Investor Relations Overview
Regenicin, Inc. is a development stage company focusing on next-generation tissue-engineered skin substitutes to restore the qualities of healthy human skin. It is devoted to the discovery, development, manufacture and marketing of innovative, high-technology therapies and products for the wound care, tissue regeneration and therapeutic support system markets with its lead product candidate for commercialization PermaDerm™ - the only tissue-engineered skin prepared from a patient’s own skin cells.
- 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 positioning itself to become a leader in one of the fastest growing industries in biotechnology.
- PermaDerm™ will offer significant advantages over the competition, and its new management team is working diligently to bring it to market.
Regenicin has purchased a worldwide know-how license from our exclusive manufacturing partner, Swiss pharmaceutical company Lonza Group Ltd. (“Lonza”) for the exclusive proprietary technology related to an autologous skin substitute. Lonza is the world’s leading supplier to the pharmaceutical, healthcare and life science industries, headquartered in Basel, Switzerland with $2.7 billion in revenues for the year ending 2009.
This exciting breakthrough technology utilizes the patient’s own skin to generate the product candidate PermaDerm™. Perma-Derm™ is a living, tissue-engineered skin that is being tested in clinical trials for use in severe burn victims. By scientific rationale, it may be developed to treat patients with chronic wounds, or for use in reconstructive plastic surgery. Biomedical polymer and Allogenic Cell Products (any remaining skin), both components of PermaDerm™, may be commercialized as well.
PermaDerm™ is being developed as tissue-engineered skin prepared from autologous (on a patient’s own) skin cells. PermaDerm™ is composed of both epidermal (outer skin) and dermal (inner skin) layers on a collagen matrix (biomedical polymer). A postage stamp-sized biopsy of the patient’s skin can be grown in the laboratory to a sheet of PermaDerm™ 100 times its area in as little as 30 days. Self-to-self skin grafts form permanent 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 has been clinically tested in over 75 pediatric patients with encouraging results, and the goal is to improve the long-term quality of life for chronically burned patients. PermaDerm™ is patented and trademarked worldwide.
PermaDerm™ is being developed to save lives, while also reducing healthcare costs by decreasing the patient’s stay in the Critical Care Unit and reducing the need for additional surgeries. An insurance company procedural code has been approved for reimbursement of costs to hospitals for cultured skin substitutes. 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.
Technolgy and Manufacturing
PermaDerm™ and related product candidates will be produced at Lonza Biosciences - a cGMP facility contract Manufacturer - in Walkersville Maryland; Verviers, Belgium; and Singapore (2011) through the strategic, long-term alliance with Regenicin. All Process Development and Manufacturing Services are being completed by Lonza. Permaderm™ will be shipped directly from Lonza to the hospital ready for the treating physician to graft on to catastrophically burned patients.
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