Investor Relations Overview
Regenicin, Inc. is an early-stage, biotechnology company specializing in the development of regenerative cell therapies for wound care and tissue regeneration. Regenicin's lead product is, NovaDerm® a cultured cell technology that uses a small full thickness biopsy of the patient's skin that can be grown in the laboratory to generate new living skin for grafting large areas of the patient in cases where there is insufficient healthy skin to cover the damaged areas (wounds, ulcers or thermal electrical or chemical burns). This approach is intended to reduce the chances of patient immune rejection, by using autologous grafts that can connect to the blood supply and continue to regenerate and, grow like normal skin. In addition, NovaDerm is intended to provide physicians and patients with a new, safer approach to skin regeneration, by using technologies that can protect the patient from external pathogens that might be found in traditional collagen-based products.
- Tissue engineering and cell therapy represents a market that is expected to grow from $6.9 billion in 2009 to almost $32 billion by 2018 in the U.S. alone, according to MedMarket Diligence.
- The rapid growth has been attributed primarily to demonstrable clinical benefits, a clearly defined regulatory path, and a readiness by clinicians to adopt products for use.
- Regenicin is well positioned to become a leader in one of the fastest growing industries in biotechnology.
NovaDerm is being developed as regenerative cell therapy that can re-grow a patient's own skin by harvesting fibroblast and keratinocytes from full thickness skin biopsy that is a small fraction of the size of the damaged area of skin. NovaDerm is composed of both epidermal (outer skin) and dermal (inner skin) layers with an autologous extracellular matrix. The cell culturing process followed by meshing can provide enough autologous skin to graft an area up to 200 times larger than the initial biopsy. NovaDerm when grafted is not just a dermis and epidermis from the patient's own cells but also contains collagen produced by the patient's own fibroblast during culturing. The autologous fibroblast produce reticular and elastic fibers that make up the extracellular matrix. NovaDerm is currently being validated to test the company's new process and approach to developing NovaDerm with its unique collagen matrix.
NovaDerm is expected to be the only cultured skin substitute to not be designated with a drug component by the U.S. Food and Drug Administration (FDA) for treating Burn victims with total burned surface areas greater than 30%. NovaDerm is being developed to ensure the cultured skin substitute is available when the patient needs it. NovaDerm may be available for grafting in less than a month and with a shelf life longer than a week.
As antibiotic resistance is on the rise, and superbugs are none responsive to the current antibiotics on the market, it is more important now than in any other time in history to take the proper precautions to protect our population from pathogens.
Collagen is a protein that is naturally produced in the bodies of animals (especially mammals) and is the main component of connective tissues like cartilage. NovaDerm, like other regenerative skin candidates in development, are built on collagen scaffolds. Most of the collagen supply comes from animals of unknown origins or medical history. A large amount of animal components destined for medical use are imported from foreign countries like China for which the FDA has no authority before the abattoir. Currently the majority of animal components are collected from slaughter houses which do not have the traceability or adequate controls to prevent the use of animal components contaminated with pathogens. The controls used for food are not adequate for materials that are going to be used for medical products. However, since the 2008 Heparin Crisis where, large amounts of heparin was found to be contaminated contributing to the deaths of patients, additional testing procedures were put into place to prevent it from happening again. The FDA and other regulatory bodies have established regulations to mitigate the risk of pathogens being transplanted into humans. Those regulations have yet to be enforced.
In an effort to find safe collagen supplies within the U.S. and abroad, Regenicin, is identifying and will only enter into exclusive agreements with suppliers that only produce collagen from closed herds. A closed herd has an advantage in that the animals within the herd are no longer being exposed to potential carriers of diseases or parasites brought in from outside the herd. In fact, each source of collagen can be traced back to a specific certified animal, its health, its food supply and more. In broad terms closed herd animal products ensures that controls have been put into place to prevent exposure of the parents and grandparents of the closed herd animal, the entire life of the harvested animal, a dedicated facility to harvest the materials, and traceability through cGMP manufacturers and the use by the patient.
NovaDerm is intended to be the first product of its kind to use a collagen matrix produced exceeding international and FDA closed herd regulations. NovaDerm's collagen scaffold has the traceability required for Xenotranspant materials. NovaDerm is processed to mitigate the risk of contamination of unwanted pathogens in every step of the process.
Technology and Manufacturing
NovaDerm and related product candidates will be produced a cGMP facility, ensuring safety and efficacy. A small full thickness biopsy of the patient's skin can be expanded to cover 200 times its area in as little as 30 days. Self-to-self skin grafts form skin tissue that is not rejected by the immune system of the patient, which is a critical possibility in porcine or cadaver skin grafts used today.
The technology for NovaDerm has been developed by studying the development of skin substitutes over the last 25 years. The skin substitute technologies that are the basis of the NovaDerm product have been clinically tested in numerous FDA sanctioned clinical trials by various companies. Integra Dermal Regeneration Template, Apligraft, and Dermagraft all similar temporary skin substitute technologies have been approved by the FDA. NovaDerm® is the only permanent autogolus cultured skin substitute designed to be available for the patient within 30 days of acquiring the harvest skin used to culture NovaDerm®. The American Medical Association has assigned CPT (Current Procedural Terminology) code for cultured skin substitutes under the dermal substitute category, which enables insurance companies to process, and hospitals to be reimbursed for, cultured skin substitutes once approved by the FDA.