There are approximately 70 million procedures annually in the United States involving wounds, including: 45 million surgical procedures, 10 million leg ulcers, 8 million pressure sores and 8 million burn wounds. Upwards of $20 billion is spent each year by the U.S. healthcare system on wound care, creating a large, unmet need for therapies that accelerate healing and reduce cost burden. These costs became increasing burdensome to hospitals and patients because since October 2008, Medicare no longer pays for certain hospital-acquired conditions considered preventable in the hospital setting, including wound related events such as infections and pressure ulcers. This provides significant opportunity for therapies that will accelerate the wound repair process and minimize downstream complications. Despite this large opportunity, few therapeutic options provide clinically compelling and commercially relevant data that have been proven to accelerate healing for these injuries.

Delayed wound closure can lead to increased tissue damage, infection, and scarring conditions – all of which have traditionally been controlled by sutures, tapes, skin grafts, fibrin glues, and sealants. Wound dressings play a vital role in the early healing process by leaving wounds undisturbed and keeping wounds intact at body temperature, giving the body a chance to heal. At present, the wound healing industry is experiencing a paradigm shift from typical sutures, staples, and adhesives to modern biocompatible polymers, silver dressings, tissue-engineered skin constructs, hyperbaric oxygen therapy, and biopharmaceuticals.

Current estimates indicate that advanced wound healing represents nearly a $2 Billion market opportunity growing at a CAGR of nearly 11%. The rapid growth of this sector can be attributed to demand for efficacious products to heal refractive wounds. Preference for repair and regeneration of tissues has further boosted the acceptance of these products. These products are often targeted at hard-to-heal wounds, including burns, diabetic foot ulcers, venous stasis ulcers and pressure ulcers. To date, the focus for active wound management therapies has been skin replacement or bio-materials that attempt to accelerate the healing process. With growing market acceptance, focus is transitioning to incorporating cells and regenerative factors into wound healing products that will further enhance repair and proper scar formation.

A recent innovation is the creation of “bioactive bandages” that contain growth factors to accelerate wound healing of deep skin lacerations. If properly formulated, these dressings employ cutting edge advances in genetic engineering and cellular preservation in compositions that can be preserved, easily transported, and handled/stored. They can release different growth factors at various stages of wound healing and control release rate in light of wound severity. SDF-1 is constitutively expressed in normal human skin cells and recent evidence has demonstrated that upregulation of SDF-1 expression is an important component of wound healing in healthy human skin. Increased SDF-1 expression was observed in the wounds of burn patients and was shown to directly contribute to the rate of wound healing. Similarly, increased expression of SDF-1 at the wound margin has been suggested to help recruit endothelial progenitor cells and accelerate neovascularization, indicating that increased SDF-1 expression is a pro-healing event. SDF-1 is a strong chemo-attractant of stem cells and progenitor cells that promote tissue preservation and increased and sustained healing of wounded tissue.