Advanced BioHealing Inc. (ABH) has begun selling and shipping the bioengineered tissue product Dermagraft. Dermagraft is approved by the US Food and Drug Administration (FDA) as a treatment for full-thickness diabetic foot ulcers.
"Since acquiring Dermagraft in June of 2006, we have diligently worked on building the manufacturing and commercial infrastructure necessary for success in the marketplace, meeting our stated goal of launching Dermagraft during the first quarter of 2007," said Kevin Rakin, CEO of Advanced BioHealing. "Over the next two years we will be focused on re-establishing Dermagraft as a leading advanced wound care treatment. By accomplishing this goal, we will drive the commercial success of the company while simultaneously supporting development of our next-generation bioengineered product."
ABH has established commercial operations, which include sales, marketing, health economics, customer service, product reimbursement and technical support professionals. The company has strategically placed initial representatives in markets that generated significant revenues in the past. In addition, inside sales professionals will be focusing on opportunities in other geographic regions, in particular large wound care centres. ABH will continue to add representatives throughout 2007 commensurate with projected revenue growth.
In addition to commercial operations, ABH also has a state-of-the art manufacturing facility staffed with professionals already familiar with the production and quality control elements of Dermagraft. This facility has passed numerous inspections, including a critical State of California licensing process. Since Dermagraft was previously available in the U.S. market, the product already has appropriate purchase and application codes to ensure physicians are reimbursed for utilizing the product.
"This launch is a significant milestone and points to the strength and commitment of the ABH management and team," said Stephen Bloch, MD, Venture Partner with canaan Partners and chairman of the ABH Board of directors. "In addition to the launch of Dermagraft, ABH has made significant progress in building a pipeline of complementary wound healing products, evidenced by the recent initiation of a pilot study evaluating the safety of Celaderm in treating venous leg ulcers."
Dermagraft is a cryopreserved human fibroblast-derived dermal substitute. It is supplied frozen in a clear bag containing one piece of approximately 2 x 3 inches for a single-use application. The product is approved for marketing in the US and in a number of other countries.
Advanced BioHealing is an industry leader in the science of regenerative medicine. The company is focused on the commercialisation of cell-based and tissue-engineered products including two that have FDA approval for marketing: Dermagraft, for diabetic foot ulcers and TransCyte, to treat full and partial thickness burns.