BELGRADE, Mont., Sept. 11, 2012-- Bacterin International Holdings, Inc. (NYSE MKT: BONE), a leader in the development of revolutionary bone graft material and antimicrobial coatings for medical applications, announces that the first clinical results using the OsteoSponge SC product for regeneration of subchondral bone in complex lesions of the talus involving advanced subchondral bone damage have been published in the peer reviewed journal, Foot & Ankle Specialist.
The article reports six month post-operative outcomes on a series of seven patients which included pain and activity scales as well as radiographic findings. Each of the seven patients reported a clinically significant reduction in pain and improvement in activity at six months post-operation relative to their preoperative baseline scores. MRI confirmed graft incorporation and restoration of an intact subchondral plate.
The Company estimates the current annual market size addressing subchondral defects in the foot, ankle and knee to be approximately $1.7 billion annually and growing as more advanced repair technologies become available. OsteoSponge SC, a form of OsteoSponge designed to be used in subchondral bone repair, has delivered favorable clinical outcomes. Bacterin believes OsteoSponge SC could potentially and significantly change the standard of care for the treatment of damaged subchondral bone.
"We are pleased with the outcome of this clinical series demonstrating an increase in the quality of life for these patients," said Guy Cook, Bacterin's CEO. "These early clinical outcomes using the OsteoSponge SC product provide another validation of Bacterin's core mission in providing innovative, safe, reliable, and cost effective solutions for the medical needs of patients."
The company has begun a 75 patient registry for OsteoSponge SC and has received IRB approval in five of six sites and the first patient was enrolled in July. To date, OsteoSponge SC has been implanted in more than 250 patients and continues to produce excellent clinical outcomes.
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