Becker's Spine Review

Becker's Spine Review May/June 2017

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30 Executive Briefing Innovation in Bone Growth Stimulation and Healing: How Orthofix's Technology & New App are Changing the Game By Laura Dyrda T here is a huge need for nonsurgical treatment options to address healing nonunion fractures as well as promot- ing bone growth for spinal fusion patients. The patented pulsed electromagnetic field technology from Orthofix helps to fill that void by using uniform, low-level electromagnetic fields to activate and augment the body's natural healing process. For the past 30 years, the company has provided FDA-ap- proved bone growth stimulators to orthopedic patients and now is focused on developing next generation technology and establishing new clinical indications. "We believe in investing in this space and are committed to this technology and future development," says Brad Niemann, Pres- ident of Orthofix's BioStim Division. "We're also considering ex- panding the therapeutic treatment into other areas such as soft tissue repair and new bone applications. It's an investment and commitment to the technology and product enhancements we've made and will continue to make as we invest in clinical trials to expand indications for the technology." Orthofix is also stepping into the new value-based healthcare economy with digital technology to enhance the patient experi- ence, recovery processes and data gathering, which augments established clinical success. Market analysis Orthofix's PhysioStim™, CervicalStim™ and SpinalStim™ de- vices are designed to help activate and augment the natural healing process, which is invaluable to thousands of people who suffer from nonunion fractures or undergo spine fusion surgeries every year. Six million people suffer bone fractures every year and around 300,000 are slow to heal or don't heal at all, according to the American Academy of Orthopaedic Surgeons. The global spi- nal fusion market is expected to grow at a compound annual growth rate of 5.3 percent through 2021 to reach $17.27 bil- lion, according to a MarketsandMarkets report. Last October, the North American Spine Society issued a first- of-its kind coverage recommendation related to electrical bone growth stimulators. The policy's evidence-based recommenda- tion supports coverage for pulsed electromagnetic field stimu- lation devices as an adjunct to spinal fusion surgery. Orthofix's CervicalStim device is the only FDA-approved bone growth stim- ulator for use as a non-invasive adjunctive treatment to cervical fusion, and its SpinalStim device is the only FDA-approved bone growth stimulator for use as both a lumbar spinal fusion adjunct and treatment option for failed spinal fusion patients." Coming off the positive coverage recommendations from a credible medical organization such as NASS, we have received a lot of physician support and interest in the products," says Mr. Niemann. The first generation SpinalStim device'stechnology received FDA approval in 1990 and the CervicalStim device received ap- proval in 2004. The SpinalStim device has a 92 percent clinical success rate as an adjunct to spinal fusion surgery; the Cervi- calStim device's overall clinical success rate is 84 percent. The devices followed the IDE-PMA pathway as class III devices and the company is now producing next generation technology. However, the company's experience in the field goes beyond spi- nal devices. Orthofix's BioStim division dates back to 1986 when its first product — PhysioStim — received FDA approval. The Phys- ioStim device is indicated for treating nonunions acquired sec- ondary to trauma under specific conditions. This year the com- pany is building on the strength of its BioStim division. In 2016, Orthofix reported BioStim's net sales grew 7 percent year-over- year and investments in ongoing clinical trials and innovation. Overall, the bone growth stimulator market was valued at $922.2 million in 2014 and expected to grow at a compound annual growth rate of 9.5 percent through 2025, hitting $2.5 bil- lion by the year's end, according to a Future Market Insights re- port. The market accounts for 20 percent of the global orthobi- ologics market and North America is expected to lead the way. Clinical data Several studies over the past two decades prove Orthofix's technology clinically effective at promoting spinal fusion and bone healing. A May 2008 study published in Spine showed the effectiveness of CervicalStim technology to promote fusion. In a group of 323 patients who underwent anterior cervical discectomy and fu- sion, researchers randomly assigned patients to receive PEMF stimulation after surgery or no PEMF stimulation. Otherwise, postoperative care was similar between the two groups. Patients in both groups reported comparable baseline diagno- ses and number of operative levels. Six months after surgery, the patients in the PEMF group reported higher fusion rates — 83.6 percent — than the control group — 68.6 percent. A separate clinical study examined the success rate of SpinalS- tim, including 54 surgeons at 31 centers. Patients participating in the prospective, randomized double-blinded trial underwent lumbar fusion with SpinalStim as an adjunct to fusion. One year after surgery 92.2 percent of the patients reported solid fusions while 67.9 percent of the patients who received a placebo de- vice reported solid fusion. The consistent SpinalStim users had a 36 percent increase in fusion success when compared with inconsistent and placebo device users. Sponsored by

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