Simplify Medical Raises $21 Million!
Elizabeth Hofheinz, M.P.H., M.Ed. • Thu, July 27th, 2017
Even in today’s expensive research climate, $21 million can go a long way. Simplify Medical Pty Ltd, based in Sunnyvale, California, has announced the closing of a Series B financing of $21 million, with LSP (Life Sciences Partners) leading the round.
There was additional investment from Sectoral Asset Management and returning investor M.H. Carnegie. The company will use these funds to complete two 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.
The company wrote in its July 19, 2017 news release, “Two Simplify Disc U.S. pivotal trials are currently enrolling. The two-level, prospective pivotal trial will enroll 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 non-concurrent control group.”
“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.”
Chief Executive Officer David Hovda commented to OTW, “Recently, there has been increasing attention in the clinical community and in journals relative to managing the dangers of radiation with patients, and overuse of CT scans has been an area of concern.”
“With that in mind, we have developed a cervical disc designed to eliminate the need for CT scans, which have been common in post-procedure patient management. Instead, our disc is made of PEEK and ceramic, which enables it to be clearly viewed on MRI, reducing patient risk from CT radiation and contrast media injections in the cerebrospinal fluid.”
“In addition, the Simplify Disc is the lowest profile cervical disc available, with heights as low as 4mm, when most other cervical discs offer heights greater than 5.5mm. So, our ultra-low-profile device better fits the anatomy of many female patients and patient populations from certain regions globally. This can enable more patients to preserve motion with an artificial disc, and may contribute to better outcomes when a device better fits the anatomy.”
“Lastly, we have all seen the unfortunate problems of metal wear in other areas of orthopedics. To minimize that, we have designed our device using polymer and ceramic composite for low levels of wear and long-term durability.”
“When considering which device to use, surgeons always consider the risk profile. By reducing the radiation risk from CT, minimizing wear, and better fitting certain patient anatomy, we feel we have developed a disc with a very attractive risk profile.”
“Patients that they may not have considered appropriate for an artificial disc due to smaller anatomies may now be able to benefit from the motion preservation that comes from an ultra-low-profile artificial cervical disc.”
“Some artificial discs can be complicated to implant. The Simplify Disc can be implanted as one pre-assembled unit using a streamlined three-step procedure, potentially increasing efficiency and decreasing OR time.”