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Tuesday, 11 September 2012
Bacterin says results from clinical trials of bone regeneration product published in Foot & Ankle Specialist
Bacterin International Holdings (AMEX:BONE) Tuesday said that the first clinical results of its OsteoSponge SC product for bone regeneration have been published in the peer reviewed journal, Foot & Ankle Specialist.
Shares of Bacterin rose over four per cent on the news, trading at $1.72 as at 11 a.m. ET.
The company said that the article reports six month post-operative outcomes on a series of seven patients using the OsteoSponge SC, for the regeneration of subchondral bone in complex lesions of the talus. This included pain and activity scales as well as radiographic findings.
The OsteoSponge allograft consists of 100 per cent demineralized human cancellous bone, with no additional carrier materials. The material is prepared using methods that preserve native growth factors. The product has been used in over 100,000 procedures.
Bacterin said that each of the seven patients in the OsteoSponge SC trials reported a “clinically significant” reduction in pain and improvement in activity at six months post-operation, relative to their preoperative baseline scores, and that MRIs confirmed graft incorporation and restoration of an intact subchondral plate.
“We are pleased with the outcome of this clinical series demonstrating an increase in the quality of life for these patients,” said CEO Guy Cook.
“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 said it has begun a 75-patient registry for OsteoSponge SC and has received approval in five of six sites, with the first patient enrolled in July. To date, OsteoSponge SC has been implanted in more than 250 patients and continues to produce “excellent clinical outcomes”, the company added.
Bacterin estimates the current annual market size addressing subchondral defects in the foot, ankle and knee to be approximately $1.7 billion annually, growing as more advanced repair technologies become available.
The company develops manufactures and markets biologics products to domestic and international markets. Its products optimize the growth factors in human allografts to create the ideal stem cell scaffold to promote bone, subchondral repair and dermal growth.
These products are used in a variety of applications including enhancing fusion in spine surgery, relief of back pain, promotion of bone growth in foot and ankle surgery, promotion of cranial healing following neurosurgery and subchondral repair in knee and other joint surgeries.
Bacterin's medical device division develops bioactive coatings for various medical device applications.
The article, titled, “Reconstruction of Complex Osteochondral Lesions of the Talus with Cylindrical Sponge Allograft and Particulate Juvenile Cartilage Graft: Provisional Results with a Short-Term Follow-up”, can be viewed at the following link: