Simplify Medical, which is working on nonmetal spine implant technology, raised $21 million in series B funding to support two U.S. pivotal trials of its cervical artificial disc.
The investigational Simplify Disc has a ceramic core and two endplates made of a polymer called polyether ether ketone (PEEK). Designed to treat cervical degenerative disc disease, the device is in pivotal trials studying its use in one level of the spine and in two adjacent levels of the spine, according to a statement. Patients with the nonmetal implant can avoid radiation by undergoing magnetic resonance imaging (MRI) rather than computed tomography (CT) imaging.
Cervical degenerative disc disease refers to the collapse or reduction in height of discs in the cervical spine. Bone spurs may also be present. The disease can cause neck pain, as well as tingling, numbness and pain in areas including the arms and hands. If nonsurgical pain management is insufficient, patients may be treated with spinal fusion.
While spine surgeons typically use MRI to plan surgery, they often use CT imaging after the implant has been placed, Simplify said in the statement. This is because metal parts in some implants can show up on an MRI image. But CT scanning has its own downsides, such as exposing the patient to X-ray radiation, rather than the magnetic fields and radio frequency pulses used by an MRI.
“We are gratified by the confidence investors are showing in our Simplify Disc, which is designed to be clearly viewed on MRI without the artifact that can result from metal used in typical spine implants,” said Simplify CEO David Hovda. “By avoiding the radiation that would otherwise accompany a computed tomography (CT) scan, we intend to minimize patient exposure to unnecessary radiation risk.”
“Not only does the Simplify Disc avoid substantial radiation exposure, it also avoids metal wear that has been problematic for other orthopedic devices. In addition, it offers the lowest-profile device available, opening up a broader patient population for the technology,” said Fouad Azzam, general partner at Life Sciences Partners, which led the financing.