You’d be hard-pressed to argue that the past decade hasn’t been a good one for medical device companies focused on the spine (Especially with me. Full disclosure: I’m involved in two spine startups. I’m on AxioMed’s technical advisory panel and I’m a minority shareholder of Innovative Surgical Designs. At the time of this writing, I also own shares of TranS1).
Sometimes it seems like you can’t swing a pedicle screw without hitting a new spine start-up. Anthony Viscogliosi recently estimated that are 200 venture capital-backed spine companies.
Similarly, a recent blog post by Duke Prof. Larry Boyd lists about 200 spine companies in alphabetical order. A second blog post, by HealthPoint Capital back in 2004, mentions that they are aware of 202 spine companies.
However, based on the number of exhibitors at recent North American Spine Society, Spine Arthroplasty Society, International Meeting on Advanced Spine Techniques and the American Academy of Orthopaedic Surgeons, I think these estimates might even be low.
In any case, market conditions have been favorable for spinal start-ups. Why? Well, approximately 80 percent of Americans complain of lower back pain at some time in their lives, so the potential market is huge.
Traditional surgical treatments have 75 percent to 85 percent good to excellent results. Newer medical devices and physical therapy show similar results.
But so does doing nothing. In fact, I’d wager that a double-blind, prospective clinical trial of thermal-auricular therapy — which is purported to draw out evil spirits — would also result in 75 percent to 85 percent good to excellent results.
In other words, there is an unmet need for a truly superior remedy for back pain. The fact that the spine is so complex leaves open the door for a huge variety of potential solutions.
The size of the market has also proved a fertile M&A ground. Two of the biggest in recent years, focused pretty much on a single product, are DePuy Spine’s acquisition of the Link Spine Group (for the Charité disc) for $325 million and Medtronics’ acquisition of Kyphon (for their vertebroplasty business) for $3.9 billion. Kyphon had just purchased St. Francis Medical for $725 million.
So, clearly, we have a huge, unmet need and a large number of smart people at large and small companies working on (and spending lots of money on) this problem. Why don’t we have a better solution?
I don’t think anyone knows the answer, but it has to start with the fact that, in most cases, we don’t even really know what the source of the patient’s pain is. Sure, if they have a disc that has recently bulged out and is now compressing a nerve root, there is a smoking gun.
However, the sensitivity and specificity of current diagnosis techniques is poor: Many people have pain without changes visible by current techniques and many other people have changes visible with one or more techniques but no pain.
Which company will win this race for a superior treatment for back pain? It looks like you might have a 0.5 percent chance if you pick a current entrant. If only it didn’t hurt so much to lay in bed at night waiting for the winner.