Research on the spine is where cardiac research was 10 years ago, declares Marcy Rogers. And that’s why she’s working hard to establish a presence in what she considers a soon-to-boom field.

Enter, then, San Diego-based SpineMark CRO Management, the industry’s sole spine-only contract research organization (CRO), launched in 2005 but recently ramping up considerably. Rogers is its president and CEO. She’s also president and CEO of SpineMark Hospital, from which the CRO was spun off.

Recent Acceleration

“Specialized treatments for the spine are being developed and launched at a rapid pace, and research and physician specialization in the field of spinal medicine have dramatically accelerated in the last 10 years,” says Rogers. “Procedures performed on the spine have gone from major operations to a minimally invasive setting.”

The numbers she points to: Nearly 80 percent of Americans will experience back pain during their lifetime. Back pain is one of the most common reasons for missed work. It’s the second most common reason for visits to the doctor’s office, outnumbered only by upper-respiratory infections.

Infrastructure Lacking

At the same time, though, Rogers says, infrastructures for research on the spine are lacking. She has seen this first-hand heading up SpineMark Hospital.

“We saw the issues facing device manufacturers in the field,” she says. “Traditionally, physicians weren’t very well organized, in a lot of ways, to handle research. Medical device manufacturers would come out with a new device and they would fly around to hundreds of doctors and end up with just a few doctors who would participate in a trial. There were a whole lot of inefficiencies and a whole lot of cost.”

SROs

The plan, then? Launching and growing a spine-centric CRO with a network of spine experts across the nation and beyond. The hope is that that will attract contracts from the increasing number of medical device manufacturers who focus on the spine, and don’t have any organized entity to turn to for research. Rogers is calling them “spine research organizations” or SROs. 

So far, as of this spring, there are two hubs in the network. In the Denver area, SpineMark has signed on the Littleton Adventist Hospital of Littleton, and the Lone Tree Ambulatory Surgery Center in Lone Tree.

L.A., Too

Next: L.A. On the heels of forming those relationships, the SpineMark SRO of Los Angeles was founded by Drs. Patrick Johnson, Carl Lauryssen and Jeff Wang and includes, says Rogers, key opinion leaders in all disciplines of spine care, psychiatry, orthopedic surgery, neurosurgery and interventional pain.

And the SROs’ first clinical trial is under way. They are now evaluating StabiliMax NZ, a device from Applied Spine Technologies designed to provide dynamic stabilization of the spine without fusion in patients undergoing decompression surgery for the treatment of spinal stenosis, says Rogers.

Growth Ahead

SpineMark CRO has 35 employees. The company currently has seven contracts with device manufacturers, with seven sites doing research in the U.S. Most contracts are for one-year studies with two- to three-year follow-up.

The goal is to have 15 more sites up and running by the end of 2008. Also, the company expects to have 10 to 15 more contracts in place by then, says Rogers.

Site in Seoul

Internationally? SpineMark just signed a letter of intent with a large health system in Seoul, South Korea, and is sniffing around for more sites abroad, says Rogers.

And she’s in a hurry. Because the space is hot.

“I’m sure there are others trying to do the same thing as we are even as we speak,” Rogers says.

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