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ACON-News
ACON-Events
Aclarion Launches CLARITY Clinical Trial at University of Arizona
Aclarion announced the University of Arizona College of Medicine in Phoenix as a new clinical site in its CLARITY trial. The CLARITY study is designed to demonstrate Nociscan's clinical and economic value in spine surgery. The University of Arizona College of Medicine in Phoenix joins a growing network of high-volume CLARITY trial sites including Johns Hopkins University, Northwestern Medicine, Advocate Aurora Research Institute, Texas Back Institute, Keck Medicine at USC, UHealth, Scripps Health, Lanman Spinal Neurosurgery, and Texas Spine Care Center. The CLARITY trial is a 300-patient, prospective, randomized, multi-center study evaluating Nociscan in patients undergoing surgical treatment for discogenic low back pain. 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 company anticipates having an initial internal data readout and an expected public disclosure of early interim results in Q4 2026. Nicholas Theodore, chairman of neurosurgery at University of Arizona College of Medicine in Phoenix at Banner University Medical Center Phoenix, serves as principal investigator of the CLARITY trial.
Aclarion Receives USPTO Allowance for Multi-Voxel Lumbar Disc Evaluation Patent
Aclarion announced that the United States Patent and Trademark Office has issued a Notice of Allowance for U.S. Patent Application titled "Multi-Voxel Prescription for Lumbar Disc Evaluation." The allowed claims address a significant efficiency and quality challenge in MRS-based disc evaluation. By displaying both plan and shifted voxel locations during scan prescription, the innovation is designed to reduce the trial-and-error associated with voxel positioning, minimize the need for multiple scan series when optimal placement is uncertain, and lower the chance of a repeat study due to suboptimal voxel placement. Together, these improvements are designed to deliver a more efficient and consistent scan experience.
Aclarion Responds to Echo Lake's $4.00 Per Share Acquisition Offer
Aclarion issued the following statement in response to the press release issued by Echo Lake Capital and its offer to acquire the company for $4.00 per share in cash and contingent value rights: "Aclarion's Board of Directors and management team are committed to acting in the best interests of the Company and all of its shareholders. We regularly review our strategic priorities and evaluate opportunities to enhance value for all stakeholders. To that end, the Board of Directors will carefully review and evaluate Echo Lake's proposal to determine the course of action that it believes is in the best interests of the Company and its shareholders. The Board authorized a share repurchase program underscoring our conviction that Aclarion's current market valuation does not fully reflect the strength of our platform or the long-term opportunity ahead. This action also reflects our commitment to deploying capital in ways that serve the interests of all shareholders while continuing to invest in our business. The Company notes that the Echo Lake communication contains numerous assertions regarding governance and other matters that lack important context and are presented in a manner that the Board believes is misleading. Aclarion's Board comprises seven highly qualified directors with relevant expertise in healthcare, regulatory affairs, technology investing, payer contracting, public company leadership and scaling medical technologies. The Board is committed to ongoing Board enhancement and regularly evaluates its composition to ensure it brings the fresh perspectives and appropriate skills necessary to drive value creation for all Aclarion shareholders. Accordingly, five new directors have been appointed within the last six years, all of whom bring diverse perspectives that directly align with Aclarion's strategic priorities."
Echo Lake Capital Proposes to Acquire Aclarion at $4.00 per Share
Ephraim Fields of Echo Lake Capital sent a letter to the Board of Directors of Aclarion. The letter criticized the directors' performance, compensation and qualifications and noted the tremendous destruction of shareholder value that has occurred. The letter also described a proposal whereby Fields would acquire all of the company's outstanding shares and a suggestion that the board could create even greater shareholder value by effecting a reverse takeover. The letter said, "In an effort to create value for ACON's long-suffering shareholders, we are submitting a proposal under which we would acquire 100% of ACON's outstanding common shares for $4.00 per share in cash plus a contingent value right representing the right for stockholders to receive 80% of net the proceeds from the sale of Nociscan... While we believe our Proposal would be overwhelming approved by ACON's shareholders, we feel even more shareholder value could be created if you sold Nociscan and used the resulting excess cash and public shell to effect a reverse takeover with a high-quality company. In such a transaction, we estimate ACON's public shell would be worth at least $6 million, which combined with the company's other assets, would represent a significant premium to where the stock has traded. Such a transaction can be easily and quickly consummated as we have recently seen with many companies similar to ACON."
Aclarion Establishes Second Commercial Agreement with Weill Cornell Medicine
Aclarion announced it has established a second commercial agreement with Weill Cornell Medicine. The agreement brings Nociscan to Weill Cornell Medicine and Och Spine at NewYork-Presbyterian/Weill Cornell Medical Center through a trial led by renowned neurosurgeon, Roger Hartl, MD, the founder and director of the Weill Cornell Medicine Center for Comprehensive Spine Care and co-director of Och Spine at NewYork-Presbyterian. The trial is entitled "Bone Marrow Aspirate Concentrate Injection with MRI's - a Prospective Randomized Controlled Trial," conducted under IRB Protocol No. 24-09027977. The purpose of this study is to evaluate the long-term effects of lumbar microdiscectomy surgery with and without an intradiscal bone marrow aspirate concentrate injection on patient reported outcomes, intervertebral disc health, and pain biomarkers in a 2-year prospective study. The aim is to learn more about the natural history of degenerative disc disease, its causes, and inform its treatments.
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