Austin, TX, May 5, 2014 (GLOBE NEWSWIRE) -- LDR Holding Corporation (Nasdaq: LDRH), a global medical device company focused on designing and commercializing novel and exclusive device technologies for the treatment of patients suffering from spine disorders, announced today that six presentations were delivered on the Mobi-C Cervical Disc (Mobi-C) at the 2014 International Society for the Advancement of Spine Surgery (ISASS) meeting. The presentations highlighted the results of the Mobi-C one and two-level Investigational Device Exemption (IDE) clinical trial. The presentations provided patient outcomes up to 48-month follow-up, and represent the most Mobi-C results presented at any one given venue to date.
"We are very pleased with the significant focus on Mobi-C at the 2014 ISASS Meeting," said Christophe Lavigne, President and CEO of LDR. "Mobi-C is the only cervical disc in the U.S. with FDA approval for both one and two-level indications. The decision by ISASS to prominently feature cervical total disc replacement (CTDR) in the scientific session indicates a strong interest from the surgical community for CTDR, and ISASS should be commended for providing attendees with the most current and scientifically valid information. The Mobi-C IDE two-level data, including proof of 48-month statistical superiority in terms of the primary study outcome, is one of the most exciting developments in spine surgery in recent years. We feel that the growing body of long-term evidence on Mobi-C, including what was presented at the ISASS annual meeting, further supports the role this technology has in providing patients with a treatment alternative to fusion."
Presentations on the Mobi-C IDE results and key findings at the 2014 ISASS Annual meeting included:
Hisey M., et al: Sagittal Alignment of One-level TDR and ACDF Patients: An Analysis of Patient Outcomes from a Randomized, Prospective Clinical Trial.
(Winner: BEST CLINICAL PAPER, ISASS 2014)
· ACDF patients with a kyphotic C2-C7 angle at 24 months experienced statistically significantly worse outcomes in NDI score, satisfaction, and SF-12 Mental Component Score than those with lordotic C2-C7 measurement.
· There are no significant differences between outcomes of C2-C7 lordotic and kyphotic Mobi-C patients at 24-month follow-up.
Davis RJ, et al: Two-level Cervical Total Disc Replacement versus ACDF: Results of a Prospective, Randomized Clinical Trial with 48 Months Follow-up.
· Safety and efficacy of Mobi-C at two-levels is statistically validated and on average, Mobi-C patients performed significantly better than their Anterior Cervical Discectomy and Fusion (ACDF) counterparts in pain, function, satisfaction, subsequent surgery rates, and the incidence of adjacent segment degeneration.
· At 48 months, two-level Mobi-C Overall Study Success was 66.0% versus 36.0% for two-level ACDF (p<0.0001).
Hisey M., et al: Cervical Total Disc Replacement versus ACDF: Results from a FDA IDE Clinical Trial through 48 Months.
· Safety and efficacy of Mobi-C at one-level is statistically validated and on average, Mobi-C patients demonstrated significantly lower subsequent surgery and adjacent segment degeneration rates compared to the ACDF control group.
· At 48 months, one-level Mobi-C Overall Study Success was 69.5% versus 58.7% for one-level ACDF.
· Specifically, one-level Mobi-C showed statistical superiority over ACDF at 12 and 36 months for the primary study endpoint.
Bae H, et al: One-level versus Two-level Cervical Disc Arthroplasty: Comparative Results from a FDA IDE Clinical Trial with Four-year Follow-up.
· The 48-month results suggest that unlike ACDF, there is no evidence of a reduction in efficacy or an increase in complications as the number of levels treated with Mobi-C increases from one level to two levels.
· Through 48 months, the rate of secondary surgery for one and two-level Mobi-C replacements was 3.0% and 4.0% respectively, versus 9.9% and 15.2% for one and two-level ACDF, respectively.
Davis RJ, et al: Sagittal Alignment of Two-level TDR Patients: An Analysis of Patient Outcomes from an FDA IDE Randomized, Prospective Clinical Trial.
· Both lordotic and kyphotic two-level Mobi-C patients enjoy similar pain relief and satisfaction at 24 months.
· On average global lordosis increased significantly from 10.7⁰ to 14.2⁰.
Simela A, Kanim L, Bae H: What Specific Questions Are Responsible in Driving NDI Superiority of Two-level ADR over Two-level Fusion. Post hoc Item Analysis of Self-reported Outcomes of Two-level Cervical Disc Arthroplasty (CDR, Mobi-C®) vs. Two-level ACDF Treated Patients from the IDE US-RCT.
· NDI item analysis at 48 months revealed statistically significantly greater improvement in Personal Care (p<0.01), Work (p<0.01), Headaches (p<0.01), Reading (p<0.02), Lifting (p<0.02) and Recreation Headaches (p<0.04) in the Mobi-C group versus the ACDF group.
Mobi-C is a cobalt chromium alloy and polyethylene, mobile-bearing prosthesis specifically designed as a bone-sparing, cervical intervertebral disc replacement for both one and two-level indications. In addition to the unique mobile-bearing feature, Mobi-C offers a simplified surgical technique as compared to other, commercially available devices, all of which are approved in the U.S. by the FDA for one-level use only.
About LDR Holding
LDR Holding Corporation is a global medical device company focused on designing and commercializing novel and proprietary surgical technologies for the treatment of patients suffering from spine disorders. LDR's primary products are based on its exclusive VerteBRIDGE® fusion and Mobi® non-fusion technology platforms and are designed for applications in the cervical and lumbar spine. These technologies enable products that are less invasive, provide greater intra-operative flexibility, offer simplified surgical techniques and promote improved clinical outcomes for patients as compared to existing alternatives. LDR recently received approval from the U.S. Food and Drug Administration (FDA) for the Mobi-C® cervical disc replacement device, the first and only cervical disc replacement device to receive FDA approval to treat both one-level and two-level cervical disc disease. For more information regarding LDR Holding and the Mobi-C Cervical Disc, visit www.ldr.com or www.cervicaldisc.com.
Forward-Looking Statements
This press release contains statements that constitute forward-looking statements within the meaning of the Securities Act of 1933 and the Securities Exchange Act of 1934, as amended by the Private Securities Litigation Reform Act of 1995. Forward-looking statements contained in this press release include the intent, belief or current expectations of LDR and members of its management team with respect to LDR's future business operations as well as the assumptions upon which such statements are based. Forward-looking statements include specifically, but are not limited to, the highly concentrated nature of our product offerings; our ability to compete successfully (including without limitation our ability to convince surgeons to use our products and our ability to attract and retain sales and other personnel); coverage and reimbursement determinations by third-party payers, including Medicare and Medicaid; our lack of experience selling Mobi-C® in the United States; the lack of long-term clinical results of our products; unforeseen safety issues in connection with the use of our products, which may result in regulatory actions against us, including recalls, and litigation against us by patients; ongoing regulatory obligations and oversight and determinations by regulatory and administrative governmental authorities which may delay or restrict LDR's ability to continue to develop or commercialize LDR's products; competing products and product candidates that may be superior to LDR's products and product candidates; and our success in defending legal proceedings brought against us. Additional factors that could cause actual results to differ materially from those contemplated within this press release can also be found in LDR's Risk Factors disclosure in its Annual Report on Form 10-K, filed on March 4, 2014, and in LDR's other filings with the SEC. LDR disclaims any responsibility to update any forward-looking statements.
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