A Digital Publication for the Practicing Medical Specialist, Industry Executive & Investor

ONWARD Medical Announces Topline Results from the LIFT Home Study Supporting Safety and Feasibility of ARC-EX Therapy to Treat People with Spinal Cord Injury at Home

ONWARD Medical N.V. (Euronext: ONWD), the medical technology company creating innovative therapies to restore movement, independence, and health in people with spinal cord injury (SCI), today reported topline results from the LIFT Home study, evaluating the safety and feasibility of ARC-EX Therapy when used at home. ARC-EX Therapy is a proprietary non-invasive spinal cord stimulation technology designed to restore movement and other functions in people with spinal cord injury (SCI) and other movement disabilities.

The Company recently reported its Up-LIFT pivotal study evaluating ARC-EX Therapy in clinics achieved its primary endpoint, demonstrating statistically significant and clinically meaningful improvement in upper extremity strength and function.

“Today’s results from the LIFT Home study support the potential for ARC-EX Therapy to be used safely at home, which would enable people with spinal cord injury to live even more independently,” said Dave Marver, CEO of ONWARD. “We expect to launch first in clinics, but as the community gains more experience with ARC-EX Therapy, we envision many patients will also want to use this technology at home.”

“To maximize recovery after spinal cord injury, it’s critical that we develop treatments that can be safely and effectively delivered in the home environment,” said Principal Investigator, Candy Tefertiller, PT, DPT, Ph.D., NCS, Executive Director of Research and Evaluation at Denver’s Craig Hospital. “Integrating home-based therapy not only facilitates opportunities for ongoing recovery, but also allows therapy to focus on more relevant activities for that specific individual.”

The LIFT Home study is a single-arm observational study. The main objective of the study is to evaluate the safety and feasibility of ARC-EX Therapy when used at home. Seventeen people were enrolled at five leading spinal cord injury research centers in the United States: Craig Hospital in Denver, Colorado, Shepherd Center in Atlanta, Georgia, Spaulding Research Institute in Boston, Massachusetts, University of Minnesota, and the University of Washington. Participants performed training on activities of daily living three times per week over a one-month period. Approximately 97% of these sessions were completed without usability issues, supporting the feasibility of home-based treatment. The absence of any device-related adverse events confirmed the favorable safety results observed during the Up-LIFT Study when ARC-EX Therapy was used in clinics.

ONWARD plans to discuss the findings from the LIFT Home study with regulatory authorities to define the appropriate approval pathway for home use, with a goal to facilitate access to ARC-EX Therapy for as long as needed without the burden of continued visits to a clinic.

Medical Device News Magazinehttps://infomeddnews.com
Medical Device News Magazine provides breaking medical device / biotechnology news. Our subscribers include medical specialists, device industry executives, investors, and other allied health professionals, as well as patients who are interested in researching various medical devices. We hope you find value in our easy-to-read publication and its overall objectives! Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

More News!

The Evolut ™ FX+ TAVR system leverages market-leading valve performance with addition of larger windows to facilitate coronary access
The study was an analysis of AstraZeneca’s Phase 2 52-Week clinical trial of tralokinumab in patients with Idiopathic Pulmonary Fibrosis (IPF). The patient data from the trial was processed with Brainomix’s e-Lung tool. The tool is uniquely powered by the weighted reticulovascular score (WRVS), a novel biomarker that incorporates reticular opacities and vascular structures of the lung.
“Since the algorithm for matching patients with donors is changing across for all organs, this was a prime time to better understand whether transplant team decisions to accept a donated organ varied by patient race and gender,” she said. “We wanted to understand how the process of receiving a transplant after listing varied by race and gender, and the combination of the two, so that steps can be taken to make that process more equitable," said Khadijah Breathett, MD.
The Mount Sinai study found that primary care physicians’ approach reflects a dearth of evidence-based guidance for lung cancer screening shared decision-making in patients with complex comorbidities
This is the first ever transplantation of a genetically engineered porcine kidney into a living human recipient.

By using this website you agree to accept Medical Device News Magazine Privacy Policy