ASPN Top Abstract awarded for analysis
demonstrating benefits associated with the
Evoke® System's utilization of objective measurements to achieve
maximum analgesic effect for SCS
Separate analysis suggests 98% positive
predictive value of long-term SCS therapy success on day zero of
trial period
MINNEAPOLIS, July 18,
2024 /PRNewswire/ -- Saluda Medical, Inc., a
commercial-stage medical device company focused on developing
treatments for chronic neurological conditions driven by a novel
closed-loop, dose-control neuromodulation platform, today announced
the recent presentations of two abstracts analyzing biomarker-based
spinal cord stimulation (SCS) data at the American Society of Pain
and Neuroscience (ASPN) 2024 Annual Conference, held July 11-14, 2024, in Miami, FL. The abstracts, which were among 10
total abstracts with Saluda Medical clinical data presented at
ASPN, relied on evidence from patients treated with the Evoke
System in clinical studies. Key takeaways from these two abstracts
demonstrate the significance of objective neurophysiological
measurements in SCS with evoked compound action potential (ECAP)
dose-controlled closed-loop therapy.
Key Abstracts Presented:
- "Maximal Analgesic Effect Attained by the Use of
Objective Neurophysiological Measurements with ECAP Dose-Controlled
Closed-Loop SCS": Authored by Dr. Robert Levy, MD, PhD, and based on a paper
accepted for recent publication in the journal
Neuromodulation, this abstract was awarded "Top Abstract"
out of more than 300 clinical abstracts, and was also featured as
an oral presentation; the abstract sought to characterize the
biomarker-based dose-response relationship that produced a
patient's maximal analgesic effect. The analysis showed a
statistically significant relationship between usage over ECAP
threshold, ECAP dose and pain relief across the patient population.
In addition, the analysis demonstrated that the clinical benefit
observed in the trial period was reproduced following permanent
implantation when the neurophysiological metrics remained
consistent.
- "Identifying SCS Trial Responders Immediately after
Postoperative Programming with ECAP Dose-Controlled Closed-Loop
Therapy": Authored by Dr. Jason
Pope, MD and based on the recent published paper by Pope,
Antony, Petersen, et al., this
abstract was also featured in an oral presentation; the abstract
sought to analyze the benefits of closed-loop, dose-control SCS as
it relates to trial outcomes and the predictability of long-term
success. The analysis compared neurophysiological and certain
patient reported metrics between the day of the trial procedure, or
day 0, and the end of the trial. Success criteria included
confirmation of neural activation and dose-controlled closed-loop
therapy, patient reported pain relief, functional improvement and
willingness to proceed. The analysis measured patients who passed
all success criteria on day 0 and demonstrated that these success
criteria had a 98% positive predictive value for being responsive
to therapy at the end of the trial period.
"Saluda's scientific presence at this year's ASPN conference is
reflective of our commitment to elevate SCS therapy with
best-in-class clinical evidence grounded in real world data and our
double-blinded EVOKE RCT, and we sincerely thank our clinical
investigators and their patients," said Jim
Schuermann, President and CEO of Saluda Medical. "These two
abstracts, highlighting biomarker-based measurements, in particular
are significant to the field of SCS. We believe that the Evoke
System's ability to objectively measure and respond to these
neurophysiological metrics allows it to improve the reliability and
reproducibility of patient outcomes from the trial period through
the long-term follow-up."
About Saluda Medical
Saluda Medical is a commercial-stage medical device company focused
on developing treatments for chronic neurological conditions driven
by a novel neuromodulation platform. The Company's closed-loop,
dose-control platform is designed to sense and measure neural
responses to stimulation and automatically adjust therapy based on
real-time neurophysiological feedback. The Company's first product,
the Evoke® System, is indicated as an aid in the management of
chronic intractable pain of the trunk and/or limbs, including
unilateral or bilateral pain associated with failed back surgery
syndrome, intractable low back pain, and leg pain, and is designed
to treat chronic neuropathic pain and can sense and measure neural
activation to optimize and adjust therapy in real time with every
stimulation pulse, up to 250 times per second. 12-month results
from the EVOKE study, the first double-blind randomized controlled
trial (RCT) used in support of Premarket Approval (PMA) in spinal
cord stimulation history, were published in The Lancet
Neurology, 24-month results have been published in JAMA
Neurology, and unprecedented 36-month data, demonstrating
enduring and consistent pain relief results were published in
Regional Anesthesia and Pain Medicine. To learn more, including
risks & important safety information,
visit www.saludamedical.com/us/safety/.
Saluda and Evoke are registered trademarks owned by Saluda
Medical Pty Ltd.
Investor Contact:
Brian Johnston or Sam
Bentzinger
brian@gilmartinir.com
sam@gilmartinir.com
View original content to download
multimedia:https://www.prnewswire.com/news-releases/saluda-medical-announces-presentation-of-two-chronic-pain-biomarker-based-analyses-at-aspn-2024-annual-conference-302200003.html
SOURCE Saluda Medical