KeraCure(TM) Initiates Multi-Center Pivotal Study in Diabetic Foot Ulcers
CHICAGO - KeraCure, Inc. announced today that the first patients have been treated in a Multi-Center Pivotal Study for the treatment of diabetic foot ulcers. The study was recently approved by the Food and Drug Administration (FDA) to test the safety and efficacy of the KeraPac(TM) device in approximately 270 subjects in 16 clinical sites across the U.S. The Company expects to complete enrollment in approximately one year.
KeraCure believes that its KeraPac addresses the primary obstacles that rivals have faced in their bid to penetrate the cell-based dressing segment. The KeraPac focuses on simplicity, low cost, ease of manufacture and off-the-shelf availability. Gretchen Johnson, President and COO of KeraCure commented, "We believe that our KeraPac can improve the lives of 2.8 million Americans who suffer from diabetic foot ulcers. Diabetic Foot Ulcers have been shown to heal significantly faster when treated with cultured cells than wounds treated with conventional passive wound dressings."
The KeraPac device is comprised of human keratinocytes, grown on microcarrier beads and packaged in a unique patented dressing configuration. The KeraPac is placed externally on a clean wound and removed several days later. It is distinguished by its simplicity, low cost to produce and storage capability. KeraCure has signed a strategic agreement with Genzyme Corporation of Cambridge, MA to manufacture its KeraPac for the study. Genzyme offers tremendous value with its experience, infrastructure and state of the art manufacturing.
The American Diabetes Association reported that 18.2 million people or 6.5% of the U.S. population currently has diabetes; a statistic that is steadily increasing on a yearly basis. Fifteen percent of all diabetics will experience at least one foot ulcer. Unlike people in the general population with other chronic ulcers, those with diabetes may lose the feeling in their feet and be unaware of trauma that breaks the skin or damages the feet. This often results in serious complications, hospitalization and even amputation. Riley Rees, M.D., FACS and Director of the University of Michigan Wound Care Center added, "In order to reduce the amputation rate in diabetes, an effective, simple treatment for diabetic foot ulcers is required."
About KeraCure, Inc.
KeraCure is a company commercializing products for the advanced wound healing market. The Company's focus is the application of its KeraPac to heal chronic wounds such as diabetic foot ulcers, venous stasis ulcers and pressure ulcers. Its proprietary platform technology was developed at the University of Michigan School of Medicine and Wayne State University. For additional information, visit the web site at:
www.keracure.com.
This press release contains forward-looking statements that express the belief, potential anticipation or expectation, as well as other statements which are not historical fact, and statements related to the clinical trials and their results, design, FDA product approvals or other marketing approvals, features, functionality and performance. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected in these forward-looking statements. These risks and uncertainties include, among others: the regulatory approval process in the U.S. for new device product development; market acceptance of new products; the ability to obtain and maintain patent or other proprietary intellectual property protection and the actual impact of those patents and rights; general market and economic factors; dependence on and retention of key personnel; availability of product liability insurance in the event of commercialization of the Company's products; ability to effect transition from pilot-scale to large-scale commercial production of products; and availability of additional manufacturing capacity on acceptable terms. These statements speak only as of the date of this press release, and we undertake no obligation to update or revise these statements.
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