Mayo Clinic joins Biomerica’s InFoods® Irritable Bowel Syndrome ("IBS") Diagnostic-Guided Therapy clinical trial
June 01 2020 - 7:38AM
Biomerica Inc. (NASDAQ: BMRA) today announced they have signed
definitive agreements with Mayo Clinic to join the clinical trial
for Biomerica’s new InFoods® diagnostic-guided therapy (DGT),
designed to alleviate Irritable Bowel Syndrome (IBS)
symptoms. Mayo Clinic is joining Beth Israel Deaconess
Medical Center Inc., a Harvard Medical School Teaching Hospital,
Houston Methodist and the University of Michigan as primary
enrollment centers for this study. Mayo Clinic can now begin
enrollment of patients in this trial.
Biomerica has added several new, large medical centers and
groups to assist with accelerating completion of the endpoint trial
and to participate in the subsequent pivotal trial needed for final
FDA clearance. Biomerica continues to add leading
gastrointestinal ("GI") physicians operating in world-renowned
centers to the InFoods® IBS clinical study, who are potential users
and advocates for this product once cleared by the FDA.
Biomerica also announced today that the Japanese Patent Office
has issued Biomerica’ s first Japanese patent pertaining to the
Company’s InFoods® family of products that allow for a
revolutionary new treatment option for patients suffering from IBS
and several other disease states. Specifically, this patent
(JP,6681907,B) contains numerous claims that broadly cover a
product that enables 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, but not limited to, constipation, diarrhea,
bloating, pain and indigestion. It is estimated that about 19
million people in Japan suffer from IBS.
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 well-being of a patient
and a person’s ability to function both at home and in the
workplace.
A clinical lab version of the product is being used in this
clinical trial. However, the Company is also developing
InFoods® IBS DGT as a point-of-care product that allows physicians
to perform the test in-office using a finger stick blood
sample. A billable CPT code that can be used by both clinical
labs and physicians' offices is already available for the InFoods®
IBS products. Market research conducted by a leading, independent
pharmaceutical marketing research firm, determined that seventy
percent (70%) of physicians surveyed would utilize the InFoods® DGT
without reimbursement and over 90% would utilize it with
reimbursement.
Importantly, the InFoods® DGT can be used without or in
conjunction with current pharmaceuticals 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.
This clinical endpoint trial is expected to be completed in
approximately 6 months. However, due to the novel coronavirus’
impact on the U.S.’s healthcare system, it may take longer. If all
goes as expected, Biomerica plans to commence the final pivotal
trial several 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 excited to have Mayo Clinic join the InFoods® IBS
trial. IBS patients who desperately seek symptom relief will
be the beneficiaries of this revolutionary disruptive technology.
Also, we are pleased to have additional countries issue
patents with broad claims that acknowledge the novel and innovative
attributes of this technology platform that can be used to help
patients that suffer from IBS and many other diseases.”
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.
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, the rapidity of testing results, pricing of the
Company’s test kits, commencement of FDA clinical trials,
completion of clinical trials, favorable outlook pertaining to
clinical trial outcomes, the FDA’s acceptance of clinical trials
data, clearance from the FDA for the Company’s products to be sold
in the US, receipt of regulatory approvals for the Company’s
products to be sold outside of the US, 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 test; regulatory approvals necessary prior to
commercialization of the Company’s test and or therapy;
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 or
therapy; competition 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 other things; 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 competes and will be competing,
the impact of the coronavirus on the Company’s operations, revenues
and the completion of the clinical trials, the and the Company's
dependence on partners and 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
1 The epidemiology of irritable bowel syndromeClin Epidemiol.
2014; 6: 71–80. . doi: 10.2147/CLEP.S40245Caroline
Canavan, Joe West, and Timothy Card
Biomerica (NASDAQ:BMRA)
Historical Stock Chart
From Mar 2024 to Apr 2024
Biomerica (NASDAQ:BMRA)
Historical Stock Chart
From Apr 2023 to Apr 2024