LDR receives one- and two-level approval for cervical disc device for commercial sale, distribution

LDR Holding Corporation announced that it has received FDA approval allowing the commercial sale and distribution of its Mobi-C Cervical Disc for one- and two-level indications in the United States.

The Mobi-C is a cobalt-chromium alloy and polyethylene, mobile-bearing prosthesis specifically designed as a bone-sparing, cervical intervertebral disc replacement. According to a press release, Mobi-C demonstrated non-inferiority in overall trial success in the one-level arm of the Investigational Device Exemption trial (IDE) and superiority in overall trial success in the two-level arm IDE trial compared anterior cervical discectomy and fusion.

“We are pleased that the FDA, after an intensive review of our submissions, has determined that Mobi-C is safe and effective for both one and two-level indications in the United Sates, and superior to fusion for two-level cervical disc replacement, based on the results of our prospective, concurrently controlled and randomized, multi-center clinical trials,” Christophe Lavigne, president and chief executive officer of LDR, stated in the release.

LDR Holding also filed a registration on Form S-1 with the Securities and Exchange Commission for a proposed initial public offering of its common stock. According to a company press release, the number of shares to be offered and the price range for the proposed offering have yet to be determined.