Spine Startup Snags $21M for MRI-Friendly Cervical Disc

Amanda Pedersen 1

July 20, 2017

4 Min Read
Spine Startup Snags $21M for MRI-Friendly Cervical Disc

Simplify Medical raised $21 million to support two ongoing U.S. pivotal trials of its cervical disc implant. The company designed the disc to be clearly viewed on MRI to eliminate the radiation exposure from CT scans.

Amanda Pedersen

Getting investors' attention isn't the easiest accomplishment for a startup--especially in a mature and competitive market. But for one Sunnyvale, CA-based spine company, finding a way to stand out from the crowd with its Simplify cervical disc turned out to be, well, simple.

The motion preservation sector of the spine market has been around for about 10 years now since the first disc implant was approved, said David Hovda CEO of Simplify Medical. But the technology didn't have reimbursement back then and it took longer than most people expected for the cervical disc market to take off, he said.

"But it's done really well, I think largely through LDR's leadership. Reimbursement is much better, it's a bigger dynamic market within the spine space so I think it's an area of investors within spine," Hovda told Qmed.

Indeed, LDR did a bang-up job of paving the way for future companies to enter the cervical disc replacement market. Zimmer-Biomet Holdings must have thought so, anyway, because the orthopedic device maker bought LDR for $1 billion last year, just one year after the company completed its own mega merger. LDR was best known for its Mobi-C cervical disc replacement device and MIVo products to support lumbar and cervical fusion procedures.

Now it's Simplify Medical's turn to bring fresh innovation to the space, like its cervical disc that is designed to be clearly viewed on MRI without the artifact that can result from the metal used in typical spine implants. By avoiding the radiation that would otherwise accompany a CT scan, Hovda said, the company intends to minimize patient exposure to unnecessary radiation risk. The device is composed of a medical-grade polymer and ceramic composite, so it also has no metal wear from articulating components.

"If you have to have a CT scan, you have to have a CT scan and that's important," Hovda said. "But I think one thing that's underappreciated is the amount of radiation that patients are exposed to in CT scans. So we felt if we had a device that worked well clinically but offered a potential safety benefit that really doesn't exist in the market today, that would be useful."

And that was one thing that jumped out at potential investors, as well as surgeons involved in the company's clinical trials, Hovda said. The device is available in Europe under CE mark and the company is now enrolling in two U.S. pivotal trials that will include up to 200 patients at 15 centers.

Simplify Medical just raised a $21 million financing round that will be used to complete those two trials, which are designed to study the use of the Simplify cervical disc in one level of the spine and in two adjacent levels of the spine as a treatment for cervical degenerative disc disease. LSP (Life Sciences Partners) led the round, with additional investment from Sectoral Asset Management and returning investor M.H. Carnegie.

The company will be pursuing two premarket approvals from FDA, which will take some time. The company aims to complete the one-level trial early next year, and the two-level trial by the end of 2018, and FDA requires two-year follow-up data on patients in spinal implant IDE studies. 

"Another thing that we spent a lot of time working on was developing fully articulating lower height devices," Hovda said. "In the early days of cervical motion preservation, most of the companies picked heights that were similar to fusion spacers as a start."

But fusion is very different from motion preservation, he said, and those devices often use bone grafts that are partially re-absorbed by the body over time. So if a surgeon implants a 6-millimeter spinal fusion spacer, for example, the device is probably only 5 millimeters after a year because some of it is absorbed. That's fine for fusion procedures, which are intended to stretch ligaments and stop motion. But it doesn't work so well when the whole point is to retain motion.

"We think if a disc is too tall it can be disadvantageous from a biomechanical perspective," Hovda said.

Simplify Medical has done a lot of research on this issue, he said and concluded that the cervical disc space in North American patients is about 4 millimeters. "So we felt it was important to come up with smaller disc heights, so we have a 4-millimeter disc."

While it might not sound like there would be much difference between a 4-millimeter disc and a 5-millimeter disc, Hovda said, but it's actually a fairly significant difference for a spinal implant.

Amanda Pedersen is Qmed's news editor. Contact her at [email protected].

[Image credit: Simplify Medical Inc.]

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