CeraPedics Announces Results of P-15(TM) Non-Union/Delayed Union Pilot Study Published in International Orthopaedics.

LAKEWOOD, Colo. -- CeraPedics, a privately held company focused on the development of synthetic bone graft products incorporating its proprietary P-15(TM) technology, announced today that the results from a pilot study for the treatment of non-union and delayed union fractures have been published in the International Orthopaedics journal. The purpose of the study was to assess the feasibility and clinical outcome of using CeraPedics' P-15 bone graft substitute (P-15 BGS) to treat non-union and delayed union fractures.

The pilot study involved two centers treating 22 patients with various long bone non-unions or delayed union fractures. Treatment involved the placement of the P-15 BGS in combination with various osteosynthesis techniques to ensure adequate fixation of the fracture site. All patients were evaluated clinically and with independent radiographic analysis every two weeks until first callus formation, with monthly follow-up thereafter. Assessment criteria included time elapsed for bone bridging, and time to full consolidation. Full consolidation was achieved in 90% (20 of 22) of the patients treated with the P-15 BGS. The average time for full consolidation was 4.2 months. In addition, histological assessment of the fracture callus in five of the patients confirmed the positive clinical and radiographic results.

"The data presented in this report combined with positive pre-clinical results, gives us the confidence that P-15 BGS is a safe, economical and clinically useful alternative to autograft," said Andrew J. Tofe, Ph.D., Chief Executive Officer of CeraPedics. "We are planning additional pre-clinical and pilot clinical studies to assess the safety and potential efficacy of P-15 in other orthopaedic applications."

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 orthopaedic procedures. The Company's first product, P-15 Putty, is an orthopaedic bone graft material consisting of the synthetic P-15 peptide bound to anorganic bone mineral (ABM), suspended in an inert hydrogel carrier. P-15 Putty is not available for sale in the United States and is limited to investigational use. CeraPedics is currently conducting a U.S. pivotal human clinical trial evaluating P-15 Putty for use in cervical spine fusion. For more information please visit www.cerapedics.com.