3-month results show the
Altius® System significantly reduces pain,
decreases opioid use, and improves patient quality of life
ALISO
VIEJO, Calif., May 22, 2024
/PRNewswire/ -- Neuros Medical, Inc. announced today acceptance for
publication of the 3-month results from the landmark QUEST Study
demonstrating treatment with the Altius® Direct Electrical
Nerve Stimulation System results in immediate and lasting pain
reduction, decreased opioid use, and improved quality of life in
patients suffering with chronic post-amputation pain. The study,
which enrolled 180 patients with a unilateral lower limb amputation
across 35 sites in the U.S., is the largest prospective,
double-blinded, randomized study ever conducted for treatment of
chronic post-amputation pain.
Summary of 3-Month Results
Primary efficacy and safety
endpoints were met, demonstrating superiority of treatment over
active-sham control. Patients receiving Altius® treatment also
experienced the following benefits compared to control
patients:
- Highly statistically significant reduction in acute pain at 30
minutes after initiating treatment that increased significantly at
120 minutes.
- 32% reduction in daily average pain scores, indicating a
lasting effect of the treatment on their pain profiles.
- 56% decrease in opioid use.
- 39% improvement in quality of life.
The study authors concluded that treatment with the
Altius® System represents a significant advancement for lower
limb amputees suffering with chronic post-amputation pain where
there is currently a lack of effective treatment options.
Highlights from the 3-month results were presented at the
16th World Congress of the International Neuromodulation
Society earlier this month by Dr. Leonardo Kapural MD, PhD,
Professor of Anesthesiology at Florida
Atlantic University and Partner at Carolinas Pain Institute
and the QUEST Study National Principal Investigator.
"We have never seen a study of this magnitude and rigor in this
patient population," said Dr. Kapural. "The data demonstrated clear
and lasting benefit of treatment for pain reduction and functional
outcomes at three months, creating great optimism for the long-term
study results. These findings represent a significant advancement
for an at-risk and underserved patient population in desperate need
of reliable and effective treatment."
"On behalf of the entire Neuros organization, I would like to
thank the principal study site investigators and their teams for
outstanding clinical execution and patient centric care," said
David Veino, President & CEO,
Neuros Medical. "The QUEST primary endpoint data demonstrates to
the amputee community that relieving pain and restoring life is
more than just hope, it's now a reality. We look forward to the
longer term 12-month results being published later this year."
About the QUEST Study
The QUEST Study is a multicenter, double-blinded, randomized,
active-sham controlled pivotal study designed to assess the
efficacy and safety of the Altius® Direct Electrical Nerve
Stimulation System in patients with chronic post-amputation lower
limb pain. The Investigational Device Exemption (IDE) study
enrolled 180 patients with a unilateral lower limb amputation
across 35 sites in the U.S. Patients were randomized 1:1 to active
treatment or active sham groups with a single arm cross-over to
active treatment at 3 months and follow-up to 12 months. The
primary efficacy endpoint was at least a 50% pain reduction in at
least 50% of treatment sessions 30 minutes after initiating
treatment. Secondary efficacy endpoints included at least a 50%
pain reduction in at least 50% of treatment sessions after 120
minutes, change in opioid medication use, and improvement in
quality of life. The primary safety endpoint was incidence of all
serious adverse events.
About the Altius® Direct Electrical Nerve Stimulation
System
The Altius® System is a patient-controlled, on demand
system that uses Neuros' patented technology to address the
underlying cause of post-amputation pain by inhibiting pain signal
transmission from the damaged peripheral nerves near the site of
amputation to the central nervous system. The system consists of a
nerve cuff electrode placed around an affected nerve and an
implantable pulse generator (IPG). Patients initiate an on-demand
30-minute treatment session as needed for targeted pain relief.
Caution – Investigational Device. Limited by Federal (or
United States) law to
investigational use.
About Neuros Medical, Inc.
There are nearly two million amputees in the U.S., with 185,000
new amputations occurring every year. Post-amputation pain includes
both phantom limb pain and residual limb pain, and impacts nearly
one million Americans, representing a significant unmet medical
need, as existing treatment options are limited and consist
primarily of opioids and gabapentinoids. Neuros Medical is a
privately held company and the maker of the Altius® Direct
Electrical Nerve Stimulation System designed for the treatment of
chronic post-amputation pain. Our mission is to reduce pain and
restore life for people suffering with post-amputation pain. We are
a passionate team guided by our core values and committed to our
patients and the healthcare professionals who care for them.
Our Core Values: Patients First, Deliver Excellence, Responsible
Ambition, Inspire and Empower.
For additional information regarding Neuros Medical, please
contact:
Steve Bosrock,
Vice President, Marketing
sbosrock@neurosmedical.com
www.neurosmedical.com
Tel: 440-951-2565
View original content to download
multimedia:https://www.prnewswire.com/news-releases/landmark-study-of-a-revolutionary-device-for-the-treatment-of-post-amputation-pain-accepted-for-publication-in-the-journal-of-pain-research-302152023.html
SOURCE Neuros Medical