Aankondiging • Aug 13
Aclarion Receives Notice Of Allowance For Patent Advancing Accuracy And Adoption Of Nociscan's MR Spectroscopy Scan Process Aclarion received a Notice of Allowance for U.S. Patent Application titled “Multi-Voxel Prescription for Lumbar Disc Evaluation.” Patent protects the precision of MRS data capture within the target disc — a critical step in the Nociscan workflow. Designed to reduce scan time, support faster technologist onboarding and deliver more reproducible results across imaging centers. Extends Aclarion's IP protection to over 65 issued and pending patents worldwide, complementing its broader portfolio covering spectroscopy acquisition, data processing, biomarkers and analytics. 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. At a technical level, the patent covers Aclarion's method for precisely positioning the MRS sampling locations within the lumbar disc during scan setup. Nociscan analyzes chemical shifts in intervertebral discs, and scanning these small anatomical structures precisely presents a meaningful technical challenge. Different chemical shifts can correspond to different physical sampling locations, making it critical that the scan does not inadvertently extend beyond the disc boundary and sample adjacent tissue. This patent covers methods and systems that account for this effect during scan prescription and ensure that the data Nociscan analyzes reflects the disc itself, not surrounding structures or unwanted endplate lipid signals. These capabilities are designed to improve MRS data reliability, simplify the acquisition workflow, and reduce scan variability across sites and MRI technologists. Once issued, the patent would extend Aclarion's intellectual property protection into the MRS scan-prescription stage, complementing the Company's broader portfolio of over 65 issued and pending patents worldwide, covering spectroscopy acquisition, data processing, biomarkers, and analytics. 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. When used with other diagnostic tools, Nociscan demonstrates a 97% surgical success rate when all Nociscan-positive discs are treated. Aankondiging • Jul 07
Aclarion Announces Texas Spine Care Center as New CLARITY Site Aclarion, Inc. announced Texas Spine Care Center as a new clinical site in its CLARITY (Chronic Low bAck pain Randomized Independent Trial studY) trial. The CLARITY study is designed to demonstrate Nociscan's clinical and economic value in spine surgery. CLARITY is a prospective, randomized clinical trial designed to demonstrate Nociscan’s ability to improve surgical outcomes 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). Texas Spine Care Center is a San Antonio-based orthopedic spine practice with two locations dedicated exclusively to spine care. The practice offers a comprehensive range of surgical and non-surgical treatment options, with a patient care philosophy centered on understanding the precise source of a patient's pain before determining the best course of treatment. Texas Spine Care Center 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 — University of Miami Health System, Scripps Health and Lanman Spinal Neurosurgery. The principal investigator for the trial is Dr. Nicholas Theodore, Chairman of Neurosurgery at the University of Arizona College of Medicine – Phoenix. The CLARITY trial is a 300-patient, prospective, randomized, multi-center study evaluating Nociscan in patients undergoing surgical treatment (Fusion /TDR) 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 Fourth Quarter 2026. 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. 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 when all Nociscan-positive discs are treated. Aankondiging • Jun 09
Echo Lake Capital cancelled the acquisition of Aclarion, Inc. (NasdaqCM:ACON). Echo Lake Capital proposed to acquire Aclarion, Inc. (NasdaqCM:ACON) on May 28, 2026. Echo Lake Capital offered to acquire Aclarion for $4 per share in cash and contingent value rights.
The transaction is subject to approval of merger agreement by target board.
Goodwin Procter LLP acted as legal advisor for Aclarion, Inc.
Echo Lake Capital cancelled the acquisition of Aclarion, Inc. (NasdaqCM:ACON) on June 8, 2026. Aankondiging • May 29
Echo Lake Capital proposed to acquire Aclarion, Inc. (NasdaqCM:ACON). Echo Lake Capital proposed to acquire Aclarion, Inc. (NasdaqCM:ACON) on May 28, 2026. Echo Lake Capital offered to acquire Aclarion for $4 per share in cash and contingent value rights.
The transaction is subject to approval of merger agreement by target board.
Goodwin Procter LLP acted as legal advisor for Aclarion, Inc. Reported Earnings • May 14
First quarter 2026 earnings: EPS exceeds analyst expectations while revenues lag behind First quarter 2026 results: US$1.34 loss per share. Net loss: US$2.85m (loss widened 40% from 1Q 2025). Revenue missed analyst estimates by 15%. Earnings per share (EPS) exceeded analyst estimates by 14%. Aankondiging • May 09
Aclarion, Inc. Announces Addition of First Private Practice Site in Los Angeles into CLARITY Trial to Further Accelerate Enrollment Aclarion, Inc., a healthcare technology company that is leveraging biomarkers and proprietary augmented intelligence algorithms to help physicians identify the location of chronic low back pain, announced the addition of Lanman Spinal Neurosurgery as a clinical site in its CLARITY (Chronic Low Back pain Randomized Independent Trial studY) trial. Based in Beverly Hills, Lanman Spinal Neurosurgery is a spine-focused private practice known for its expertise in complex spinal procedures, early adoption of advanced technologies aimed at improving patient outcomes and high surgical volume. The inclusion of a premier private practice site reflects the growing interest in integrating Nociscan into real-world clinical workflows beyond academic medical centers. The addition of Lanman Spinal Neurosurgery marks an important milestone in the continued expansion of the 300-patient CLARITY trial, a prospective, randomized, multi-center study evaluating Nociscan in patients undergoing surgical treatment (Fusion /TDR) 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 Fourth Quarter 2026. 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. 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 when all Nociscan-positive discs are treated. Aankondiging • Apr 30
Aclarion, Inc. Appoints Daniel Keefe as Commercial Director, Western U.S Aclarion, Inc. announced the appointment of Daniel Keefe as Commercial Director, Western U.S. Dan will lead commercial efforts across the Western region, building on Aclarion’s existing footprint and supporting continued adoption of Nociscan. Aclarion has established a growing presence across the Western U.S., with engagement spanning both academic institutions and high-volume private practice spine centers, supported by strong volume growth. Dan’s appointment reflects the Company’s focus on expanding this momentum and deepening adoption in a key strategic region. Dan joins Aclarion with more than 20 years of experience in medical device and healthcare technology sales, including leadership roles at Centinel Spine, Brainlab, Zimmer Biomet, and Intuitive Surgical. Most recently, he served as Regional Sales Manager at Centinel Spine, where he consistently exceeded performance targets and delivered significant year-over-year growth across the Northern California region. Throughout his career, Dan has demonstrated success in building strategic relationships with surgeons and hospital leadership, launching new technologies, and expanding market presence in competitive environments. His experience spans capital equipment, surgical technologies, and advanced clinical solutions across spine, orthopedics, and image-guided surgery. Aankondiging • Apr 23
Aclarion, Inc. (NasdaqCM:ACON) announces an Equity Buyback for $2.5 million worth of its shares. Aclarion, Inc. (NasdaqCM:ACON) announces a share repurchase program. Under the program, the company will repurchase up to $2.5 million worth of its shares. The repurchases will be funded from existing cash and cash equivalents. The program will be valid for 12 months. Aankondiging • Apr 07
Aclarion, Inc., Annual General Meeting, Jun 04, 2026 Aclarion, Inc., Annual General Meeting, Jun 04, 2026. Location: offices of aclarion, inc, 8181 arista place, suite 100, broomfield, colorado 80021., United States Major Estimate Revision • Mar 26
Consensus EPS estimates upgraded to US$4.37 loss The consensus outlook for fiscal year 2026 has been updated. 2026 losses forecast to reduce from -US$13.71 to -US$4.37 per share. Revenue forecast unchanged from US$139.0k at last update. Healthcare Services industry in the US expected to see average net income growth of 22% next year. Consensus price target down from US$23.00 to US$7.00. Share price was steady at US$3.28 over the past week. Price Target Changed • Mar 25
Price target decreased by 68% to US$7.00 Down from US$22.00, the current price target is provided by 1 analyst. New target price is 117% above last closing price of US$3.23. Stock is down 79% over the past year. The company is forecast to post a net loss per share of US$4.37 next year compared to a net loss per share of US$13.61 last year. Reported Earnings • Mar 19
Full year 2025 earnings: EPS exceeds analyst expectations while revenues lag behind Full year 2025 results: US$13.61 loss per share. Net loss: US$7.24m (loss widened 2.7% from FY 2024). Revenue missed analyst estimates by 1.6%. Earnings per share (EPS) exceeded analyst estimates by 10%. Aankondiging • Jan 09
Aclarion, Inc. has filed a Follow-on Equity Offering in the amount of $10.359982 million. Aclarion, Inc. has filed a Follow-on Equity Offering in the amount of $10.359982 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 200,000
Price\Range: $5.18
Discount Per Security: $0.3108
Security Name: Pre-Funded Warrants
Security Type: Equity Warrant
Securities Offered: 1,800,000
Price\Range: $5.17999
Discount Per Security: $0.3108
Transaction Features: Registered Direct Offering New Risk • Jan 09
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of American stocks, typically moving 17% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (17% average weekly change). Earnings are forecast to decline by an average of 18% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (over 316x increase in shares outstanding). Revenue is less than US$1m (US$67k revenue). Market cap is less than US$10m (US$3.86m market cap). Minor Risk Currently unprofitable and not forecast to become profitable next year (US$8.8m net loss next year). Aankondiging • Jan 07
Aclarion, Inc. Announces First Patient Enrollments At Two Additional CLARITY Trial Sites and Provides Guidance on Expected Availability of Initial Data Aclarion, Inc. announced that Northwestern Medicine and Scripps Health have enrolled their first patients in the company's pivotal CLARITY (Chronic Low bAck pain Randomized Independent Trial studY) trial, advancing enrollment progress in the trial. The trial represents a key clinical and commercial catalyst for the company and is intended to support future reimbursement discussions in the U.S. With the latest enrollments by Northwestern and Scripps, four sites have enrolled one or more patients. Seven clinical sites have completed the required regulatory approvals, contracting, training, and study setup, enabling them to begin enrolling patients. These CLARITY sites include Texas Back Institute, University of Miami Health, Advocate Health, Northwestern Medicine, Scripps Health, Keck Medicine of USC, and Johns Hopkins University. The company recently hired Jason Brosniak as Commercial Director for the Eastern U.S. and Andy Murillo as Director of Market Access to focus on driving CLARITY trial enrollment and adding more sites to accelerate enrollment progress. The company continues to actively evaluate additional sites to ensure it meets enrollment targets. The CLARITY trial is a multi-site trial designed to evaluate whether incorporating Nociscan into standard surgical planning can improve outcomes that significantly exceed the current 54% industry benchmarks for patients undergoing surgery for chronic low back pain. The study will enroll up to 300 patients, randomized between surgeons who are blinded-to-Nociscan results and unblinded-to-Nocisc an results to guide surgical planning for Fusion/TDR. The Company aims to enroll approximately 25% of patients by the end of Second Quarter 2026. Biomarker data is entered into proprietary algorithms to indicate if a disc may be a source of pa in. 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. New Risk • Dec 04
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 11% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risks Earnings are forecast to decline by an average of 18% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (over 580x increase in shares outstanding). Revenue is less than US$1m (US$67k revenue). Market cap is less than US$10m (US$4.81m market cap). Minor Risks Currently unprofitable and not forecast to become profitable next year (US$8.8m net loss next year). Share price has been volatile over the past 3 months (11% average weekly change). Aankondiging • Dec 03
Aclarion, Inc. Appoints Jason Brosniak as Commercial Director for the Eastern U.S Aclarion, Inc. announced the appointment of Jason Brosniak as Commercial Director, Eastern U.S. Jason is a proven commercial leader with more than 20 years of experience accelerating revenue growth and building high-performing teams for high-growth MedTech companies, including roles at Relievant Medsystems (acquired by Boston Scientific), Kyphon (acquired by Medtronic), and Intrinsic Therapeutics. His background in successfully launching breakthrough technologies and establishing new market categories across spine, orthopedics, and pain management makes him exceptionally well-positioned to drive the adoption of Nociscan in the Eastern U.S. Major Estimate Revision • Nov 21
Consensus revenue estimates decrease by 14% The consensus outlook for fiscal year 2025 has been updated. 2025 revenue forecast fell from US$90.0k to US$80.0k. EPS estimate unchanged at -US$15.13 per share. Healthcare Services industry in the US expected to see average net income growth of 34% next year. Consensus price target up from US$22.00 to US$23.00. Share price was steady at US$6.06 over the past week. Reported Earnings • Nov 14
Third quarter 2025 earnings: EPS and revenues miss analyst expectations Third quarter 2025 results: US$2.93 loss per share. Net loss: US$1.71m (loss widened 24% from 3Q 2024). Revenue missed analyst estimates by 5.3%. Earnings per share (EPS) also missed analyst estimates by 11%. Revenue is forecast to grow 99% p.a. on average during the next 2 years, compared to a 11% growth forecast for the Healthcare Services industry in the US. Aankondiging • Nov 06
Aclarion, Inc. Appoints Dan Isherwood as UK Commercial Director Aclarion, Inc. announced the appointment of Dan Isherwood as UK Commercial Director. Dan has vast experience in advanced imaging and spine technologies combined with a demonstrated ability to drive adoption of new clinical tools. Aclarion believes this positions him perfectly to accelerate the adoption of Nociscan in the UK. In his new role, Dan will execute Aclarion's UK commercial expansion strategy and strengthen relationships with physicians and imaging centers. His appointment follows the recent traction that has established Nociscan as an integral part of the care pathway for chronic low back pain at a leading London spine clinic which led to Nociscan being covered by three of the four top private insurers in the UK, reaching more than 5.2 million covered lives. Dan joins Aclarion following an accomplished career that spans key roles in advanced imaging and spine technology at industry leaders, including J&J MedTech (DePuy Synthes), EOS Imaging (now part of the ATEC Spine Group), and NuVasive (now part of Globus Medical). Importantly, he began his career as a healthcare provider at Warrington and Halton Hospitals NHS Foundation Trust, bringing a genuine, patient-centered understanding to Aclarion's commercial strategy. Aankondiging • Oct 14
Aclarion, Inc. has filed a Follow-on Equity Offering in the amount of $2.507998 million. Aclarion, Inc. has filed a Follow-on Equity Offering in the amount of $2.507998 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 64,000
Price\Range: $8.36
Discount Per Security: $0.5852
Security Name: Pre-Funded Warrants
Security Type: Equity Warrant
Securities Offered: 236,000
Price\Range: $8.35999
Discount Per Security: $0.585199
Transaction Features: Registered Direct Offering Aankondiging • Sep 26
Aclarion, Inc. Announces First Patients Enrolled at UHealth - University of Miami in Aclarion's Pivotal CLARITY Trial Aclarion, Inc. announced that the UHealth - University of Miami Health System and the Miller School of Medicine enrolled its first two patients in the CLARITY (Chronic Low bAck pain Randomized Independent Trial studY) trial. The pivotal CLARITY study is designed to demonstrate Nociscan's clinical and economic value in spine surgery. The CLARITY trial is a prospective, randomized multi-center study evaluating patients who are scheduled to undergo surgical treatment for discogenic back pain in up to two lumbar levels. The study will enroll 300 patients at multiple high-volume sites across the US, and all patients will receive a Nociscan prior to surgery. 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. Aankondiging • Sep 04
Aclarion, Inc. Appoints Greg Gould as Chief Financial Officer, Effective 03 September 2025 Aclarion, Inc. announced the appointment of Greg Gould as Chief Financial Officer (CFO), effective 03 September 2025. Greg brings more than 30 years of public and private company experience with a proven track record of creating shareholder value, raising capital for growth and collaborating with executive leadership to drive business profitability, revenue and cash flow. He succeeds long-time CFO John Lorbiecki, who has announced his plans to retire. Greg brings extensive financial and operational leadership experience to Aclarion. He has raised more than $450 million in public company debt and equity offerings, led over ten acquisitions, successfully sold three publicly-traded companies, and guided three organizations through uplistings to Nasdaq. He has a proven track record of building and streamlining accounting, finance, and administrative functions, with expertise spanning financial controllership, planning and analysis, compliance, consolidation, integration, and auditing. Most recently, Greg served as CFO of Nanos Health, a pre-revenue pharmaceutical startup pioneering nanotechnology-based drug delivery solutions. He has also held CFO roles at 7 publicly-traded companies, including Charlottes Web (TSX: CWEB, OTC: CWBHF) and Aytu BioScience among others. He received a Bachelor of Science in Business from the University of Colorado Boulder and is a Certified Public Accountant (CPA). Reported Earnings • Aug 15
Second quarter 2025 earnings: EPS and revenues miss analyst expectations Second quarter 2025 results: US$2.75 loss per share. Net loss: US$1.60m (loss widened 29% from 2Q 2024). Revenue missed analyst estimates by 36%. Earnings per share (EPS) also missed analyst estimates by 22%. Revenue is forecast to grow 95% p.a. on average during the next 2 years, compared to a 10% growth forecast for the Healthcare Services industry in the US. Board Change • Jul 01
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 8 experienced directors. 2 highly experienced directors. Independent Director Steve Deitsch was the last director to join the board, commencing their role in 2022. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. Aankondiging • Jun 25
Aclarion, Inc. Announces First Patient Enrolled in Clinical Trial Aclarion, Inc. announced the first patient enrollment in the CLARITY (Chronic Low bAck pain Randomized Independent Trial studY) trial evaluating Nociscan's clinical and economic value in spine surgery. The first patient was enrolled at the Texas Back Institute. 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 principal investigator for the trial is Dr. Nicholas Theodore of Johns Hopkins Medicine. Other sites that have been activated include Northwestern Medicine, Advocate Aurora Research Institute, Keck Medicine at USC and UHealth - University of Miami Health System and University of Miami Miller School of Medicine. 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 non pain discs in the lumbar disc. Nociscan objectively quantifies chemical biomarkers demonstrated to be associated with disc pain and has the potential to drive better surgical outcomes. Aankondiging • Jun 21
John Lorbiecki Intents to Retires from Aclarion, Inc. as CFO On June 16, 2025, John Lorbiecki notified Aclarion, Inc. of his intention to retire from his position as the Company's Chief Financial Officer. The Company has initiated a search for Mr. Lorbiecki's replacement. The Company expects to appoint its new CFO before the end of the third quarter of 2025. Mr. Lorbiecki will remain with the Company over the next several months and will lead the effort to transition the CFO duties to his replacement. Mr. Lorbiecki, age 62, joined the Company as CFO in October 2021 prior to the Company's April 2022 initial public offering. Aankondiging • May 21
Aclarion, Inc. Announces Addition of Keck Medical Center of USC as CLARITY Trial Site Aclarion, Inc. announced the addition of Keck Medical Center of USC as a CLARITY (Chronic Low bAck pain Randomized Independent Trial studiesY) trial site. The pivotal CLARITY study is designed to demonstrate Nociscan's clinical and economic value in spine surgery. Keck Medicine of USC is the latest CLARITY trial site, joining Johns Hopkins Medicine, Northwestern Medicine, Advocate Aurora Research Institute and Texas Back 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. 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 non pain 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. Aankondiging • May 14
Aclarion, Inc., Annual General Meeting, Jul 07, 2025 Aclarion, Inc., Annual General Meeting, Jul 07, 2025. Location: 8181arista place, suite 100, co80021, broomfield United States Aankondiging • May 12
Aclarion, Inc. Announces Texas Back Institute as New Clarity Trial Site Aclarion, Inc. 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 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. 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 non painful discs in the lumbar pain. Nociscan objectively quantifies chemical biomarkers demonstrated to be associated with disc pain and has the potential to drive better surgical outcomes. Aankondiging • Apr 01
Aclarion, Inc. announced delayed annual 10-K filing On 03/31/2025, Aclarion, Inc. announced that they will be unable to file their next 10-K by the deadline required by the SEC. Aankondiging • Feb 11
Aclarion, Inc. Receives US Patent to Protect Expanded Applications of Magnetic Resonance Spectroscopy Data Processing to Identify Pain and Infection Biomarkers Throughout the Body Aclarion, Inc. announced it has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for its 24th issued US patent. Whereas previous issued patents in the Aclarion portfolio limit the use of propionic acid (PA) identification by magnetic resonance spectroscopy (MRS) to the disc, this new patent expands Aclarion's ability to use MRS to identify PA throughout the body to identify potential sources of infection and pain. MRS is an existing capability of leading magnetic resonance imaging (MRI) scanners which are commonly used for medical imaging. MRI creates images of the soft tissue structures of the body while MRS generates spectral data information on the levels of various chemical biomarkers within the soft tissues such as proteins, carbohydrates, acids, etc. However, conventional MRS post-processing approaches can be challenging and fall short of generating sufficient quality data for reliable chemical analysis. Several of Aclarion's patents relate to novel inventions that address many of these challenges, resulting in more reliable, higher quality spectral data for more sophisticated chemical biomarker analysis, ensuring the accuracy and reliability of the Nocisca n solution and other MRS applications. Aankondiging • Jan 31
Aclarion, Inc. has filed a Follow-on Equity Offering in the amount of $4.687928 million. Aclarion, Inc. has filed a Follow-on Equity Offering in the amount of $4.687928 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 506,803
Price\Range: $9.25
Transaction Features: Registered Direct Offering Aankondiging • Jan 04
Aclarion, Inc. has completed a Follow-on Equity Offering in the amount of $0.3 million. Aclarion, Inc. has completed a Follow-on Equity Offering in the amount of $0.3 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 1,606,211
Price\Range: $0.186775
Transaction Features: At the Market Offering New Risk • Jan 03
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of American stocks, typically moving 35% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (35% average weekly change). Shareholders have been substantially diluted in the past year (over 17x increase in shares outstanding). Revenue is less than US$1m (US$49k revenue). Market cap is less than US$10m (US$1.48m market cap). Minor Risk Currently unprofitable and not forecast to become profitable next year (US$5.9m net loss next year). Aankondiging • Dec 11
Aclarion, Inc. has filed a Follow-on Equity Offering in the amount of $31.5 million. Aclarion, Inc. has filed a Follow-on Equity Offering in the amount of $31.5 million.
Security Name: Common Stock
Security Type: Common Stock
Security Name: Pre-Funded Warrants
Security Type: Equity Warrant
Security Name: Series A Common Warrants
Security Type: Equity Warrant
Security Name: Series B Common Warrants
Security Type: Equity Warrant Aankondiging • Dec 03
Aclarion, Inc., Annual General Meeting, Dec 31, 2024 Aclarion, Inc., Annual General Meeting, Dec 31, 2024. Location: 8181 arista place, suite 100, colorado 80021., broomfield United States Major Estimate Revision • Nov 29
Consensus revenue estimates decrease by 18%, EPS upgraded The consensus outlook for fiscal year 2024 has been updated. 2024 revenue forecast fell from US$70.0k to US$60.0k. EPS estimate increased from -US$0.87 to -US$0.79 per share. Healthcare Services industry in the US expected to see average net income growth of 18% next year. Consensus price target down from US$1.25 to US$1.15. Share price was steady at US$0.18 over the past week. Reported Earnings • Nov 17
Third quarter 2024 earnings: EPS exceeds analyst expectations while revenues lag behind Third quarter 2024 results: US$0.14 loss per share. Net loss: US$1.37m (loss widened 37% from 3Q 2023). Revenue missed analyst estimates by 42%. Earnings per share (EPS) exceeded analyst estimates by 12%. Revenue is forecast to grow 136% p.a. on average during the next 2 years, compared to a 9.7% growth forecast for the Healthcare Services industry in the US. Aankondiging • Oct 14
Aclarion Provides Update on Non-Compliance with Nasdaq’s Stockholders’ Equity Requirement and Nasdaq’s Bid Price Requirement As previously disclosed, on April 8, 2024, Aclarion, Inc. (the ‘Company’) received a written notice (the ‘April Notice’) from the Listing Qualifications Department of The Nasdaq Stock Market (‘Nasdaq’) indicating that the Company is not in compliance with the $1.00 Minimum Bid Price requirement set in Nasdaq Listing Rule 5550(a)(2) for continued listing on The Nasdaq Capital Market (the ‘Bid Price Requirement’). The Nasdaq Listing Rules require listed securities to maintain a minimum bid price of $1.00 per share and, based upon the closing bid price of the Company’s common stock for the 30 consecutive business days for the period ending April 5, 2024, the Company no longer met this requirement. As previously disclosed, the Company received written notice from Nasdaq on August 22, 2024, that the Company was not in compliance with Nasdaq Listing Rule 5550(b)(1) (the ‘Stockholders’ Equity Rule’), which requires the Company to maintain a minimum of $2.5 million in stockholders’ equity for continued listing on The Nasdaq Capital Market. In its quarterly report on Form 10-Q for the period ended June 30, 2024, the Company reported stockholders’ equity of $1,642,177, and, as a result, did not satisfy Listing Rule 5550(b)(1). The Company had previously appealed the Stockholders’ Equity Rule matter to a Nasdaq hearing panel (the ‘Panel’). The hearing request stays any suspension or delisting action pending the conclusion of the hearing process and the expiration of any additional extension period granted by the Panel following the hearing. The appeal hearing for the Stockholders’ Equity Rule matter was scheduled for October 10, 2024. October 2024 Notice of $1 Bid Price Non-Compliance: The company did not regain compliance with the Bid Price Requirement prior to the expiration of the 180 calendar day period on October 7, 2024. Accordingly, on October 8, 2024, the company received from the Nasdaq staff (the ‘Staff’) written notification (the ‘October Notice’) that the company’s securities are subject to delisting from the Nasdaq Capital Market for non-compliance with the Bid Price Requirement. The October Notice also indicated that the Company’s Bid Price Requirement compliance would also be considered by the Panel at the previously scheduled October 10, 2024 hearing. The previously scheduled hearing with the Panel occurred on October 10, 2024. At this hearing, the Company presented a compliance plan to the Panel addressing both the Stockholders’ Equity Requirement and the Bid Price Requirement. The hearing request stays any suspension or delisting action pending the conclusion of the hearing process and the expiration of any additional extension period granted by the Panel following the hearing. While the appeal process is pending, the suspension of trading of the Company’s common stock will be stayed. The company’s common stock will continue to trade on Nasdaq until the hearing process concludes and the Panel issues a written decision. At the Company’s special stockholders’ meeting on September 23, 2024, the Company’s stockholders approved a proposal to grant discretionary authority to the Company’s board of directors to (i) amend the Company’s certificate of incorporation to combine outstanding shares of the Company’s common stock into a lesser number of outstanding shares, or a ‘reverse stock split,’ at a specific ratio within a range of one-for-five (1-for-5) to a maximum of a one-for-fifty (1-for-50) split, with the exact ratio to be determined by the Company’s board of directors in its sole discretion; and (ii) effect the reverse stock split, if at all, within one year of the date the proposal was approved by stockholders. The Company intends to implement a reverse stock split in the near future in order to assist with the Company’s compliance with Nasdaq’s Bid Price Requirement. The Company intends to take all reasonable measures available to regain compliance under the Nasdaq Listing Rules and remain listed on Nasdaq. Aankondiging • Oct 02
Aclarion, Inc. announced that it has received $1 million in funding Aclarion, Inc. entered into a securities purchase agreement with accredited investors to issue 1,000 shares of Series C convertible preferred stock at a purchase price of $1,000 per share of Series C Preferred Stock and warrants exercisable for 5,685,049 shares of Common Stock with a 5.5 year term for gross proceeds of $1,000,000 on September 30, 2024. Series C Preferred Stock is convertible into Common Stock at an initial conversion price of $0.1759 per share of Common Stock. Warrants initial exercise price is of $0.1759 per share. The Company and each Buyer is executing and delivering this Agreement in reliance upon the exemption from securities registration afforded by Section 4(a)(2) of the Securities Act of 1933, as amended (the “ 1933 Act ”), and Rule 506(b) of Regulation D (“ Regulation D ”) as promulgated by the United States Securities and Exchange Commission (the “ SEC ”) under the 1933 Act. Holders of the Series C Preferred Stock will be entitled to dividends in the amount of 10% per annum, payable quarterly. Aankondiging • Sep 27
Aclarion's Nociscan AI Plays Key Role in Advanced Understanding of Modic Changes Aclarion, Inc. announced that the Nociscan solution was utilized to better understand Modic changes (MC) in patients suffering from chronic low back pain (cLBP). The prospective study of 88 patients with low back pain for greater than 3 months was presented at the 50thInternational Society for the Study of the Lumbar Spine Annual Meeting 2024 in Milan, Italy. 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. Biomarker data is entered into proprietary algorithms to highlight 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. Aankondiging • Sep 25
Aclarion, Inc. has filed a Follow-on Equity Offering in the amount of $1.075 million. Aclarion, Inc. has filed a Follow-on Equity Offering in the amount of $1.075 million.
Security Name: Common Stock
Security Type: Common Stock
Transaction Features: At the Market Offering Aankondiging • Sep 05
Aclarion Launches Surgeon Partnership to Apply Nociscan's Ai Technology to Personal Injury and Workers Compensation Market Aclarion, Inc. announced the launch of a program to develop a statewide network of providers in New Jersey to utilize Nociscan throughout the personal injury and workers compensation population. Justin Kubeck, MD, an orthopedic surgeon and founder of Ocean Pain and Spine in Toms River, NJ will initiate a focused effort to improve the objective evaluation of chronic low back pain patients throughout the complex personal injury and workers compensation system that aims to provide the right treatments and financial compensation to patients suffering from injury. Workers compensation and personal injury claims involving the neck and back have significant financial implications for workers, employers, and insurance companies. Although there are many factors that go into the final settlement or jury verdict associated with these cases, whether surgical intervention is required or not is often a clear delineating point for the size of the settlement. Because Nociscan directly measures biomarkers in the lumbar disc correlated to pain and structural integrity, Nociscan is positioned to provide important objective data that providers can use as they formulate and defend their recommended treatment plan. Aankondiging • Aug 25
Aclarion Receives Non-Compliance Letter from Nasdaq Due to Non-Compliance with the Nasdaq Minimum Stockholders’ Equity Requirement On August 22, 2024, Aclarion, Inc. (the ‘Company’) received a letter from The Nasdaq Stock Market LLC (‘Nasdaq’) indicating that it is not in compliance with Nasdaq Listing Rule 5550(b)(1), which requires companies listed on The Nasdaq Stock Market to maintain a minimum of $2,500,000 in stockholders’ equity for continued listing. In its annual report on Form 10-Q for the period ended June 30, 2024, the Company reported stockholders’ equity of $1,642,177, and, as a result, does not currently satisfy Listing Rule 5550(b)(1). Nasdaq’s letter has no immediate impact on the listing of the Company’s common stock, which will continue to be listed and traded on Nasdaq, subject to the Company’s compliance with the other continued listing requirements. Nasdaq’s letter provides the Company has until August 29, 2024, to request an appeal of this determination, or the trading of the Company’s common stock will be suspended at the opening of business on September 3, 2024. The hearing request would stay any suspension or delisting action pending the conclusion of the hearing process and the expiration of any additional extension period granted by the panel following the hearing. The Company intends to take all reasonable measures available to regain compliance under the Nasdaq Listing Rules and remain listed on Nasdaq. The Company is currently evaluating its available options to resolve the deficiency and regain compliance with the Nasdaq minimum stockholders’ equity requirement. The Company intends to request an appeal of this determination by the Nasdaq deadline. The Company’s receipt of this letter from Nasdaq does not affect the Company’s business, operations or reporting requirements with the Securities and Exchange Commission. Reported Earnings • Aug 16
Second quarter 2024 earnings: EPS exceeds analyst expectations while revenues lag behind Second quarter 2024 results: US$0.15 loss per share (improved from US$2.83 loss in 2Q 2023). Net loss: US$1.24m (loss narrowed 16% from 2Q 2023). Revenue missed analyst estimates by 51%. Earnings per share (EPS) exceeded analyst estimates by 21%. Revenue is forecast to grow 106% p.a. on average during the next 2 years, compared to a 10.0% growth forecast for the Healthcare Services industry in the US. New Risk • May 22
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 0.3% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$5.0m free cash flow). Share price has been highly volatile over the past 3 months (26% average weekly change). Earnings are forecast to decline by an average of 0.3% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (over 15x increase in shares outstanding). Revenue is less than US$1m (US$60k revenue). Market cap is less than US$10m (US$2.54m market cap). Minor Risk Currently unprofitable and not forecast to become profitable next year (US$6.5m net loss next year). Reported Earnings • May 17
First quarter 2024 earnings released: US$0.44 loss per share (vs US$2.39 loss in 1Q 2023) First quarter 2024 results: US$0.44 loss per share. Net loss: US$2.40m (loss widened 103% from 1Q 2023). Aankondiging • Apr 13
Aclarion Receives Notice from Nasdaq Regarding Non-Compliance with the $1.00 Minimum Bid Price Requirement Set Forth in Nasdaq Listing Rule 5550(a)(2) On April 8, 2024, Aclarion, Inc. (the ‘Company’) received a written notice (the ‘Notice’) from the Listing Qualifications Department of The Nasdaq Stock Market (‘Nasdaq’) indicating that the Company is not in compliance with the $1.00 Minimum Bid Price requirement set forth in Nasdaq Listing Rule 5550(a)(2) for continued listing on The Nasdaq Capital Market (the ‘Bid Price Requirement’). The Notice does not result in the immediate delisting of the Company’s common stock from The Nasdaq Capital Market. The Nasdaq Listing Rules require listed securities to maintain a minimum bid price of $1.00 per share and, based upon the closing bid price of the Company’s common stock for the 30 consecutive business days for the period ending April 5, 2024, the Company no longer meets this requirement. The Notice indicated that the Company will be provided 180 calendar days (or until October 7, 2024) in which to regain compliance. If at any time during this 180 calendar day period the bid price of the Company’s common stock closes at or above $1.00 per share for a minimum of ten consecutive business days, the Nasdaq staff (the ‘Staff’) will provide the Company with a written confirmation of compliance and the matter will be closed. Alternatively, if the Company fails to regain compliance with Rule 5550(a)(2) prior to the expiration of the initial 180 calendar day period, the Company may be eligible for an additional 180 calendar day compliance period, provided (i) it meets the continued listing requirement for market value of publicly held shares and all other applicable requirements for initial listing on The Nasdaq Capital Market (except for the Bid Price Requirement) and (ii) it provides written notice to Nasdaq of its intention to cure this deficiency during the second compliance period by effecting a reverse stock split, if necessary. In the event the Company does not regain compliance with Rule 5550(a)(2) prior to the expiration of the initial 180 calendar day period, and if it appears to the Staff that the Company will not be able to cure the deficiency, or if the Company is not otherwise eligible, the Staff will provide the Company with written notification that its securities are subject to delisting from The Nasdaq Capital Market. At that time, the Company may appeal the delisting determination to a Hearings Panel. The Company intends to monitor the closing bid price of its common stock and is considering its options to regain compliance with the Bid Price Requirement. The Company’s receipt of the Notice does not affect the Company’s business, operations or reporting requirements with the Securities and Exchange Commission. Aankondiging • Feb 28
Aclarion, Inc. has completed a Composite Units Offering in the amount of $3.0015 million. Aclarion, Inc. has completed a Composite Units Offering in the amount of $3.0015 million.
Security Name: Units
Security Type: Equity/Derivative Unit
Securities Offered: 5,175,000
Price\Range: $0.58
Discount Per Security: $0.0406 Reported Earnings • Feb 22
Full year 2023 earnings released: US$8.82 loss per share (vs US$19.61 loss in FY 2022) Full year 2023 results: US$8.82 loss per share (improved from US$19.61 loss in FY 2022). Net loss: US$4.91m (loss narrowed 34% from FY 2022). Aankondiging • Jan 17
Aclarion Announces Updated Product Release That Expands Mri Scanner Access for Nociscan Solution Aclarion, Inc. announced the product release of Nociscan 2.6 which includes support for additional leading magnetic resonance imaging (MRI) scanners. With this product release Nociscan can now be performed on MRI machines beyond those manufactured by Siemens. The advancement of augmented intelligence decision support solutions, like Nociscan, is rapidly improving the lives of millions of patients. Aclarion is honored to be leading the industry in addressing a global healthcare problem that impacts approximately 266 million people who suffer from degenerative spine disease and low back pain. New Risk • Jan 07
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 72% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (26% average weekly change). Negative equity (-US$828k). Earnings have declined by 7.8% per year over the past 5 years. Shareholders have been substantially diluted in the past year (72% increase in shares outstanding). Revenue is less than US$1m (US$84k revenue). Market cap is less than US$10m (US$2.57m market cap). Aankondiging • Nov 23
Aclarion, Inc. announced that it has received $0.25 million in funding Aclarion, Inc. announced that it has entered into a securities purchase agreement with an accredited investors pursuant to which it issued fixed rate unsecured non-convertible note financing due April 19, 2024 for an aggregate gross proceeds of $250,000 on November 21, 2023. The notes carry fixed rate of interest of 8% payable. The notes will mature on April 19, 2024. The notes will have a 15% original issue discount. The aggregate principal amount of the notes is $294,117.65. The notes may be prepaid by the Company at any time without penalty. If the Company completes one or more qualified offerings of securities, then the notes become redeemable at the option of the investor. After an event of default, the interest rate on the notes increases to 15%, and the notes become redeemable (at the option of the investor) at a redemption premium of 25%. Reported Earnings • Nov 17
Third quarter 2023 earnings released: US$0.12 loss per share (vs US$0.21 loss in 3Q 2022) Third quarter 2023 results: US$0.12 loss per share (improved from US$0.21 loss in 3Q 2022). Net loss: US$998.0k (loss narrowed 39% from 3Q 2022). Aankondiging • Nov 15
Aclarion, Inc., Annual General Meeting, Dec 18, 2023 Aclarion, Inc., Annual General Meeting, Dec 18, 2023, at 09:30 US Mountain Standard Time. Location: 8181 Arista Place, Suite 100 Broomfield Colorado United States Agenda: To elect seven director nominees to the board of directors, to serve until the Company's 2023 annual meeting of stockholders and until their successors have been duly elected and qualified, or until their earlier death, resignation or removal ; to ratify the appointment of Haynie & Company as the independent registered public accounting firm for the fiscal year ending December 31, 2023; to authorize, in accordance with Nasdaq Listing Rule 5635(d), the issuance of shares of our common stock, pursuant to the Company's Equity Line of Credit; and to transact any other business properly brought before the Annual Meeting or any adjournment or postponement of the Annual Meeting. Aankondiging • Sep 08
Nasdaq Staff Determines to Delist the Aclarion Common Stock from Nasdaq, Unless the Company Timely Requests an Appeal of the Staff’s Determination to A Hearings Panel As previously disclosed, on March 3, 2023, Aclarion, Inc. (the “Company”) received a letter from The Nasdaq Stock Market LLC (“Nasdaq”) indicating that it was not in compliance with Nasdaq Listing Rule 5550(b)(1), which requires companies listed on Nasdaq to maintain a minimum of $2,500,000 in stockholders’ equity for continued listing (the “Stockholders’ Equity Requirement”). On April 20, 2023, the Company received a letter (the “Extension Notice”) from Nasdaq notifying the Company that it had been granted a 180-day period, or until August 30, 2023, to regain compliance with the Stockholders’ Equity Requirement. Separately, the Company is also not currently in compliance with Nasdaq Listing Rule 5550(a)(2), which requires that the Company maintain a bid price for the Company’s common stock of above $1.00 per share (the “Bid Price Requirement”). The Company remains subject to a grace period to regain compliance with the Bid Price Requirement through January 31, 2024. On August 31, 2023, the Nasdaq staff notified the Company that it had not met the terms of the Extension Notice. Accordingly, the Nasdaq staff had determined to delist the Company’s common stock from Nasdaq, unless the Company timely requests an appeal of the staff’s determination to a hearings panel (the “Panel”), pursuant to the procedures set forth in the Nasdaq Listing Rule 5800 Series. The Company has requested a hearing before the Panel to appeal the delisting notice from the staff. While the appeal process is pending, the suspension of trading of the Company’s common stock will be stayed. Common stock will continue to trade on Nasdaq until the hearing process concludes and the Panel issues a written decision. The Company intends to take all reasonable measures available to regain compliance under the Nasdaq Listing Rules and remain listed on Nasdaq. There can be no assurance that a favorable decision will be obtained from the Panel. If trading in the Company’s common stock is suspended on Nasdaq or the Company’s common stock is delisted by Nasdaq for any reason, it could negatively impact the Company as it would likely reduce the liquidity and market price of the Company’s common stock; reduce the number of investors willing to hold or acquire the Company’s common stock; negatively impact the Company’s ability to access equity markets and obtain financing; and impair the Company’s ability to provide equity incentives. Aankondiging • Sep 01
Nasdaq Confirms Aclarion Regains Compliance with Rule 5250(c)(1) Regarding Filing of 10-Q Report On August 23, 2023, Aclarion, Inc. received a notice from Nasdaq notifying the Company that because the Company remained delinquent in filing its Form 10-Q, the Company no longer complied with Nasdaq Listing Rule 5250(c)(1), which requires companies with securities listed on Nasdaq to timely file all required periodic reports with the SEC. As previously reported in a Form 12b-25 Notification of Late Filing filed by the company on August 14, 2023, the Company was delayed in filing with the Securities and Exchange Commission (the ‘SEC’) its Quarterly Report on Form 10-Q for the quarter ended June 30, 2023 (the ‘Form 10-Q’). The Company was not able to file the Form 10-Q by the extended deadline of August 21, 2023. The Company filed the Form 10-Q on August 25, 2023. On August 28, 2023, Nasdaq confirmed that the Company had regained compliance with Rule 5250(c)(1) and that this matter is now closed. Aankondiging • Aug 27
Aclarion Announces Update on Non-Compliance Notice from Nasdaq Regarding Late Filing of 10-Q Report As previously reported in a Form 12b-25 Notification of Late Filing filed by Aclarion, Inc. (the ‘Company’) on August 14, 2023, the Company has been delayed in filing with the Securities and Exchange Commission (the ‘SEC’) its Quarterly Report on Form 10-Q for the quarter ended June 30, 2023 (the ‘Form 10-Q’). The Company requested an extension to allow more time for the company's independent registered public accounting firm to complete their review of interim financial statements. The Company was not able to file the Form 10-Q by the extended deadline of August 21, 2023. The Company filed the Form 10-Q on August 25, 2023. On August 23, 2023, the Company received a notice from Nasdaq notifying the Company that because the Company remains delinquent in filing its Form 10-Q, the Company no longer complies with Nasdaq Listing Rule 5250(c)(1), which requires companies with securities listed on Nasdaq to timely file all required periodic reports with the SEC. The notice received from Nasdaq has no immediate effect on the listing or trading of the Company’s securities on Nasdaq. However, if the Company would fail to timely regain compliance with Rule 5250(c)(1), the Company’s securities would be subject to delisting from Nasdaq. Under the Nasdaq rules, the Company has until October 22, 2023 (60 days after Nasdaq’s notice) to submit a plan to regain compliance with the Rule 5250(c)(1). The Company filed the Form 10-Q on August 25, 2023. The Company believes, therefore, that it has regained compliance with Rule 5250(c)(1). Board Change • Aug 16
High number of new and inexperienced directors There are 6 new directors who have joined the board in the last 3 years. The company's board is composed of: 6 new directors. 5 experienced directors. No highly experienced directors. Independent Director Bill Wesemann is the most experienced director on the board, commencing their role in 2016. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors. Aankondiging • Aug 11
Aclarion Receives Non-Compliance Notice From Nasdaq On August 4, 2023, Aclarion, Inc. (the “Company”) received a written notice (the “Notice”) from the Listing Qualifications Department of The Nasdaq Stock Market (“Nasdaq”) indicating that the Company is not in compliance with the $1.00 Minimum Bid Price requirement set in Nasdaq Listing Rule 5550(a)(2) for continued listing on The Nasdaq Capital Market (the “Bid Price Requirement”). The Notice does not result in the immediate delisting of the Company’s common stock from The Nasdaq Capital Market. The Nasdaq Listing Rules require listed securities to maintain a minimum bid price of $1.00 per share and, based upon the closing bid price of the Company’s common stock for the 30 consecutive business days for the period ending August 3, 2023, the Company no longer meets this requirement. The Notice indicated that the Company will be provided 180 calendar days in which to regain compliance. If at any time during this 180 calendar day period the bid price of the Company’s common stock closes at or above $1.00 per share for a minimum of ten consecutive business days, the Nasdaq staff (the “Staff”) will provide the Company with a written confirmation of compliance and the matter will be closed. Alternatively, if the Company fails to regain compliance with Rule 5550(a)(2) prior to the expiration of the initial 180 calendar day period, the Company may be eligible for an additional 180 calendar day compliance period, provided (i) it meets the continued listing requirement for market value of publicly held shares and all other applicable requirements for initial listing on The Nasdaq Capital Market (except for the Bid Price Requirement) and (ii) it provides written notice to Nasdaq of its intention to cure this deficiency during the second compliance period by effecting a reverse stock split, if necessary. In the event the Company does not regain compliance with Rule 5550(a)(2) prior to the expiration of the initial 180 calendar day period, and if it appears to the Staff that the Company will not be able to cure the deficiency, or if the Company is not otherwise eligible, the Staff will provide the Company with written notification that its securities are subject to delisting from The Nasdaq Capital Market. At that time, the Company may appeal the delisting determination to a Hearings Panel. The Company intends to monitor the closing bid price of its common stock and is considering its options to regain compliance with the Bid Price Requirement. The Company’s receipt of the Notice does not affect the Company’s business, operations or reporting requirements with the Securities and Exchange Commission. Aankondiging • Jul 08
Aclarion, Inc. Regains Compliance with Nasdaq As previously disclosed, on May 23, 2023, Aclarion, Inc. received a notice from Nasdaq notifying the Company that because the Company was delinquent in filing its Form 10-Q for the quarter ended March 31, 2023, the Company no longer complied with Nasdaq Listing Rule 5250(c)(1), which requires companies with securities listed on Nasdaq to timely file all required periodic reports with the SEC. On July 3, 2023, the Company filed its Form 10-Q for the quarter ended March 31, 2023 with the SEC. On July 5, 2023, the Company received a letter from Nasdaq indicating that the Company was now in compliance with Nasdaq Listing Rule 5250(c)(1). Aankondiging • Jun 21
Aclarion, Inc. Regains Compliance with Nasdaq Minimum Bid Price Requirement As previously disclosed, on December 20, 2022, Aclarion, Inc. (the Company") received a written notice (the Notice") from the Listing Qualifications Department of The Nasdaq Stock Market (Nasdaq") indicating that the Company was not in compliance with the $1.00 Minimum Bid Price requirement set forth in Nasdaq Listing Rule 5550(a)(2) for continued listing on The Nasdaq Capital Market (the Bid Price Requirement"). The Notice indicated that the Company would be provided 180 calendar days in which to regain compliance with the Bid Price Requirement. On June 15, 2023, the Nasdaq staff (the Staff") notified the Company that the Company had regained compliance with the Minimum Bid Price Requirement based on the closing bid price of the Company's common stock having been at $1.00 per share or greater for the 10 consecutive business days from June 1, 2023 to June 14, 2023. Aankondiging • May 31
Aclarion, Inc. Receives Nasdaq Notice Regarding Late Filing of 10-Q Report On May 23, 2023, Aclarion, Inc. received a notice from Nasdaq notifying the Company that because the Company remains delinquent in filing its Form 10-Q, the Company no longer complies with Nasdaq Listing Rule 5250(c)(1), which requires companies with securities listed on Nasdaq to timely file all required periodic reports with the SEC. The notice received from Nasdaq has no immediate effect on the listing or trading of the Company’s securities on Nasdaq. However, if the Company would fail to timely regain compliance with Rule 5250(c)(1), the Company’s securities would be subject to delisting from Nasdaq. Under the Nasdaq rules, the Company has until July 22,2023 (60 days after Nasdaq’s notice) to submit a plan to regain compliance with the Rule 5250(c)(1). The Company expects that the Form 10-Q will be filed well in advance of such July 22, 2023 date. The Company believes that it will regain compliance with Rule 5250(c)(1) once the Form 10-Q is filed with the SEC. Aankondiging • May 17
Aclarion, Inc. announced delayed 10-Q filing On 05/16/2023, Aclarion, Inc. announced that they will be unable to file their next 10-Q by the deadline required by the SEC. Reported Earnings • Mar 01
Full year 2022 earnings released: US$1.25 loss per share (vs US$6.58 loss in FY 2021) Full year 2022 results: US$1.25 loss per share. Net loss: US$7.61m (loss widened 28% from FY 2021). Revenue is forecast to grow 127% p.a. on average during the next 2 years, compared to a 13% growth forecast for the Healthcare Services industry in the US. Aankondiging • Jan 18
Aclarion, Inc. George Frey MD as Key Opinion Leader Aclarion, Inc. announced that George Frey MD, Founder of the Colorado Comprehensive Spine Institute, will advise the company as a key opinion leader. Dr. Frey is a renowned surgeon and inventor with dozens of US and worldwide patents in medical devices, technologies, and methods. Dr. Frey’s experiences as a clinician and entrepreneur will provide valuable direction to Aclarion. Chronic low back pain (cLBP) is a leading cause of opioid addiction in the U.S. and the single most expensive diagnosis in the United States. 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. Biomarker data is entered into proprietary algorithms to highlight 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. Aankondiging • Dec 26
Aclarion, Inc. Receives a Written Notice from the Listing Qualifications Department of the Nasdaq Stock Market On December 20, 2022, Aclarion, Inc. received a written notice (the Notice") from the Listing Qualifications Department of The Nasdaq Stock Market indicating that the Company is not in compliance with the $1.00 Minimum Bid Price requirement set forth in Nasdaq Listing Rule 5550(a)(2) for continued listing on The Nasdaq Capital Market (the Bid Price Requirement"). The Notice does not result in the immediate delisting of the Company's common stock from The Nasdaq Capital Market. The Nasdaq Listing Rules require listed securities to maintain a minimum bid price of $1.00 per share and, based upon the closing bid price of the Company's common stock for the 30 consecutive business days for the period November 4 through December 19, 2022, the Company no longer meets this requirement. The Notice indicated that the Company will be provided 180 calendar days in which to regain compliance. If at any time during this 180 calendar day period the bid price of the Company's common stock closes at or above $1.00 per share for a minimum of ten consecutive business days, the Nasdaq staff (the Staff") will provide the Company with a written confirmation of compliance and the matter will be closed. Alternatively, if the Company fails to regain compliance with Rule 5550(a)(2) prior to the expiration of the initial 180 calendar day period, the Company may be eligible for an additional 180 calendar day compliance period, provided (i) it meets the continued listing requirement for market value of publicly held shares and all other applicable requirements for initial listing on The Nasdaq Capital Market (except for the Bid Price Requirement) and (ii) it provides written notice to Nasdaq of its intention to cure this deficiency during the second compliance period by effecting a reverse stock split, if necessary. In the event the Company does not regain compliance with Rule 5550(a)(2) prior to the expiration of the initial 180 calendar day period, and if it appears to the Staff that the Company will not be able to cure the deficiency, or if the Company is not otherwise eligible, the Staff will provide the Company with written notification that its securities are subject to delisting from The Nasdaq Capital Market. At that time, the Company may appeal the delisting determination to a Hearings Panel. The Company intends to monitor the closing bid price of its common stock and is considering its options to regain compliance with the Bid Price Requirement. The Company's receipt of the Notice does not affect the Company's business, operations or reporting requirements with the Securities and Exchange Commission. Aankondiging • Dec 22
Aclarion, Inc’s Key Opinion Leader Program Adds Fifth Surgeon Advisor with Addition of Eric Potts, MD Aclarion, Inc. announced that Eric Potts M.D., Neurosurgeon at Ascension St. Vincent Hospital and member of the Board of Directors at the Goodman Campbell Brain and Spine in Indianapolis, IN, will advise the company as a key opinion leader (KOL) nationally. Chronic low back pain (cLBP) is a leading cause of opioid addiction in the U.S. and the single most expensive diagnosis in the United States. 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. Biomarker data is entered into proprietary algorithms to highlight 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. Dr. Potts is chair-elect of the American Association of Neurological Surgeons and the Congress of Neurological Surgeons (AANS/CNS) Joint Section on the Disorders of the Spine and Peripheral Nerves. He has been a long-standing Executive Committee member of this organization. Dr. Potts is passionate about leading-edge technologies and equally focused on improving quality outcomes. Board Change • Nov 16
High number of new directors There are 5 new directors who have joined the board in the last 3 years. Independent Director Steve Deitsch was the last director to join the board, commencing their role in 2022. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model. Aankondiging • Sep 20
Aclarion, Inc.'s Nociscan Selected for Inclusion in Pivotal National Institutes of Health Study for Low Back Pain Aclarion, Inc. announced their participation in the Biomarkers for Evaluating Spine Treatments Trial funded through the Helping to End Addiction Long-termSM Initiative, or NIH HEAL Initiative. BEST will enroll over 800 patients at 12 leading academic teaching institutions across the United States, with a subset of 200 undergoing advanced biomarker profiling, which includes Nociscan. Chronic low back pain (cLBP) is a leading cause of opioid addiction in the U.S., and the NIH is addressing the opioid crisis through this initiative. Armed with $150M in funding, the NIH HEAL Initiative launched the Back Pain Consortium (BACPAC) Research Program to study cLBP and recommend a definitive clinical trial to personalize cLBP treatments for each patient based on their specific biomarker profiles. BEST is the clinical trial BACPAC has designed to study the use of biomarkers as a means of optimizing the clinical treatment journey for cLBP patients. Since 2021, Aclarion has been providing biomarker data to BACPAC through the REACH center at University of California, San Francisco. Aclarion's proprietary decision-support tool, Nociscan, 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. Biomarker data is entered into proprietary algorithms to highlight 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. Reported Earnings • Aug 17
Second quarter 2022 earnings: EPS and revenues miss analyst expectations Second quarter 2022 results: US$0.49 loss per share. Net loss: US$3.84m (loss widened 465% from 2Q 2021). Revenue missed analyst estimates by 18%. Earnings per share (EPS) also missed analyst estimates by 345%. Over the next year, revenue is forecast to grow 2,425%, compared to a 17% growth forecast for the Healthcare Services industry in the US. Reported Earnings • Jun 08
First quarter 2022 earnings released: US$1.35 loss per share (vs US$0.81 loss in 1Q 2021) First quarter 2022 results: US$1.35 loss per share (down from US$0.81 loss in 1Q 2021). Net loss: US$1.22m (loss widened 67% from 1Q 2021). Recent Insider Transactions • Apr 27
Director recently bought US$150k worth of stock On the 21st of April, David Neal bought around 34k shares on-market at roughly US$4.35 per share. This was the largest purchase by an insider in the last 3 months. Insiders have collectively bought US$258k more in shares than they have sold in the last 12 months. Board Change • Apr 27
High number of new directors There are 5 new directors who have joined the board in the last 3 years. Independent Director Steve Deitsch was the last director to join the board, commencing their role in 2022. The company’s lack of board continuity is considered a risk according to the Simply Wall St Risk Model. Aankondiging • Apr 23
Aclarion, Inc. has completed an IPO in the amount of $9.41775 million. Aclarion, Inc. has completed an IPO in the amount of $9.41775 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 2,165,000
Price\Range: $4.35
Security Name: Warrants
Security Type: Equity Warrant
Securities Offered: 2,165,000
Transaction Features: Sponsor Backed Offering