Twelve-Month Results from Landmark QUEST Study Published in Neuromodulation

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Sep 26, 2024, 08:15 ET

Long-term results show Altius® delivers significant and lasting pain reduction, decreases in opioid use, and improvements in quality of life for amputees suffering from debilitating chronic post-amputation pain

ALISO VIEJO, Calif., Sept. 26, 2024 /PRNewswire/ -- Neuros Medical, Inc. announced today publication of the 12-month results from the landmark QUEST study. These long-term results demonstrated treatment with the FDA approved Altius® Direct Electrical Nerve Stimulation System results in clinically significant and lasting pain reduction, decreased opioid use, and improved quality of life in amputees suffering with chronic post-amputation pain.¹ The study enrolled 180 patients with a unilateral lower limb amputation across 35 sites in the U.S. and is the largest prospective, double-blinded, randomized study ever conducted for treatment of chronic post-amputation pain.

Highlights from the 12-Month Results¹Patients receiving treatment with the Altius® System reported the following results:

30% and 50% reduction in pain 30 minutes and 120 minutes after initiating therapy, respectively (both clinically meaningful and significant per expert consensus (IMMPACT))
Continued reduction in daily pain levels through 12 months
50% reduction in days with pain
81% of patients taking opioids decreased or eliminated opioid use
45% improvement in quality of life

The study authors concluded the Altius® System delivered sustained, on-demand pain relief, reduced opioid utilization, and improved quality of life for lower limb amputees suffering with chronic post-amputation pain.

Click the link to read the full results: https://authors.elsevier.com/sd/article/S1094-7159(24)00675-5

"Chronic post-amputation pain is a debilitating condition affecting a large majority of lower limb amputees and persists over long periods of their lifetime," said Dr. John Eidt, MD, Chief of Vascular Surgery at Baylor Scott and White Heart and Vascular Hospital in Dallas, Texas, and QUEST investigator. "An ideal treatment needs to be on-demand, patient-controlled and provide lasting reduction in pain without the risk of addiction associated with opioids. QUEST demonstrated a clinically significant reduction in pain sustained through 12 months, allowing patients to reduce or eliminate the use of opioids. The Altius® System has the potential to be the gold standard for treatment of chronic post-amputation pain."

"The 12-month results of the QUEST study demonstrate the Altius® System delivers long-term, lasting results and significant quality of life improvements for patients suffering from chronic post-amputation pain," said David Veino, President & CEO, Neuros Medical. "We look forward to working with health care providers to make the Altius® System available to their patients."

Neuros plans to begin commercialization of the Altius® System later this year. Please visit www.neurosmedical.com for more information.

Click here for important safety information.

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.

The Altius® System is indicated as an aid in the management of chronic intractable phantom and residual lower limb post-amputation pain in adult amputees.

About Neuros Medical, Inc.

There are nearly two million amputees in the U.S., with 185,000 new amputations occurring every year.^2,3Post-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.

References

¹ Kapural L., Kim B., Eidt J., Petersen E.A., Schwalb J.M., Slavin K.V., Mekhail N. 2024. Long-Term Treatment of Chronic Postamputation Pain With Bioelectric Nerve Block: Twelve-Month Results of the Randomized, Double Blinded, Cross-Over QUEST Study. Neuromodulation 2024;-: 1–10.

²Ziegler‐Graham K, MacKenzie EJ, Ephraim PL, et al., Estimating the prevalence of limb loss in the United States: 2005 to 2050. Arch Phys Med Rehabil. 2008;89:422–42.

³Owings MF, Kozak LJ. Ambulatory and inpatient procedures in the United States, 1996. National Center for Health Statistics. Vital Health Stat 13(139). 1998.

For additional information regarding Neuros Medical, please contact:

Steve Bosrock, Vice President, Marketing
sbosrock@neurosmedical.com
www.neurosmedical.com
Tel: 440-951-2565

SOURCE Neuros Medical