapies for IBS. We
plan to continue to add leading medical centers to the InFoods
trials.”
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 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,
commencement of FDA clinical trials, completion of clinical trials,
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 INFORMATION
Zackary Irani 949-645-2111 www.biomerica.com
[1] The epidemiology of irritable bowel syndromeClin Epidemiol.
2014; 6: 71–80. . doi: 10.2147/CLEP.S40245Caroline
Canavan, Joe West, and Timothy Card
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