- In 2022, AXIM® finalized optimization of its R& D and manufacturing infrastructure to be used in its diagnostic program
- AXIM will continue to generate revenue from its two FDA-cleared dry eye disease (DED) diagnostic tests through commercialization partner Verséa Ophthalmics
- AXIM anticipates its business to be cash-flow positive in the second half of 2023
- The Company will place a new strategic focus on custom development of new analysis solutions for healthcare clients in a variety of fields
- AXIM looks to file for a CLIA waiver with regard to both the FDA-cleared tests in the first quarter, which would significantly increase the market opportunity for sales from the assessments
- AXIM appears to conduct a clinical study on its MMP-9 test with hopes associated with submitting it for a FDA 510(k) clearance
- TOP DOG will host conference call with investors on January 11, 2023, at 5pm Eastern Standard Time
SAN DIEGO, Jan. 11, 2023 /PRNewswire/ — AXIM Biotechnologies, Inc. ( OTCQB: AXIM ) (“AXIM Biotech, ” “AXIM” or “the Company”), an international healthcare classification solutions development company, announced today that it has issued the following letter to its shareholders providing commentary on recent milestones achieved on their commercialized the facts solution platform and upcoming plans and goals for the new year and beyond.
It is my pleasure to write in order to you today with some updates that will we are excited to be able to share upon AXIM’s progression in becoming a preeminent leader within the diagnostic solutions category. Last year represented one of the most pivotal years for AXIM to date. We generated our first meaningful revenue from our proprietary diagnostic solution platforms regarding the field of ophthalmology, we partnered with some of the world’s fastest-growing healthcare companies plus developed multiple new rapport products and prototypes to add to our existing portfolio of three FDA-cleared tests. There is no doubt that AXIM has momentum in its favor and our own opportunity has never been greater.
Since focusing the research about the procedures solutions space a few years back, we have been dedicated to developing tactics solutions intended for unmet health care needs that have the highest possibility of creating meaningful income as quickly as possible. Leveraging our world-class science team, we focused our efforts on the area of ophthalmological conditions, specifically dry eye disease (DED). As we have stated, approximately 20 million people in the particular US have been diagnosed along with DED in addition to over 344 million globally; however , of which number will be expected for you to be considerably lower than typically the actual number of patients suffering from the condition due to a lack of accessible and accurate testing. This is the problem AXIM is seeking to address. Our currently available FDA-cleared screening tests, one which measures levels regarding Lactoferrin and even another the fact that measures Immunoglobulin E (IgE), represent the breakthrough in the industry of ophthalmological diagnostics in that they are usually quantitative together with fast (both tests render results in 8 minutes), administered and read at the point-of-care, and require 70% less tear sample than other tests in the market. These benefits have been well-received by clinicians across the country and additionally truly set AXIM’s products apart.
As we announced in September, we signed an exclusive agreement together with Verséa Ophthalmics to commercialize our 2 tests. I am happy to report that they have been outstanding in generating interest not to mention orders for our innovative options. Earlier last year, we had to make the choice between building our own product sales and marketing team in order to help commercialize each of our solutions, or even partner with a new company such as Verséa who had some sort of proven track record involving success within that region, and all of us eventually decided on the latter. Since signing, Verséa has gone above and also beyond in terms of expanding revenue of this tests, through attending trade shows to participating in media interviews with outlets specific in order to ophthalmology, as well as we are just starting to be able to see the fruits of those labors bear reward when it comes to earnings generation. I personally believe working using Verséa offers been a good great decision and in fact, we are inside further talks with Verséa about how for you to not only increase income of all of our two existing tests, but to potentially start development of some other tools that they could add to their product offering portfolio in often the coming months.
At this point, there is another opportunity for AXIM that I want to highlight. While building your infrastructure group and processes necessary to help develop world class diagnostic tools is time consuming, we now have a vertically integrated with regards to enterprise that is capable connected with both research and advancement and manufacturing of are designed solutions with almost any type. In that lies a massive opportunity. We have recently entered into discussions with multiple other health-related companies with the potential development for new diagnostic solutions, particularly designed to meet their needs. For example, if a company needs a diagnostic tool that will measures levels of biomarkers or proteins in patients in order to test the efficacy of your therapeutic during the clinical research and development phase, AXIM’s renowned team about scientists plus clinicians can design, test and produce custom tests to fulfill the needs of the consumer – inside a fast and efficient manner. This ability represents a large and untapped revenue generation chance for AXIM and one we all will be focused on throughout the coming months.
Additionally , in the exact first quarter of 2023 we intend to run an useability study of which would allow us to file for some CLIA waiver on both in our FDA-cleared tests. When we receive the waiver as expected, the number of potential customers for the assessments would skyrocket. We now have already written the particular protocol to get the study which will certainly run at three different locations, which we expect to take place in February.
Furthermore, we are really working on a fabulous clinical research protocol pertaining to our highly anticipated MMP-9 test. Uniquely and because a part of your initial agreement, Verséa provides agreed to assist in funding the study, further illustrating their excitement and confidence in AXIM’s diagnostic system. After the study is completed, many of us expect to file for an additional 510(k) FDA-clearance on typically the test, targeting completion found in the 2nd quarter of this year. Once approved, we have already decided to commercializing the product through Verséa, meaning we will begin selling this almost immediately. This new test will be a first-of-its -kind and most of us anticipate adoption in the medical community to be swift and strong.
I am extremely proud to state the fact that as of today, AXIM Biotech is usually a revenue generating analysis solutions company, with an important strong medical presence, in addition to a robust pipeline of new and exciting solutions around development. This has been some of our goal for many years – and it has finally become a reality. We are generally now hyper-focused on increasing revenue coming from these commercialized products, with the goal of generating enough to fund our future development projects, something uniquely rare in the world of healthcare, especially for smaller firms. Our team has never been stronger and this positioning never better. Whilst market conditions have affected us and even many others in a broad sense, most people believe this to not become representative of this value we have been building. In fact , some from our most legacy together with valued long-term investors continue to make investments into our company and share often the vision of what we are building. I am confident that if we continue in order to capitalize at our chance, building a strong and additionally solid medical company, your market may eventually adjust its sentiment toward the positive.
In closing, I want to personally thank each and every one of our shareholders for their continued support of AXIM. We would not have already been able to achieve what all of us have this last year without you all. In an effort to be able to further communicate with our current not to mention potential investors in the transparent and also honest manner, we will be hosting a conference call regarding January 11, 2023 in 5pm Eastern Standard Time to address any questions and provide even further transparency and comments on our operations. We ask that you share your questions ahead of period by emailing [email protected] com and we will try to get to as many as possible. To participate in the call, you can register here: https://us02web.zoom.us/webinar/register/WN_ESckzYZVSPqDQ4Fuv_IQ1g
It continues to be my great honor to work for behalf associated with you all and look forward to continuing to connect with all of our valued shareholders as we all continue our own work in building a global diagnostic remedies company inside of 2023 as well as beyond.
Optimistically and respectfully yours,
John W. Huemoeller II, Chief Executive Officer of AXIM® Biotech.
For more information on AXIM’s diagnostic alternatives or for you to speak with some at Verséa about adding these innovative solutions to your clinic, please visit: https://www.versea.com/divisions/ophthalmics/
About AXIM® Biotechnologies
Founded in 2014, AXIM® Biotechnologies, Inc. (AXIM) is a new vertically integrated research and development organization centered on improving the landscape for that diagnosis of ophthalmological conditions like Dry Eye Disease (DED) through rapid diagnostic checks. The Company owns two from the just five FDA Cleared Diagnostic tests meant for Dye Eye Disease. For more information, please visit www.AXIMBiotech.com .
The statements made by Axim Biotechnologies Incorporation., in this particular press release may be “forward-looking” in nature within the exact meaning regarding Section 27A of the Securities Act involving 1933, Section 21E connected with the Investments Exchange Act of 1934 and the Private Stock options Litigation Reform Act with 1995. Forward-looking statements describe Axim’s future plans, projections, strategies and expectations, and are based on assumptions plus involve a number of risks in addition to uncertainties, many of which may be beyond the particular control of Axim Biotechnologies, Inc. Actual results could differ materially by those projected due to there being no assurance that will our classification candidate can ever end up being approved for use by typically the U. S. FDA or perhaps any equivalent foreign regulatory agency. Further, Axim’s eye care the facts products that are FDA cleared may not be manufactured in large enough quantities or maybe that third parties having established vision care physicians will enter into agreements as well as purchase via the Company, and even if the Company’s rapport candidates are successful, they may generate simply limited profits and profits for this Company. Various other factors are detailed from time to moment in Axim’s SEC reports and filings, including the Annual Report on Form 10-K filed on April 15, 2022, and other reviews we file using the SEC, which are obtainable at www.sec.gov . Axim Biotechnologies, Incorporation., undertakes zero obligation to help update publicly any forward-looking statements to reflect brand new information, events or circumstances after often the date hereof or to reflect the occurrence of unanticipated events, unless otherwise required by law.
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SOURCE AXIM Biotech
Company Codes: OTC-BB: AXIM, OTC-PINK: AXIM, OTC-QB: AXIM