Here are five things to know about the clinical trial:
1. The company will use the funds from the financing round to initiate a U.S. Food and Drug Administration-approved clinical trial of the M6-C artificial cervical disc as well as expand international commercialization and clinical programs. The M6 device was introduced worldwide in 2006 and is available in over 27 countries, with approximately 30,000 implants to date.
2. The clinical trial will compare single-level cervical disc replacement using the M6 device to single-level cervical fusion. Enrollment has begun at numerous spine centers, including Texas Back Institute in Plano, Rocky Mountain Spine Arthroplasty Associates in Johnstown, Colo., and Carolina Neurosurgery and Spine in Charlotte, N.C.
3. In all, the clinical trial will include 243 subjects — 162 M6 device subjects from up to 15 clinical sites as well as 81 anterior cervical discectomy and fusion subjects at up to five clinical sites. "Surgeons, patients and our investors have been extremely supportive of the M6 and have enabled us to take this critical step. We look forward to working with the U.S. sites to complete the clinical trial while continuing to expand M6 availability internationally," said Tom Afzal, president and CEO of Spinal Kinetics in a news release.
4. The United States nonfusion and diagnostic devices market which is expected to reach $1.1 billion by 2017, according to a new report from Global Information. The largest segment of this market is minimally invasive discectomy devices, which accounted for approximately 46.5 percent of sales in 2012.
Also, the U.S. implantable medical devices market is expected to reach $73.9 billion by 2018, according to a Transparency Market Research report. It was valued at $43.1 billion in 2011, and is expected to grow at a compound annual growth rate of 8 percent from 2012 to 2018.
5. While artificial disc replacement is gaining steam in the United States, M6 faces some competition from other device companies focused on disc replacement, such as LDR and ProDisc. LDR has the only artificial disc approved for one- and two-level cervical procedures—the Mobi-C—and the company had strong sales growth in the United States during the first quarter of 2014. The company announced their initial public offering last year and a follow-on public offering in May. The company's discs have also shown positive results when compared with fusion for both one- and two-level procedures.
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