SI-BONE, a company focused on the minimally invasive approach to sacroiliac joint fusion, launched an initial public offering in October.
The company's iFuse minimally invasive SI joint device has been commercially available since 2009, and data from 60-plus peer-reviewed journal publications prove the device's effectiveness.
President, Chairman and CEO of SI-BONE Jeffrey Dunn discusses how he has grown the company and where the technology is headed in the future.
Question: As chairman and CEO of SI-BONE since its founding in 2008, what was your strategy for growing the company from an idea to the IPO stage? What were your guiding principles?
Jeffrey Dunn: Since SI-BONE was founded in 2008, our vision has always been to fundamentally transform the lives of people with debilitating back pain caused by SI joint dysfunction with our unique, patented and clinically proven technology. We've accomplished this over the last 10 years by taking a high-level scientific approach, including well-designed and well-executed clinical studies that have proven the safety, effectiveness, quality of life and health economic benefits of our iFuse Implant System®.
More than 60 peer-reviewed publications, including data from three prospective multicenter trials, support the safety and effectiveness of the procedure. No other SI joint fusion device on the market is supported by this level of clinical evidence. With this approach as our foundation along with significant investments in education, we continue to invest in ongoing clinical trials to ensure patients receive lasting relief from the pain caused by SI joint dysfunction.
Q: How has the SI joint fusion arena changed over the past decade? How has SI-BONE taken advantage of being an early mover in the minimally invasive SI joint fusion space?
JD: Studies show that the SI joint is the source of pain in 15 to 30 percent of patients with chronic lower back pain. Despite the prevalence of SI joint dysfunction, treatment options available prior to 2009 were morbid, invasive, had modest success rates and high complication rates. As such, most doctors did not focus on the SI joint as a source of chronic lower back pain given there was no patient-friendly or surgeon-friendly solution and misdiagnoses were common. A better understanding of the role of SI joint dysfunction in causing chronic pain — and new treatment options for patients — were needed.
As the pioneer in the minimally invasive SI joint fusion space, 35,000 SI-BONE iFuse Procedures™ have been performed by over 1,700 surgeons in the United States and 33 other countries around the world. Being an early mover has enabled us to secure exclusive reimbursement relationships through the development of unmatched clinical data, and to create a unique, patented design and solution that is delivering outcomes that are changing lives. But, we've only scratched the surface in helping patients with SI joint dysfunction. There is a significant, addressable and growing market opportunity for iFuse with 279,000 eligible patients each year in the United States alone, translating to a $2.7 billion market opportunity.
Q: How has the payer landscape changed and responded to SI-BONE? How do you expect it to continue evolving in the future?
JD: Our robust published clinical evidence demonstrates clinically important patient benefits, including reduced pain and incidence of opioid use among patients treated with iFuse as well as improved patient function and quality of life. In today's healthcare environment, payers demand high-quality clinical evidence that demonstrates safety, effectiveness, low revision rates and economic value in order to provide coverage.
SI-BONE has worked diligently with both payers and societies to establish strong and often exclusive reimbursement coverage. Our unparalleled clinical evidence has enabled us to establish positive coverage decisions from 44 of the 65 largest private payers as well as 26 iFuse exclusive commercial coverage policies, covering more than 47 million lives. We also have exclusive positive coverage for iFuse with the French National Healthcare System, and iFuse is the only product recommended for treatment of SI joint dysfunction by the UK National Institute for Health and Care Excellence. We are not aware of any other SI joint fusion product that has the clinical data to support equivalent claims or that has given rise to these exclusive positive coverage policies and recommendations.
Q: What are SI-BONE's plans over the next five to 10 years? How will the company grow differently post-IPO?
JD: The proceeds from our offering will enable us to continue to expand our commercial footprint in the United States and overseas, and better target the hundreds of thousands of patients suffering from low back pain caused by SI joint dysfunction.
We plan to use our recent capital infusion to aggressively invest in growth over the next five to 10 years, by expanding sales and marketing efforts, educating and training thousands of new surgeons and medical professionals, and investing in other product development and other market expansion opportunities. As well, our focus now and into the future as a team is to be an exemplary support team to the surgeons who can help all these patients and that means delivering superior sacropelvic products and instruments, robust clinical evidence, working to make sure the patients they treat have the payer coverage, great operating room support and educational programs.