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CeraPedics Initiates P-15™ Putty Trial |
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23 Mar 2006 |
LAKEWOOD, CO,USA | Mar 22, 2006 | CeraPedics announced today that it has initiated a U.S. clinical trial of the Company’s first P-15™ based bone graft substitute, P-15 Putty, with the enrollment of the first patient by its Principal Investigator Michael E. Janssen, D.O. at the Center for Spinal Disorders in Thornton, CO. This multi-center clinical study involves up to 204 patients and will be conducted under the Company’s approved Investigational Device Exemption (IDE) application which compares P-15 Putty to local autogenous bone in a structural allograft ring for the treatment of anterior cervical discectomy and fusion. The study will be conducted at up to seven centers in the U.S. and Canada.
“The initiation of this clinical trial represents a key milestone in the development and future commercialization of this exciting new technology for bone repair,” according to Andrew J. Tofe, Ph.D., President and CEO of CeraPedics. “Our P-15 products will offer surgeons a safe and economical alternative to bone morphogenic proteins.”
P-15 is a synthetic replica of a specific sequence of 15 amino acids that has been identified as the cell-binding domain of Type-I collagen. This small section of collagen controls the transfer of signals between cells and their surrounding environment and initiates the cascade of cellular events leading to the formation of new bone. When attached to a biological scaffold, in the case of CeraPedics’ product, naturally-derived hydroxylapatite called anorganic bone mineral (ABM), an ideal environment for bone regeneration is created. P-15 Putty is the combination of ABM and P-15 suspended in a carboxymethylcellulose (CMC) hydrogel for easy syringe delivery. P-15 Putty is the first of a series of products based on the proprietary P-15 technology to be introduced to the orthopedic market.
P-15 was previously approved by the FDA in 1999 for use in the oral cavity. This approval was based on two prospective multi-center clinical studies that found P-15 to be clinically and statistically superior to both allograft and synthetic products for use in the oral cavity. It is estimated that to date nearly a quarter-million bone graft procedures have been performed using P-15 bone graft technology in the oral cavity.
CeraPedics, L.L.C., founded in 2000 in Lakewood, Colorado, is a privately-held company with proprietary technology developing a line of bone substitute products and implant coatings that employ the company's small peptide P-15 technology to facilitate bone formation in orthopedic procedures. For more information please visit www.cerapedics.com.
SOURCE: CeraPedics |
