Aclarion Announces Texas Back Institute as New CLARITY Trial Site
BROOMFIELD, Colo., May 12, 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, today announced the addition of the Texas Back Institute (TBI) as a CLARITY (Chronic Low bAck pain Randomized Independent Trial studY) trial site. The pivotal CLARITY study is designed to demonstrate Nociscan's clinical and economic value in spine surgery.
'Texas Back Institute has a rich tradition of excellence in research. We remain focused on the relationship between diagnostic evaluations and treatment outcomes,' said Alexander Satin, MD, board certified orthopedic spine surgeon, Texas Back Institute. 'We have participated in numerous studies involving discography, MRI, minimally invasive procedures, and total disc replacement. The CLARITY trial is exciting, in part, because it builds on previously published evidence and aligns well with our patient population at Texas Back Institute. Our physicians and research leaders are pleased to participate in this important trial.'
Texas Back Institute joins the growing roster of previously announced CLARITY trial sites, which includes Johns Hopkins Medicine, Northwestern Medicine and Advocate Aurora Research Institute. The principal investigator for the trial is Dr. Nicholas Theodore of Johns Hopkins Medicine.
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.
'The Texas Back Institute's reputation for excellence in patient care, innovation and research is renowned,' said Ryan Bond, Chief Strategy Officer at Aclarion. 'It is common, at spine society meetings, that TBI physicians and research leaders are not only in attendance but actively presenting their extensive research to advance the spine industry. We are grateful to have this expert group of physicians and researchers participating in the CLARITY trial.'
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]
All organizations cited and/or quotes from individuals not part of Aclarion have reviewed and approved the contents herein.
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, 2024, 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.
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Just some of the symptoms of a milk allergy include vomiting, diarrhea, and rash. In the worst case scenario, a severe allergic reaction to the product can even lead to anaphylactic shock. Mars Chocolate North America — which merged into Mars Wrigley Confectionery in 2017 — is best known for its Mars chocolate bars. The popular caramel, nougat, and milk chocolate confection was launched in 1932 in the U.K, and has since become a staple grocery item around the globe. The 2016 recall had nothing to do with Mars Bars, instead centering on cracker-based snacks, including Combos Cheddar Cheese Pretzel, Cheddar Cheese Cracker, Pizzeria Pretzel, Sweet and Salty Caramel Pretzel, Pepperoni Cracker, and Buffalo Pretzel. The products were pulled off the shelves due to potential contamination with peanuts, a known allergen that can trigger potentially life-threatening reactions in sensitive individuals. Mars Chocolate North America raised the alarm after one of its suppliers, Grain Craft, issued a recall of the wheat flour used in the products, warning that it was likely to contain traces of peanuts. The products had been distributed nationwide, as well as in the Bahamas, Jamaica, St. Thomas in the U.S. Virgin Islands, Antigua, Colombia, Panama, Puerto Rico, Philippines, South Korea, Taiwan, and Singapore. Unlike most other recalls, which involve product contamination or undeclared allergens, the 1998 Nabisco recall of the company's Cheese Nips CatDog crackers centered around a legal issue. Manufactured as a part of the promotion of Nickelodeon's animated TV show "CatDog," the snack featured fish-shaped Cheese Nips crackers, which Pepperidge Farm claimed looked too much like its trademarked Goldfish Crackers. Pepperidge Farm initiated a lawsuit over this similarity, claiming that Nabisco infringed on its trademark fish-shaped cracker brand. The judge sided with Pepperidge Farm, ordering Nabisco to stop production and recall any Cheese Nips CatDog crackers that may have already found their way onto grocery store shelves. The judge also instructed Pepperidge Farm to post a $3.55 million bond to safeguard Nabisco against any potential losses if the decision was overturned. While the ruling threw a wrench into Nickelodeon's promotional plan with Nabisco, the network continued its "CatDog" advertising with other partners, including Kraft Foods and Burger King. For more food and drink goodness, join The Takeout's newsletter. Get taste tests, food & drink news, deals from your favorite chains, recipes, cooking tips, and more! Read the original article on The Takeout.
