Does the US really want less invasive spine technologies?
Does the US really want less invasive spine technologies? (LinkedIn article written by David Hooper, Founder and CEO of Minimus Spine)
I have been working in the spine industry for 18 years. I started my career with Spinal Concepts in 1999- three years into its run. We were developing pedicle screws, cervical plates and interbody cages. We were one of a handful of companies competing against much larger players. Today, it is difficult to count how many small companies are fighting it out in the ‘hardware’ business. Spinal Concepts was everything a successful start up should be: great people, interesting work, opportunities for advancement and a nice exit.
Spinal Concepts was acquired by Abbott Laboratories in 2003 and the mandate was to grow the business. The grand strategy was to commercialize products to treat patients earlier in the continuum of care, less invasively, and to reduce cost. The industry, as a whole, has been echoing these tenets for years with little to show for it.
I started Minimus Spine in 2006 to do my small part in accomplishing the grand strategy. While discectomy and fusion can effectively reduce pain for many patients, its a scary proposition and does not work for everyone. Spine pain can come from any number of sources making a specific diagnosis and treatment challenging. Some patients get worse with surgery. It is a significant decision and patients only opt for surgery because they are in debilitating pain and have exhausted their options. Minimally invasive procedures that can avoid or even delay spine surgery are worth pursuing.
In 2006, a number of physicians had been publishing positive experiences using an intradiscal injection of ozone to treat a disc herniation. That was the first signal of the opportunity and we developed Triojection to improve upon the equipment being used by those first pioneers. Since 2006, there have been many more studies reporting positive outcomes (Gallucci 2007, Zhang 2013 and Perri 2016). The mechanisms of action have been elucidated to include reducing both the size of the disc herniation and the associated inflammation (Murphy 2016). MRI studies have quantified the reduction in disc volume at 6 months (Lenhert 2012) and out to 3 years- without long-term degeneration of the disc itself (Bruno 2017). Intradiscal ozone is well tolerated and the major risks have been identified through clinical experience. Minimus joined the scientific effort in 2015, sponsoring the first ever, randomized study comparing Triojection to discectomy. All of this work has been conducted outside the US. Why, you ask?
Intradiscal ozone injection is not FDA approved and will require US clinical trials. Unquestionably, the cost and time associated with FDA clinical trials are difficult for any small company to bear and a significant amount of outside capital is almost always necessary. Given the uncertainty associated with any FDA approval process, most large institutional investors have shied away from companies facing US trials, waiting until they either secure FDA approval or can demonstrate market traction overseas. In response, angel investors have taken a greater role in early stage funding and micro funds are now being created to address the market need. However, there remains a funding gap between development and FDA approval. Without larger institutional funding to support clinical trials, spine technology in the US appears destined to largely remain stuck in the infamous year of 1976. That was the year that FDA set the bar at ‘substantially equivalent.’ Since that time, new products either need to be substantially equivalent to old products (pre-1976) or supported by rigorous clinical trials and approved by FDA. Given the funding gap, many companies are choosing to commercialize their most promising products overseas.
At what point should society direct FDA to consider relaxing (not eliminating) the US regulatory requirements? Assuming a spine procedure can be reasonably demonstrated as safe (e.g. thousands of patients similarly treated overseas), shouldn’t patients have reasonable access to these technologies outside the scope of blinded, randomized clinical trials? We put faith in the doctor patient relationship. Physicians explain treatment options to patients, who in turn weigh the risks and benefits, then choose the treatment appropriate for them. I routinely take calls from US physicians and patients that have clearly done homework on our technology. They understand that it may or may not help them, but they would accept the risks to avoid surgery.
Epidural steroid injections are ubiquitous. Steroid injections are not FDA approved to treat spinal pain but there are millions of these procedures done each year because the marginal benefit outweighs the risk. IDET is a classic example of a less invasive technology that was commercially successful for a number of years but ultimately fell out of favor. The results of IDET were in fact marginal and it was probably over utilized for a time. Even so, it did help a percentage of patients and did little harm.
In today’s world, nascent, less-invasive spine technologies increasingly require broad, yet judicious, support from spine physicians. Not only from surgeons but also the physicians most likely to perform these less invasive procedures, those in interventional radiology, pain management and anesthesiology. These specialties will need to sincerely come together to support the common goal- improving the outcomes for spine patients. Industry needs to do its part too and follow through on the long stated ambition of developing products that are less invasive and reduce the cost of care. Whether it is ozone, stem cells, or the next promising treatment, the clinical evidence should be given the opportunity to grow and the markets should be empowered to decide. That has been the basis of the European model. Patient outcomes are reported in medical journals and increasingly through social media venues such as spine-health.com. If a procedure lacks sufficient efficacy, it will be abandoned in due course. Given the issues with spine surgery, the escalating cost of care, and rampant opioid abuse in this country, we in the US should consider giving patients easier and earlier access to these less invasive treatments.
For you readers that are industry insiders, spine physicians or patients, if you had a painful herniated disc and an epidural steroid injection didn’t help, would you choose Triojection, surgery or just endure until the pain resolved? I’m certainly biased, but I know what I would do.
With respect to Minimus, the business decision for now is to stay lean and focus our efforts in Europe, where we can commercialize our product today. With a bit of good fortune, we will find the resources to do just that.