Simplify Medical, maker of the Simplify cervical artificial disc, has closed Series B financing of US$21 million. The new funds will be used to complete two ongoing US pivotal clinical trials of the Simplify Disc, studying its use in one level of the spine and in two adjacent levels of the spine as a treatment for cervical degenerative disc disease.
While magnetic resonance imaging (MRI) is widely used pre-operatively for surgical planning, spinal surgeons often switch to computed tomography (CT) postoperatively in order to accommodate metal components, a company release asserts. This can expose patients to ionising radiation, which the release says equates to 400 to 550 chest X-rays per scan.
Two Simplify Disc US pivotal trials are currently enrolling. A two-level, prospective pivotal trial will encompass up to 200 patients at up to 15 centres, 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 funding round, with additional investment from Sectoral Asset Management and returning investor MH Carnegie.
The Simplify Disc has received the CE mark and has been used to treat more than 700 patients outside the USA over the last three years. Early clinical data has shown improvement in patient pain scores and functional improvement after treatment.