Jul 8 2010
BioMimetic Therapeutics (NASDAQ: BMTI) will report today the final, one year results of its North American Pivotal Study comparing Augment Bone Graft to autograft in foot and ankle fusion surgery. The presentation of the data by Dr. Timothy Daniels, associate professor of orthopedic surgery at the University of Toronto and St. Michaels Hospital, will take place at the American Orthopaedic Foot and Ankle Society (AOFAS) summer meeting. As previously reported, the trial met its pre-specified primary endpoint of non-inferiority of Augment to autograft at six months, and the Company's Premarket Approval (PMA) application for Augment was recently accepted by the FDA.
“We didn't feel that the real costs affiliated with bone grafting were well understood by either hospitals or payers”
In Dr. Daniels' presentation, he will report the entire 52-week data set, highlighting key 52-week endpoints, which demonstrate that out of 16 secondary endpoint measures at the 52-week time point, 15 were statistically significant for non-inferiority. Further, Augment compared favorably to autograft with clinical healing rates of 87.8% and 88.3%, and a therapeutic failure rate of 7.3% and 8.0%, respectively. Importantly, safety outcomes favored the Augment treatment group, which had fewer complications and infections compared to patients treated with autograft.
The Company is also reporting the results of the European Union (EU) Augment foot and ankle fusion study, which included 108 patients at 11 clinical centers in Europe. This study demonstrated only a seven percent revision rate, which is consistent with the therapeutic failure rate observed in the U.S. pivotal trial for Augment and autograft (7.3-8.0%) and Canadian registration trial (10%), and a safety profile that was consistent with all other studies of Augment to date.
Additionally, during the AOFAS meeting earlier this morning, Dr. Nicholas Abidi, a practicing orthopedic surgeon at Santa Cruz Orthopaedic Institute, presented for the first time the results of a recently completed study that quantifies the direct medical costs of harvesting autograft in foot and ankle fusion procedures. The study concluded that the cost of harvesting autograft is between $1,100 and $2,400 depending on the harvest site, excluding the cost of treating complications associated with the harvest procedure.
"We are very pleased with the consistently positive results of all studies related to Augment's clinical performance. We are also encouraged by the results of Dr. Abidi's economic study which provides valuable insight into the cost burden in U.S. hospitals related to the use of autograft, the current standard of care," commented Dr. Samuel Lynch, president and CEO of BioMimetic Therapeutics. "The 52 week data from the Augment North American pivotal clinical trial demonstrate that patients treated with Augment have just as good an outcome after one year, and a favorable safety profile, compared to patients treated with autograft. And, the patients treated with Augment have the added benefits of not having the additional pain and risk of a procedure to harvest the autograft from another bone in their body. The European trial further confirms the clinical benefits and safety of Augment, and brings the total number of patients who have been safely treated with the product candidate to over 500. Finally, the autograft cost study confirms the significant cost of autograft harvesting and will provide us with valuable economic data as we formulate our strategy for commercial launch of Augment."
3D-printed bone model offers new possibilities for surgery