Texas device company LDR expects to start selling its new cervical disc replacement in 2013, now that the FDA has determined that the product is approvable.
If such a designation sounds incremental, you're right; it is. But so goes the often-complex U.S. regulatory process. The FDA issued an approvable letter for the company's Mobi-C cervical disc, which means it is, in fact, approvable, assuming some final conditions are met.
LDR will get there, according to its release, assuming it satisfies the FDA's quality system regulations and finalizes labeling and a postapproval study for the product. If all goes well in those areas, then the company's premarket approval application should gain the FDA's OK.
What is noteworthy is that the FDA determined that Mobi-C is approvable for two-level use to treat cervical degenerative disc disorder based on a 600-patient trial, which showed that Mobi-C was superior to fusion treatment, the current standard of care. Mobi-C is made from metal and polyethylene. As the company itself notes, the product would enter a market where the population is aging, and a large majority of those past age 50 will face some sort of disc degeneration.
LDR launched in 2000 and is based in Troyes, France, and Austin, TX.
- read the release