Info from the conference call in December which sounds like they have sufficient data to move forward with the product(s):
Olaregen first product is Excellagen. Excellagen is a three dimensional flowable dermal matrix topically applied to a variety of dermal wounds and other medical conditions. Excellagen is a 510K cleared device with a broad array of rounds including partial and full thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunneled underlying wounds, surgical wounds such as post Mohs surgery and post laser surgery, and podiatric wounds. It is also indicated for wound _____ [00:25:36].
So with that said, that enables Olaregen to market Excellagen to multiple vertical markets given that the FDA cleared the product for 17 indications. Excellagen has also received the designated Q code 4149 from CMS. This Q code designation applies to cellular tissue-based products for skin wounds. Excellagen is a highly purified, collagen-based gel, extracellular matrix,
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which has been shown to be substantially more effective than the standard of care using only one to two treatments.
The matrix study showed 68 percent more activity than the standard of care for wounds less than 3 square centimeters and 194 percent greater than standard of care for larger wounds. Equally as important is the speed at which Excellent reduces wound size. After only one application, Excellagen reduced the wound size by 362 percent over standard of care in the matrix study. The technology behind Excellagen allows for the increase of granulation tissue growth and non-healing wounds and immediately activates platelet derived growth factor. PBGS, a key biologic modulator of wound healing. Excellagen formulated form type one bovine collagen to 0.6 percent. It is highly purified. Importantly, it is acellular, unlike other live tissue-based cell products. With Excellagen, being acellular, it has little to no chance of rejection or infection. Excellagen is packaged in a one single use prefilled syringe containing FCC of Excellagen topical dermal matrix with sterile flexible applicator for precise accurate, application.
Unlike other products on the market, Excellagen is simple and easy. There is no thawing. There is no reconstitution needed. It's considered an off the shelf ready to use product that physicians will welcome. Excellagen global formulation makes it optimal the deep tunnel wouving underlying wound. No staples needed. No sutures needed, which are beneficial to physicians and patients. The optimized viscosity of Excellagen allows for complete wound coverage with only a 0.5 cc syringe. Treatment at once weekly intervals, one syringe covers up to 5 square centimeter wounds. I the matrix, the average dose was only 1.6 applications.
Excellagen requires fewer patient visits due to the significant efficacy rapid wound healing. No home care is required, no dressing changes between visits are required, which reduces the burden to caregivers.
Excellagen provides significant cost benefit compared to other products in the wound healing space. Excellagen has said that it's easy to use off the shelf product that requires no reconstitution, no cutting, no waste, and it's quick to apply.
The storage and longevity of Excellagen requires refrigeration only, no special handling or freezing and Excellagen has a two-year shelf life.
The 17 indication Excellagen is cleared for represent over 92 billion potential cases in the United States alone. With the diabetic population growing, we anticipate the cellular tissue-based product market to grow significantly into the future. Excellagen is currently revenue ready and we plan a launch of Excellagen this February 2019.
After careful evaluation of opportunities, these are the initial vertical markets and greater sales opportunities we will pursue both immediately and in the
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coming year. We are currently in negotiations with Veterans Affairs and the Department of Decent based on analysis, we anticipate aggressively penetrating hospital surgical suites, acute care hospitals, and operating rooms in addition to ambulatory care centers. We are in deep discussions with the two largest wound care center networks in the United States, _____ [00:30:18] logics and Restoril.
Our fit with Generex is ideal given their current model. The MSO and the podiatric and surgeons within the network are perfect for Excellagen. Additionally, the specialty pharmacy they have acquired, Veneto, will allow Olaregen to have an immediate distribution and will allow for assistance with the payer expertise with prior authorizations of prescriptions and patient assistance services.
Shifting gears a little bit, just to focus on Olaregen pipeline, in relation to Excellagen, Excellagen can also serve as an enabling delivery platform for _____ [00:31:06] stem cells, antimicrobial agents, small molecule drugs, DNA based biologics, conditioned cell media, peptides, and most importantly from our perspective, is our ability to be combined with exosomes. Exosomes also known as extracellular vesicles, are the residuals for stem cells. Exosomes are responsible for cell to cell signaling, which is one of the most important functions of the cell.
Olaregen initial focus will be in the advanced wound healing segment. Future products will focus on innovative regenerative therapies in bone, joint, and cartilage regeneration comprised of current Olaregen pipeline. Bone, joint, and cartilage such as rheumatoid arthritis, osteoarthritis, and cranial fractures.
In summary, Olaregen is the perfect match to fulfill the Generex vision as outlined by Jose Moscato. Generex's direct to patient services support the strategy of all-inclusive access to providers, diagnostics, therapeutics, and additional health related services. The integration of Olaregen into the end to end health model fits perfectly in Generex's innovative plans for the future. Thank you. Now, I would like to turn it back over to Joe Moscato. Joe.
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