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LIFEHAB is a randomized controlled trial in Norway comparing lumbar interbody fusion surgery with multidisciplinary rehabilitation
Norway is a single-payer national health insurance system
LIFEHAB is targeting enrollment to begin in the second quarter of 2024
BROOMFIELD, CO, April 25, 2024 (GLOBE NEWSWIRE) -- via NewMediaWire -- Aclarion, Inc., ("Aclarion" or the "Company") (NASDAQ:ACON, ACONW))),a healthcare technology company that is leveraging biomarkers and proprietary augmented intelligence algorithms to help physicians identify the location of chronic low back pain, announced today that the Nociscan solution will be utilized in the upcoming LIFEHAB Trial in Norway. The randomized controlled trial studying 202 patients with low back pain greater than 1 year in duration will compare treatment outcomes between lumbar interbody fusion surgery and multidisciplinary rehabilitation.
"Diagnosing the source of chronic low back pain is a significant challenge for clinicians," said Dr. Ansgar Espeland. "At Haukeland University Hospital, our radiology team has participated in numerous clinical trials seeking to better understand the linkage between the diagnosis and treatment of chronic low back pain. The LIFEHAB Trial is our latest effort to advance scientific understanding of chronic low back pain. The trial is headed by orthopedic surgeon Dr. Christian Hellum at Oslo University Hospital, Ulleval in cooperation with Dr. Sverre Mjones, Akershus University Hospital. We are pleased to have Nociscan as part of the trial, which we expect may provide important insights not available without Nociscan. LIFEHAB will evaluate treatment outcomes for 202 patients, comparing surgical fusion with multidisciplinary rehabilitation, a comparison we believe will help improve patient outcomes for this complicated ailment."
The Company believes the LIFEHAB trial combined with other compelling evidence, marks an important step toward achieving successful reimbursement in a single-payer national health insurance system like Norway's, which was adopted in 1966.
Globally, 266 million people suffer from degenerative spine disease and low back pain. Aclarion's Nociscan solution is the first evidence-supported SaaS platform to noninvasively help physicians distinguish between painful and nonpainful discs in the lumbar spine. Nociscan objectively quantifies chemical biomarkers demonstrated to be associated with disc pain. Biomarker data is entered into proprietary algorithms to highlight if a disc may be a source of pain. When used with other diagnostic tools, Nociscan provides critical insights into the location of a patient's low back pain.
LIFEHAB represents a new clinical trial involving Nociscan. "Aclarion is honored to be included in this ground-breaking clinical trial with global implications," says Ryan Bond, Chief Strategy Officer of Aclarion. "Dr. Espeland and his colleagues have designed a powerful trial that will add important insights to the diagnostic treatment paradigm for low back pain. The LIFEHAB trial represents the fourth important trial since 2021 to utilize Nociscan, a testament to our growing body of evidence and the relative distinction of the Nociscan solution."
For more information on the LIFEHAB Trial: https://classic.clinicaltrials.gov/ct2/show/NCT06169488
Posted In: ACON
