Aclarion Announces CLARITY Trial for Nociscan Now Fully Funded
Rhea-AI Summary
Aclarion (NASDAQ: ACON) has secured nearly $20 million in gross proceeds in 2025 to fully fund its pivotal CLARITY trial, a prospective, randomized, multicenter study designed to validate Nociscan's effectiveness in improving surgical outcomes for chronic low back pain patients.
The CLARITY trial, led by Dr. Nicholas Theodore of Johns Hopkins, will enroll 300 patients across multiple sites. Nociscan is the first evidence-supported SaaS platform that helps physicians identify painful discs in the lumbar spine through MR Spectroscopy and AI, showing a 97% surgical success rate at one-year follow-up when all Nociscan-identified pain-positive discs are treated.
The technology addresses a significant global healthcare challenge, with approximately 266 million people worldwide suffering from degenerative spine disease and low back pain.
Positive
- Secured $20 million in gross proceeds for complete CLARITY trial funding
- 97% surgical success rate at one-year follow-up with Nociscan-guided treatment
- Large addressable market of 266 million potential patients worldwide
Negative
- None.
News Market Reaction
On the day this news was published, ACON gained 2.56%, reflecting a moderate positive market reaction.
Data tracked by StockTitan Argus on the day of publication.
The Company has secured nearly
CLARITY is a prospective, randomized, multicenter study to validate Nociscan’s ability to improve surgical outcomes
Nociscan aims to become the gold standard in identifying sources of low back pain through MR Spectroscopy (MRS) and Augmented Intelligence (AI)
BROOMFIELD, Colo., Feb. 04, 2025 (GLOBE NEWSWIRE) -- Aclarion, Inc., (“Aclarion” or the “Company”) (Nasdaq: ACON, ACONW), a healthcare technology company that is leveraging biomarkers and proprietary augmented intelligence (AI) algorithms to help physicians identify the location of chronic low back pain, announced today that it has secured full funding for its pivotal CLARITY trial which is designed to demonstrate Nociscan’s clinical and economic value in spine surgery.
Chief Strategy Officer Ryan Bond stated, “This milestone ensures we reach the study’s conclusion, potentially unlocking broad payer coverage and redefining chronic low back pain treatment.”
Since January 1, 2025, Aclarion has raised nearly
Chronic low back pain (cLBP) is a global healthcare problem with approximately 266 million people worldwide suffering 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. When used with other diagnostic tools, Nociscan provides critical insights into the location of a patient’s low back pain and demonstrates a
For more information about CLARITY, please visit: CLARITY Trial
To find a Nociscan center, view our site map here.
For more information on Nociscan, please email: info@aclarion.com
This press release is for informational purposes only and is not intended to and shall not constitute an offer to sell or the solicitation of an offer to sell or to buy any securities or a solicitation of any proxy, consent, vote or approval with respect to any securities of Aclarion, Inc. No offer, sale, issuance or transfer of securities shall be made in any jurisdiction in which such offer, sale, issuance or transfer would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction.
About Aclarion, Inc.
Aclarion is a healthcare technology company that leverages Magnetic Resonance Spectroscopy (“MRS”), proprietary signal processing techniques, biomarkers, and augmented intelligence algorithms to optimize clinical treatments. The Company is first addressing the chronic low back pain market with Nociscan, the first, evidence-supported, SaaS platform to noninvasively help physicians distinguish between painful and nonpainful discs in the lumbar spine. Through a cloud connection, Nociscan receives magnetic resonance spectroscopy (MRS) data from an MRI machine for each lumbar disc being evaluated. In the cloud, proprietary signal processing techniques extract and quantify chemical biomarkers demonstrated to be associated with disc pain. Biomarker data is entered into proprietary algorithms to indicate 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, giving physicians clarity to optimize treatment strategies. For more information, please visit www.aclarion.com.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 about the Company’s current expectations about future results, performance, prospects and opportunities. Statements that are not historical facts, such as “anticipates,” “believes” and “expects” or similar expressions, are forward-looking statements. These forward-looking statements are based on the current plans and expectations of management and are subject to a number of uncertainties and risks that could significantly affect the Company’s current plans and expectations, as well as future results of operations and financial condition. These and other risks and uncertainties are discussed more fully in our filings with the Securities and Exchange Commission. Readers are encouraged to review the section titled “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, as well as other disclosures contained in the Prospectus and subsequent filings made with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date and the Company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
Investor Contacts:
Kirin M. Smith
PCG Advisory, Inc.
646.823.8656
ksmith@pcgadvisory.com
Media Contacts:
Jodi Lamberti
SPRIG Consulting
612.812.7477
jodi@sprigconsulting.com
FAQ
What is the size of Aclarion's (ACON) CLARITY trial funding secured in 2025?
How many patients will be enrolled in Aclarion's CLARITY trial for Nociscan?
What is the success rate of Nociscan-guided spine surgeries?
Who is leading Aclarion's CLARITY trial for Nociscan?
What is the global market potential for Aclarion's Nociscan technology?
