Biomerica Inc. (NASDAQ: BMRA) announced today that the Japanese
Patent Office has issued a notice of allowance for Biomerica’s
first patent pertaining to a revolutionary new treatment option for
patients suffering from depression. Specifically, this allowed
patent contains broad claims that enables physicians to identify
patient specific foods (e.g. salmon, milk, shrimp, broccoli,
chickpeas, etc.), that when removed from the patient’s diet, may
alleviate or improve an individual's depression symptoms.
There is considerable recent clinical research which shows
strong correlation between Irritable Bowel Syndrome (IBS) and
depression. This field of study, linking depression and IBS, has
gained momentum with research around the gut-brain axis and
alterations in gut microbes that affect mental health.¹ Further,
anxiety/depression and irritable bowel syndrome (IBS) are highly
prevalent and burdensome conditions, and their co-occurrence
prevalence is an estimated 44% to 84% of patients.² Research
performed at Biomerica that formed the basis for claims in this
allowed depression-related patent, indicates that certain foods are
linked to an elevated adverse immune response in patients with
depression. While there is still additional research and
development to be done, this technology could potentially improve
the lives of the hundreds of million people worldwide that live
with depression.
Depression represents the number one cause of disability
worldwide and is often fatal. Inflammatory processes have been
linked to the pathophysiology of depression. It is now well
established that dysregulation of the immune systems occurs in
depressed patients. In addition, these changes affect prognosis and
response to antidepressant therapy. Studies suggest the immune
system regulates mood and is the potential cause of a dysfunctional
inflammatory response in depressed patients.ᶾ
Biomerica’s InFoods® technology utilizes a simple blood test to
determine if a patient is suffering an elevated adverse immune
response to one or more specific foods (e.g. milk, salmon, barley,
etc.), that have been identified as potentially problematic for
patients with depression. Once identified, eliminating the
problematic food(s) may result in an improvement in the patient’s
depression symptoms.
Biomerica has now been granted or allowed 8 patents in the US
and globally on its IBS related technology, while this Japanese
patent is the first to be allowed for a disease other than IBS.
Further, the Company has dozens of additional patents filed that
are in active prosecution (under review by patent offices) in the
US and many other countries for these and other diseases. For
example, Biomerica also recently received notice of allowance from
the Mexican Patent Office for its initial InFoods® IBS patent filed
in that country.
Biomerica is in the process of finalizing its first clinical
study utilizing the InFoods® diagnostic guided therapy technology
on patients suffering from IBS. The InFoods® diagnostic-guided IBS
therapy is in clinical studies at the Mayo Clinic, Beth Israel
Medical Center Inc., a Harvard Medical School Hospital, the
University of Michigan University Hospital, the Texas Health
Science Center at Houston, and Houston Methodist (part of Texas
Medical Center, the largest medical complex in the world). Since
the InFoods® IBS product is a diagnostic-guided therapy, and not a
drug, it has no drug-type side effects.
Biomerica is working to provide diagnostic guided therapies to
alleviate disease symptoms and dramatically improve quality of life
and general health. The Company has performed research with
findings of an elevated immune response to differing groups of
foods in patients suffering from diseases which include: Irritable
Bowel Syndrome (IBS), functional dyspepsia, Crohn’s disease,
ulcerative colitis, gastroesophageal reflux disease (GERD),
migraine headaches, depression, and attention deficit/hyperactivity
disorder. The Company’s longer term strategy is to also move
forward with clinical studies for addressing these other diseases
with the InFoods technology.
“We are very close to the completion of the first InFoods®
diagnostic guided therapy study for IBS patients performed by
leading medical institutions in the US. With the growing body of
evidence that specific foods can cause inflammation in the body and
lead to or intensify physical and mental illnesses, we believe the
InFoods® Technology platform has the ability to revolutionize how
patients are diagnosed and treated. Our InFoods® Technology has the
potential to offer a dramatic reduction in suffering and improve
people’s ability to live happy productive lives,” said Zack Irani,
Chairman and Chief Executive Officer of Biomerica.
- Mudyanadzo, T.A., et al., Irritable Bowel Syndrome and
Depression: A Shared Pathogenesis. Cureus, 2018. 10(8): p.
e3178.
- Simpson, C.A., et al., Feeling down? A systematic review of the
gut microbiota in anxiety/depression and irritable bowel syndrome.
J Affect Disord, 2020. 266: p. 429-446.
- Beurel, E., M. Toups, and C.B. Nemeroff, The Bidirectional
Relationship of Depression and Inflammation: Double Trouble.
Neuron, 2020. 107(2): p. 234-256.
About InFoods® IBSThe 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
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 40 million people in America currently suffer
from IBS making it a leading cause for patient doctor visits.
(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.
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
breadth and quality of the claims in the Company’s patents, and the
effectiveness of the Company’s patents to impede competition from
competitors, future clinical trials, or FDA clearance of, the
Company’s products, the results of current and future clinical
trials, the rapidity of testing results, uniqueness of the
Company’s products and performance of these products as compared to
competitors’ products, test result accuracy of products, ability of
the Company’s products to diagnose or treat various diseases,
pricing of the Company’s test kits, demand for domestic or
international orders, retailer and distributor interest in the
Products, 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, including its COVID-19
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 regulatory clearance for the company’s
manufacturing facilities and other clearances needed to manufacture
and sell a medical related product, and the Company’s ability to
obtain patent protection on any aspects of its rapid test
technologies or other products. 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 revenue
fluctuations, drop in demand for the Company’s products, changes in
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.
Biomerica (NASDAQ:BMRA)
Historical Stock Chart
From Apr 2024 to May 2024
Biomerica (NASDAQ:BMRA)
Historical Stock Chart
From May 2023 to May 2024