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Has Orthovita's Fight Finally Ended?

Executive Summary

Orthovita had spent the past eight years building up a small commercial pipeline while it ran its flagship bone augmentation material Cortoss through years of a demanding clinical trial. But two months after the FDA approved the product, the company had to clear another unforeseen hurdle: two controversial clinical trials.

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A decade ago, the treatment of vertebral compression fractures (VCF) represented one of the fastest - and most innovative - segments of a spine industry that was set to explode. The two principal procedures - vertebroplasty and its distant cousin kyphoplasty - presented surgeons and interventionalists with a minimally invasive option to stop pain and, in the case of kyphoplasty, restore the shape and form to a broken vertebra. Now, two studies published in The New England Journal of Medicine suggesting that vertebroplasty procedures were no more effective in relieving pain than a placebo treatment have put pressure on VCF companies and doctors, who are facing pushback on reimbursement and some skepticism from even their own specialists.

Vertebral Compression Fracture Treatments Under Pressure

A decade ago, the treatment of vertebral compression fractures (VCF) represented one of the fastest - and most innovative - segments of a spine industry that was set to explode. The two principal procedures - vertebroplasty and its distant cousin kyphoplasty - presented surgeons and interventionalists with a minimally invasive option to stop pain and, in the case of kyphoplasty, restore the shape and form to a broken vertebra. Now, two studies published in The New England Journal of Medicine suggesting that vertebroplasty procedures were no more effective in relieving pain than a placebo treatment have put pressure on VCF companies and doctors, who are facing pushback on reimbursement and some skepticism from even their own specialists.

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