Bacterin International Holdings, Inc. ("Bacterin") (OTC Bulletin Board: BIHI), a developer of revolutionary bone graft material, today announced that it launched its OsteoSponge®SC product at the American Academy of Orthopedic Surgeons ("AAOS") 2011 Annual Meeting taking place February 15-19 in San Diego, CA.
Based on favorable preclinical data, Bacterin has received permission from the Food and Drug Administration to market OsteoSponge®SC as a subchondral bone void filler. OsteoSponge®SC has demonstrated extraordinary re-generative properties in both preclinical and clinical data and, as a result, Bacterin will be presenting three separate case studies this week at AAOS.
OsteoSponge®SC is an acellular matrix scaffold made from donated human bone that is used to replace a patient's damaged subchondral bone. The OsteoSponge®SC process is cost effective, minimally invasive with superior handling characteristics, and enables surgeons more options in the treatment of subchondral defects. Bacterin's core technology revolves around the designing and processing of human acellular biological scaffolds that can incorporate the patient's own stem cells or bioactive agents for accelerated regeneration of tissue. To date, the Company has focused on bone regeneration with the Osteo product line, including the cornerstone product OsteoSponge®, OsteoSelect® DBM Putty, OsteoLock® / BacFast® HD, and OsteoWrap®. In addition to OsteoSponge® SC, during first quarter 2011 Bacterin will begin marketing hMatrix™, a scaffold for dermal healing and repair.
During AAOS several surgeons will be at Bacterin's booth number 1556 presenting their data and sharing experiences using OsteoSponge®SC. Of particular note, Friday, February 18, 2011, Dr. Wayne Gersoff, Founding partner of Advanced Orthopedics in Denver, Colorado, will deliver his results using OsteoSponge®SC on subchondral defects. Currently, there are over 30 patients who have undergone foot, ankle and knee surgery utilizing OsteoSponge®SC, all experiencing favorable outcomes. As of today, five surgeons have already been trained to use OsteoSponge®SC at five separate medical sites.
Commenting on the results, Guy Cook, Bacterin's chairman and CEO, said, "The current annual market size addressing subchondral defects in the foot, ankle and knee is approximately $1.7 billion annually. This market is large and growing as more advanced repair technologies become available. OsteoSponge®SC, a form of OsteoSponge® designed to be used in subchondral repair surgery, has delivered favorable outcomes, which could potentially and significantly change the standard of care in regeneration of native tissues to avoid joint replacement."