Stryker Corporation announced this week (August 22) the pending purchase of Vertos Medical, Inc., a 19-year-old, California-based company that pioneered one of the most minimally invasive procedures for treating lumbar spinal stenosis (LSS) there is. No terms were disclosed.
Adding Vertos’s mild® procedure to its spine surgery portfolio expands, in a novel and strategic way, Stryker’s presence in the world of pain docs, ASCs, and other outpatient spine care providers.
Vertos’s signature product—a procedure brand named ‘mild®’—is an uber-minimally invasive approach for relieving pain and improving mobility for patients suffering from lumbar spinal stenosis. FDA cleared the mild® procedure in in 2006. It is an image-guided treatment for lumbar spinal stenosis which does not require an implant, general anesthesia, stitches, or overnight hospital stay.
Medicare and many private insurers cover the mild® procedure. Well over 30,000 patients have been treated to date. Its safety and efficacy are chronicled in 13 clinical studies, reported in more than 25 publications.
Finally, 14 months ago, Vertos closed a $26 million financing led by Palo Alto-based Northwest Venture Partners.
Vertos Medical, Inc.
Dave Solsberg, M.D. and Don Schomer, M.D., radiology partners at the time in Denver, Colorado, founded Vertos in 2005. “We wanted to find a better way of treating patients with lumbar spinal stenosis,” remembers Dr. Solsberg today. Solsberg’s father-in-law, who was suffering from lumbar spinal stenosis, was treated with lumbar laminotomy and decompression—to very poor results. While his surgery was performed well, pre-existing complications undermined his outcome.
Trained in neurosurgery at the University of Toronto, Solsberg was fairly certain that a better, much less invasive approach to lumbar spinal stenosis was possible.
He began to research the etiology of spinal stenosis and stumbled upon an intriguing European approach to lumbar spinal stenosis—the unilateral mini-laminectomy. Not only did that approach avoid the level of tissue damage inherent in a full laminectomy with decompression, it also appeared to deliver comparable pain relief. Furthermore, the research suggested there was a connection between vascular compression and pain.
“I hypothesized that mitigating claudication and increasing blood flow could reduce pain. Furthermore, I felt that most patients would be fine with 50% pain relief with a much less invasive approach.”
Specifically, Solsberg was thinking about the ligament that runs along the back of the spinal canal, connecting vertebrae and stabilizing the spine. Known as the ligamentum flavum, when stressed and inflamed will thicken, impinging the nerves in the spinal canal.
Maybe, thought Solsberg, less is more. Why go all the way to surgery, a laminectomy with decompression? Just address the bulging ligamentum flavum.
Teaming up with one of his radiology partners, Don Schumer, M.D., Solsberg raised a little money, founded Vertos and hired a machinist to build the first set of tools and a couple of former Kyphon executives to get the company started.
First in man case, a patient with degenerative lumbar spinal stenosis with ligamentum flavum hypertrophy, was performed at the VA Hospital in Denver. The patient had a good outcome.
In 2007, Solsberg and Schomer hired a CEO. Then the ventures firms piled in. As Vertos made the turn from an R&D company to a marketing and commercial enterprise, Solsberg and Schomer found themselves out of the company they founded. According to Solsberg, all original investors significantly diluted and, effectively, wiped out.
Now Stryker Corporation is about to buy the company Solsberg and Schomer started.
The MOTION Study
Millions of people, globally, endure pain and, often, disability from lumbar spinal stenosis. Among the 13 clinical studies which tested Solsberg’s hypothesis are these two.
The MOTION study, designed by researchers Timothy Deer, Shrif Costandi, Edward Washabaugh, Timothy Chafin, Sayed Wahezi, Navdeep Jassal and Dawood Sayed, measured, in a prospective, randomized way, the Vertos approach. The study, named MOTION, employed BOTH objective and patient-reported outcomes to compare Vertos’s mild® procedure with conventional medical management of lumbar spinal stenosis.
The control arm (n=67) was conventional medical management, and the testing arm (n=64) was Vertos’s mild® approach plus conventional medical management.
Two years after treatment, the differences between the two groups was stark, with the mild® group showing statistically significantly better outcomes. Every outcome measure (Oswestry Disability Index, Numeric Pain Rating Scale, and Zurich Claudication Questionnaire, validated Walking Tolerance Test, rate of subsequent lumbar spine interventions, and safety data) favored Vertos’s mild® procedure. There were no adverse events in either group.
Quoting from the 2022 study, which was published in the online journal Pain Practice, “The durability of mild + conventional medical management (CMM) for this patient population was demonstrated for all efficacy outcomes through 2 years. Improvements in walking time from baseline to 2 years for patients treated with mild + CMM were significant and substantial. The lack of reported device or procedure-related adverse events reinforces the strong safety profile of the mild procedure. These results provide support for early interventional treatment of symptomatic LSS with the mild procedure”.
Here are two charts from the study which show the extent to which mild® exceeded conventional medical management outcomes.
The mild® procedure, which typically takes less than an hour, entails:
- No large incision
- No general anesthesia
- No implants
- No steroids or opioids
- Patients can shower the next day (just don’t scrub the incision site).
Stryker Corporation and Vertos Medical, Inc.
Stryker’s purchase of Vertos hasn’t closed yet; it’s subject to the usual due diligence and other closing conditions. The two companies continue to operate independently.
But this deal is happening. For Stryker, it’s a notable strategic acquisition and will expand Stryker’s presence in a fast-growing spine care segment.
But it’s also another sign that the practice of orthopedics and spine care is transitioning to a procedure dominant profession—image guided, navigated, robot assisted, pre-planned—and certainly minimally invasive.
