Simplify Medical, a company focused on cervical spinal disc arthroplasty and maker of the Simplify cervical artificial disc, has announced a second tranche of its Series B financing of US$23.25 million, completing the oversubscribed round totalling US$44.25 million.
The lead investor for the second tranche is Life Sciences Partners (LSP) Health Economics Fund 2, with participation from existing venture investors LSP Fund V, MH Carnegie and Co., and Sectoral Asset Management. Series B 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, and for commercialisation outside of the US.
Simplify Medical Chief Executive Officer David Hovda says, “Having an oversubscribed Series B is a testament to the large opportunity presented by the Simplify Disc. 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.”
While magnetic resonance imaging (MRI) is widely used re-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 disc levels. However, CT scans have been shown to expose patients to ionising radiation that equates to 400 to 500 chest X-rays per scan.
Composed of primarily non-metal materials (PEEK-on-ceramic), the Simplify Disc is designed to be viewed on MRI in order to minimise patient exposure to radiation. With no metal in its articulating components, the disc is also designed for low levels of wear to optimise long-term durability. Implantation of the Simplify Disc is accomplished in 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.
Fouad Azzam, from investor LSP, comments, “We have great confidence in the Simplify Disc and the clinical outcomes achieved to date, and expect the U.S. clinical trials to demonstrate the same. Risk mitigation is top of mind for hospitals, and products like the Simplify Disc that maximise patient safety are well aligned with their concerns. In addition, the Simplify Disc offers the lowest-profile device, opening up a broader patient population for the technology.”
Mark Carnegie, founding investor of Simplify Medical, says, “Simplify Medical has developed a very attractive cervical disc replacement system and the company has made tremendous progress on their multiple IDE studies and international commercialisation. Our funding will allow them to accelerate these programs and expand access to the Simplify Disc to many more patients.”
Simplify Medical recently announced the completion of a trial using the Simplify Disc for one-level cervical implantation between C3 to C7 compared with a historical control group. This trial enrolled 166 patients at 16 US sites.
Two Simplify Disc US pivotal trials are currently enrolling. The two-level, prospective pivotal trial will encompass up to 200 patients at up to 18 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 compared with one-level cervical fusion surgery.
According to Hovda, “The two-level trial is approximately 40 percent enrolled, and enrollment is expected to be completed by the end of 2018.”
The Simplify Disc received the CE Mark in 2015, and is commercially available in the UK and Germany. Over 500 patients have been treated with the Simplify Disc across the US and its European markets.
Hovda comments, “The company [Simplify Medical] has worked with a limited number of key centres in those markets, and it plans to expand commercial efforts more broadly.”
“Early clinical data has shown substantial improvement in patient pain scores and functional improvement after treatment.”