Aclarion secured $20 million to fund the CLARITY trial, validating Nociscan's effectiveness in treating low back pain.
Quiver AI Summary
Aclarion, Inc. has successfully secured nearly $20 million in gross proceeds to fund its pivotal CLARITY trial, aimed at validating the Nociscan platform's effectiveness in improving surgical outcomes for chronic low back pain. The CLARITY trial, a prospective, randomized, multicenter study led by Dr. Nicholas Theodore of Johns Hopkins, plans to enroll 300 patients and will explore Nociscan's ability to identify painful discs using Magnetic Resonance Spectroscopy and augmented intelligence. This funding is vital for reaching the study's conclusion, which could lead to broader insurance coverage and a potential shift in treatment approaches for the 266 million people globally suffering from low back pain. Nociscan is recognized as the first evidence-supported SaaS platform to noninvasively differentiate between painful and nonpainful discs, showing a 97% success rate in surgeries when targeting identified pain sources.
Potential Positives
- Aclarion has secured nearly $20 million in gross proceeds, ensuring complete funding for its pivotal CLARITY trial, which is a significant milestone in advancing its clinical research.
- The CLARITY trial aims to validate Nociscan's ability to improve surgical outcomes for chronic low back pain patients, potentially enhancing the company's reputation in the healthcare technology sector.
- Nociscan's objective quantification of chemical biomarkers associated with disc pain could position the technology as a crucial tool for physicians, suggesting a promising future market adoption.
- The trial's leadership by a respected investigator from Johns Hopkins strengthens the credibility and visibility of Aclarion's research initiatives in the medical community.
Potential Negatives
- The press release highlights the necessity of external funding for the pivotal CLARITY trial, indicating that the company may not have sufficient internal resources to support its projects without external investment.
- While Aclarion claims their Nociscan solution aims to become the gold standard for identifying sources of low back pain, it has yet to complete the pivotal trial to validate its effectiveness, which may raise questions about its current standing in the market.
- The presence of forward-looking statements underscores uncertainties and risks regarding the company's future performance, suggesting that the anticipated outcomes are not guaranteed.
FAQ
What is the CLARITY trial about?
The CLARITY trial is a multicenter study to validate Nociscan’s effectiveness in improving surgical outcomes for chronic low back pain.
How much funding has Aclarion secured for the CLARITY trial?
Aclarion has raised nearly $20 million in gross proceeds to fully fund the CLARITY trial.
What technology does Nociscan use?
Nociscan uses Magnetic Resonance Spectroscopy (MRS) and augmented intelligence algorithms to identify sources of low back pain noninvasively.
Who is leading the CLARITY trial?
The CLARITY trial is led by Dr. Nicholas Theodore from Johns Hopkins University as the principal investigator.
What are the expected outcomes of the Nociscan trial?
The trial aims to demonstrate Nociscan's clinical and economic value, potentially redefining the treatment of chronic low back pain.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
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Full Release
The Company has secured nearly $20 million in gross proceeds in 2025 ensuring complete funding for its pivotal CLARITY trial
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 $20 million in gross proceeds, which fully funds the CLARITY trial. CLARITY is a prospective, randomized, multicenter, clinical trial led by Dr. Nicholas Theodore of Johns Hopkins as principal investigator. The trial aims to validate Nociscan’s ability to improve surgical outcomes for chronic low back pain patients. Enrolling 300 patients across multiple sites, it builds on peer-reviewed data demonstrating Nociscan’s potential to drive better surgical outcomes by matching the surgical intervention to the specific discs identified by Nociscan as being a source of pain.
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 97% surgical success rate at one year follow up when all Nociscan-identified pain positive discs are treated.
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: [email protected]
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
[email protected]
Media Contacts:
Jodi Lamberti
SPRIG Consulting
612.812.7477
[email protected]