UHealth — University of Miami Health System and the University of Miami Miller School of Medicine provide world-class research and renowned clinical expertise in spine surgeryCLARITY 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) BROOMFIELD, Colo., June 10, 2025 (GLOBE NEW ...

BROOMFIELD, Colo., May 20, 2025 (GLOBE NEWSWIRE) -- Aclarion, Inc., ("Aclarion" or the "Company") (Nasdaq: ACON, ACONW), a healthcare technology company that is leveraging biomarkers and proprietary augmented intelligence (AI) algorithms to help physicians identify the location of chronic low back pain, today announced the addition of Keck Medical Center of USC as a CLARITY (Chronic Low bAck pain Randomized Independent Trial studY) trial site. The pivotal CLARITY study is designed to demonstrate Nociscan's ...

市场规模与用户数据 - 美国低背痛市场的总规模为1350亿美元，其中包括融合和非融合手术及术前护理[17] - 美国腰椎融合和椎间盘置换市场的规模为100亿美元[17] - 每年全球有2.66亿患者患有退行性脊柱疾病和低背痛，其中美国有1600万患者[17] 技术与产品研发 - Nociscan技术通过生化信号和挑衅性椎间盘造影的相关性，将每个椎间盘标记为疼痛或无痛，提供个性化治疗路径[14] - MRS（磁共振波谱）在44个椎间盘的研究中，准确率为87%，灵敏度为100%，特异性为80%[47] - 使用Nociscan诊断算法的MRS在识别慢性低背痛手术候选者方面显示出显著的成本效益优势，提供更好的手术结果[51] - Nociscan的专有信号处理软件将原始光谱数据转化为清晰的生物标志物，符合FDA和CE标记的要求[64] - Aclarion拥有23项已授予的美国专利，涵盖使用光谱学识别椎间盘炎的技术[39] - Aclarion已发行40项美国及国际专利，另有13项待审，支持其平台技术[105] 成本效益与市场前景 - Nociscan每位患者手术的成本节省为1712美元，年化美国总节省为2.83亿美元[53] - Nociscan在美国、欧盟和英国的商业化路径已获得CPT代码和监管支持，市场规模高达1345亿美元[105] - Aclarion在全球范围内已完成超过1100例商业Nociscan检查[97] - Aclarion在美国、欧盟和英国设有25个商业及客户赞助研究站点[98] 临床试验与未来展望 - 2024年和2025年将进行两项新的临床试验，分别为LIFEHAB和CLARITY，评估不同治疗方案的效果[56][58] - Aclarion计划在2024年推出重要的CLARITY试验[101] - Nociscan将在2024年RSNA会议上被Siemens MAGNETOM Flash特别介绍[100] - Aclarion的Nociscan AI在ISSLS 2024会议上将发挥关键作用，深入理解Modic变化[100] - Aclarion在伦敦宣布获得3项支付方覆盖[100] - Aclarion的Nociscan在开创性的LIFEHAB试验中得到应用[100]

财务数据关键指标变化 - 营收与成本 - 2025年第一季度总营收18,991美元，较2024年同期的10,114美元增加8,877美元，增幅88%[130][132] - 2025年第一季度营收成本23,479美元，较2024年同期的19,476美元增加4,003美元，增幅21%[130][133] 财务数据关键指标变化 - 费用 - 2025年第一季度销售和营销费用302,584美元，较2024年同期的181,056美元增加121,528美元，增幅67%[130][134] - 2025年第一季度研发费用198,190美元，较2024年同期的239,042美元减少40,852美元，降幅17%[130][135] - 2025年第一季度一般及行政费用986,663美元，较2024年同期的845,847美元增加140,816美元，增幅17%[130][136] 财务数据关键指标变化 - 现金状况 - 截至2025年3月31日，公司现金及现金等价物为14,760,272美元，其中包括10,000美元受限现金[150] - 2025年第一季度经营活动使用现金2,510,782美元，2024年同期使用2,238,557美元[153][154] - 2025年和2024年第一季度投资活动分别使用现金78,288美元和63,657美元[153][155] - 2025年第一季度融资活动提供现金16,885,681美元，2024年同期为3,413,780美元[153] 财务数据关键指标变化 - 资金筹集与收益 - 2025年第一季度，公司通过多种方式共筹集2010万美元总收益[151][156] - 2025年1月15日，公司承销公开发售100,000股普通股、143,900,000份预融资认股权证、144,000,000份A类普通股认股权证和144,000,000份B类普通股认股权证，发售单价为0.10美元，此次发售净收益为1340万美元[159][160] - 2024年第一季度，公司完成5,175,000个单位的公开发售，单价0.58美元，总收益约300万美元[167] 业务线数据关键指标变化 - 认股权证与优先股 - 预融资认股权证行使价为每股0.00001美元，截至2025年3月31日已全部行使；A类和B类普通股认股权证行使价均为每股0.20美元，A类认股权证有效期为行使日起五年，B类为两年半[161] - 2025年3月5日，股东批准A类和B类认股权证对应的普通股发行，B类认股权证持有人已行使大部分认股权证，公司发行约1470万股普通股[162] - 2025年1月22日，公司以1,213,590美元现金赎回所有B类优先股及相关应计股息[163] - 2024年第四季度，部分持有人将126股C类优先股及相关应计股息转换为739,050股普通股；2025年第一季度，剩余874股C类优先股转换为6,211,618股普通股[164][165] - 2025年第一季度，C类认股权证持有人行使5,685,049份认股权证，公司收到付款336,411美元[166] 财务数据关键指标变化 - 历史债务处理 - 2024年第一季度，公司支付300,974美元本金和应计利息，随后与投资者达成交换协议，发行644,142股普通股换取1,519,779美元本金和应计利息[168][169] 公司财务相关特殊情况 - 公司作为新兴成长公司选择延长过渡期采用新会计准则，财务报表可能与其他公司不可比；作为较小报告公司，市值低于7亿美元且年收入低于1亿美元[176][177] - 截至2025年3月31日，公司无资产负债表外的合同义务和表外安排，近期无重大会计公告[173][174][175]

Texas Back Institute is a world leader in advancing spine technology, science, and education, as well as patient careCLARITY is a 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) BROOMFIELD, Colo., May 12, 2025 (GLOBE NEWSWIRE) -- Aclarion, Inc., (“Aclarion” or the “Company”) (Nasdaq: ACON, ...

Advocate Health actively participates in research studies and is an innovator in technology, including spine The CLARITY trial is 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) BROOMFIELD, Colo., May 05, 2025 (GLOBE NEWSWIRE) -- Aclarion, Inc., (“Aclarion” or the “Company”) (Nasdaq: ACON, ACONW), a healthcare techno ...

Expands access to first customer using Philips MR Spectroscopy (MRS), demonstrating ease of Nociscan integration across multiple MRS platforms Nociscan now commercially available at 17 sites covering eight states and four countries BROOMFIELD, Colo., April 29, 2025 (GLOBE NEWSWIRE) -- Aclarion, Inc., (“Aclarion” or the “Company”) (Nasdaq: ACON, ACONW), a healthcare technology company that is leveraging biomarkers and proprietary augmented intelligence (AI) algorithms to help physicians identify the locatio ...

Aclarion (ACON) 2025 Conference April 23, 2025 12:00 PM ET Speaker0 Good morning. The next presentation with MicroCap is a Clarion. This is Brent Ness. Good morning and thank you for attending this session where we'll be talking about a global epidemic of chronic low back pain. First, let me hit the strategic highlights of the business. We have nearly 14,600,000.0 in cash on hand as of the 10 k filed this month, which gives us a cash runway into q three of twenty twenty six. We have a clean cap table, zero ...

BROOMFIELD, Colo., April 23, 2025 (GLOBE NEWSWIRE) -- Aclarion, Inc., ("Aclarion" or the "Company") (NASDAQ:ACON, ACONW)), a healthcare technology company that is leveraging biomarkers and proprietary augmented intelligence (AI) algorithms to help physicians identify the location of chronic low back pain, will be presenting at the Planet MicroCap Showcase: VEGAS 2025 in partnership with MicroCapClub on Wednesday, April 23, 2025 at 12:30 PM ET. Brent Ness, Chief Executive Officer of Aclarion, will be present ...

Independent Cost-Effectiveness Analysis Concludes Nociscan is Effective and Less Costly Compared to Provocative DiscographyConclusions Illustrate Nociscan Saves $1,712 per Patient and Improves Surgical Success by 10% BROOMFIELD, Colo., April 21, 2025 (GLOBE NEWSWIRE) -- Aclarion, Inc., ("Aclarion" or the "Company") (NASDAQ:ACON, ACONW)), a healthcare technology company that is leveraging biomarkers and proprietary augmented intelligence (AI) algorithms to help physicians identify the location of chronic low ...