There is a huge need for nonsurgical treatment options to address healing nonunion fractures as well as promoting 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 30years, the company has provided FDA-approved 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, President of Orthofix's BioStim division. "We're also considering expanding 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 experience, recovery processes and data gathering, which augments established clinical success.
Market analysis
Orthofix's PhysioStim™, CervicalStim™, and SpinalStim™ devices 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 spinal fusion market is expected to grow at a compound annual growth rate of 5.3 percent through 2021 to reach $17.27 billion, 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 recommendation supports coverage for pulsed electromagnetic field stimulation devices as an adjunct to spinal fusion surgery. Orthofix’s CervicalStim device is the only FDA-approved bone growth stimulator 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 approval in 2004. The SpinalStim device has a 92 percent clinical success rate as an adjunct to spinal fusion surgery; the CervicalStim 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 spinal devices. Orthofix's BioStim division dates back to 1986 when its first product — PhysioStim — received FDA approval. The PhysioStim device is indicated for treating nonunions acquired secondary to trauma under specific conditions. This year the company 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 billion by the year's end, according to a Future Market Insights report. The market accounts for 20 percent of the global orthobiologics 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 fusion, 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 diagnoses 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 SpinalStim, 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 device reported solid fusion.
The consistent SpinalStim users had a 36 percent increase in fusion success when compared with inconsistent and placebo device users.
Orthofix has built on this clinical success, recently launching the next generation technology with patient enhancements to improve fit, comfort and ease of use.
Mobile App
In January, Orthofix received FDA clearance and the European CE Mark for the next-generation CervicalStim and SpinalStim bone growth stimulators. Devices in the US are now accompanied by the Stim onTrack™ mobile application. Patients can download the app on their smartphones and other mobile devices to track and follow their prescription. The app produces daily reminders and a device usage calendar for patients. It also has a first-to-market feature that enables providing physicians with real-time data on patient adherence to treatment protocol.
In essence, Orthofix helps manage patient education, compliance and reporting as it relates to the device.
"This is a merger between our products and technology advancement to improve outcomes," says Mr. Neimann. "Technology is really finding its way into healthcare, whether its products or services or the way we interact with providers."
The app aims to:
• Facilitate patient compliance
• Improve clinical outcomes
"We developed the mobile application to help facilitate patient compliance and improve clinical outcomes," says Terrence Wright, Vice President of Marketing and International Development at Orthofix. "One of the big advantages of our next generation technology is that it enables physicians to see how patients are adhering to their prescriptions in real time."
The company branched out from the traditional technology and device development to produce the mobile app, providing a tool to help patients take an active role in their recovery. "We are redefining the recovery experience by helping engage patients in their recovery process,” says Mr. Wright.
Healthcare has changed to examine the patient holistically and many organizations seek to provide care on a continuum; the mobile app supports those goals. "Sharing compliance information with the physician and being able to provide the service of helping facilitate the patients' compliance post-surgery is an added service and benefit for the continuum of care in partnership with the physician's office," says Mr. Niemann.
"As we all know, patients who are educated about their postsurgical care are less likely to be readmitted and more likely to have better outcomes," says Mr. Wright. "As part of the postsurgical care, we make personalized follow-up phone calls to help ensure patients understand their treatment regimen and applications for our devices. There are many components of the recovery experience, but our end goal is to provide products and services to help deliver desired clinical outcomes."
New clinical trials
Orthofix is in the process of conducting two IDE clinical trials. The first trial is collecting data on the CervicalStim system for odontoid fractures, according to Orthofix's Chief Scientific Officer James Ryaby, PhD. The prospective, double-blind, randomized, placebo-controlled, multicenter Odontoid Fracture Study plans to enroll 360 patients 50 years old or older at up to 50 sites in the U.S. where patients will be randomized to either receive a placebo control or the company's PEMF therapy with the Orthofix CervicalStim device for six months with total follow-up of one year.
Dr. Ryaby has additional projects examining indications for the technology. He presented data using animal models in March at the Orthopedic Research Society Annual Meeting on PEMF effects on rotator cuff repair, herniated disc repair, as well as a treatment of osteoporosis.
"We aren't currently committed to clinical trials in all of the above indications, but what it says about Orthofix is that we're investing in this type of research to really figure out where other future indications may lead and that's exciting," says Dr. Ryaby.
Finally, the company is also conducting a IDE clinical trial using the PhysioStim device for patients with knee osteoarthritis.
"When we are conducting the PEMF knee clinical trials, from the FDA standpoint, we will more carefully and accurately assess how patients enrolled in the clinical studies are actually complying with the use of the clinical device," says Dr. Ryaby. "We are also preparing a new IDE for the PhysioStim device as an adjunct to rotator cuff repair, where patients enrolled in the study will be able to take advantage of the mobile app which will provide real time compliance monitoring. For patients undergoing the rotator cuff repair, the study will evaluate whether use of the PhysioStim device will increase the rate of repair and early return to full function and strength."
This article is sponsored by Orthofix.