Inventor Dr. Lois Chandler, PhD Presents Excellagen® Clinical Trial Data Demonstrating Rapid Healing of Diabetic Neuropathic Foot Ulcers
MIRAMAR, FL, April 18, 2019 (GLOBE NEWSWIRE) -- via NEWMEDIAWIRE -- Generex Biotechnology Corporation (www.generex.com) (OTCQB:GNBT) (http://www.otcmarkets.com/stock/GNBT/quote) is pleased to announce that the company’s subsidiary Olaregen Therapeutix participated as a sponsor of the prestigious Diabetic Limb Salvage Conference in Washington, DC as part of its continued commitment to Wound Care Education. The Conference was attended by 600 influential experts and healthcare providers involved in the research and management of wounds, with specific emphasis on diabetic foot ulcers (DFUs). Olaregen hosted an exhibit to present information on its now commercial wound care product, Excellagen®, formulated fibrillar collagen (2.6%) wound conforming matrix, indicated for the management of several wound types, significant among them, DFUs.
Lois Chandler, PhD, the inventor of Excellagen®, presented Wound Conforming Matrix (WCM) Promotes Rapid Healing of Diabetic Neuropathic Foot Ulcers: Subset Analysis of Randomized Controlled Trial at the Conference’s formal poster presentations. The findings of the Subset Analysis revealed that a single application of Excellagen induced rapid acceleration within the first week with a 208% relative improvement in healing rate over Standard of Care (SOC). By week two, 35% of Excellagen treated patients achieved ≥ 75% wound area reduction vs. 8% in the (SOC) arm reflecting a 338% relative improvement.
Over 23 million Americans have been diagnosed with diabetes mellitus (DM), and an estimated 7 million are undiagnosed, together representing more than 9% of the total U.S. population. Diabetic foot ulcers (DFU) are a common complication of DM, affecting 19% to 34% of patients during their lifetime, and are associated with significant morbidity, mortality and healthcare costs. Greater than 50% of DFUs become infected, and more than 80% of amputations in patients with DM are reported to be preceded by a DFU. DFU is a leading cause of DM-related hospitalizations and amputations, with a well-established all comers 5-year mortality rate after a major lower limb amputation of 50%, worse than many common types of cancer. The financial burden of DFU on public and private payers accounts for approximately one-third of the total cost of diabetic care and is estimated to range from $9-13 billion.
“We were extremely pleased with the enthusiastic reception we received at the Conference,” said Anthony Dolisi, Chief Executive Officer of Olaregen and Chief Commercial Officer of Generex. “Excellagen’s demonstrated effect on accelerated healing rates means that the potential for infection and complications associated with DFUs can be mitigated. Along with our value-based pricing, we are highly confident Excellagen will capture its place in an unsatisfied 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 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 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 Contact:
Generex Biotechnology Corporation
Joseph Moscato
646-599-6222
Todd Falls
1-800-391-6755 Extension 222
investor@generex.com