BY LAUREN UZDIENSKI, JUNE 9, 2009
Orthovita has received 510(k) clearance to market Cortoss Bone Augmentation Material for the treatment of vertebral compression fractures, and it’s the first cement other than PMMA to be cleared for this use. The product was under review by the FDA for nearly a year and a half on account of additional data requests from the agency.
On the call, the company described its expansive clinical program. The company believes they have the largest collection of data for any product of this type, with over 500 patients treated with Cortoss between the U.S. IDE study and in other studies in the U.S. in Europe. The Cortoss pivotal was a prospective, randomized, multi-center study comparing Cortoss to PMMA, with a primary outcome of non-inferiority. Secondary outcomes included improvement in VAS scores for pain and ODI scores for disability.
256 patients were enrolled, 162 of which received Cortoss, and 94 received PMMA. Study participants had a median age of nearly 79, and many suffered from osteoporosis and a variety of other ailments. The company achieved non-inferiority at 24 months, with a composite success rate of 77% for patients treated with Cortoss and 73% for PMMA patients. ODI scores at 24 months improved by 97% for Cortoss patients and 88% for PMMA, which represented a statistically significant benefit. The study had a high rate of long-term follow-up, with 83% at 24 months, which, to the company’s knowledge, is the highest ever achieved in vertebral augmentation. Earlier results showed a statistically significant benefit for pain relief, with VAS scores at three months improved by 87% for Cortoss and 75% for PMMA.
Other results observed in the study included Cortoss patients requiring less material to achieve equivalent outcomes and a 43% reduction in adjacent-level vertebral fractures. The company noted that this reduction in adjacent-level VCFs was not yet statistically significant, but called it a “clear trend.” Much of the discussion on the Q&A portion of the call focused on this result, which CEO Anthony Koblish said could possibly be attributed to how Cortoss coats the damaged level without displacing adjacent structures.
Orthovita plans to submit these results to association meetings for presentation and for publication. They will also continue to invest in their clinical programs and post-market surveillance to identify additional trends and benefits.
Cortoss also offers a number of additional handling benefits over PMMA. Among them, the material is prepared in a mix-on-demand system that allows surgeons a high level of flexibility during surgery, including the ability, for example, to stop injecting the material and then start again. Among other characteristics of the product are highly consistent viscosity and set time.
The company plans to initiate a controlled launch for Cortoss, including extensive surgeon training, and then expand to a full launch after 90 days. Cortoss will be sold by the company’s existing sales force, and the company declined to release the product’s price.
Fourth quarter 2009 sales of $24.4 million reflect 17% growth over fourth quarter 2008; full year 2009 sales of $92.9 million increased 21% over 2008.