GNBT - Generex Biotechnology Expands Medical Device Portfolio with Acquisition of Olaregen Therapeutix Inc (2024)

Miramar, FL -- November 28, 2018 --InvestorsHub NewsWire -- Announces Commercial Launch of FDAApprovedExcellagen®, Proprietary, PatentedWound Care Product Focused on the Treatment of Complicated Woundsincluding Diabetic Ulcers and 16 Other FDA Approved Indications-

Generex Biotechnology Corporation (GNBT) announced today the signing ofa Letter of Intent to acquire 51 percent of Olaregen TherapeutixInc., a New York based regenerative medicine company. Generex madean initial payment of $400,000 on November 27, 2018 to secure theagreement, and the company is in the process of completing thelegal documents with a plan to close the transaction in the comingweeks.

Olaregen will introduce its first product, Excellagen®, aflowable dermal matrix that is a 510K FDA cleared medical devicefor utilization for a variety of wound types that has recently beenawarded a U.S. patent with a 17 year right of exclusivity.Excellagen® is a highly-purified Type 1 collagen-based, flowablegel formulation approved for 17 indications , including partial andfull thickness wounds, pressure ulcers, venous ulcers, diabeticulcers, chronic vascular ulcers, tunneled/undermined wounds,surgical wounds (donor sites/grafts, post-Mohs surgery, post-lasersurgery, podiatric, wound dehiscence), trauma wounds (abrasions,lacerations, second- degree burns, and skin tears) and drainingwounds.

Excellagen® activates platelets, triggering the release ofessential growth factors and providing a structural scaffold forcellular infiltration and migration, this process significantlyaccelerates the growth of granulation tissue. Excellagen's® uniqueflowable fibrillar collagen formulation is topically appliedthrough easy-to-control, pre-filled sterile syringes, and isdesigned for application at once weekly intervals.

Additionally, Excellagen® can serve as an EnablingDelivery Platform delivering peptides, small molecule drugs, DNAbiologics, antimicrobials, stem cell and exosomes. Exosomes,commonly referred to as extracellular vesicles are the residualcomponents of stem cells responsible for cell-to-cell signaling,the most significant aspect of a cell’s function. Combined withcertain tissue types, Excellasome® can provide a significantadvance in regenerative medicine.

Olaregen’s pipeline will focus on developing Excellasome®for the regeneration of bones, joints and cartilage. R&Defforts will address the use of Excellasome® in the treatment Osteoand Rheumatoid Arthritis, cartilage repair and plantarfasciitis.

Excellagen® also offers an innovative opportunity in thetreatment of the rare disease Ehlers-Danlos Syndrome, consisting of13 subtypes. The Ehlers-Danlos syndromes are a group of connectivetissue disorders that can be inherited and are varied both in howthey affect the body and in their genetic causes. They aregenerally characterized by joint hypermobility (joints that stretchfurther than normal), skin hyperextensibility (skin that can bestretched further than normal), and tissue fragility. Researchstatistics of the Ehlers-Danlos syndromes show the total prevalenceas 1 in 2,500 to 1 in 5,000 people. Olaregen will seek Orphan Drugapproval for the use of Excellagen® in this rare disorder withlimited therapeutic options at this time.

Excellagen®has a reimbursem*nt code by theHealthcare Common Procedure Coding System that has a unique Q Codedesignation 4149 referred to as a skin substitute.

“We are enthusiastic to bring Olaregen into the Generexfamily of companies,” stated Joe Moscato, CEO of Generex. “Thisacquisition perfectly illustrates our corporate strategy as webuild a new pharmaceutical companymodel.Excellagen®is FDA cleared and ready tolaunch using our investment, which is directed at building salesand commercial value almost immediately. We arelaunchingExcellagen®through our direct tophysician market channels established with our recently announcedacquisitions in pharmacy and management services. As we have statedall along, Generex is focused on building an “end-to-end” solutionto improve healthcare for doctors and patients, and the acquisitionof Olaregen is a clear demonstration of this model. All of theirpieces fit together beautifully in our current structure and in ourplans for the future.”

Terry Thompson, COO of Generex and President of NuGenerexDistribution Solutions, added, “We are actively pursuing newproducts to support our MSO network of physicians and surgeons.Excellagen will be a game changer for our physician networks andtheir patients in providing a cutting-edge regenerative medicinesolution to promote healing and tissue repair of difficult to treatdiabetic foot ulcers and tunneling wounds. This acquisition clearlyadvances our overall mission to solidify the doctor patientrelationship by providing innovative medicines that improve healthoutcomes.”

Anthony J. Dolisi, CEO of Olaregen, continued, “We areproud to be joining the Generex family of companies with this newventure. This is an exciting time for the team at Olaregen, whichwas established with the primary purpose ofcommercializingExcellagen®, a proprietary, patented,advanced wound healing product that has been FDA cleared based onexcellent clinical results and has a 17 year patent protection. TheGenerex family of companies provides a unique opportunity toexecute our commercial launch strategy to deliver product throughsurgical centers, department of defense, operating rooms, VAsystem, wound care centers, as well as podiatrists’ offices on thefront line in the diagnosis and treatment of patients with woundsand ulcers resulting from diabetes and cardiovascularcomplications. Collectively Olaregen and Generex have a dedicationto clinical excellence and patients and their families stand at thecenter of all we do.”


Excellagenis an FDA-clearedaseptically-manufactured, syringe-based, ready to use, topical,flowable, 3-dimensional dermal matrix that supports a favorablewound healing environment.Excellagenactivatesplatelets triggering release of Platelet-Derived Growth Factor(PDGF), key wound healing growth factors. It is designed toaccelerate granulation tissue growth by providing a structuralscaffold for cellular migration and proliferation, and activatesplatelets, triggering the localized release of endogenous growthfactors including PDGF. Upon contact with small amounts ofblood,Excellagenimmediately activates theexpression of PDGF and activates the healingprocess.Excellagenis an FDA-approved medicaldevice, a highly-purified Type 1 collagen-based gel extra-cellularmatrix and delivery system approved for 17 indications in woundcare, 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, wounddehiscence), trauma wounds (abrasions, lacerations, second- degreeburns, and skin tears) and drainingwounds.Excellagencan also serve as an EnablingDelivery Platform for pluripotent stem cells, antimicrobial agents,small molecule drugs, DNA-Based Biologics, conditioned cell mediaand peptides.Excellagenis intended for use byhealthcare professionals in the United States.

About Olaregen Therapeutix

Olaregen Therapeutix, Inc. is a regenerative medicinecompany focused on the development, manufacturing andcommercialization of products that fill unmet needs in the currentwound care market. The company aims to provide advanced healingsolutions that substantially improve medical outcomes whilelowering the overall cost of care.Olaregen's first productintroduction,Excellagen(flowable dermalmatrix) is a topically applied product for dermal wounds and otherindications. The company is focused in advancing wound careincluding diabetic foot ulcers (DFU), venous leg ulcers andpressure ulcers. Future products focusing on innovative therapiesin bone and joint regeneration comprise the current pipeline. Thecompany's mission is to become a significant force in regenerativemedicine and advance the science of healing.

About Generex Biotechnology

Generex is a strategic, diversified healthcare holdingscompany with offerings in a variety of services, diagnostics,medical devices, and pharmaceutical development. The Company’sdirect-to-patient services support its strategy of all-inclusiveaccess to doctors, diagnostics, therapeutics, and additionalhealth-related services to greatly improve the patient experiencein receiving care. On the provider side, Generex’s managementservices remove administrative burdens in multiple providersettings, including private practice and hospital, allowing doctorsto devote more time to patient care. Revenue from the Company’ssubsidiaries will support clinical advancement of its wholly ownedtherapeutic products with a focus in immunotherapeutics based onstimulating critical members of the immune response, known as Thelper cells, and its proprietary buccal administration ofinsulin.

Cautionary Note Regarding Forward-LookingStatements

This release and oral statements made from time totime by Generex representatives in respect of the same subjectmatter may contain "forward-looking statements" within the meaningof the Private Securities Litigation Reform Act of 1995. Thesestatements can be identified by introductory words such as"expects," "plan," "believes," "will," "achieve," "anticipate,""would," "should," "subject to" or words of similar meaning, and bythe fact that they do not relate strictly to historical or currentfacts. Forward-looking statements frequently are used in discussingpotential product applications, potential collaborations, productdevelopment activities, clinical studies, regulatory submissionsand approvals, and similar operating matters. Many factors maycause actual results to differ from forward-looking statements,including inaccurate assumptions and a broad variety of risks anduncertainties, some of which are known and others of which are not.Known risks and uncertainties include those identified from time totime in the reports filed by Generex with the Securities andExchange Commission, which should be considered together with anyforward-looking statement. No forward-looking statement is aguarantee of future results or events, and one should avoid placingundue reliance on such statements. Generex undertakes no obligationto update publicly any forward-looking statements, whether as aresult of new information, future events orotherwise.Generex claims the protection of the safeharbor for forward-looking statements that is contained in thePrivate Securities Litigation Reform Act.

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