Aclarion's CLARITY Trial for Nociscan: A Breakthrough in Chronic Low Back Pain Diagnosis

Aclarion Announces Northwestern Medicine as First CLARITY Trial Site - Aclarion (NASDAQ:ACONW), Aclarion (NASDAQ:ACON)

Northwestern Medicine is a global leader in clinical trial research, including spine CLARITY is a randomized study designed to demonstrate Nociscan's ability to improve surgical outcomes while reducing costs for chronic low back pain 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. 06, 2025 (GLOBE NEWSWIRE) -- Aclarion, Inc., ("Aclarion" or the "Company") 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, today announced Northwestern Medicine as the initial site in the pivotal CLARITY trial, which is designed to demonstrate Nociscan's clinical and economic value in spine surgery. "Northwestern Medicine is a leader in clinical trials. In 2024, Northwestern led over 6,900 clinical studies with 372,561 study participants," said Alpesh Patel, MD, Professor and Co-Director of the Northwestern Center for Spine Health. "We are pleased to participate in Aclarion's CLARITY trial, a groundbreaking randomized controlled trial examining Nociscan's impact on discogenic low back pain surgical outcomes. Low back pain is a complex problem and advancements like Nociscan are helping to advance our understanding of low back pain in fundamentally important ways." Aclarion recently announced that the CLARITY trial is fully funded and will be led by Dr. Nicholas Theodore of Johns Hopkins as principal investigator. The CLARITY trial is a prospective, randomized multi-center study evaluating patients who are scheduled to undergo surgical treatment of 1- or 2- level discogenic low back pain. The study will enroll 300 patients at multiple high-volume sites across the US and all patients will receive a Nociscan prior to surgery. The study will be randomized at a 1:1 ratio of surgeons blinded-to-Nociscan and unblinded-to-Nociscan to guide the surgical treatment (Fusion / TDR). The primary endpoint is change in back pain as measured on a 100mm VAS Back at 12 months compared to baseline, with several secondary endpoints collected. "We are pleased to launch the CLARITY trial with a prestigious institution like Northwestern and renowned spine expert Dr. Alpesh Patel. I saw firsthand from my earlier experiences commercializing algorithms in the cardiology space how well-designed clinical trials could drive the adoption of cloud-based, augmented intelligence platforms. When compared to traditional testing options, these technologies improved diagnostic accuracy, reduced unnecessary procedures and ultimately saved the health system significant costs," said Brent Ness, CEO, Aclarion. "At Aclarion, we are committed to building the same level of evidence to ensure adoption of Nociscan for all stakeholders is a logical and well-supported step for chronic low back pain." Chronic low back pain 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 and has the potential to drive better surgical outcomes. 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. 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. [email protected] Media Contacts: Jennie Kim SPRIG Consulting [email protected] ACONAclarion Inc$6.773.99%WatchlistOverviewACONWAclarion Inc$0.0502-8.23%Market News and Data brought to you by Benzinga APIs

Aclarion Announces CLARITY Trial for Nociscan Now Fully Funded - Aclarion (NASDAQ:ACON)

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") 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. 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] ACONAclarion Inc$8.9935.2%WatchlistOverviewMarket News and Data brought to you by Benzinga APIs

Aclarion to Showcase Groundbreaking NOCISCAN Technology at the Selby Spine Conference - Aclarion (NASDAQ:ACON)

Dr. Sigurd Berven to Highlight NOCISCAN Capabilities, Combining MR Spectroscopy and Augmented Intelligence (AI) NOCISCAN as New Gold Standard in Identifying a Source of Discogenic Pain BROOMFIELD, Colo., Jan. 31, 2025 (GLOBE NEWSWIRE) -- Aclarion, Inc. ("Aclarion" or the "Company") 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 its participation in the Selby Spine Conference. Renowned spine specialist, Dr. Sigurd Berven, will present Aclarion's flagship platform, NOCISCAN, highlighting its innovative, evidence-supported capabilities. "Aclarion is pleased to have NOCISCAN featured at the Shelby Spine Conference," said Ryan Bond, Chief Strategy Officer. "We are honored to have renowned physicians like Dr. Berven illustrate how utilizing NOCISCAN can help physicians identify what they can't 'see' with traditional imaging so they can personalize treatment for patients with chronic low back pain." Dr. Berven's presentation, titled "MR Spectroscopy, Augmented Intelligence, and Low Back Pain - A New Gold Standard," will delve into how NOCISCAN empowers physicians to noninvasively identify biomarkers that are invisible on traditional MRI scans. This breakthrough enables tailored, data-driven treatment plans for chronic low back pain patients. Details of the Presentation: Date: Friday, January 31, 2025Time: 5:55 PMLocation: Selby Spine Conference, Deer Valley, UT NOCISCAN is revolutionizing spine surgery and chronic pain management by combining cutting-edge MR Spectroscopy with augmented intelligence, setting a new standard for noninvasive diagnostics. 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. For a copy of the NOCISCAN presentation, please email: [email protected] To find a NOCISCAN center, view our site map here. 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. 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 Contact: Kirin M. Smith PCG Advisory, Inc. 646.823.8656 [email protected] Jennie Kim SPRIG Consulting [email protected] ACONAclarion Inc$7.20-14.3%WatchlistOverviewMarket News and Data brought to you by Benzinga APIs

Aclarion : Announces Pricing of Registered Direct Offering of Common Stock Priced at the Market

BROOMFIELD, CO - January 30, 2025 (NEWMEDIAWIRE) - 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, today announced that it has agreed to sell 506,803 shares of its common stock at a price per share of $9.25 in a registered direct offering priced at the market. All of the shares of common stock in the offering are being sold by Aclarion. The closing of the offering is expected to take place on or about January 31, 2025, subject to the satisfaction of customary closing conditions. The gross proceeds to Aclarion from this offering are expected to be approximately $4.7 million, before deducting the placement agent's fees and other offering expenses payable by Aclarion. Aclarion intends to use the net proceeds from the offering to fund market development and clinical evidence, product development and quality, and general and administration support, and other general corporate purposes. Dawson James Securities, Inc. is acting as the sole placement agent for the offering. The offering is being made pursuant to a shelf registration statement on Form S-3 (File No. 333-281999) that was declared effective by the Securities and Exchange Commission ("SEC") on September 23, 2024. The offering may be made only by means of a prospectus supplement and accompanying prospectus. A final prospectus supplement with the final terms of the offering will be filed with the SEC and will be available for free on the SEC's website, located at www.sec.gov. Copies of the prospectus supplement and the accompanying prospectus relating to the offering may be obtained, when available, from Dawson James Securities, Inc., 101 North Federal Highway, Suite 600, Boca Raton, FL 33432 or by telephone at (561) 391-5555, or by email at [email protected]. This press release does not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of that state or 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. Caution Regarding Forward-Looking Statements This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Words such as "may," "might," "will," "should," "believe," "expect," "anticipate," "estimate," "continue," "predict," "forecast," "project," "plan," "intend" or similar expressions, or statements regarding intent, belief, or current expectations are forward-looking statements and reflect the current beliefs of Aclarion's management. Such forward-looking statements include, without limitation, statements relating to the completion of the offering and the intended use of proceeds. These statements are not guarantees of future performance and are subject to certain risks, uncertainties and other factors that could cause actual results and events to differ materially and adversely from those indicated by such forward-looking statements including, among others: risks and uncertainties related to market conditions and the satisfaction of customary closing conditions related to the offering, and other risks and uncertainties related to the offering, as well as the risks and uncertainties set forth in the "Risk Factors" section and elsewhere in the prospectus supplement related to the offering filed with the SEC and in our other filings with the SEC and available at www.sec.gov, including in our Annual Report on Form 10-K. Any forward-looking statements that we make in this announcement speak only as of the date of this press release, and Aclarion assumes no obligation to update forward-looking statements whether as a result of new information, future events or otherwise after the date of this press release, except as required under applicable law.