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For our investors, current news and developments in key areas of the medical diagnostics field.


Volume 6 No. 3 (December 2009)

Patent For Glycated Albumin Test Approved By US Patent Office

The United States Patent and Trademark Office has informed Epinex that all claims for the patent for the G1ATM test have been allowed. Epinex expects that the patent will be granted within three months.


Epinex Terminates Loan Agreement

Epinex has terminated its agreement with Valor Investments, Ltd. of Vancouver BC, Canada for debt financing, after drawing $475,000.


Former Managing director For Bear Stearns

Mr. Steven Antebi has joined the Board of Directors of Epinex, and will serve as Chairman of the Board. Steven Antebi is the President, and Chairman of the Board of Maple Capital Management since 1993. Maple Capital Management is an equity fund focusing its attention on equity investments in North America. He is also President and CEO of Galileo Partners LLC and president of Blue and Gold Enterprises Inc. Both funds invest in PIPE Transactions, Registered Direct Investments, Private Placements and open market equity transactions. Both companies invest in a variety of debt instruments and do asset based lending. Mr. Antebi had a long tenure at Bear Stearns & Company for over nineteen years in senior positions: including institutional sales, trading of the firm's capital, investment banking, and syndicate. He began in 1972 as a limited partner and left the firm in 1991 as a shareholder and managing director. He has nearly twenty years of research expertise and experience in Business Development and Management in Healthcare, Natural Resources, Technology, and Interactive Media. Mr. Antebi has worked in collaboration with different academic and governmental organizations doing extensive research on the U.S. Economy and is very active in political and community advocacy. He has been a member of the Board of Governors of Cedars Sinai Hospital, in Los Angeles, one of the largest hospital/research centers in the world, for over ten years. Mr. Antebi holds a Bachelor's Degree with honors from the University of California at Los Angeles, majoring in History, as well as a Masters equivalent in Medieval Papal History. He is also a graduate of the MBA program Anderson School of Business at U.C.L.A., and the Loyola University School of Law (Los Angeles).

Epinex Engages Global Hunter Securities

The Company has engaged Global Hunter Securities, LLC to secure both debt and equity financing, and expects to have bridge financing in place to carry the Company forward as the agreement with GHS is put into motion.

company completes Financial Audit

The Company has completed an audit of its financial records, conducted by KMJ/ Corbin & Company, in preparation for offering shares in the public market.


A study published in the December issue of Diabetes Care attributes much of the rising diabetes prevalence and increasing costs to our aging population, with Medicare spending on diabetes projected to nearly quadruple. The report demonstrates the pressing need for a shift in the diabetes monitoring and management paradigm. Epinex's monthly G1ATM test, which promotes preventive care, has the potential to be a valuable cost-saving tool for our overburdened healthcare system.

Corporate Office:

Epinex Diagnostics, Inc. 14351 Myford Rd., Unit J Tustin, California 92780 USA

Corporate Finance:

Jeff Byrd, Vice President Toll Free: (866) 592-3746 [email protected]


creating a revolution in biotech-based diagnostics

Epinex Moves To Expanded Facility


The Company has completed its move to a newly renovated 8,000 square foot facility, having outgrown the 4,000 square foot office space it occupied for the previous five years. The new facility contains a complete research laboratory, including both wet and dry labs, dedicated space for strip manufacturing,


Market research associates Jacqueline Morales and Henna Zaidi attended the 36th annual meeting of the American Association of Diabetes Educators (AADE). The AADE conference is designed for healthcare professionals who provide diabetes education/ management services. This year's meeting, held at the Georgia World Congress Center in August, attracted approximately 4,000 nurses, dieticians, pharmacists, and other diabetes healthcare professionals. The AADE is a multidisciplinary professional association that supports diabetes educators by providing valuable resources and network opportunities. Education will be a key component to establishing a monthly glycated albumin (GA) test as a standard of care for diabetes monitoring. The meeting, which focused on "exploring new dimensions" in diabetes education, gave Epinex insight on the needs, challenges, and frustrations that diabetes educators face today. Epinex associates attended over 20 sessions covering crucial issues such as creative teaching tools, self-care behaviors, technology, and reimbursement. The information gathered from the meetings will aid Epinex in developing a diabetes management and education program (based on the monthly G1ATM testing paradigm) that can be used effectively by existing diabetes education centers.

With construction of the new laboratory space completed, Epinex has begun the process of making the facility fully FDA and cGMP compliant. We have filed with the California State Medical Device Board for a manufacturing license, with plans to begin pilot production of test strips as soon as the license is granted.

Company Reception Area

and offices and conference space for the Company's expanding roster of management, science and engineering specialists. There is also an affiliated clinical research facility that will be used to conduct validation studies for the G1ATM diabetes test and subsequent products.

Immunoassay Strip Development

Research & Development Wet Laboratory

The Company plans to keep product development and manufacturing for its rapid immunoassay test cassettes in house, while subcontracting the design and manufacture of reader devices to outside sources. Epinex has now expanded to sixteen employees, and will continue to add to its personnel roster as the company grows.

Epinex Invited To NyAS Symposium

In September, Epinex was invited to exhibit at a diabetes conference hosted by the New York Academy of Sciences (NYAS) in New York City. The symposium was titled "Type 2 Diabetes Disparities in Ethnic Minorities: Origin, Challenges and Solutions." Scientists, physicians, medical students, and public health professionals convened to discuss the disproportionate burden of type 2 diabetes experienced by racial and ethnic minorities. The NYAS meeting gave Epinex a unique opportunity to present the Company's work to the scientific and public health community.

Epinex Booth at NYAS

company develops Model For POc Unit

Unique Features Highlight Epinex Platform Technology

Epinex has taken a major step towards production of the commercial version of the G1ATM test by producing a fully realized three-dimensional model of the Point of Care desktop unit. The model features a wireless handheld unit for conducting tests and a docking station for patient data management. The initial industrial design was completed in-house by Jaycee Delizo and Christy Purnajo using CAD software and "printed" using a three-dimensional prototyping printer. As envisioned by the Epinex design team, the components of the G1ATM Point-of-Care unit have been designed to support the unique functionality of the Epinex Platform Technology System. The Platform Test System will allow for a wide variety of tests to be performed within the same instrument, and will streamline management of results and patient records through the use of cutting edge electronics and communications technology. The Platform Test System includes a handheld reader, docking station, built-in printer, and charging module. The system will meet CLIA and CLSI requirements for quality control, with auto calibration done for each test strip. The Docking Station features a full-color touch screen with adjustable viewing angles, power via AC/DC adapter or batteries, USB and wireless connection capabilities, a disc drive for software upgrades and updates and a built-in printer. The Docking Station will accommodate multiple handheld units and will update the handheld for new tests added to the Platform Test System. It will sync with hospital or laboratory information systems (HIS/LIS) for patient appointments and medical records to verify if the correct patient is to be tested using the correct rapid test. The Docking Station will also enable test result printing using the system's internal printer for quick hardcopy data or will transfer data to the HIS/LIS for more complete medical record printout. The Handheld Reader features a fullcolor, intuitive touch screen interface, language selection capability, a barcode scanner, a rechargeable built-in battery, and visual and auditory status indicators. It will read and quantify all cartridges in Epinex' lines of rapid tests, including diabetes monitoring, infectious diseases, and drugs of abuse, with test results available within minutes. A wireless link to the Docking Station will facilitate patient identification and record retrieval and test result printing.

Manager of Research Engineering Jaycee Delizo and Research Associate Christy Purnajo

Epinex Engineering Team Attends development Workshop

In November, Research Engineers Andrew and Thien-Toan attended the BioDot Workshop on the Theory & Practice of POC Tests held in San Francisco. They learned about the current state of lateral flow immunoassay technology, including inline automated manufacturing for test strip production, and established networking contacts for future collaborations or partnerships. The focal point of the workshop featured a lecture series, supplemented by a series of "hands on" laboratory sessions where Biodot displayed the functionality of various manufacturing machines.

Andrew Lee and Thien-Toan Tran

company Focuses On International Market Potential

New company Web Site Launched

Epinex has taken a number of significant steps in the past several months to builvd its international reputation and prepare for worldwide marketing of the Epinex G1ATM test. The Company web site was completely redesigned to emphasize the significance of the test from a marketing perspective, and has been translated into several key international languages, including French, German and Spanish. A Chinese translation will follow soon.

Epinex cEO Establishes Key European contacts

Epinex CEO Asad Zaidi made two trips to Central Europe to meet with potential manufacturing and sales partners in Germany and Switzerland. DEWS, the governmentsponsored development corporation for the Western Switzerland provinces of Vaud and Neuchatel, requested Development of human meetings and showed significant interest in the potential resources within the for future collaboration in the European market. Company has been a primary goal of Epinex CEO and founder Asad Zaidi. Intensive training and on-thejob education has paid off as several junior associates have received promotions In November, to positions of responsibility Epinex CEO Asad within the Company and Zaidi attended former assistants have been the meeting on moved to full-time associate Contemporary Clinical & Serop Gharibian Regulatory Manager of Operations Issues in Point of Care Testing, positions. Serop Gharibian sponsored by the American Association for Clinical has been appointed Manager Chemistry in New Orleans. Topics explored included of Operations and Jaycee current trends in POC testing, including glycemic control, Delizo Manager of Research as well as education on regulatory compliance. The meeting andEngineering,whileAndrew offered Epinex an opportunity to interact with some of the Lee and Thien-Toan Tran have leading voices in diagnostic testing. Among the contacts been promoted to Research who expressed very strong interest in the potential of the Engineers from Assistants. Jaycee Delizo the G1ATM test to transform diabetes testing was Dr. Frank In senior management, Manager of Wians, Associate Director of Clinical Pathology at the Research Engineering Chief Technology Officer University of Texas Southwestern Medical Center. Henry Smith has assumed the duties of Vice-President of Operations, and James Smith has come on board as Director of Regulatory Affairs. creating a revolution in biotech-based diagnostics

Epinex Builds On Its Internal Resources In design, Product development and Operations

G1ATM Test Generates Attention At POc Meeting




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