Generex Biotechnology Subsidiary Olaregen Therapeutix Inc. Plans Launch of FDA Cleared Excellagen® Wound Conforming Gel Matrix with Three Dosage Options

  • Plans Commercial Launch of three dosing options for Excellagen in
    pre-filled syringes
  • The 0.5 cc and 0.8 cc and 3.0 cc doses provide optimal wound coverage
    while reducing waste and costs
  • 3 cc dose has utility in surgical applications for the treatment of
    larger wounds and surgical incisions
  • In negotiations with major surgical wound care networks for treatment
    of diabetic foot ulcers, venous stasis ulcers, and difficult to heal
  • Nationally Renowned Wound Care Thought Leader, Dr. Peter A. Blume of
    Yale School of Medicine, provides insight

MIRAMAR, Fla.–(BUSINESS WIRE)–Generex Biotechnology Corporation (OTCQB:GNBT) is pleased to announce
that Olaregen Therapeutix Inc., a subsidiary of Generex Biotechnology
will launch three doses of FDA 510K-Cleared Excellagen, the company’s
wound conforming gel matrix that is designated as a Cellular & Tissue
Based Product or CTP for wound healing. The 0.5 cc and a 0.8 cc syringes
will be utilized to treat smaller wounds such as diabetic foot ulcers,
venous stasis ulcers, and pressure ulcers, and in patients who have
undergone MOHs surgery for removal of cancerous tissue. The 3 cc syringe
has been developed for larger wounds that are most frequently seen in
emergency departments, operating rooms, and surgical suites. Excellagen
has a designated reimbursement code in the Healthcare Common Procedure
Coding System, with a unique Q Code designation 4149 referred to as a
skin substitute.

The Excellagen® launch team is introducing the product in
surgical centers, the Department of Defense and VA system, operating
rooms, and wound care centers, as well as through podiatric practices.
The company is currently in contract negotiations with major nation-wide
surgical wound care centers for the use of Excellagen® for the treatment
of a variety of wound types, including partial and full thickness
wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic
vascular ulcers, tunneled/undermined wounds, surgical wounds (donor
sites/grafts, post-Mohs surgery, post-laser surgery, podiatric, wound
dehiscence), trauma wounds (abrasions, lacerations, second-degree burns,
and skin tears) and draining wounds. Additionally, NuGenerex
Distribution Solutions, a wholly-owned subsidiary of Generex, will
immediately launch Excellagen® through its MSO network of surgeons and
podiatrists in five states.

“We’ve heard time and again about the issue of waste, or the need for
multiple applications per a single procedure because the existing
products don’t necessarily accommodate the size of the wound. This is
not only time consuming for the doctor but is cost inefficient,” said
Anthony J. Dolisi, Chief Executive Officer of Olaregen. “As part of our
commitment to our customers, we listen carefully to their needs. After a
thorough analysis of the market, and through discussions with
physicians, we determined that Olaregen will launch Excellagen with
multiple dosage options that offer clinical flexibility and cost savings
with improved clinical outcomes.”

Dr. Peter Blume, D.P.M., F.A.C.F.A.S., Medical Director/HVC/Ambulatory
Surgery, Yale New Haven Health Systems, Assistant Clinical Professor Of
Surgery Anesthesia and Cardiology, Yale School of Medicine, provides his
views on Excellagen®, “The average wound size in the surgical setting
can be variable and quite large depending on the amount of debridement
of soft tissue and bone. Olaregen’s decision to manufacture a 0.5 cc and
a 0.8 cc for smaller wounds such as DFU, VSU and Pressure ulcers and a 3
cc syringe for the surgical setting will not only save doctors time but
will be highly cost effective and reduce product waste. The company is
collaborating with physicians and surgeons with respect to the needs of
the wound care community and addressing the unmet needs.”

The wound care market is extensive, with an estimated 77 million
surgical wounds in the U.S., a percentage of which Excellagen is cleared
for use. The wound conforming gel is also indicated to treat Diabetic
Foot Ulcers (1,260,000), Venous Stasis Ulcers (1,625,000), and MOHs
surgery (850,000) among the 17 wound types Excellagen is cleared to
treat. Further, a recent study published in Value in Health
(Volume 21, September 2018, 27 – 32) found that total Medicare spending
estimates for all wound types ranged from $28.1 to $96.8 billion, as
nearly 15% of Medicare beneficiaries or 8.2 million people had at least
one type of wound or tissue infection. These figures do not reflect the
incidence of burns, amputations, and traumatic wounds and lacerations
all which Excellagen is cleared for use. With the aging population and
the increase in the incidence of diabetes, these numbers are expected to
grow significantly in the future.

Anthony J. Dolisi, Chief Executive Officer, provided his view of the
market, “We have created a wound care expert salesforce to help guide
physicians on the optimal Excellagen dose for a given wound type. As an
example, in the surgical setting, a 3 cc pre-filled syringe of
Excellagen will cost substantially less than our CTP competitors with
demonstrated improvements in healing rates. Olaregen is aggressively
pursuing a ‘Value Based Healthcare’ strategy in line with the goals of
the Centers for Medicare and Medicaid Services, which has announced that
they will be assessing waste in the wound care system. Discarding unused
wound care products is a tremendous cost in the wound care space, so our
strategy of multiple dosing options puts Olaregen in a strong market

About Generex Biotechnology Corp.

Generex Biotechnology is an integrated healthcare holding company with
end-to-end solutions for patient centric care from rapid diagnosis
through delivery of personalized therapies. Generex is building a new
kind of healthcare company that extends beyond traditional models
providing support to physicians in an MSO network, and ongoing
relationships with patients to improve the patient experience and access
to optimal care.

In addition to advancing a legacy portfolio of immune-oncology assets,
medical devices, and diagnostics, the Company is focused on an
acquisition strategy of strategic businesses that complement existing
assets and provide immediate sources of revenue and working capital.
Recent acquisitions include a management services organization, a
network of pharmacies, clinical laboratory, and medical device companies
with new and approved products.

Our newly formed, wholly-owned subsidiary, NuGenerex Distribution
Solutions (NDS), integrates our MSO network with a pharmacy network,
clinical diagnostic lab, durable medical equipment company (DME-IQ) and
dedicated call center.

About Olaregen Therapeutics

Olaregen Therapeutix, Inc. is a regenerative medicine company focused on
the development, manufacturing and commercialization of products that
fill unmet needs in the current wound care market. The company aims to
provide advanced healing solutions that substantially improve medical
outcomes while lowering the overall cost of care. Olaregen’s first
product introduction, Excellagen (flowable dermal matrix) is a
topically applied product for dermal wounds and other indications. Excellagen
is a FDA 510K cleared device for a broad array of dermal wounds,
including partial and full thickness wounds, pressure ulcers, venous
ulcers, diabetic ulcers, chronic vascular ulcers, tunneled/undermined
wounds, surgical wounds (donor sites/grafts, post-Mohs surgery,
post-laser surgery, podiatric, wound dehiscence), trauma wounds
(abrasions, lacerations, second-degree burns and skin tears) and
draining wounds, enabling Olaregen to market Excellagen in
multiple vertical markets. Additionally, Excellagen can serve as
an Enabling Delivery Platform for pluripotent stem cells, antimicrobial
agents, small molecule drugs, DNA-Based Biologics, conditioned cell
media and peptides. Olaregen’s initial focus will be in advanced wound
care including diabetic foot ulcers (DFU), venous leg ulcers and
pressure ulcers. Future products focusing on innovative therapies in
bone and joint regeneration comprise the current pipeline. The company’s
mission is to become a significant force in regenerative medicine and
advance the science of healing.

About our Service-Disabled Veteran-Owned Small Business (SDVOSB)

This is a Service-Disabled Veteran-Owned Small Business (SDVOSB) that
specializes in the sale, marketing, and distribution of innovative
medical products through a nationwide network of veteran owned
distribution services.

Cautionary Note Regarding Forward-Looking Statements

This release and oral statements made from time to time by Generex
representatives in respect of the same subject matter may contain
“forward-looking statements” within the meaning of the Private
Securities Litigation Reform Act of 1995. These statements can be
identified by introductory words such as “expects,” “plan,” “believes,”
“will,” “achieve,” “anticipate,” “would,” “should,” “subject to” or
words of similar meaning, and by the fact that they do not relate
strictly to historical or current facts. Forward-looking statements
frequently are used in discussing potential product applications,
potential collaborations, product development activities, clinical
studies, regulatory submissions and approvals, and similar operating
matters. Many factors may cause actual results to differ from
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variety of risks and uncertainties, some of which are known and others
of which are not. Known risks and uncertainties include those identified
from time to time in the reports filed by Generex with the Securities
and Exchange Commission, which should be considered together with any
forward-looking statement. No forward-looking statement is a guarantee
of future results or events, and one should avoid placing undue reliance
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any forward-looking statements, whether as a result of new information,
future events or otherwise.
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safe harbor for forward-looking statements that is contained in the
Private Securities Litigation Reform Act.


Generex Biotechnology Corporation
Joseph Moscato, 646-599-6222

Falls, 800-391-6755, ext. 222

Therapeutix, Inc.
Anthony J. Dolisi, Chief Executive Officer