Article preview from IN VIVO - July 1, 2011
With estimated revenues in excess of $5 billion per year worldwide, the advanced wound care market has garnered the attention of both major companies and investors for its tremendous potential. Growth in this market is being driven by the development of new bioactive products that can successfully heal chronic wounds such as diabetic foot ulcers, which are among the most challenging and costly to treat.
Article preview from IN VIVO - July 1, 2011
With estimated revenues in excess of $5 billion per year worldwide, the advanced wound care market has garnered the attention of both major companies and investors for its tremendous potential. Growth in this market is being driven by the development of new bioactive products that can successfully heal chronic wounds such as diabetic foot ulcers, which are among the most challenging and costly to treat.
Chronic, hard-to-heal wounds, including venous and arterial ulcers, pressure ulcers, and diabetic foot ulcers, are strongly associated with the aging process and age-related conditions that can lead to poor vascularity. For example, many individuals who develop skin ulcers have comorbidities, such as diabetes, cardiovascular disease, and obesity, that adversely affect vascularity, and in many cases these ulcers become chronic, nonhealing wounds. Unlike acute or surgical wounds, which heal by "primary intent" – the joining of the wound edges by sutures, staples, or adhesive strips – skin ulcers and severe burns heal by "secondary intent," through the formation of granulation tissue, contraction of the wound, and epithelialization. A normal wound heals in approximately 21 days in organized phases of inflammation, proliferation, and remodeling, but chronic wounds often stall between the inflammatory and proliferation stages, creating wounds that can last for months or even years.
The biologic wound care arena has taken center stage recently with the introduction and rapid adoption of more advanced products. Broad coverage by the Centers for Medicare and Medicaid Services (CMS) is critical to success in this market, as the vast majority of hard-to-heal wounds occur in people aged 65 and older. A product can be sold upon receiving US Food and Drug Administration (FDA) clearance or approval, but without reimbursement it is not likely to gain much traction.
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