This new phase of clinical research will test the safety and feasibility of ANEUVO's non-invasive therapy for future use by individuals living with chronic spinal cord injury (SCI)
ANEUVO
ExaStim®
Study Highlights:
The study, which will focus on improving upper limb motor function, will enroll an estimated 30-35 participants who were participants of the initial ASPIRE trial. Conducted as a single-arm, prospective, observational study and expected to take six months from enrollment to completion, all participants will receive ExaStim therapy for the entire study duration.
Participants will have no restriction on the number of stimulation sessions. However, there will be a minimum and maximum amount of stimulation time they can engage in weekly to provide the most accurate insights into the device's real-world applications outside of a clinical setting.
The clinical teams at Marquette University College of Health Sciences in Milwaukee, Spaulding Rehabilitation Hospital in Boston, Craig Hospital in Denver, Kennedy Krieger Institute in Baltimore, and TryAbility Neurorecovery Center in Chicago will collect the study data.
"Testing ExaStim in a home environment represents an important step forward in understanding how daily use of this technology can empower individuals with chronic spinal cord injuries,” said Dr. Randy Trumbower, Principal Investigator for the study at Spaulding Rehabilitation Hospital in Boston, MA. "This research phase will help us evaluate the device's impact beyond the clinic, potentially offering a new level of accessibility and independence.”
The original ASPIRE™ trial, which focused on evaluating the safety and efficacy of ExaStim® in a clinical setting, completed enrollment across 14 sites in the United States. With more than 120 participants completing the study, this foundational research provided key data that laid the groundwork for the ASPIRE Home Study.
By enabling participants to perform ExaStim therapy at home, the ASPIRE Home Study aims to evaluate how this non-invasive device can fit into patients' everyday lives, potentially increasing adherence and effectiveness.
For more information about ANEUVO and the ASPIRE Home Study, visit www.aneuvo.com.
Caution: Investigational device. Limited by United States law to investigational use.
About ANEUVO
ANEUVO is developing revolutionary bioelectronic medicine to help restore functional independence, improve quality of life, and create a healthier and more equitable world for people living with chronic diseases and conditions. Leveraging the company's advanced biotechnology platform and deep expertise, ANEUVO is tackling critical healthcare challenges to deliver meaningful solutions to underserved patients in need. For more information, visit www.aneuvo.com.
Attachments
CONTACT: Diane Mulligan
ANEUVO
720-273-0927
dmulligan@mandccommunications.com
