Registration is on observe with anticipated inside provisional outcomes from the second quarter randomised examine. We assess Nociscan’s capacity to enhance surgical outcomes of persistent low again ache.
Bloomfield, CO, September 25, 2025 (Glove Newswire) – Aclarion, Inc. , (“Aclarion” or “Firm”) (NASDAQ: ACON, ACONW), a healthcare expertise firm that leverages biomarkers and complete medical intelligence (AI) algorithms. Miami Well being System and Miller College of Drugs had been enrolled within the trial, which had clarified the primary two sufferers (ck ck ck r and a nedendent trial examine y). The extraordinarily clear examine is designed to show the scientific and financial worth of Nociscan in spinal surgical procedure.
“We’re happy to have enrolled our first affected person with the College of Miami Well being System,” commented Gregory Basil (MD), director of endoscopic spinal surgical procedure and assistant professor at Uhealth and Miller College. “Clearance is a vital trial for backbone surgeons and sufferers with decrease again ache. The extra data offered by Nociscan challenges the idea of advance consciousness concerning the supply of decrease again ache, and we look ahead to understanding the correlation between surgical outcomes and patient-specific biomarkers offered in a patient-specific cohort.”
The Readability trial is a potential, randomized, multicenter examine that evaluates sufferers scheduled to bear surgical remedy for discogenic decrease again ache at as much as two lumbar ranges. The examine enrolled 300 sufferers in a number of giant areas throughout the USA, with all sufferers receiving Nociscan earlier than surgical procedure. This examine is randomized at a 1:1 ratio of blind to non-profit surgeons and non-bl-extensive surgeons to information surgical remedy (Fusion/TDR). The first endpoint is the adjustments in decrease again ache measured at 100 mm VAS at 12 months in comparison with baseline, with a number of secondary endpoints collected. The lead investigator for the trial is Dr. Nicholas Theodore of Johns Hopkins Drugs. Different registered websites embrace Northwest Drugs, Advocate Well being, Texas Again Institute, and USC.
“We’re dedicated to offering an amazing alternative that will help you,” stated Ryan Bond, Chief Technique Officer at Aclarion. “The Readability Trial timeline is on observe as our examination investigators and their crew are dedicated to serving to NOCISCAN transfer ahead and generate the proof wanted to extend entry to sufferers in want.”
An estimated 266 million folks worldwide reside with persistent again ache, making it one of many widest well being challenges. Aclarion’s Nociscan answer is the primary evidence-supported SaaS platform that helps medical doctors distinguish between painful and non-unstable disks within the lumbar backbone. Nociscan objectively quantifies chemical biomarkers which were demonstrated to be related to disc ache, and should enhance surgical outcomes in sufferers affected by degenerative spinal illness and decrease again ache world wide.
For extra details about Readability, see the Readability Trial
To seek out the Nociscan Heart, try the positioning map right here.
For extra details about Nociscan, please ship an electronic mail: (Protected E mail)
Clarification, Inc. About
Aclarion is a healthcare expertise firm that leverages magnetic resonance spectroscopy (“MRS”), proprietary sign processing expertise, biomarkers, and prolonged intelligence algorithms to optimize scientific remedies. The corporate has now helped medical doctors distinguish between Nociscan, the SaaS platform supported by the primary proof, from the Nociscan, a disc with lumbar ache and non-unstable discs. By means of cloud connections, Nociscan receives magnetic resonance spectroscopy (MRS) knowledge from MRI machines for every lumbar disc being evaluated. Within the cloud, proprietary sign processing strategies extract and quantify chemical biomarkers which were confirmed to be associated to disc ache. The biomarker knowledge is entered right into a proprietary algorithm to point whether or not the disk is the reason for the ache. When used with different diagnostic instruments, Nociscan offers essential perception into the affected person’s decrease again ache location, and medical doctors make clear to optimize remedy methods. For extra data, please go to www.aclarion.com.
A optimistic assertion
This press launch incorporates forward-looking statements throughout the which means of the Personal Securities Litigation Reform Act of 1995, Part 27A of the Securities Act of 1933 and Part 21E of the Securities Alternate Act of 1934. Statements that aren’t historic details akin to “anticipation,” “imagine,” “expectation,” or comparable expressions are forward-looking statements. These forward-looking statements are primarily based on present plans and expectations of administration and are topic to many uncertainties and dangers that would considerably have an effect on our present plans and expectations, in addition to future operational and monetary place outcomes. Ahead-looking statements on this launch embrace, amongst different issues, affected person registration in ongoing scientific trials, the anticipated date of inside preliminary outcomes, the potential advantages of NOCISCAN expertise, and the corporate’s plans for future regulatory and commercialization actions. These and different dangers and uncertainties have been mentioned extra totally of their filings with the Securities and Alternate Fee. Readers are inspired to overview the part titled “Threat Components” of our Annual Report on Type 10-Ok for the yr ended December 31, 2024, and different disclosures contained within the prospectus and subsequent subsequent filings made with the Securities and Alternate Fee. Any forward-looking statements contained on this announcement will likely be made as of this date and the Firm has no obligation to publicly replace or amend any forward-looking statements because of new data, future occasions, or different outcomes.
Investor Contact Info:
Kirin M. Smith PCG Advisory, Inc. (E mail safety)
Media Contact:
Jessica Sterman (electronic mail safety)
Kai Hill Uhealth – College of Miami Well being System (E mail Safety)
