Advanced BioHealing Commences Efficacy Trial for Dermagraft

     Advanced BioHealing Inc (Westport, Conn) has initiated a pivotal trial of Dermagraft® in subjects with venous leg ulcers (DEVO-Trial) to assess the product’s safety and efficacy in the promotion of healing venous leg ulcers (VLUs). Dermagraft is a bio-engineered skin substitute that assists in restoring damaged tissue and supports the body’s natural healing process. It is FDA-approved for the treatment of diabetic foot ulcers (DFUs) and used in more than 1000 wound care and outpatient clinics in the US. The international pivotal trial will enroll more than 400 patients in eight countries, making it the largest randomized, controlled, clinical study on a skin graft and/or bioengineered skin replacement planned to date. It is designed as a prospective, multicenter, randomized, controlled clinical study, in which subjects are assigned into one of two groups. The experimental group receives weekly applications of Dermagraft and four-layer compression dressings only. The company has initiated patient enrollment and activated 30 clinical centers globally and expects the study to be complete by May 2011.

Visit www.ABH.com for more information.

KCI Announces Final Approval to Enter Japanese Market

     Kinetic Concepts Inc (San Antonio, Tex) recently announced that the Ministry of Health Labor and Welfare (MHLW) in Japan has granted final regulatory approval for the company to market and sell its renowned V.A.C.® Therapy System in the country. Japan has a deep heritage of providing outstanding medical care and the professionals of KCI are pleased to have the opportunity to serve this unmet medical need within Japan for difficult to heal wounds. Reimbursement applications have been submitted following regulatory approval. Operational preparations such as employee hiring are underway for a commercial launch at the time of reimbursement approval. The company anticipates reimbursement approval in the first half of 2010.

Visit www.kci1.com for more information.

Centers for Medicare & Medicaid Services Retain Single NPWT Code

     The Advanced Wound Management division of Smith & Nephew (St. Petersburg, Fla), a subsidiary of Smith & Nephew applauded the federal government’s decision to maintain the current, single reimbursement code for negative pressure wound therapy (NPWT) devices. The decision, announced by the US Centers for Medicare & Medicaid Services (CMS), affirms the conclusion reached by the Agency on Healthcare Research & Quality (AHRQ) earlier this year. AHRQ, like CMS, concluded that evidence does not exist to determine a significant therapeutic distinction between NPWT systems. As a result, CMS decided to maintain a single code for NPWT product components, including the canister and the wound care set. Separate from this decision by CMS, Smith & Nephew recently highlighted results of a multi-center study demonstrating that gauze-based NPWT achieves many of the common treatment goals defined for foam-based NPWT systems, including a reduction in wound dimension and exudate, improvement in granulation tissue, and enhancement of skin graft take.

Visit www.smith-nephew.com for more information.

Hill-Rom and Encompass Group Form Joint Business Venture

     Hill-Rom (Batesville, Ind) and Encompass Group (McDonough, Ga) recently formed a joint business venture that will focus on the sale and distribution of a comprehensive range of surface replacement systems that are intended to be sold separate from a bed frame and as replacements for surfaces that are technologically obsolete or at the end of their useful life.