$23.25 Million Raised for Simplify Medical
Elizabeth Hofheinz, M.P.H., M.Ed. • Wed, February 28th, 2018
Simplify Medical Pty Ltd, based in Sunnyvale, California, has announced that it has completed a $23.25 million fund raise.
The funds are a second tranche of its Series B financing of $23.25 million, completing the oversubscribed round totaling $44.25 million. As the company wrote in the February 9, 2018 news release, “The lead investor for the second tranche is LSP Health Economics Fund 2 (LSP HEF 2), with participation from existing venture investors LSP Fund V, MH Carnegie & Co., and Sectoral Asset Management. Series B funds will be used to complete two ongoing U.S. 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, and for commercialization outside of the U.S.”
“Having an oversubscribed Series B is a testament to the large opportunity presented by the Simplify Disc,” said Simplify Medical Chief Executive Officer David Hovda. “The Simplify Disc is designed to eliminate the need for CT [computed tomography] scans post-surgery, reducing patient risk from associated radiation and solving a significant clinical problem in spine arthroplasty today.”
“Composed of primarily non-metal materials (PEEK-on-ceramic), the Simplify Disc is designed to be viewed on MRI [magnetic resonance imaging] in order to minimize patient exposure to radiation.”
“With no metal in its articulating components, the disc is also designed for low levels of wear to optimize long-term durability.”
According to the company, surgeons will be able to implant the Simplify Disc using a straightforward, three-step procedure.
“The Simplify Disc is also anatomically designed with low height implant options to accommodate patients with smaller cervical disc spaces, making it ideal for women and certain regional populations. The device is considered MRI-conditional, posing no known hazard in an MRI environment within prescribed conditions of use.”
“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 18 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 compared with one-level cervical fusion surgery.”
David Hovda told OTW, “Both trials are testing a device that is uniquely designed to minimize patient risk during and after implantation of a cervical spinal disc. In addition, both trials are utilizing historical control data to speed and streamline the process.”
“While MRI is widely used pre-operatively for surgical planning, spine surgeons often switch to CT scans post-operatively in order to accommodate metal components, which can make it difficult to view the devices, as well as the facets and adjacent disc levels. However, CT scans have been shown to expose patients to ionizing radiation that equates to 400 to 550 chest X-rays per scan.”