Biomerica Inc. has expanded its contract development and manufacturing services to meet growing market demand.
“We are now formalizing and expanding these CDMO services, providing clients with end-to-end support from concept through commercial manufacturing,” Chief Executive Zack Irani said in a statement.
The global biomedical technology company, based in Irvine, offers in-vitro diagnostic solutions with a focus on gastrointestinal and inflammatory diseases.
After expanded offerings, Biomerica’s contract manufacturing services span “the entire development lifecycle” from supply chain sourcing to manufacturing and assembly.
The company last month reported first-quarter sales of $1.4 million, down 22% from the same period a year ago, while operating expenses decreased 12% to $1.5 million. The revenue decrease reflects reduced market activity and global tariffs impacting international orders, according to the company.
Shares in Biomerica have fallen 78% since hitting a 52-week high of $10.16 on Jan. 16 when one of its tests for early detection of prostate cancer received approval from the United Arab Emirates Ministry of Health and Prevention. At press time, they traded at $2.30 with a $6.8 million market cap (Nasdaq: BMRA).
In April, Biomerica announced a 1-for-8 reverse stock split to help the company meet the Nasdaq’s $1 minimum bid price requirement for continued listing.
$30B IBS Market in the U.S.
Biomerica is known for making tests for irritable bowel syndrome (IBS) patients, a “massive and underserved” group for whom there are no existing FDA-approved drug treatments yet, the company said.
IBS is the number one most common diagnosis made by gastroenterologists, representing a $30 billion total market with 40 million IBS patients in the U.S., according to Biomerica.
It has developed what it says is the first drug-free treatment for IBS.
The InFoods IBS test, currently available as a laboratory developed test (LDT), uncovers what foods are triggering bloating, abdominal pain and other IBS symptoms using a finger stick blood sample and generating personalized results.
Biomerica said it’s in the midst of getting reimbursement for the test through Medicare.
Last month, the company announced a partnership with healthcare products and services distributor Henry Schein to market the inFoods IBS test in the U.S., excluding New York.
The company also offers products that screen for ulcers, colon disease and the prostate.
Biomerica has identified gastric cancer as a growth opportunity and received FDA 510k clearance for a biochemical test called Hp Detect, which picks up on a bacteria responsible for a range of issues such as peptic ulcer disease and indigestion, as well as gastric cancer.
Company Pivot to Diagnostics
Biomerica has two manufacturing facilities at its main campus in Irvine, as well as Mexicali, Mexico.
It’s the 11th largest diagnostics company in OC with 33 local workers, down 13% from last year. Companywide, it employs 53.
Biomerica currently offers 83 diagnostic products and has 100 patents filed, according to the company’s website.
Some of its customers in the U.S. include Mayo Clinic, Cleveland Clinic, Gastro Health, Northwestern Medicine and Yale New Haven Health.
Irani has served as chairman and CEO of Biomerica since 1997.
Biomerica was started by Irani’s uncle Joseph and his partner Ish Sultanian. The company, previously a small, diversified healthcare company, got rid of its noncore assets and switched focuses to diagnostic tests when Irani took over.
Biomerica’s board of directors include Evolus Inc. (Nasdaq: EOLS) Chief Executive and President David Moatazedi, who joined the board in 2022 and owns 36,188 shares as of Oct. 20, according to an SEC filing.
