The U.S. Food and Drug Administration granted Simplify Medical an investigational device exemption approval for their non-metal artificial disc.
Here are five things to know:
1. The company will initiate a clinical trial comparing the Simplify Disc with anterior cervical discectomy and fusion.
2. The cervical disc is non-metal, which makes it MRI-friendly. The materials are designed to eliminate invasive CT scans and reduce ionizing radiation exposure.
3. The disc has heights as low as 4.2 mm for smaller patient anatomy.
4. Simplify Medical recently received the CE Mark for international commercialization.
5. The Australian private equity/venture capital group M.H. Carnegie recently acquired Simplify Medical.
"We invested in Simplify Medical because we believe they have a better option for treating patients in a growing market in spine," said Mark Carnegie, Managing director of M.H. Carnegie. "We are working with the company to accomplish their mission of providing non-metallic, MRI-friendly, anatomically appropriate cervical artificial discs to patients."