NEW YORK--(BUSINESS WIRE)--Kaia Health, the digital therapeutics company on a mission to democratize access to healthcare, today announced results of the first comprehensive safety study of a musculoskeletal (MSK) digital therapeutic, further demonstrating Kaia Health’s ability to deliver high-quality, equitable care to patients, anywhere and at any time. In the study population, fewer than 1% of Kaia Health MSK solution users reported any adverse events (AEs). Additionally, no relationship between gender and the reporting of adverse events was found.
Published in the peer-reviewed JMIR Human Factors, the study evaluated the safety profile of the Kaia Health MSK solution by performing a comprehensive assessment of reported AEs by nearly 140,000 users. Study authors reported that AEs involving Kaia Health’s digital therapy were consistent with those reported for in-person therapies for low back pain.
"This study highlights the importance of, and historical lack of, adverse event reporting in digital therapeutics,” said Deeptee Jain, M.D., orthopedic spine surgeon at Washington University in St. Louis and co-author of the study. “The findings are encouraging, given that the overall rate of reported adverse events was very low and generally consistent with those described for in-person therapies for low back pain.”
Using a standardized process for post-market surveillance of patient-reported outcomes, the observational study analyzed messages sent by users via the Kaia Health MSK app. These messages were then analyzed to determine if they described an AE. By integrating patient-reported outcomes into the assessment of digital rehabilitation apps, Kaia Health continues to demonstrate its dedication to providing safe, clinically validated, and equitable digital MSK care.
“This study provides the first and only comprehensive assessment of reported adverse events associated with real-world use of digital therapeutics for lower back pain,” said Justin Yang, M.D., Kaia Health Chief Medical Officer, U.S. Commercial. “Investigating both the efficacy and safety of our MSK pain solution is hugely important. This latest study further demonstrates Kaia Health’s ability to make safe, high-quality care accessible to all patients—wherever they are in their journey—and deliver the best outcomes.”
Kaia Health is the world’s most clinically validated digital MSK pain solution and covers 60 million lives globally. A recent clinical study demonstrated that its patented motion analysis technology is as accurate as a physical therapist in suggesting exercise corrections, while demonstrating consistent care across gender, age, body mass index (BMI), and location of pain. Pairing the accuracy of motion analysis technology with the safety profile of the Kaia Health MSK solution, patients are able to access safe, accurate, equitable therapy from the comfort of their homes.
About the digital therapeutic safety study
This study evaluated the safety profile of Kaia Health by performing a comprehensive assessment of reported AEs among 138,337 active users as captured by a standardized process for post-market surveillance. Relevant messages sent by users via the app were collected according to a standard operating procedure regulating post-market surveillance of the device. These messages were then analyzed to determine if they described an AE. Messages describing an AE were then categorized based on type of AE, seriousness, and relatedness to the app, and they were described by numerical counts. Of the active Kaia Health app users, 125 (0.09%) reported at least one AE, and just 0.00014 AEs per active day on the app were reported.
Media inquiries
Kaia Health Chief Medical Officer, U.S. Commercial, Justin Yang, M.D., and Kaia Health President Nigel Ohrenstein are available for interviews.
About Kaia Health
Kaia Health is a digital therapeutics company that creates accessible, evidence-based treatments for a range of conditions, including MSK pain and COPD. Kaia Health covers 60 million lives globally, and its clinically proven motion analysis capability is transforming and democratizing healthcare through technology that patients can access anytime, anywhere, with the camera of their smartphone or tablet. Kaia Health is the most clinically validated digital MSK provider, and its motion analysis technology is as accurate as physical therapists in suggesting exercise corrections, resulting in equitable care regardless of BMI, age, gender, or location. Kaia Health is a member of the Digital Therapeutics Alliance (DTA) and has offices in New York and Munich. Learn more at www.kaiahealth.com.
