Simplify Medical said it was recently acquired by Australian private equity shop M.H. Carnegie for an undisclosed amount, as it gears up for a U.S. clinical trial of its MRI-safe artifical cervical disc.
"We invested in Simplify Medical because we believe they have a better option for treating patients in a growing market in spine. We are working with the company to accomplish their mission of providing non-metallic, MRI-friendly, anatomically appropriate cervical artificial discs to patients worldwide," M.H. Carnegie managing director Mark Carnegie said in a statement.
M.H. Carnegie, which bills itself as a “venture capital, private equity and alternative asset manager," has about $200 million under management, according to its website
Mountain View, Calif.-based Simplify Medical also said it won an investigational device exemption from the FDA for a study comparing its MRI-safe artificial cervical disc with fusion surgery in patients with chronic neck pain.
“We have worked collaboratively with the FDA to achieve IDE approval, and we look forward to starting our study later this year. We are excited to move forward with the Simplify Disc, which demonstrated promising clinical performance in an OUS clinical trial and commercial settings," CEO David Hovda said in prepared remarks.
The Simplify disc, which last month won CE Mark approval in Europe, is made of MRI-friendly ceramic and polymer-based components, unlike traditional metal artificial discs.