Hema Diagnostic Systems in Discussions for Equity Investment by Generex Biotechnology Corp.

Miramar, Florida, September 30, 2015 (Newswire.com) -  Hema Diagnostic Systems, LLC (HDS), a leading U.S. manufacturer of in-vitro, point-of-care medical devices for infectious diseases, announced today the execution of a non-binding letter of intent (LOI)  with Generex Biotechnology Corporation (Generex) (www.generex.com) (OTCQB:GNBT) whereby Generex will acquire a 51% equity interest in HDS in exchange for a purchase price of $15,000,000.

HDS initially entered into the market of rapid diagnostic tests (RDTs) in 2001 with a series of rapid diagnostic tests for HIV, Syphilis and Tuberculosis which targeted markets in Brazil and parts of Africa. To maintain pace with the market, other analytes were added to the product mix.

"There are synergies between the HDS product development work and the research and development work undertaken by Antigen Express, Inc. (www.antigenexpress.com), a wholly-owned subsidiary of Generex, in the area of vaccines for infectious diseases. HDS will seek to leverage the Generex experience and expertise in infectious diseases to incorporate avian and swine influenzas into the HDS product line, thereby expanding exposure and appeal to the world markets. Certainly, we welcome this opportunity which should provide significate positive results for each company."

Lawrence Salvo, President and CEO

Understanding the need for an easy to use, rapid diagnostic test for in-field and in-clinic use, HDS has since developed a series of low-cost delivery systems that eliminate, to a substantial degree, user-error. Additionally, the HDS product designs are also configured to significantly prevent problems closely associated with cross-contamination.  HDS has incorporated its delivery systems into all HDS infectious disease tests that it produces, unifying their method of use and making the training of test administrators in the field easier and more efficient.

Lawrence Salvo, President and CEO of Hema Diagnostic Systems said today: “There are synergies between the HDS product development work and the research and development work undertaken by Antigen Express, Inc. (www.antigenexpress.com), a wholly-owned subsidiary of Generex, in the area of vaccines for infectious diseases.  HDS will seek to leverage the Generex experience and expertise in infectious diseases to incorporate avian and swine influenzas into the HDS product line, thereby expanding exposure and appeal to the world markets.  Certainly, we welcome this opportunity which should provide significate positive results for each company.”

As HDS has been in the world markets for many years, it has developed relationships in many countries throughout Africa, South and Central America, Eastern Europe and into the Arab Gulf. These relationships, many of which are direct with health ministries, open certain doors for us. Therefore, it is of ultimate importance that HDS proceed to the next level in its business development plan. This includes the registration, evaluation and approval of our many tests by the relevant authorities around the world.

Mr. Salvo further stated: “Therefore, in cooperation with Generex, HDS will immediately undertake the required steps to gain FDA approvals and to expand those approvals to include additional HDS products.”  HDS will also actively move forward with additional product submissions, expanding its requested approvals from other international agencies including the World Health Organization (WHO) and the Global Fund.

Following the evaluation of our RAPID 1-2-3® HEMA EXPRESS® HIV tests by the US CDC (Centers for Disease Control), HDS is on the approved list under PEPFAR (Presidents Emergency Plan for AIDS Relief). Additionally, HDS malaria rapid tests are on the approved WHO product testing report and are therefore covered under multiple purchasing programs provided by such groups as PFSCM (The Partnership for Supply Chain Management) and the Global Fund. HDS is also an approved vendor under UNESCO, UNICEF, UNPD and Aramco.

Primary product approvals sought will include (1) New 4th Generation HIV rapid test- capable of reducing the window of detection of an HIV infection; (2) New Tuberculosis-XT- capable of detecting the active form of m.Tuberculosis; (3) New Syphilis (Treponema pallidum);    (4) New Anthrax rapid- capable of detecting both the Lethal Factor (LF) and the Protective Antigen (PA).

The current HDS product line includes rapid tests for HIV, Malaria, Syphilis, Hepatitis-B, Hepatitis-C and Tuberculosis. Products under development include Dengue IgG/IgM, Dengue NS1, Ebola and Anthrax (LF/PA).

HDS will also undertake US FDA PMA and 510K for those appropriate analytes necessary to establish and promote sales of our products within the USA and to help expedite the international regulatory approvals. Mr. Salvo also stated: “Of significant interest in this process will be the introduction of our Express II system which will be the first price competitive alternative to the established, cumbersome and difficult to use cassette system which has existed in the world markets for the past 30 years”.

 

About Hema Diagnostic Systems

Hema Diagnostic Systems, LLC (www.rapid123.com) is a rapidly growing biotechnology company involved in the development, manufacture, assembly and distribution of diagnostics targeting primary as well as orphan infectious diseases. Incorporating rapid, Point-Of-Care test devices. Hema Diagnostic Systems continues to expand its product line to meet the needs of the worldwide market. Point-of-Care test devices are made simple to use and are highly cost effective when incorporated into Hema Diagnostic Systems’ patented delivery systems. The Rapid 1-2-3 Hema® EXPRESS® and Rapid 1-2-3® EXPRESS II as well as the Rapid 1-2-3® Hema EZ® are novel delivery systems that are self-contained and easy to use.

This release may contain forward-looking statements. These forward-looking statements involve risks and uncertainties that could cause actual results to differ, and such differences could be material. Such risks and uncertainties include, but are not limited to, the following: continued acceptance of the Company's products, increased levels of competition in our industry, the acceptance of new products, inherent risks associated with product development and intellectual property rights, the Company’s dependence on key personnel, third party sales and suppliers. There can be no assurance that the Company will be successful in addressing such risks and uncertainties and the Company assumes no duty to update any forward-looking statements based upon actual results.