Dry Eye Disease, also known as DED, is a condition that can be difficult to diagnose. Mira Mesa-based AXIM Biotechnologies (OTBQB: AXIM) is working to put it in a better light.
Late last month (May 24), AXIM announced the launch of its diagnostic platform, lining up more than 40 clinics to use its FDA-cleared diagnostic assays for DED.
AXIM secured commitments from clinics located across the United States with the help of distribution partner Versea Ophthalmics of Tampa, Florida. The company said it aims to double the number of committed clinics by the fourth quarter.
The San Diego company produces two types of assays: Ocular Immunoglobulin E (or IgE) and Lactoferrin.
Some 344 million people worldwide suffer from Dry Eye Disease, according to the American Academy of Ophthalmology, and the condition poses significant challenges for clinicians in terms of accurate diagnosis and treatment.
AXIM announced in April that it had begun to manufacture its assays. As is a standard practice, AXIM has begun manufacturing three separate lots of each assay that will be used for an internal reproducibility study with the third lot available to ship to customers. AXIM’s current manufacturing capacity is up to 25,000 units per month.
Separately, the company announced on May 23 that it had appointed Kurt Phinney as chief operating officer. Phinney will drive scaling and optimization of AXIM’s manufacturing unit.
Phinney was previously vice president of operations at Versea Health and is principal consultant for Accalle Group. In previous roles, he successfully reduced costs, increased capacity, and shortened production time, boosting manufacturing output from 11,000 assays to 225,000 assays per week.
By adding Phinney to the team, AXIM aims to increase manufacturing capacity by at least 50% by the fourth quarter. AXIM said this expansion is essential to meet the growing demand driven by its commercialization partner.
A ‘Tremendous’ Response
“Since launching our diagnostic platform, we have looked forward to the day where our solutions would officially begin to improve the lives of thousands of patients a week, and today we can share that dream is a reality,” said AXIM CEO John Huemoeller II.
CEO
AXIM Biotechnologies
“Versea has been showcasing our platform at industry trade shows and to clinics across the country and the initial response has been tremendous. I could not be more excited about the opportunity before us and every day we continue to scale manufacturing to be able to meet the growing demand.”
AXIM Biotechnologies said it aims to address an unmet medical need through the further introduction of its diagnostic platform.
AXIM tests are designed to be administered at the point-of-care, providing results in less than nine minutes and offering a qualitative assessment of biomarkers and enzymes that indicate the plausibility of DED. Beyond initial diagnosis, consistent testing is necessary to evaluate the effectiveness of DED treatment; AXIM says this creates a recurring need for its solutions at the point-of-care.
AXIM is publicly traded. During the last 12 months, shares have traded in the range of 1.6 cents to 12.5 cents. Shares closed May 30 at 2.2 cents. Some 33% of shares are held by insiders, according to Yahoo Finance.
The business had a market capitalization of $4.78 million as of May 30. It had an accumulated deficit of $66.9 million as of March 31, according to a Securities and Exchange Commission filing. The company intends to raise additional capital through private placements of debt and equity securities and has done so during the first five months of 2023, according to SEC filings.
Bringing Clinics on Board
As part of the onboarding process, each of the 40 participating clinics either possesses their Clinical Laboratory Improvement Amendments (CLIA) moderate complexity license or is in the application process.
Upon obtaining the CLIA license, AXIM will provide its clinic partners with a validation kit and a reader to interpret the results. The clinics will then conduct the required amount of validation test assays to prepare for full-scale implementation.
After completing the initial validation testing, the clinics are expected to reorder approximately 200-300 tests per month on average.
The 40 committed clinics will introduce the diagnostic platform and receive a combination of IgE and Lactoferrin diagnostic assays. Versea Ophthalmics continues to meet with clinics and educate them about the diagnostic platform, aiming to secure additional commitments.
While currently, clinics must hold CLIA-moderate complexity certification before running the tests, AXIM is in the process of preparing the necessary research trial and paperwork for submission to the appropriate regulatory body. The company seeks a CLIA-waiver, which, if obtained, would significantly expand the market opportunity for the introduction of the diagnostic tests.
AXIM Biotechnologies
FOUNDED: 2014
CEO: John Huemoeller II
HEADQUARTERS: Mira Mesa
BUSINESS: Research and development company focused on improving the landscape for the diagnosis of ophthalmological conditions such as Dry Eye Disease (DED) through rapid diagnostic tests
REVENUE: $8,875 (2022)
STOCK: AXIM (OTCQB)
EMPLOYEES: Six full-time, three part-time, as of Dec. 31
WEBSITE: www.aximbiotech.com
CONTACT: 858-923-4422
NOTABLE: The company has two types of assays: Ocular Immunoglobulin E (or IgE) and Lactoferrin
