GNBT - Generex Biotechnology
Subsidiary Olaregen Therapeutix Receives American Podiatry Medical
Associations Seal of Approval
MIRAMAR, FL -- June 26, 2019 -- InvestorsHub NewsWire --
Generex Biotechnology Corporation (GNBT) (www.generex.com) (GNBT) announced today that
their subsidiary, Olaregen Therapeutix, Inc., received the
prestigious “Seal of Approval” from the American Podiatric Medical
Association (APMA) for their Cellular Tissue Product, Excellagen
Wound Conforming Matrix. Founded in 1912, the APMA is the leading
resource for foot and ankle health information. Currently, the
organization represents a vast majority of the estimated 18,000
podiatrists in the U.S.
The APMA Seal of Approval/Acceptance Program evaluates the use
of therapeutic agents and their adjuncts (pharmaceuticals) and
regulated medical devices. The seal is granted to a product after
the Podiatric Seals Committee, a standing committee of the American
Podiatric Medical Association, evaluates and determines whether the
product allows normal foot function and promotes quality foot
health. Additionally, evidence of usefulness and safety must be
established, either by an appropriately recognized laboratory or
clinical investigation, or by the products meeting certain physical
standards. A detailed review is conducted by each committee member
on every product. The committee then sends its recommendation to
the APMA Board of Trustees, which has the authorization to either
accept or reject the recommendation.
Excellagen is an FDA- 510(k) cleared Cellular Tissue Product
with an indication for the management of wounds including Diabetic
Foot Ulcers. Excellagen is a ready to use 3-dimensional wound
conforming matrix that supports a favorable wound healing
environment. It is designed to accelerate granulation tissue growth
by providing a structural scaffold for cellular migration and
proliferation, and activates platelets, triggering the localized
release of endogenous growth factors including Platelet-Derived
Growth Factor (PDGF), a key biological mediator of wound
healing.
Joe Moscato, CEO of Generex commented, “Receiving the “APMA Seal
of Approval” is tremendous news for our subsidiary, Olaregen
Therapeutix. The process for receiving the seal is a rigorous
evaluation of clinical utility and value, so our customers can feel
confident in choosing Excellagen to manage their hard to heal
wounds knowing that our best in class product meets the high
standards set by the APMA. In addition, this is a great affiliation
with the APMA, and we look forward to working with them and all
APMA member surgeons and podiatrists to help manage their diabetic
foot ulcers using Excellagen. I would love to hear from APMA
members about their experience in the use of Excellagen in managing
their patients hard to heal wounds.”
Anthony Dolisi, CEO of Olaregen Therapeutix commented, “Our
customers include surgeons, patients, their caregivers and payors.
The APMA Seal of Approval strengthens our value with our customer
base. With demonstrated superior clinical data and strong economic
value, the seal adds additional reason on why we believe Excellagen
will be a disruptive technology in the Regenerative Wound Care
Market. Equally as important is the impact Excellagen makes on
patients with hard to heal wounds that are difficult to manage
causing a poor quality of life.”
About Generex Biotechnology Corporation
Generex Biotechnology Corporation 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 immuno-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.
Revenue from the Company’s subsidiaries will support clinical
advancement of its wholly owned therapeutic products with a focus
in immunotherapeutics based on stimulating critical members of the
immune response, known as T helper cells, and its proprietary
buccal administration of insulin.
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. 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.
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 forward-looking statements,
including inaccurate assumptions and a broad 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 on such statements. Generex undertakes no obligation
to update publicly any forward-looking statements, whether as a
result of new information, future events or otherwise. Generex
claims the protection of the safe harbor for forward-looking
statements that is contained in the Private Securities Litigation
Reform Act.
Generex Contacts:
Joseph Moscato
646-599-6222
Todd Falls
1-800-391-6755 Extension 222
investor@generex.com
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