New Financing to Complete Pivotal Artificial Disc Studies

Simplify Medical Pty Ltd, maker of the Simplify® cervical artificial disc, has announced the closing of a Series B financing of $21 million.


While magnetic resonance imaging (MRI) is widely used pre-operatively for surgical planning, spine surgeons often switch to CT post-operatively in order to accommodate metal components, which can make it difficult to view the devices, as well as the facets and adjacent levels. However, CT scans have been shown to expose patients to ionizing radiation that equates to 400 to 550 chest X-rays per scan.

A past visitor to our pages, Simplify Medical is focused on cervical spinal disc arthroplasty, using innovative, MRI-friendly materials designed to decrease the need for ionizing radiation and enhance patient options. Indeed we covered the technology earlier this year, here. The Simplify Disc has received the CE Mark and has been used to treat more than 700 patients outside the U.S. over the last three years. Early clinical data has shown substantial improvement in patient pain scores and functional improvement after treatment.

Two Simplify Disc U.S. pivotal trials are currently enrolling. The two-level, prospective pivotal trial will encompass up to 200 patients at up to 15 centers, comparing cervical implantation of the device in two contiguous discs from C3 to C7 with two-level cervical fusion surgery. The other pivotal trial is studying one-level cervical implantation of the device between C3 to C7 with cervical fusion surgery from a historical nonconcurrent control group.

LSP (Life Sciences Partners) led the new financing round, with additional investment from Sectoral Asset Management and returning investor M.H. Carnegie. The new funds will be used to complete the aforementioned U.S. pivotal clinical trials.

Company comments

“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. By avoiding the radiation that would otherwise accompany a computed tomography (CT) scan, we intend to minimize patient exposure to unnecessary radiation risk,” said Simplify Medical Chief Executive Officer David Hovda. “The new funds will enable us to develop the rigorous evidence that gets us one step closer to availability for U.S. patients in need.”

Source: Simplify Medical

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