Table of Contents As filed with the Securities and Exchange Commission on December 11, 2023 Registration No. 333-______ UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Aclarion, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) Delaware 8071 47-3324725 (I.R.S. Employer Identification Number) ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________ to __________ Commission File Number: 001-41358 ACLARION, INC. (Exact name of registrant as specified in its charter) Delaware 47-3324725 (Stat ...

Table of Contents As filed with the Securities and Exchange Commission on October 20, 2023 Registration No. 333-274914 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Pre-Effective Amendment No. 1 to FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Aclarion, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) (Name, address, including zip cod ...

Table of Contents As filed with the Securities and Exchange Commission on October 10, 2023 Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Aclarion, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) Delaware 8071 47-3324725 (I.R.S. Employer Identification Number) (Addres ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________ to __________ Commission File Number: 001-41358 ACLARION, INC. (Exact name of registrant as specified in its charter) Delaware 47-3324725 (State or ...

Table of Contents As filed with the Securities and Exchange Commission on July 12, 2023 Registration No. 333-273113 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO. 1 TO (Primary Standard Industrial Classification Code Number) Delaware 8071 47-3324725 (I.R.S. Employer Identification Number) 8181 Arista Place, Suite 100 Broomfield, Colorado 80021 (833) 275-2266 (Address, including zip code, and telephone number, including area code, of registrant's principal executive off ...

Table of Contents As filed with the Securities and Exchange Commission on July 3, 2023 Registration No. 333-______ UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Aclarion, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) Delaware 8071 47-3324725 (I.R.S. Employer Identification Number) 8181 ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________ to __________ Commission File Number: 001-41358 ACLARION, INC. (Exact name of registrant as specified in its charter) Delaware 47-3324725 (State or ...

Technology and Innovation - Aclarion's technology aims to improve surgical outcomes for chronic discogenic low back pain, with a clinical study showing that 97% of patients met the criteria for clinical improvement when all discs identified as painful were included in treatment, compared to 54% when they were not[32]. - The company has developed proprietary MR Spectroscopy technology, which identifies chemical compositions of tissues, and has a patent portfolio that includes 22 U.S. patents and 17 foreign patents[30]. - Aclarion's first commercial product, NOCISCAN, utilizes proprietary biomarkers to assist surgeons in determining which intervertebral discs are pain generators, potentially becoming a standard protocol for surgical intervention[38]. - Aclarion's NOCISCAN platform is currently compatible with approximately 1,500 SIEMENS MRI scanner models in the U.S. and 4,320 worldwide, with plans to collaborate with other vendors for broader compatibility[36]. - Aclarion's research indicates that chemical changes in lumbar discs, which cannot be detected by standard MRI, may be responsible for pain, underscoring the need for advanced diagnostic solutions[34]. - NOCISCAN uses MRS technology to analyze intervertebral discs, providing a non-invasive method to identify painful discs, enhancing diagnostic capabilities[59][66]. - The NOCISCAN platform includes a proprietary MRS exam protocol that extends standard MRI exams by approximately 30 minutes for 5 lumbar discs[62]. - NOCICALC processes MRS exam data into final spectra and performs calculations for degenerative pain biomarkers, while NOCIGRAM provides a diagnostic report for clinicians[63][64]. - Aclarion's technology aims to improve patient outcomes by providing objective, quantitative diagnostic information for degenerative disc pain[68]. - The NOCISCAN product addresses a $10 billion annual market in the U.S. for spine fusion procedures, with potential to expand to a $40 billion market by including pre-surgical conservative therapy costs[80]. Clinical Evidence and Market Potential - A clinical study showed that 97% of patients who underwent surgery for discs identified as painful by NOCISCAN achieved significant clinical improvement, compared to only 54% when NOCISCAN data was not utilized[75][79]. - The company plans to track patients through clinical registries to build on early clinical evidence and correlate MRS findings to improved surgical outcomes, potentially expanding the market opportunity[81]. - The company aims to address the entire low back and neck pain market, which represents an annual expenditure of $134.5 billion in healthcare[82]. - The company is participating in a $150 million NIH-funded study to evaluate data inputs for predicting optimal treatment paths for back pain patients[82][83]. - The company has published positive clinical data from over 100 patient trials, showing high diagnostic accuracy and improved surgical outcomes[214]. Regulatory and Compliance - The company has a License Agreement with the Regents of the University of California, which includes a royalty fee of 4% of net sales, with a minimum annual royalty fee of $50,000[52]. - The NOCICALC product is classified as a Class I "exempt" medical device under FDA regulations, specifically under the product classification "Calculator/Data Processing Module, for Clinical Use"[124]. - The NOCIGRAM product is considered Clinical Decision Support software (CDS) and is not regulated as a medical device by the FDA, based on the 21st Century Cures Act[125]. - The FDA requires that any modifications to a device that significantly affect its safety or effectiveness must undergo a new 510(k) clearance or a PMA application[121]. - The FDA has established a Unique Device Identification (UDI) system that requires certain medical devices to be marked with unique identifiers[138]. - The FDA's recent guidance emphasizes the need for cybersecurity controls in connected medical devices, requiring manufacturers to monitor and validate software updates[139]. - The company is subject to extensive regulations, including the FDA's periodic inspections, which could lead to significant penalties for non-compliance[140]. - The EU's Medical Devices Regulation (MDR) went into effect on May 26, 2021, requiring stricter compliance for medical devices, including the company's NOCISCAN product suite[156][159]. - The company is adapting to new regulatory requirements in the UK post-Brexit, which necessitate compliance with local regulations in addition to EU standards[160]. - The implementation of the General Data Protection Regulation (GDPR) and the California Consumer Privacy Act (CCPA) imposes stringent compliance obligations, with significant penalties for non-compliance[161][164]. Financial Performance and Challenges - The company has incurred significant net losses, reporting $7,605,542 for the year ended December 31, 2022, and an accumulated deficit of $39,907,101 as of the same date[190]. - The company expects to continue incurring significant expenses and operating losses for the foreseeable future, with plans to hire additional personnel and expand its product pipeline[190]. - Current cash resources of approximately $1.5 million are projected to fund operations only into the second quarter of 2023, raising concerns about the ability to continue as a going concern[188]. - The company qualifies as an "emerging growth company," allowing it to take advantage of reduced reporting requirements until certain revenue or market value thresholds are met[173]. - The company has identified a material weakness in internal control over financial reporting, which could adversely affect investor confidence and stock price[192]. - The company anticipates increased expenses related to sales, marketing, and engineering as it continues to bring products to market[196]. - The company relies on additional financing to complete product development and scale products with market fit, which may not be available on acceptable terms[197]. - The company anticipates that achieving profitability will require significant marketing efforts and may never be realized, impacting its ability to raise capital and expand operations[191]. Market Competition and Strategy - The company faces competition from established diagnostic standards, with competitors having greater market share and resources[165]. - The commercial success of the company's technology depends on widespread market adoption and positive clinical data acceptance by clinicians[209]. - The company is focusing on securing payer contracts for Category III CPT codes to transition from out-of-pocket revenue to full commercial operations[86]. - A significant increase in the adoption of NOCISCAN technology by surgeons and imaging centers is necessary to convert CPT codes from Category III to Category I, impacting revenue generation[220]. - The company is expanding its sales and marketing efforts to various target markets, including major metropolitan areas like NYC, San Francisco, and Chicago[87]. - The company may seek additional capital through public and private equity offerings, debt financings, and strategic partnerships, which could dilute existing stockholder ownership[198]. - Price competition in the medical device software market may impact the company's ability to maintain satisfactory prices, affecting gross margins and investment capacity[225]. Operational Risks - The COVID-19 pandemic poses risks that could disrupt operations, delay clinical trials, and impact financial performance[187]. - The company currently relies on a single clinical study for its product, which may affect the perceived efficacy and market acceptance of its technology[183]. - The company is limited to marketing its product in the U.S. and certain CE mark countries, which restricts its market expansion opportunities[180]. - The company is highly dependent on its senior management and key personnel, with potential risks if they are unable to retain or attract necessary talent[199]. - The company may face challenges in managing the training and skill levels of healthcare providers using its technology, which could affect patient outcomes and adoption rates[221]. - Inadequate training for healthcare providers could lead to negative patient outcomes, harming the company's business and financial condition[222]. - The company anticipates difficulties in managing growth, which could harm future revenue and operating results if not effectively addressed[224]. - Accurate forecasting of customer demand is critical, with potential negative impacts from various factors including competition and economic conditions[226].

PART I. FINANCIAL INFORMATION [Financial Statements](index=5&type=section&id=Item%201.%20Financial%20Statements) This section presents unaudited condensed financial statements, reflecting a significant post-IPO transformation to positive equity and increased cash, despite continued operating losses [Condensed Balance Sheets](index=5&type=section&id=Condensed%20Balance%20Sheets) The balance sheet as of September 30, 2022, shows marked improvement post-IPO, with increased cash, decreased liabilities, and a shift to positive stockholders' equity Balance Sheet Summary | Metric | Sep 30, 2022 (Unaudited) ($) | Dec 31, 2021 ($) | | :--- | :--- | :--- | | **Assets** | | | | Cash | $2,656,108 | $432,530 | | Total Current Assets | $2,879,921 | $732,204 | | Total Assets | $4,101,162 | $1,889,465 | | **Liabilities & Equity** | | | | Total Current Liabilities | $1,168,426 | $7,618,784 | | Total Stockholders' Equity (Deficit) | $2,932,736 | $(12,831,606) | - Following the IPO, all mezzanine equity (redeemable preferred stock) valued at **$7.1 million** as of Dec 31, 2021, was converted, resulting in a zero balance as of September 30, 2022[13](index=13&type=chunk) [Condensed Statements of Operations](index=7&type=section&id=Condensed%20Statements%20of%20Operations) The company reported a reduced net loss in Q3 2022 but a widened net loss for the nine-month period, driven by significantly increased operating expenses Three Months Ended September 30 | Metric | Three Months Ended Sep 30, 2022 ($) | Three Months Ended Sep 30, 2021 ($) | | :--- | :--- | :--- | | Revenue | $18,222 | $10,865 | | Total Operating Expenses | $1,634,454 | $792,034 | | Net Loss | $(1,633,033) | $(2,952,418) | | Net Loss Per Share | $(0.21) | $(3.58) | Nine Months Ended September 30 | Metric | Nine Months Ended Sep 30, 2022 ($) | Nine Months Ended Sep 30, 2021 ($) | | :--- | :--- | :--- | | Revenue | $37,924 | $48,315 | | Total Operating Expenses | $4,761,676 | $1,879,781 | | Net Loss | $(6,276,636) | $(3,936,119) | | Net Loss Per Share | $(1.21) | $(5.14) | [Condensed Statements of Cash Flows](index=10&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) For the nine months ended September 30, 2022, net cash used in operations increased, while IPO proceeds significantly boosted financing activities, leading to a net increase in cash Cash Flow Summary | Cash Flow Activity (Nine Months Ended Sep 30) | 2022 ($) | 2021 ($) | | :--- | :--- | :--- | | Net cash used in operating activities | $(4,179,118) | $(1,567,690) | | Net cash used in investing activities | $(159,622) | $(84,984) | | Net cash provided by financing activities | $6,552,318 | $2,939,500 | | **Net increase in cash** | **$2,213,578** | **$1,286,826** | - Significant non-cash financing activities in 2022 included the conversion of **$25.75 million** of preferred stock and **$4.27 million** of preferred stock dividends to common stock as part of the IPO[23](index=23&type=chunk) [Notes to Condensed Financial Statements](index=11&type=section&id=Notes%20to%20Condensed%20Financial%20Statements) The notes detail significant corporate restructuring from the April 2022 IPO, highlight a going concern uncertainty due to limited funding, and disclose a substantial increase in share-based compensation - On April 26, 2022, the company completed its IPO, receiving net proceeds of approximately **$8.6 million**; all outstanding preferred stock and accrued dividends were converted into common stock in connection with the IPO[32](index=32&type=chunk)[33](index=33&type=chunk) - Management has concluded that recurring losses from operations and the need for additional financing raise substantial doubt about the Company's ability to continue as a going concern[44](index=44&type=chunk) Share-Based Compensation Expense | Share-Based Compensation Expense | Nine Months Ended Sep 30, 2022 ($) | Nine Months Ended Sep 30, 2021 ($) | | :--- | :--- | :--- | | General and administrative | $1,037,882 | $77,976 | | **Total** | **$1,050,826** | **$93,476** | [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=24&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses financial performance, highlighting mixed revenue trends and rising post-IPO expenses, while acknowledging substantial doubt about the company's ability to continue as a going concern due to limited cash runway [Results of Operations](index=25&type=section&id=Results%20of%20Operations) Q3 2022 revenue grew, but nine-month revenue declined, while operating expenses, especially G&A, significantly increased across both periods due to IPO-related costs and compensation - The **170% increase** in Q3 G&A expenses was driven by increased compensation expense from the vesting of stock options for the Executive Chairman and executives, new management hires, bonuses, and higher D&O liability insurance[105](index=105&type=chunk) - For the nine-month period, revenue decreased by **22%** due to a lower number of medical professionals ordering Nociscan reports[109](index=109&type=chunk) - The **389% increase** in nine-month interest expense was primarily driven by a **$1.3 million** beneficial conversion rate charged upon the conversion of accrued interest on promissory notes into common stock and warrants during the IPO[112](index=112&type=chunk) [Liquidity and Capital Resources](index=29&type=section&id=Liquidity%20and%20Capital%20Resources) The company's liquidity primarily stems from IPO proceeds, with current cash sufficient only until Q2 2023, raising substantial doubt about its ability to continue as a going concern - The Company believes its cash on hand of **$2.7 million** will be sufficient to fund current operating plans only into the second quarter of 2023, raising substantial doubt as to its ability to continue as a going concern[119](index=119&type=chunk) - To date, operations have been financed through private placements, debt, forgiven PPP loans, and the April 2022 IPO, which raised net proceeds of **$8.5 million**[120](index=120&type=chunk) Cash Flow Summary (Nine Months Ended Sep 30, 2022) | Cash Flow Summary (Nine Months Ended Sep 30, 2022) | Amount ($) | | :--- | :--- | | Cash used in operating activities | $(4,179,118) | | Cash used in investing activities | $(159,622) | | Cash provided by financing activities | $6,552,318 | | **Net increase in cash** | **$2,213,578** | [Quantitative and Qualitative Disclosures About Market Risk](index=31&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, Aclarion, Inc. is exempt from providing quantitative and qualitative disclosures about market risk - The company is a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and is not required to provide quantitative and qualitative disclosures about market risk[136](index=136&type=chunk) [Controls and Procedures](index=31&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of September 30, 2022, with no material changes to internal control over financial reporting - Based on an evaluation as of September 30, 2022, the Chief Executive Officer and Chief Financial Officer concluded that the company's disclosure controls and procedures were effective at a reasonable assurance level[137](index=137&type=chunk) - There were no changes in the company's internal control over financial reporting during the third quarter of 2022 that have materially affected, or are reasonably likely to materially affect, internal controls[138](index=138&type=chunk) PART II. OTHER INFORMATION [Legal Proceedings](index=32&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings - The company is not currently a party to any material legal proceedings that could have a material adverse effect on its operations or financial position[140](index=140&type=chunk) [Risk Factors](index=32&type=section&id=Item%201A.%20Risk%20Factors) There have been no material changes to the company's risk factors from those disclosed in the April 2022 IPO Prospectus - There have been no material changes to the company's risk factors from those included in the Prospectus dated April 21, 2022[141](index=141&type=chunk) [Other Items (Items 2, 3, 4, 5, 6)](index=32&type=section&id=Other%20Items) This section confirms no unregistered equity sales, no senior security defaults, no other material information, and provides a list of exhibits - The company reported no unregistered sales of equity securities (Item 2), no defaults upon senior securities (Item 3), and no other material information (Item 5); Mine safety disclosures are not applicable (Item 4)[141](index=141&type=chunk)[142](index=142&type=chunk)