Issue link: https://beckershealthcare.uberflip.com/i/829284
31 Executive Briefing Orthofix has built on this clinical success, recently launching the next generation technology with patient enhancements to im- prove 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 accom- panied by the Stim onTrack™ mobile application. Patients can download the app on their smartphones and other mobile de- vices 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, compli- ance and reporting as it relates to the device. "This is a merger between our products and technology ad- vancement to improve outcomes," says Mr. Neimann. "Technol- ogy 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 pa- tient compliance and improve clinical outcomes," says Terrence Wright, Vice President of Marketing and International Develop- ment at Orthofix. "One of the big advantages of our next gen- eration technology is that it enables physicians to see how pa- tients are adhering to their prescriptions in real time." The company branched out from the traditional technology and device development to produce the mobile app, provid- ing 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 infor- mation 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 partner- ship with the physician's office," says Mr. Niemann. "As we all know, patients who are educated about their post- surgical care are less likely to be readmitted and more likely to have better outcomes," says Mr. Wright. "As part of the postsur- gical care, we make personalized follow-up phone calls to help ensure patients understand their treatment regimen and appli- cations for our devices. There are many components of the re- covery 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 Offi- cer James Ryaby, PhD. The prospective, double-blind, random- ized, 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 re- ceive a placebo control or the company's PEMF therapy with the Orthofix CervicalStim device for six months with total fol- low-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 as- sess 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 un- dergoing 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." Orthofix International N.V. is a diversified, global medical device company focused on improving patients' lives by providing re- constructive and regenerative orthopedic and spine solutions to physicians worldwide. Headquartered in Lewisville, Texas, the Company has four strategic business units: BioStim, Biologics, Extremity Fixation and Spine Fixation. For more information, please visit www.orthofix.com. "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. " - Terrence Wright of Orthofix