Vertos Medical's Blue Ocean Opportunity

Article preview reprinted from IN VIVO -  November/December, 2009  

Given how many start-up companies and their investors have rushed into spine over the past decade or so, one might assume that getting spine surgeons to adopt new technology is relatively easy. - But less than five years after the launch of the first artificial disc was supposed to usher in the era of motion preservation, surgeons are still arguing for the benefits of fusion over disc replacement--underscoring the tension between new devices and traditional therapy options. But one start-up, Vertos Medical Inc., has found a creative way around the adoption issue. Promoting a novel approach to spinal stenosis, Vertos' solution is to focus on the patient, rather than the surgeon, treating stenosis earlier in the continuum of care by reaching out to a new clinical specialty, interventional pain physicians. Read more...

Vertos Medical's Blue Ocean Opportunity

Article preview reprinted from IN VIVO -  November/December, 2009  

Vertos has a promising new device to treat spinal stenosis and a strategy that focuses not on spine surgeons, but on a new breed of pain specialists.

** Spinal stenosis is a painful, debilitating condition that can seriously inhibit a person's mobility. Treated mostly by drugs and physical therapy, stenosis is now attracting more attention from device companies.

**Vertos Medical has a new approach, called minimally invasive lumbar decompression, that relieves pain and may help to hold off the need for surgery later on.

**But the company's earlier sales and marketing efforts ran into trouble because they targeted spine surgeons, who don't see enough of these patients who, most often, aren't yet candidates for surgery.

**Vertos has now revamped and streamlined its sales efforts, focusing on a small group of interventional pain specialists, who are more likely to treat these patients, thereby greatly expanding its population of potential patients.

Consider all of the things that have to go right to successfully develop and launch a new medical device: first of all, it has, of course, to be safe and effective, delivering on the therapy that its developers intended it to. If it passes those tests, it's likely to satisfy device regulators, but still has to prove to payors that it warrants coverage—something that used to be a given once FDA approval or clearance was gained but is no longer a sure thing. Finally, the device has to be one that physicians are comfortable with—unlike drugs, devices are tools in the hands of clinicians and if doctors find the device uncomfortable to work with or the procedure it requires too complex, many are likely to stick with an older device they're already accustomed to using.

Each of those issues presents a hurdle in its own right: in spine, one of the most fertile grounds for new device development over the past decade, add one more hurdle: a surgeon customer base that is, at once, overwhelmed by all of the new device options spine companies are creating, and a conservative mindset that requires substantial clinical proof of a device's effectiveness before surgeons feel comfortable adopting it. Indeed, given how many start-up companies and their investors have rushed into spine over the past decade or so, one might assume that getting spine surgeons to adopt new technology is relatively easy. Just the opposite, as evidenced by the fact that, less than five years after the launch of the first artificial disc was supposed to usher in the era of motion preservation, surgeons are still arguing for the benefits of fusion over disc replacement--underscoring the tension between new devices and traditional therapy options.

Two other factors further play into the difficulty of a successful launch of a new spine technology: the strong role played by an entrenched distribution system, which has a tendency to bias in favor of technology and companies already well-established in the marketplace, and the complexity and myriad of spinal problems, many of which don't immediately require surgical therapy. What's a small company to do? There's not much it can do about the regulatory or reimbursement challenges. But one spine start-up, Aliso Viejo, CA-based Vertos Medical Inc. has found a creative way around the adoption issue. Promoting a novel approach to spinal stenosis, Vertos' solution to the distribution channel issue is to focus on the patient, rather than the surgeon, treating stenosis earlier in the continuum of care by reaching out to a new clinical specialty, interventional pain physicians.

A Mild Approach

Vertos was founded in 2005 by two interventional neuroradiologists, Donald Schomer, MD, and David Solsberg, MD, who were looking for a way to treat cancer patients who had also developed lumbar spinal stenosis but, because of their cancer, couldn't tolerate surgery.

Spinal stenosis is a painful condition that results from a narrowing of the spinal canal; in effect, the nerves in the neural foramen and spinal canal become trapped and pinched when the canal narrows. Patients who suffer from spinal stenosis experience little or no pain when seated because the foramen and canal areas open up, but have a hard time when standing because the trapped nerves are squeezed when the area narrows. (The pinched nerves can cause both pain and a feeling of weakness in the legs.) Thus, many patients with spinal stenosis use walkers to get around—the forced stooping the walker causes relieves the pain by keeping the foramen and canal areas from collapsing on the nerves.

Because it's a degenerative condition, spinal stenosis occurs more often in elderly patients, though it can occur in younger patients as well—as noted, Vertos' founders were targeting cancer patients, who can be of any age. Today, most therapy focuses on treating the pain, rather than the underlying cause, and includes non-surgical approaches such as anti-inflammatory drugs like NSAIDs, and epidurals, physical therapy, and lifestyle modifications. Such therapies palliate the pain, but they have a significant impact on the patient's lifestyle—spinal stenosis patients can no longer play golf or tennis and even are likely to cut back on walking.

For those patients who don't respond to drugs or physical therapy, there's always a surgical alternative: a laminectomy or surgical decompression to remove the hypertrophic ligament and bone, a procedure that is highly invasive and, like all surgeries, traumatic with a higher risk of complications. "In a laminectomy, you remove the whole ligament and bone, it does decompress the spine," notes Vertos president and CEO Jim Corbett. "But it also destabilizes the spinous process and can lead to the need for a fusion later on."

Vertos' device, which is called the mild system, uses a fluouroscopically guided approach to de-bulk the ligaments in the stenotic region that are pressing on the nerves, causing pain. After a trocar is inserted into the lamina space, a bone cutting device is used to clear space in both the inferior and superior parts of the lamina where the disc has collapsed or compressed. (The cutter also retrieves the bone shards since they can't just be suctioned out as they would in an open surgical procedure.) A proprietary sculpting tip is then used to allow the surgeon to reduce the size of the ligament; in stenotic patients, a ligament that is normally two millimeters thick, may expand to six or eight millimeters, which results in nerve compression. The de-bulking relieves the pressure and the resulting pain and an epiduragram tells the physician when he or she has removed enough of the ligament to achieve pain relief.

David Cassak

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Companies mentioned in this article:

Abbott Laboratories Inc.

Boston Scientific Corp.

Cleveland Clinic

Globus Medical Inc.

Integra LifeSciences Holdings Corp.

Medtronic Inc.

Medtronic Sofamor Danek

NuVasive Inc.

Pathway Medical Technologies Inc.

SenoRx Inc.

Sonova Holding AG

St. Jude Medical Inc.

Vertos Medical Inc.

Zimmer Holdings Inc.

ev3 Inc.

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