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According to a new series of reports on the U.S. market for soft tissue reinforcement and regeneration devices market by iData Research, the proportion of Americans affected by obesity and diabetes is increasing. As a result, the incidences of diabetic foot ulcers will rise dramatically in the country. This will fuel the demand for skin repair devices for the treatment of this common type of diabetic foot pathology, which comprises approximately 80% of all lower extremity amputations. Skin substitutes may be indicated for use on burns or other chronic wounds, including venous leg ulcers and diabetic ulcers.

“Individuals at risk of developing chronic wounds are the elderly, those with chronic venous disease, diabetics and those who develop ulcers on tissue over bony prominences as a result of extended immobility,” explains Jeffrey Wong, Strategic Analyst Manager at iData Research. “This increases the number of potential patients from the low thousands to millions.”

Soft tissue augmentation and reinforcement devices add significant costs to suture-based repair procedures. The cost varies, depending on the type of device used and the repair being performed, but in general, biological devices, such as allografts and xenografts, cost significantly more than synthetic devices within the same market segment. For instance, biological devices may offer superior long-term benefits in hernia repair by avoiding risks of infection and premature degradation and failure, but their high cost continues to deter surgeons from using them broadly, limiting the sales of the more expensive allografts and xenografts in uncomplicated hernia repair. Until biological devices can provide a better cost-benefit ratio, synthetic meshes will remain dominant in the hernia repair market.

However, with limited medical reimbursement in the U.S., high cost becomes a significant deterrent to overall sales. Because augmentation and reinforcement devices for tendon repair are expensive and clinical evidence is not completely compelling, third parties are reluctant to provide reimbursement. This discourages the use of these products in more cost-conscious settings. As a result, the surgical center must absorb all or part of the cost of the device into the total cost of the surgery itself; this may not be an option for facilities with constrained budgets. These issues are also apparent in the skin repair market, where recent changes in reimbursement will limit growth of this market in the future.

LifeCell is the leading competitor in the U.S. soft tissue reinforcement and regeneration device market and continues to devote efforts to penetrate markets with other existing products while developing and commercializing additional tissue matrix devices and applications to expand into new markets and geographies. In May 2016, LifeCell released the latest, enhanced version of its acellular dermal matrix, AlloDerm® SELECT™. AlloDerm® SELECT™ comes in two varieties: the RTM and the DUO™, with the former offering additional thickness options and the latter offering advanced cutting options for more precise and customized treatment.

C. R. Bard is among the top three overall competitors in the market, thanks to its array of products used in various applications across different soft tissue segments. The company’s broad range of hernia repair products allowed it to be one of the top players in this market. Additional competitors in the U.S. market for soft tissue reinforcement and regeneration devices include Acelity, Ethicon, MiMedx, Integra LifeSciences, Covidien, Organogenesis and Boston Scientific among others.

For Further Information
More on the soft tissue reinforcement and regeneration device market in the U.S. can be found in a report suite published by iData Research entitled U.S. Market for Soft Tissue Reinforcement and Regeneration. The suite covers reports on the following markets: Breast Reconstruction, Dural Repair, Skin Repair, Dental Soft Tissue Regeneration, Hernia Repair, Vaginal Sling, and Sports Medicine and Tendon Reinforcement.

The iData report series on soft tissue reinforcement and regeneration devices covers the United States, Germany, France, the United Kingdom, Italy, Spain, Belgium, Netherlands, Luxembourg, Denmark, Finland, Norway, Sweden, Austria, Switzerland and Portugal. Reports provide a comprehensive analysis including units sold, procedure numbers, market value, forecasts, as well as detailed competitive market shares and analysis of major players’ success strategies in each market and segment. To find out more about global soft tissue reinforcement and regeneration market data or procedure data, register online or email us at [email protected] for a U.S. Market for Soft Tissue Reinforcement and Regeneration brochure and synopsis.
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