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

HEMA DIAGNOSTIC SYSTEMS Announces the Execution of A Non-Binding Letter Of Intent with Generex Biotechnology Corporation. HDS And Generex Will Work Together To Bring Technologies Developed By Both Companies Together By Incorporating The New And Novel Rapid Diagnostic Test Systems For Worldwide Market Expansion

MIRAMAR, FL / ACCESSWIRE / October 1, 2015 / 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.

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(R) HEMA EXPRESS(R) 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(R) EXPRESS(R) and Rapid 1-2-3(R) EXPRESS II as well as the Rapid 1-2-3(R) Hema EZ(R) 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.

SOURCE: Hema Diagnostic Systems, LLC

ReleaseID: 432348