LIFT Home study evaluated the safety and feasibility of ARC-EX Therapy in the home setting
100% of subjects completed the study with no reported serious adverse events
97% of therapy sessions were successfully completed supporting the feasibility of home use
EINDHOVEN, the Netherlands & LAUSANNE, Switzerland & BOSTON, October 05, 2022--(BUSINESS WIRE)--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.
About Spinal Cord Injury
Spinal cord injury (SCI) represents a major unmet medical need for which there is no cure. Approximately 7 million people globally have a spinal cord injury, with over 650,000 in the U.S. and Europe alone. The quality of life of people with SCI can be poor, with paralysis and loss of sensation, issues with blood pressure control and trunk stability, increased potential for infection, incontinence, and loss of sexual function. Assistance is required for daily living activities. And SCI is costly, with the average lifetime cost for a paraplegic (paralysis of the legs) of $2.5 million and $5 million for a tetraplegic (paralysis of all four limbs). Treatments are urgently needed to restore movement and improve quality of life.
About ONWARD Medical
ONWARD is a medical technology company creating innovative therapies to restore movement, independence, and health in people with spinal cord injuries. ONWARD’s work builds on more than a decade of basic science and preclinical research conducted at the world’s leading neuroscience laboratories. ONWARD’s ARC Therapy, which can be delivered by implantable (ARC-IM) or external (ARC-EX) systems, is designed to deliver targeted, programmed spinal-cord stimulation to restore movement and other functions in people with spinal cord injury, ultimately improving their quality of life.
ONWARD has received three Breakthrough Device Designations from the U.S. FDA encompassing both ARC-IM and ARC-EX. ARC-EX is an external, non-invasive platform consisting of a wearable stimulator and wireless programmer. Positive top-line data were reported in September 2022 from the company’s first pivotal study, called Up-LIFT, evaluating the ability of ARC-EX Therapy to improve upper extremity strength and function. The company is now preparing marketing approval submissions for the U.S. and Europe. ARC-IM consists of an implantable pulse generator and lead that is placed near the spinal cord. The company completed its first-in-human use of the ARC-IM neurostimulator in May 2022.
ONWARD is headquartered at the High Tech Campus in Eindhoven, the Netherlands. It maintains an office in Lausanne, Switzerland, and has a growing U.S. presence in Boston, Massachusetts, USA. For additional information about the company, please visit ONWD.com. To access our 2022 Financial Calendar, please visit IR.ONWD.com.
Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company or, as appropriate, the Company directors’ current expectations and projections about future events. By their nature, forward-looking statements involve several risks, uncertainties, and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial effects of the plans and events described herein. A multitude of factors including, but not limited to, changes in demand, competition, and technology, can cause actual events, performance, or results to differ significantly from any anticipated development. Forward-looking statements contained in this press release regarding past trends or activities should not be taken as a representation that such trends or activities will continue in the future. As a result, the Company expressly disclaims any obligation or undertaking to release any update or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions, or circumstances on which these forward-looking statements are based. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person’s officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.
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