Core Insights - Aclarion, Inc. has launched the multi-center CLUE Trial to assess how often surgeons alter their treatment plans after receiving Nociscan data, aiming to provide real-world evidence of its value in treating chronic low back pain [1][2] - The CLUE Trial is designed to complement the earlier launched CLARITY trial, which aims to demonstrate improved surgical outcomes when Nociscan data is included in decision-making [2][3] - The company emphasizes the importance of evidence-based approaches in advocating for insurance coverage of Nociscan, drawing parallels to successful strategies used in other medical fields [3] Company Overview - Aclarion is a healthcare technology company focused on chronic low back pain, utilizing Magnetic Resonance Spectroscopy (MRS) and proprietary algorithms to differentiate between painful and non-painful discs [4] - Nociscan is the first evidence-supported SaaS platform that aids physicians in identifying the source of low back pain through non-invasive methods [4] - The company aims to optimize treatment strategies by providing critical insights into the location of pain, thereby addressing a significant healthcare challenge [4]

Aclarion (ACON) Update Summary Company Overview - **Company**: Aclarion Incorporated - **Industry**: Medical Technology, specifically focused on low back pain diagnostics and treatment Core Points and Arguments 1. **Technology and Innovation**: Aclarion has developed an augmented intelligence algorithm that analyzes MRI data to identify biomarkers indicating whether a disc is likely to be painful, aiding surgeons in making informed treatment decisions [4][5][6] 2. **Clinical Study Results**: A clinical study conducted in 2019 showed that 97% of patients whose surgical decisions aligned with Aclarion's technology experienced significant clinical improvement at one year, compared to only 55% in the mismatch group [9][10] 3. **Economic Impact**: The technology could save approximately $1,700 per patient in the U.S. healthcare system while improving clinical success rates [11] 4. **Upcoming Trials**: Aclarion is initiating a prospective, randomized, multicenter trial called CLARITY, expected to enroll its first patient in Q4 2024, to further validate its technology [12] 5. **Revenue Generation**: Most of Aclarion's revenue comes from research studies where organizations pay to utilize their technology, highlighting its unique capability in identifying painful discs [13][14] 6. **Market Opportunity**: The U.S. market for low back pain and neck pain is valued at $135 billion annually, with Aclarion targeting the $10 billion lumbar fusion and disc replacement surgery market initially [24][25] 7. **Regulatory Progress**: Aclarion has received category three CPT codes for billing and aims to transition these to category one codes to facilitate reimbursement [27][28] 8. **Key Opinion Leaders (KOLs)**: The company is working with leading surgeons and institutions to drive adoption and payer coverage decisions [33][34] Additional Important Content 1. **Competitive Landscape**: Aclarion's noninvasive diagnostic method is positioned as superior to traditional discograms, which are invasive and subjective [20][21] 2. **Intellectual Property**: Aclarion holds a broad patent portfolio covering its technology and processes, licensed from UCSF [22] 3. **Management Team**: The leadership team has extensive experience in medical technology and commercialization, with a focus on driving the company's growth [35][36] 4. **International Expansion**: Aclarion has seen success in the UK, where surgeons have successfully advocated for payer coverage, setting a precedent for similar efforts in the U.S. [31][32] 5. **Future Expectations**: The company anticipates increased MRI activations and scan volumes, which will translate into revenue as more payers begin to cover the scans [44][48] This summary encapsulates the key insights from Aclarion's recent investor briefing, highlighting the company's innovative approach to addressing low back pain and its strategic plans for growth and market penetration.

BROOMFIELD, CO, Aug. 15, 2024 (GLOBE NEWSWIRE) -- Aclarion, Inc. (“Aclarion” or the “Company”) (Nasdaq: ACON, ACONW), 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 today that it will be presenting at the upcoming Virtual Investor Summit on August 20th, 2024. Investors may request a one-on-one meeting with management by registering here: https://investorsummitgroup.co ...

Financial Performance - Total revenue for Q2 2024 was $10,971, a decrease of $6,101 or 36% from $17,072 in Q2 2023[117] - Total revenues for the six months ended June 30, 2024, were $21,085, a decrease of 50% from $42,542 in the same period of 2023[126] - The company recorded a net loss of $1,238,077 in Q2 2024, an improvement of $226,480 compared to a net loss of $1,464,557 in Q2 2023[126] Expenses - Cost of revenue increased by 21% to $23,294 in Q2 2024 from $19,301 in Q2 2023, primarily due to increased partner fees[117] - Sales and marketing expenses rose by 8% to $225,037 in Q2 2024, driven by increased post-market clinical expenses related to the Clarity trial[118] - Research and development expenses decreased by 19% to $202,102 in Q2 2024, with no accrued bonus expense for the quarter[119] - General and administrative expenses decreased by 26% to $696,099 in Q2 2024, attributed to reduced bonus accruals and lower legal fees[119] - Interest expense increased significantly to $127,848 in Q2 2024, up by $80,709 from $47,139 in Q2 2023, due to increased debt[120] Cash Flow and Financing - As of June 30, 2024, the Company had cash of $1,182,687, which includes $10,000 of restricted cash, sufficient to fund operations into Q3 2024[145] - For the six months ended June 30, 2024, cash used in operating activities was $3,293,096, compared to $1,960,653 for the same period in 2023, indicating a 68% increase in cash outflow[146][147] - Cash provided by financing activities for the six months ended June 30, 2024, was $3,602,237, up from $1,165,000 in 2023, representing a 209% increase[146] - The Company completed a public offering of 5,175,000 units at $0.58 per unit, generating gross proceeds of approximately $3.0 million before expenses[149] - The Company raised approximately $1.4 million from an equity line in January 2024 and $0.3 million in April 2024[145] - During the six months ended June 30, 2024, the Company issued 452,343 common shares for proceeds of $1,449,532 and 1,050,000 common shares for $304,500[150] - The Company paid $300,973 of principal and interest on unsecured non-convertible notes, leaving a remaining balance of $898,380[150] - The Company issued 644,142 shares in exchange for $1,519,779 of principal and accrued interest on notes, with a remaining balance of $5,145,037[152] Future Funding Needs - The company anticipates needing additional funding to continue its technology development and maintain liquidity[141] - The Company anticipates needing to raise additional funds to continue technology development, which may involve dilution of existing stockholders' interests[154] Off-Balance Sheet Arrangements - The Company does not have any off-balance sheet arrangements as of June 30, 2024[156]

Core Insights - Aclarion, Inc. has established a commercial agreement with Sheridan Community Hospital to introduce Nociscan, a healthcare technology solution for chronic low back pain, to central Michigan [1][3] - Nociscan is the first evidence-supported SaaS platform that helps physicians noninvasively distinguish between painful and nonpainful discs in the lumbar spine, utilizing biomarkers and augmented intelligence algorithms [2][4] Company Overview - Aclarion is focused on addressing the chronic low back pain market with its Nociscan platform, which leverages Magnetic Resonance Spectroscopy (MRS) and proprietary signal processing techniques to optimize clinical treatments [4] - The Nociscan solution quantifies chemical biomarkers associated with disc pain and provides critical insights when used alongside other diagnostic tools, enhancing treatment strategies for physicians [4] Market Context - Chronic low back pain affects approximately 266 million people globally, highlighting the significant healthcare challenge that Aclarion aims to address with its innovative technology [2] - The introduction of Nociscan in markets like Sheridan is a step towards broader payer coverage in the US, following recent insurance coverage announcements in the UK [3]

Vitality is a top 4 Provider of Private Medical Insurance in the UK. Aclarion now has Payer Coverage From 3 of the 4 Largest Private Health Insurers in the UK. Nearly 60% of all Patients With Private Health Insurance in the Greater London Market now Have Access to Aclarion's Nociscan. BROOMFIELD, CO, Aug. 13, 2024 (GLOBE NEWSWIRE) -- Aclarion, Inc., ("Aclarion" or the "Company") (Nasdaq: ACON, ACONW), a healthcare technology company that is leveraging biomarkers and proprietary augmented intelligence algori ...

Core Insights - Aclarion, Inc. has achieved a significant milestone with the second payer coverage of its Nociscan technology by Aviva in London, UK, enhancing access for patients suffering from chronic low back pain [1][2] - Aviva, a leading private medical insurance provider in the UK, covers approximately 14% of the private medical insurance market, with an estimated 1.2 million insured customers [2] - The collaboration with The London Clinic allows Nociscan to be available to 45% of patients with private insurance in the Greater London area, following AXA's coverage [2][3] Company Overview - Aclarion is a healthcare technology company focused on chronic low back pain, utilizing Magnetic Resonance Spectroscopy (MRS) and proprietary algorithms to assist physicians in diagnosing and treating patients [4] - Nociscan is the first evidence-supported SaaS platform designed to noninvasively differentiate between painful and nonpainful discs in the lumbar spine, providing critical insights for treatment optimization [4] Market Context - In the UK, self-pay and private medical insurance account for nearly 70% of private hospital revenues, indicating a growing trend in private medical insurance adoption [2] - The London Clinic has integrated Nociscan as a key decision support tool for diagnosing chronic low back pain, which affects up to one third of the UK adult population annually [3]

Core Insights - Aclarion, Inc. has achieved a significant milestone with the second payer coverage of its Nociscan technology by Aviva in London, UK, enhancing access for patients suffering from chronic low back pain [1][2] - Aviva is one of the top four private medical insurers in the UK, holding approximately 14% of the private medical insurance market, which translates to around 1.2 million insured customers [2][3] - The collaboration with Aviva, alongside AXA, allows Nociscan to be accessible to approximately 45% of patients with private insurance in the Greater London area [2] Company Overview - Aclarion is a healthcare technology company focused on chronic low back pain, utilizing Magnetic Resonance Spectroscopy (MRS) and proprietary algorithms to assist physicians in diagnosing and treating patients [4] - Nociscan is the first evidence-supported SaaS platform designed to noninvasively differentiate between painful and nonpainful discs in the lumbar spine, providing critical insights for treatment optimization [4] Market Context - In the UK, self-pay and private medical insurance account for nearly 70% of private hospital revenues, indicating a growing trend in the adoption of private medical insurance [2] - The London Clinic has integrated Nociscan as a key decision support tool for diagnosing chronic low back pain, which affects up to one-third of the UK adult population annually [3]

Core Insights - Aclarion has secured its first payer coverage for Nociscan from AXA, marking a significant milestone for the company in the UK healthcare market [1][2] - The approval by AXA, which holds approximately 30% of the private medical insurance market in the UK, is expected to drive volume and revenue for Aclarion [1][2] - Nociscan is being adopted by The London Clinic as a decision support tool for diagnosing and treating chronic low back pain, expanding access for insured patients [3] Company Overview - Aclarion, Inc. is a healthcare technology company focused on chronic low back pain, utilizing Magnetic Resonance Spectroscopy (MRS) and proprietary algorithms to assist physicians in treatment [4] - The Nociscan platform is the first evidence-supported SaaS solution designed to differentiate between painful and non-painful discs in the lumbar spine [4] - The company aims to optimize clinical treatments by leveraging biomarkers and augmented intelligence algorithms [4] Market Context - In the UK, self-pay and private medical insurance account for nearly 70% of private hospital revenues, indicating a growing market for private medical insurance [2] - AXA is one of the four leading private medical insurers in the UK, with an estimated 3 million insured customers [2]

Core Insights - Aclarion has secured its first payer coverage for Nociscan from AXA, marking a significant milestone for the company in the UK healthcare market [1][2] - The approval by AXA, which holds approximately 30% of the private medical insurance market in the UK, is expected to drive volume and revenue for Aclarion [1][2] - Nociscan is being adopted by The London Clinic as a decision support tool for diagnosing and treating chronic low back pain, expanding access for insured patients [3] Company Overview - Aclarion, Inc. is a healthcare technology company focused on chronic low back pain, utilizing Magnetic Resonance Spectroscopy (MRS) and proprietary algorithms to assist physicians in treatment [4] - Nociscan is the first evidence-supported SaaS platform designed to noninvasively differentiate between painful and non-painful discs in the lumbar spine [4] - The company aims to optimize clinical treatments by leveraging biomarkers and augmented intelligence algorithms [4] Market Context - In the UK, self-pay and private medical insurance account for nearly 70% of private hospital revenues, indicating a growing market for private medical insurance [2] - AXA is one of the four leading private medical insurers in the UK, with an estimated 3 million insured customers [2]