Biomerica, Inc. (NASDAQ:BMRA)

Biomerica Inc (NASDAQ:BMRA) ($2.97; $29.0M market cap), a company that develops, manufactures, and markets medical diagnostic products for the early detection and monitoring of chronic diseases and medical conditions, 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.

 “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.”

Biomerica Inc (NASDAQ:BMRA) ($3.02; $29.6M market cap), a company that develops, manufactures, and markets medical diagnostic products for the early detection and monitoring of chronic diseases and medical conditions, announced Q1 2020 results:

• Sales of $1.19 million vs $1.27 million in the prior year period

• Net loss of $0.05 vs net loss of $0.05 in the prior year

“Although revenues in Q1 2020 were slightly lower than the prior year, we expect sales of our specialty diagnostics to begin increasing in Q2, as compared to the same quarterly sales in the previous year," said Zackary Irani, CEO of Biomerica, Inc. “We also expect to be near completion of the enrollment of patients for clinical trials for our H. Pylori diagnostic product in fiscal Q2 and plan to submit to the FDA shortly thereafter. Once approved, the H. Pylori product should contribute significantly to our revenues. Further, during Q2 we plan to announce important progress in the clinical trials for our diagnostic guided therapy, InFoods® technology, which we expect to make a significant impact on some of the 45 million Americans who suffer from Irritable Bowel Syndrome (IBS). We are expecting to hit several major milestones at Biomerica over the next 12 months, and are excited to see the impact these milestones will have on shareholder value."

Biomerica Inc (NASDAQ:BMRA) ($2.91; $28.1M market cap) develops, manufactures, and markets medical diagnostic products for the early detection and monitoring of chronic diseases and medical conditions. Today, the company announced that The Republic of Colombia’s 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 Company also announced the hiring of a sales and marketing director for Europoe and South America.

“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.”

Biomerica Inc (NASDAQ:BMRA) ($4.51; $38.4M market cap) was added to our Multi-Bagger Mock Portfolio on May 5, 2017 at $2.51 due to the possible blockbuster development stage irritable bowel syndrome (“IBS”) product which has been showing some positive signs for blood test that tells patients which foods most affect their IBS.  On January 10, 2018 shares rocketed on news that the China Food and Drug Administration approved BMRA’s colorectal screening test to help identify early signs of colorectal cancer.  Shares have since retraced back to levels prior to the CFDA news.

Yesterday after the close, BMRA announced Q2 2018 results:

• Sales of $1.6 million vs $1.4 million in the prior year

• Net loss of $0.03 vs a loss of $0.02 in the prior year

Comments from management:

While we are pleased with our continued growth in sales, the combination of fully establishing our maquiladora production facility and reduction of finished goods/WIP inventory resulted in a higher cost of goods sold,” said Zackary Irani, Biomerica CEO.  “We are excited about moving our InFoods® IBS product forward through the regulatory process and recently announced signing definitive agreements with two of America’s leading research institutes (Beth Israel Deaconess Medical Center Inc., a Harvard Medical School Teaching Hospital, and the University of Michigan) to perform trials for the product.  It is estimated that up to 45 million Americans suffer from IBS, and we believe our approach is differentiated by focusing on a possible root cause of IBS compared to simply treating symptoms.

We continue to believe the main focus on  BMRA remains on the successful development and approval of its IBS product.

BMRA ($2.70) reported Q4 2017 results:

• Sales of $1.4 million vs $1.3 million in the prior year

• Net loss of $346,000 vs $506,000 in the prior year

Quotes from management:

The Company is very enthusiastic about the clinical and commercialization opportunities for our blood based InFoods® IBS technology, a diagnostic guided therapy that should allow for the identification of specific foods that are contributing to a person’s irritable bowel syndrome (IBS) symptoms. InFoods® IBS technology could revolutionize the way IBS is treated,” said Zackary Irani, Biomerica's Chief Executive Officer. “We have also been making progress in our goal to start the InFoods® clinical trial and look forward to announcing more details in the future.”

“We continue to seek out distribution partners globally as we believe that distribution agreements and licensing are the most effective means for us to broaden our international sales. This is a strategy we employed with our recently announced Mexico distribution agreement for the supply of one of Biomerica’s point of care products to a multinational pharmaceutical company with over $1.4 billion in sales. These types of agreements are significant validations of our products and we hope to announce more licensing and distribution agreements with these or other partners in the future”

BMRA ($2.75) announced a product distribution agreement with a multi-national pharmaceutical company for distribution in Mexico.  

“This point of care product has already received approval from COFEPRIS (the Comisión Federal para la Protección contra Riesgos Sanitarios), which is Mexico’s equivalent of the U.S. Food & Drug Administration (FDA), thereby clearing it for immediate sale in Mexico.

I am very pleased to announce this sales contract with a leading global pharmaceutical corporation,” said Mr. Zackary Irani, CEO of Biomerica.  “This is a tremendous validation of our product by a large healthcare company and we hope to announce more distribution agreements with them or other partners down the road. Both companies are excited about the sales potential for this point of care product in the Mexican market.”

BMRA was added to our Multi-Bagger Mock Portfolio on May 5, 2017 due to the possible blockbuster development stage irritable bowel syndrome (“IBS”) product which has been showing some positive signs for blood test that tells patients which foods most affect their IBS.