ROCKVILLE, MD--(Marketwire - February 14, 2011) -
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BioSET, Inc Website |
AMPLEX Osteobiologics |
The first patient enrolled in the AMPLEX™ Foot and Ankle Fusion Study in Canada was treated successfully by Dr. Mark Glazebrook, Orthopaedic Surgeon and Associate Professor at Dalhousie University and Principal Investigator for the study, who performed the surgery at Queen Elizabeth II Health Sciences Center in Halifax.
Dr. Glazebrook commented, "Our first subject in this study of a very novel biologic graft material underwent a subtalar fusion for degenerative arthritis. My first impression is that AMPLEX™ handles quite reasonably and may prove to be a very safe and effective alternative to taking bone graft from elsewhere on the patient. Capital Health/QEII Orthopedic Research is excited to be participating in the first use of BioSET's AMPLEX™ in patients requiring surgical treatment of end stage ankle arthritis."
The AMPLEX™ Foot and Ankle study is a randomized, prospective, multi-center, controlled clinical study comparing AMPLEX™ to the current gold standard of autograft taken from either the iliac crest of the hip or from the tibia. As a pilot study to evaluate the safety and preliminary effectiveness of the novel osteobiologic construct, 24 subjects will be enrolled across three centers in Canada. To date 6 subjects have entered the study and completed their surgery.
Tom Roueche, President and CEO of BioSET, commented, "The promising early clinical results with our AMPLEX™ device in lumbar fusion led us to begin investigation in other surgical procedures where surgeons and patients seek an effective alternative to the painful harvesting of bone graft from a second surgical site. We thank our clinical investigators, their teams and most importantly, their patients for participating in our quest to provide robust and reliable scientific evidence in this very confounding field of bone grafts and bone regeneration."
About BioSurface Engineering Technologies, Inc.
BioSET is a private, clinical stage company developing proprietary therapeutic peptides as medical devices to improve bone and soft tissue repair. BioSET is believed to be the only company developing chemically synthetic peptide mimetics of native growth factors for advanced tissue regeneration. BioSET products incorporate their novel growth factor mimetics with procedure specific biomaterials to address multiple large and clinically relevant applications. The company's lead program combines BioSET's B2A osteo-promotive peptide with a resorbable bone scaffold to offer substantial safety and cost benefits to currently available bone grafting alternatives. BioSET's second peptide candidate is F2A, a potent angiogenic biologic which is being co-developed for soft tissue repair in sports medicine applications. For more information, please contact BioSET at: 301.795.6010 or visit www.biosetinc.com.
